Stockwinners Market Radar for June 01, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

ACC

Hot Stocks

20:54 EDT American Campus says 93.3% of residents made May rent payments - The company states: "With regard to the company's private off-campus properties and on-campus 12-month ACE apartment communities, approximately 94.8% of residents made their April rent payments, representing April rent delinquency of approximately $3.0M. In addition, through May 31, 2020, the company estimates that approximately 93.3% of residents have made their May rent payments, representing May rent delinquency of approximately $3.8M. As previously announced, the company has formed a Resident Hardship Program to provide relief on a case-by-case basis to those residents and families who have endured financial hardship due to COVID-19. For the months of April and May combined, the company has granted approximately $4.3M in rent relief to over 4,800 qualified residents. As reported in the company's first quarter earnings release, in collaboration with its university partners, the company has agreed to refund a portion of students' rent at certain on-campus ACE properties that primarily have lease terms ending in May. The company is still working through the ultimate amount of refunds that will be provided, but the company continues to believe refunded revenue will be in the range of approximately $13M to $17M."
WELL

Hot Stocks

20:44 EDT Welltower says portfolio trends reflect slowing pace of occupancy declines - In its June Business Update, the company states: "Recent Seniors Housing Operating portfolio trends reflect a slowing in the pace of occupancy declines, from -50 to -60 bps per week through April and early May to -20 to -30 bps per week during the last two weeks of May. Seniors Housing Operating communities are beginning to remove admissions bans. Trailing two-week COVID case count within Seniors Housing Operating portfolio down about 50% from peak; 87% of communities have reported zero COVID cases as of May 29th on a TTW basis." Reference Link
USNA

Hot Stocks

20:27 EDT Usana CEO sells 12.7K shares of common stock - In a regulatory filing, Usana disclosed that its CEO Kevin Guest sold 12.7K shares of common stock on May 28th to June 1st. The total transaction size was $1.1M.
DRE

Hot Stocks

20:07 EDT Duke Realty collected 95.4% of rent billed in May - Duke Realty announced the results of rent collection and leasing activity for the months of April and May. As of May 31st, the company noted the following metrics: Collected 98.3% of originally billed April rents with combined collections and deferrals totaling 99.8%; collected 95.4% of originally billed May rents with combined collections and deferrals totaling 99.1%; collected May rents at a faster pace than April rents were collected.
FDP

Hot Stocks

19:48 EDT Fresh Del Monte CEO sells 40.3K shares of common stock - In a regulatory filing, Fresh Del Monte disclosed that its CEO Mohammad Abu-Ghazaleh sold 40.3K shares of common stock on May 28th to June 1st. The total transaction size was over $990K.
HNI

Hot Stocks

19:32 EDT HNI Corporation says orders in workplace furnishings have stabilized - CEO Jeff Lorenger says: "Recovery to pre-pandemic levels will take some time, but recent order trends are encouraging given the conditions. We generated positive order growth in building products during May as builders worked through their backlogs. Builder commentary and purchase mortgage applications are also encouraging and point to second half improvement. Although the recent trends are positive, we do expect short-term declines in the summer months, consistent with the recent housing permit data. Domestic orders in workplace furnishings have stabilized and are generally showing week-over-week improvement. We expect this trend to continue as the economy improves and businesses begin to open. Our e-Commerce business continues to generate strong growth, primarily from a spike in home office demand."
NOW

Hot Stocks

19:12 EDT ServiceNow's Goon sells 1,805 common shares - In a regulatory filing, ServiceNow principal accounting officer Fay Sien Goon disclosed the sale of 1,805 common shares of the company on May 29 at a price of $382.092 per share.
TPH

Hot Stocks

19:02 EDT TRI Pointe reports 472 net new home orders in May - TRI Pointe Group announced net new home orders for the months of April and May 2020 in anticipation of upcoming meetings with investors. Net new home orders for April 2020 were 235 compared to 507 for the prior-year period, a decrease of 54%. Net new home orders for May 2020 were 472 compared to 498 for the prior-year period, a decrease of 5%. The rate of cancellations as a percentage of gross orders was 36% and 23% for the months of April and May 2020, respectively.
ULTA

Hot Stocks

18:33 EDT Ulta Beauty CEO: We have a very strong business model - In an interview on CNBC's Mad Money, Mary Dillon said 75% of the company's stores are open for curbside pickup and 50% are open for retail. Most everything should open by the end of June, she said. "We became an e-commerce company overnight," Dillon noted. "We are not recession proof, but have a very strong business model."
GPI

Hot Stocks

18:31 EDT Group 1 Automotive names Daniel McHenry CFO - Group 1 Automotive, Inc. announced the appointment of Daniel McHenry as Chief Financial Officer effective August 15, 2020. He will replace long time Group 1 CFO John Rickel, who has elected to retire from the company at the end of this year after almost 15 years of service. McHenry has served as Group 1's UK Finance Director since 2007. Group 1 CEO Earl Hesterberg commented, "Working with Daniel directly over the past 12 years I have witnessed firsthand his passion for the retail automotive business. He has been responsible for the creation of our back-office systems, processes and financial controls, as we have grown our UK operations from three dealerships in 2007 to 50 dealerships today. His familiarity with our company, people and processes makes him the perfect candidate to step into this important role."
AWK

Hot Stocks

18:26 EDT American Water acquires assets and operations of the Waimea Wastewater Company - Hawaii American Water acquired the assets and operations of the Waimea Wastewater Company, Inc., and is the new wastewater service provider for those customers. Located on the Big Island of Hawaii, Waimea Wastewater Company is a regulated wastewater utility that serves approximately 217 residential and commercial connections, including North Hawaii Community Hospital and the Parker Ranch Center.
GLD

Hot Stocks

18:24 EDT SPDR Gold Shares holdings rise to 1,128.40MT from 1,123.14MT - This is the fourth consecutive increase and the highest level of holdings since April of 2013.
CMG

Hot Stocks

18:23 EDT Chipotle CEO: Heavy investment in digital has paid off - In an interview on CNBC's Mad Money, Brian Niccol said the company has been investing heavily into digital, people and operations and that has served it well during the COVID-19 crisis. Niccol is "very optimistic" about the new digital access points and Chipotle's "food with integrity" approach. "We're building a culture that is inclusive," Niccol said. "Our group loves creativity and isn't afraid to take risks."
RPAI

Hot Stocks

18:14 EDT Retail Properties of America reports May rent collection 52.4% as of 5/28 - Retail Properties of America provided an update on cash rent collection statistics for the months of April and May. Compared to the previously reported 52.4% of April rent collected as of April 30, the company has received 60.3% of April rent as of May 28. Rent collection for May as of May 28, 2020 totals 52.4%, consistent with April month-end collection levels.
PAAS

Hot Stocks

18:06 EDT Pan American Silver resumes operations at Dolores, La Colorada mines - Pan American Silver announced that operations have resumed at its Dolores and La Colorada mines in Mexico, which follows the restart of its Shahuindo, La Arena, San Vicente and Manantial Espejo operations that was initiated in May. The mines are initially operating at reduced capacities to accommodate new protocols in response to COVID-19. Pan American is currently awaiting the regulatory authorization to resume the Huaron and Morococha operations in Peru. Pan American had suspended normal operations at its mines in Mexico, Peru, Argentina and Bolivia in March to comply with mandatory national quarantines imposed in response to the COVID-19 pandemic. The Timmins West and Bell Creek mines in Canada have continued to operate at 90% of capacity. Detailed protocols have been introduced at all mines to protect the health and safety of the workforce. These protocols include strict sanitary measures, return-to-work health screenings and on-site medical personnel to monitor and respond to any health concerns. Pan American is remobilizing the workforce gradually in order to provide greater physical distancing and to allow time to progressively assess and refine the new protocols. Pan American withdrew its 2020 operating guidance on March 12, given the uncertainties related to the COVID-19 pandemic, and plans to update its guidance for 2020 once the impact of the new protocols on operations can be better determined. Pan American also notes that some of the sustaining capital projects planned for 2020 will be carried over into 2021 as a result of COVID-19.
TLND

Hot Stocks

18:03 EDT Talend director Steven Singh purchases almost $460K in company shares - Talend director Steven Singh disclosed in a filing that he had purchased 15,000 shares of company stock at $30.61 per share on May 29. The total transaction value was $459,144.
USM TDS

Hot Stocks

18:02 EDT U.S. Cellular names Laurent Therivel as new CEO - U.S. Cellular (USM), an 83%-owned subsidiary of Telephone & Data Systems (TDS) announced that Laurent Therivel will be appointed President and CEO, effective July 1, 2020. Kenneth Meyers will be appointed to "Senior Advisor to the CEO" until his retirement on September 4, 2020. Therivel will also be appointed to replace Meyers on both the U.S. Cellular and TDS Boards of Directors.
OSW

Hot Stocks

17:58 EDT ISS recommends OneSpaWorld shareholders vote "FOR" proposed equity financing - OneSpaWorld commented on a report by Institutional Shareholder Services recommending that OSW shareholders vote "FOR" the previously announced $75M equity financing at the company's Annual Meeting of Shareholders on June 10. "We are pleased ISS recognizes that OSW's equity financing is in the best interests of shareholders and is necessary to the company's ability to continue as a going concern," said Leonard Fluxman, Executive Chairman. "This financing is required for OSW to fund its operations while its business is impaired due to the COVID-19 pandemic and to remain in compliance with our debt covenant as of June 30, 2020. We urge OSW shareholders to follow this independent recommendation and vote today in favor of Proposals 3 and 4, which also will enable us to quickly restart operations when our cruise line partners resume sailing, facilitate innovation in our service and product offerings and wellness experiences, and position us for long-term operation and growth."
NSC

Hot Stocks

17:56 EDT Norfolk Southern chief strategy officer John Scheib steps down - Norfolk Southern announced that John Scheib is stepping down as executive VP and chief strategy officer, effective June 1. In conjunction with this change, the company also announced several organizational enhancements. Functions within the service optimization and customer engagement division, which include strategic planning, network planning and optimization and customer operations, will be integrated into the finance, operations and marketing divisions, respectively.
EGP

Hot Stocks

17:51 EDT EastGroup Properties reports May rent collection of 95.0% vs. 97.7% in April - Marshall Loeb, CEO, stated, "While we acknowledge the pandemic is far from over, we are pleased with our results to date. Specifically, the strength of our monthly rent collections as reflected below, tenant rent relief requests only rising by 2% in May, the pickup in prospect leasing activity we're seeing as markets re-open, and internally, how well our team was able to shift our operating strategy and work remotely. Longer term, we remain optimistic about increased demand for industrial space given the anticipated accelerating growth in e-commerce, higher inventory levels, nearshoring and reshoring of manufacturing as a result of the pandemic; and continued population shifts to our fast-growing Sunbelt markets." As of June 1, 2020, EastGroup's operating portfolio is 96.9% leased and 96.5% occupied. The company's rent collections for March was 99.3%, April at 97.7% and May of 2020 at 95.0%.
ALT

Hot Stocks

17:21 EDT Venrock reports 3M passive stake in Altimmune - Venrock Healthcare Capital Partners disclosed a 19.3% stake in Altimmune. The filing does not allow for activism.
RH

Hot Stocks

17:12 EDT RH sees 'clear path to 20% operating margins over next few years' - RH released a copy of Chairman & CEO Gary Friedman's Annual Letter to Shareholders.The letter said in part: "Fiscal 2019 was an outstanding year for Team RH. We achieved record results across every key metric of our business while continuing to elevate the brand and create strategic separation in our industry. Revenues increased 5.4% over last year to $2.647 billion, adjusted operating margins reached an industry best 14.3%, and adjusted diluted earnings per share increased 49% to $11.66. We also generated $330M of free cash flow in 2019, and achieved industry leading ROIC of 35.3%... Our strategy to open new design galleries in every major market will unlock the value of our vast assortment, generating revenues of $5 to $6B North America, with the long term potential to become a $20B dollar global brand. ..Our vision is to move the brand beyond curating and selling product to conceptualizing and selling spaces by building an ecosystem of products, places, services and spaces that elevate and establish the RH brand as a global thought leader, taste, and placemaker...We believe the ecosystem can be expanded globally, multiplying the market opportunity to approximately $7 to $10T, quite possibly one of the largest and most lucrative addressed by any brand in the world today. A one percent share of the global market represents a $70 to $100B opportunity...The emergence of RH as a luxury brand generating luxury margins is becoming evident as our adjusted operating margin has expanded over 700 basis points in the past two years from 7.0% in 2017 to 14.3% in 2019. We continue to expect operating margins to expand in 2020 despite the current setbacks from COVID-19, and now see a clear path to 20% operating margin over the next few years," said RH management in a letter to shareholders.
FRT

Hot Stocks

17:10 EDT Federal Realty provides COVID-19 update, sees all 104 properties remaining open - Federal Realty provided the following updates related to COVID-19 as of May 29, 2020: "All 104 properties remain open and operating. Approximately 54% of total May 2020 billed recurring rents have been collected to date, ahead of pace for April 2020 collections at April month-end. Approximately 57% of total April 2020 billed recurring rents have been collected to date. Approximately 54% of our commercial tenants are open and operating based on annualized base rent. Openings are expected to continue over the next few weeks as many of our markets begin and continue phased re-openings in June."
INFU

Hot Stocks

17:04 EDT InfuSystem director Gregg Lehman sold almost $460K in company shares - InfuSystem director Gregg Lehman sold 43,083 shares at $10.66 per share on May 28 for a total transaction value of $459,265.
SLG

Hot Stocks

17:03 EDT SL Green Realty provides update on collections, One Vanderbilt Avenue - SL Green Realty has provided an update on recent activities and progress on key initiatives. Since April, SL Green has closed, or placed under contract, dispositions and joint ventures totaling $919.3M of transaction value. Throughout the COVID-19 pandemic, SL Green has collected the vast majority of its property billings, reflecting the credit-quality of the company's office and retail tenants. April collections have now reached 95.1% for office, 63.3% for retail and 89.1% overall, up from 91.8%, 60.0% and 85.7%, respectively, as of April 30. To date, May collections are on a similar trajectory to April with collections of 91.1% for office, 54.7% for retail and 84.7% overall. The company expects May collections to increase further during June as some tenants are taking longer to make payments than they have historically. SL Green continues to make significant progress on the company's development and redevelopment projects, including the 1.7M square foot, 1,401 foot tall One Vanderbilt Avenue, which remains ahead of schedule and more than $100M under budget. The tower is 67% leased and is now expected to obtain its temporary certificate of occupancy, or TCO, on or before September 14. "Despite the challenges created by the Covid-19 crisis, I'm very pleased with the performance of the Company throughout the last several months. Our collections have held up well as a result of our high quality, long dated and creditworthy rent roll, and we have amassed a substantial amount of cash liquidity in a short period of time, which is the reflection of the hard work of our employees and the resiliency of the Manhattan real estate marketplace. We have developed a strong re-entry plan to welcome tenants back to their offices in the coming weeks," said Marc Holliday, chairman and CEO of SL Green Realty. "This is also a time to give back to the City we love, and we're proud of our role in launching Food1st, which has now raised $2.0 million and has already served over 100,000 free meals to first responders and New Yorkers in need."
LGND GILD

Hot Stocks

16:59 EDT Ligand working with Gilead to meet need for remdesivir - Ligand Pharmaceuticals Incorporated (LGND) announces that Chief Executive Officer John Higgins issued a letter to Ligand's Captisol customers. "Ligand is in a period of momentous planning and scale-up. As you may know, Captisol is a key ingredient in Gilead Sciences' (GILD) antiviral remdesivir, which is being developed as a treatment for COVID-19. This drug has received an unprecedented amount of attention," Higgins said. "I want to update you as to where Ligand stands in fulfilling our commitment to all our Captisol customers and discuss our plans to increase manufacturing capacity. On behalf of the entire team at Ligand, I want you to know we are dedicated to fulfilling your Captisol needs with the highest level of service, reliability and quality." "In January 2020 Gilead informed us they needed Captisol for remdesivir as a potential treatment for COVID-19. That outreach was a natural development as we have had a relationship with Gilead for several years beginning when this drug was being tested for Ebola," Higgins added. "We were witnessing the novel coronavirus emerge as a real threat to public health, and as it became clear the virus was not going to be contained and the global health crisis became a pandemic, we anticipated Captisol demand was going to increase substantially. We immediately began coordination on the necessary planning for production needs as initial orders for Captisol were received and steadily grew. Clinical work with remdesivir in COVID-19 has been promising as studies indicate the drug reduces the length of hospital stay and may lower the mortality rate in patients with severe disease. On May 1 remdesivir received an Emergency Use Authorization from the U.S. Food and Drug Administration and became the first new drug authorized as a treatment for COVID-19. The medical need was obvious, immense and growing. Then on June 1, Gilead announced additional data in patients with moderate disease showing again that remdesivir has the potential to meaningfully benefit patients. We are working closely with Gilead to meet the urgent need for supply of this medicine. In light of Gilead's public statements, we expect their Captisol requirements will increase significantly over the next couple of years, and we expect orders beyond that. To meet global demand quickly, Gilead is establishing a consortium of generic pharmaceutical companies around the world to manufacture remdesivir. We have established initial agreements with four of those companies and are prepared to fill the full production and supply needs for all companies producing remdesivir."
ERA

Hot Stocks

16:52 EDT Era Group announces board approval to effect reverse stock split - Era Group announced that the board approved an amendment to the amended and restated certificate of incorporation of Era to effect a reverse stock split of the issued and outstanding shares of common stock of Era in connection with the consummation of the proposed merger transaction involving Era and Bristow. The approval of the reverse stock split by the board follows the board's evaluation of whether or not to effectuate the reverse stock split, which involved consultation with Era's management and outside advisors and Bristow. If the reverse stock split is effected, the shares of common stock of Era outstanding immediately prior to the effectiveness of the reverse stock split would be reclassified into a smaller number of shares such that a stockholder of Era will own one share of common stock of Era for each three shares of common stock of Era held by that stockholder immediately prior to the effectiveness of the reverse stock split. Approval of the reverse stock split requires the affirmative vote of at least a majority of all outstanding shares of common stock of Era entitled to vote at the meeting. As of May 6, Era's directors and executive officers own approximately 8.86% of the issued and outstanding shares of common stock of Era and are expected to vote for the reverse stock split.
GDOT

Hot Stocks

16:49 EDT Green Dot Chief Technology Officer Kuan Archer to step down - On June 1, 2020, Green Dot Corporation announced that Kuan Archer, its Chief Technology Officer, is leaving the company, effective July 8, 2020. In connection with his departure, Mr. Archer will enter into a separation and release agreement with the company on his last day of employment, pursuant to which he will receive $252,890 in severance benefits, which represents six months of his current base salary and seven months of COBRA premiums.
V

Hot Stocks

16:43 EDT Visa reports May total U.S. payments volume down 5% y/y - According to a regulatory filing, Visa said that, in May, total U.S. payments volume declined 5% year-over-year, a 13 percentage point improvement over April. Debit grew 12% and credit declined 21% year-over-year in May, a 17 ppt and 9 ppt improvement over April, respectively. The continued distribution of Economic Impact Payments and the relaxing of shelter-in-place restrictions in a number of states are driving these trends. International markets are at various stages of reopening and recovery. In aggregate, recovery in international markets in which we process the majority of transactions lagged the U.S. in May. Across most of Europe, as well as Australia, Canada and Japan, the trajectory so far is comparable to the U.S. India and Singapore are slowly reopening. A few markets, such as New Zealand, Denmark and Chile, have positive year-over-year constant dollar growth in May. Global processed transactions declined 12% in May, a 12 ppt improvement over April. Since April, the mix has shifted to larger ticket transactions. Cross-border volumes excluding intra-Europe transactions declined 45% in May, a 6 ppt improvement over April. As we have indicated before, cross-border volumes excluding intra-Europe transactions drive our international transaction revenues. Travel related cross-border volumes (card present and card not present) declined 78% in May while cross-border eCommerce (excluding travel) continued to grow strongly, up 18%. Cross-border volumes including intra-Europe transactions declined 35% in May, an 8 ppt improvement over April.
GH

Hot Stocks

16:40 EDT Guardant Health offers to sell 10M shares of common stock for holders - Guardant Health announced the commencement of a proposed underwritten public offering of 10,000,000 shares of its common stock, 3,000,000 of which are being offered for sale by Guardant Health and 7,000,000 are being offered for sale by SoftBank Investment Advisers. J.P. Morgan Securities LLC is acting as sole book-running manager of the offering.
TLRY

Hot Stocks

16:36 EDT Tilray confirms closure of High Park Gardens facility in Leamington, Ontario - On May 26, Tilray announced that it will permanently shut down its facility at High Park Gardens, a licensed cannabis facility in Leamington, Ontario, operated through its wholly-owned subsidiary Natura Naturals. This High Park Gardens closure is a result of changing industry dynamics and evolving business needs. High Park Gardens will close its operations over the next six weeks and such closure is expected to be completed by end of July. As a result of the closure, Tilray expects to realize annualized net savings of approximately $7.5M and avoid significant ongoing capital expenditures. Tilray estimates that the closure of High Park Gardens will result in termination costs primarily related to severance of approximately $300,000 to be recorded in 2020. In connection with the permanent shutdown of High Park Gardens, Tilray anticipates non-cash charges related to (i) its property, plant and equipment in relation to placing these assets for sale and valuing such at their fair value less normal selling costs, (ii) inventory in relation to destroying of unharvested flower, and (iii) writing down to nil its intangible assets primarily related to the acquired production license. Tilray expects to recognize non-cash charges ranging from approximately $18M-$28M resulting from these write-downs and impairment charges in the second quarter ending June 30.
SUN

Hot Stocks

16:32 EDT Sunoco LP CFO Thomas Miller to retire - Sunoco LP announced that Thomas Miller, CFO, will retire from Sunoco GP, the general partner of Sunoco LP, as of September 1.
DNOW

Hot Stocks

16:31 EDT NOW Inc. names David Cherechinsky as new CEO - NOW Inc announced that its board has appointed David Cherechinsky to lead the company as full-time CEO effective immediately. Cherechinsky, who has served as CFO of the Company since 2018, will take over the CEO role from Dick Alario, a current board Director who stepped in as interim CEO during a leadership transition in November 2019.
NDSN

Hot Stocks

16:30 EDT Nordson acquires Fluortek, terms not disclosed - Nordson Corporation has acquired Fluortek, Inc., an Easton, Pennsylvania based precision plastic extrusion manufacturer that provides custom dimensioned tubing to the medical device industry. "As Nordson MEDICAL continues to expand its differentiated product offerings, the acquisition of Fluortek enhances our ability to deliver critical components that enable our customers' most complex medical device innovations. This offering further supports Nordson MEDICAL's position as a leading full-service solution provider of component and device manufacturing capabilities for OEM's across the interventional, minimally invasive and surgical medical device landscape," said Jeffrey Pembroke, Executive Vice President, Nordson Advanced Technology Solutions. Fluortek will become part of the Nordson MEDICAL product line within Nordson's Advanced Technology Solutions segment. This acquisition builds on the company's strategic objective to grow Nordson MEDICAL's product offerings serving the medical device market. "We are excited to welcome the Fluortek employees to the Nordson MEDICAL family," continued Pembroke. "We look forward to integrating their precision extrusion expertise and enhancing our advanced components portfolio." The terms of the deal were not disclosed.
BWA

Hot Stocks

16:29 EDT BorgWarner director sells 29.2K shares of common stock - In a regulatory filing, BorgWarner disclosed that its VP Brady Ericson sold 29,156 shares of common stock on May 29th in a total transaction size of $916K.
EQC

Hot Stocks

16:27 EDT Equity Commonwealth reports May contractual rent collection 96% - In a regulatory 8-K filing, the company states: "On May 29, 2020, Equity Commonwealth sold the Georgetown-Green and Harris buildings, a 240,000 square foot office property in Washington, D.C., for $85 million. The property was held for sale as of March 31, 2020. Equity Commonwealth has collected 96% of May contractual rents, including 3% from the application of security deposits and letters of credits, from its four-property, 1.5 million square foot portfolio."
ASFI

Hot Stocks

16:19 EDT Asta Funding regains compliance with Nasdaq - Asta Funding previously received a letter from Nasdaq notifying the company that it had violated Nasdaq Listing Rule 5250 because the company had not yet filed its quarterly report on Form 10-Q for the period ended March 31 with the Securities and Exchange Commission. As previously disclosed, the quarterly report could not be filed by its May 15 deadline without unreasonable effort and expenses due to delays experienced in the collection, compilation and analysis of certain information required to be included in the quarterly report. In its letter, Nasdaq stated that the company had until July 27 to submit a plan to regain compliance. If Nasdaq accepted the company's plan, it could then grant an exception of up to 180 calendar days from the quarterly report's due date, or until November 16, to regain compliance. If Nasdaq did not accept the company's plan, the Company would have had the opportunity to appeal that decision to a Nasdaq Hearings Panel and to request a further stay pending the appeal. Nasdaq's letter has had no immediate effect on the listing or trading of the company's common stock on The Nasdaq Global Select Market. The company filed the quarterly report with the SEC and subsequently received a close-out letter from Nasdaq, which alerted the company that it had regained compliance under Rule 5250.
VICI

Hot Stocks

16:19 EDT VICI Properties says all tenants have fulfilled rent obligations for May - VICI Properties said that, since its COVID-19 update on April 16, 2020, all its tenants fulfilled their rent obligations in full for the month of May and the company expects all June rent will be paid in full. John Payne, President & Chief Operating Officer of VICI Properties said, "We are extremely proud of the strength and commitment of each of our tenants during this unprecedented period. Our tenants have demonstrated dedication to their employees, and to the states and municipalities in which they operate gaming facilities and we are truly proud to serve as their real estate partners. As we look toward the re-opening of our assets across the United States, VICI's portfolio is well diversified from a geographic perspective with approximately 71% of our rent generated from assets located in drive-to regional markets and 29% of our rent generated from assets located on the Las Vegas Strip."
AVB

Hot Stocks

16:19 EDT AvalonBay reports May average physical occupancy 94.4% vs. 95.3% in April - Reports May Like-Term Effective Rent Change down 3.5% vs. down 0.2% in April.
WCC AXE

Hot Stocks

16:18 EDT Wesco, Anixter announce post-closing leadership team - WESCO (WCC) and Anixter (AXE) announced the future leadership team and organizational structure that will become effective upon the completion of the merger of the two companies. The transaction is expected to close in the second or third quarter, subject to the satisfaction of remaining customary closing conditions. Dave Schulz, currently Senior Vice President & Chief Financial Officer of WESCO, will become Executive Vice President & Chief Financial Officer. He has served in his current position since 2016. Prior to joining WESCO, Mr. Schulz was Senior Vice President & Chief Financial Officer at Armstrong World Industries. Earlier in his career, Schulz held various financial leadership positions at Procter & Gamble and the J.M. Smucker Company. Ted Dosch, currently Executive Vice President - Finance & Chief Financial Officer of Anixter, will become Executive Vice President, Strategy & Chief Transformation Officer. Dosch has served in his current position since 2011 and previously held the position of Senior Vice President of Global Finance for Anixter. Prior to joining Anixter, Dosch held senior positions, including CFO-North America and Vice President - Maytag Integration at Whirlpool Corporation. Diane Lazzaris, currently Senior Vice President & General Counsel of WESCO, will become Executive Vice President & General Counsel. Ms. Lazzaris has served in her current position since 2014 and previously held the position of Vice President, Legal Affairs for WESCO. Prior to joining WESCO, Ms. Lazzaris served as General Counsel & Corporate Secretary at Dick's Sporting Goods. Earlier in her career, she held various leadership positions in Alcoa's legal department. Chris Wolf, currently Senior Vice President & Chief Human Resources Officer of WESCO, will become Executive Vice President & Chief Human Resources Officer. Wolf has served in her current position since 2018. Prior to joining WESCO, Ms. Wolf served as Chief Human Resources Officer of Orbital ATK, Inc. until its acquisition by Northrop Grumman, and previously was Chief Human Resources Officer of Fannie Mae and E*Trade Financial Corporation. Hemant Porwal, currently Vice President, Global Supply Chain & Operations of WESCO, will become Executive Vice President, Supply Chain & Operations. Porwal has held his current position since 2015. Previously, Porwal served as Vice President & Chief Procurement Officer with Sears Holdings. Earlier in his career, Porwal held various financial, supply chain, and operations leadership positions at PepsiCo.
JOE

Hot Stocks

16:17 EDT St. Joe commences final phase of homesite development in WaterColor community - The St. Joe Company announced it has broken ground on the final phase of homesite development in the WaterColor community. Plans call for this phase to feature 41 custom homesites to be developed north of West Lake Forest Drive. "For many years the WaterColor community has been a very special place for so many people," said Bridget Precise, Senior Vice President of Residential Real Estate for St. Joe. "What makes this phase so unique is that not only is it the final phase of new homesite development but that it will be rental restricted, creating a neighborhood within the WaterColor community that will not have short-term rentals. In addition, this new neighborhood will feature a residents-only pool offering some privacy for anyone looking to build a custom home to serve as a primary residence or a second home at the beach to experience the unique WaterColor lifestyle."
SONG

Hot Stocks

16:14 EDT Akazoo to be delisted from Nasdaq - Nasdaq announced that it will delist the ordinary shares and warrant of Akazoo. Akazoo's ordinary shares and warrant were suspended on May 27 and have not traded on Nasdaq since that time.
CDXS

Hot Stocks

16:13 EDT Codexis, Alphazyme partner to offer 'novel' enzymes to diagnostic markets - Codexis announce a Co-Marketing & Enzyme Supply Collaboration Agreement for the production and co-marketing of enzymes for life science applications. The agreement covers the launch of three enzymes to prospective customers over the second and third quarters of 2020. The first enzyme is a high-fidelity DNA polymerase, following up on Codexis' previously announced high performance DNA ligase, which was exclusively licensed to Roche in late 2019. The Codexis-developed DNA polymerase has been engineered to deliver high fidelity and uniformity of coverage, providing an accurate and representative DNA diagnostic result. The second enzyme is an evolved T7 RNA polymerase for the efficient manufacture and capping of messenger RNA therapeutics and vaccines. The third enzyme is a reverse transcriptase, a critical component in RNA-directed, point-of-care viral diagnostics. Both the T7 RNA polymerase and the reverse transcriptase enzymes are expected to address needs associated with the COVID-19 pandemic. This new collaboration will leverage the experience and industry knowledge of the Alphazyme team to accelerate the market introduction of Codexis' portfolio of high-performing life science and diagnostic enzymes, while providing Alphazyme exclusive manufacturing and co-marketing rights to certain CodeEvolver(R)-improved enzymes. This partnership will jointly promote and sell these enzymes to innovators in life science and diagnostic markets. "Leveraging the power of Codexis' CodeEvolver(R) platform, we can disrupt long-standing technical bottlenecks in molecular biology," said Chris Benoit, Alphazyme's CEO. "The high fidelity DNA polymerase is a perfect example of how the combination of world-class enzyme engineering, coupled with innovative manufacturing and formulation expertise, can advance genome biology. We are excited to roll out this partnership and connect with the best and the brightest in genomics to tackle their most difficult enzyme challenges."
REG

Hot Stocks

16:13 EDT Regency Centers provides rent collection update for April, May - Regency Centers Corporation provided a business update related to COVID-19, including an update on rent collections for April and May. As of May 31, approximately 75% of Regency's tenants were open based on pro-rata Annual Base Rent, or ABR, and the company had collected 68% and 58% of April and May pro-rata base rent, respectively.
MANH

Hot Stocks

16:12 EDT Manhattan Associates' Howell sells 31,000 common shares - In a regulatory filing, Manhattan Associates senior VP of Americas sales Robert G. Howell disclosed the sale of 31,000 common shares of the company on May 28 at a price of $90.0243 per share.
BRP

Hot Stocks

16:12 EDT BRP Group acquires TBA-RBA - BRP Group announced that BKS-Partners, the middle-market subsidiary of BRP Group, has acquired substantially all assets of Trinity Benefit Advisors and Russ Blakely & Associates, or TBA-RBA, Tennessee-based providers of employee benefit plan management, as well as marketing and benefit plans designed for middle-market companies. TBA-RBA generated annual revenues of approximately $17.3M. Following this partnership, TBA-RBA will be transitioned to the company's BKS-Partners brand.
STSA

Hot Stocks

16:11 EDT Satsuma Pharmaceuticals completes enrollment in Phase 3 Emerge trial - Satsuma Pharmaceuticals reported completion of enrollment and randomization in its EMERGE pivotal Phase 3 efficacy trial of STS101, dihydroergotamine nasal powder, for the acute treatment of migraine. Satsuma's President and Chief Executive Officer, John Kollins commented, "We are very pleased to have achieved this important milestone. We look forward to reporting EMERGE topline results in the second half of this year that we anticipate will further underscore the differentiating features of STS101, including robust anti-migraine activity and favorable tolerability that result from achieving DHE blood levels within what we believe is an optimal therapeutic window." "In addition, despite COVID-19 headwinds, our team has executed well, and we continue to advance development of STS101 per our plan and timelines. We remain on track to intiate enrollment in Q3 in the second STS101 Phase 3 trial, an open-label, multiple-administration safety trialin which patients will acutely treat their migraine attacks with STS101 on an ongoing and as-needed basis."
BRP

Hot Stocks

16:10 EDT BRP Group acquires Rosenthal Brothers - BRP Group announced that Baldwin Krystyn Sherman Partners, or BKS-Partners, the middle-market subsidiary of BRP Group, has acquired substantially all assets of Rosenthal Brothers, a Chicago-based provider of P&C insurance, employee benefits and private client solutions to middle market companies and individuals. Rosenthal Brothers generated annual revenues of approximately $18.8M. Since its founding, Rosenthal Brothers has grown its business to approximately 55 employees across two offices. In particular, Rosenthal Brothers specializes in providing insurance solutions for the real estate industry. Following this partnership, Rosenthal Brothers will be rebranded under the company's BKS-Partners banner.
CWH

Hot Stocks

16:10 EDT Camping World names Karin Bell as new CFO - Camping World announced the promotion of five executives within the company, including the promotion of Karin Bell to the position of CFO, succeeding Melvin Flanigan, who is resigning from the company for personal reasons. Mr. Flanigan's resignation will be effective June 30, 2020. He will continue to work with the company as an independent consultant and the company expects that he will work closely with Ms. Bell through the end of the year to ensure a smooth transition.
HIW

Hot Stocks

16:10 EDT Highwoods collects 99% of contractually required rents for May - Highwoods Properties provided an update on the financial impact of the COVID-19 pandemic. After collecting 99% of its contractually required rents for the month of April, the company has collected 99% of its contractually required rents for the month of May. To date, the company has agreed to grant temporary rent deferrals that represent 1.2% of its annualized rental revenues, including the deferrals disclosed in its Q1 earnings release on April 28. The company is not currently aware of any customer-specific facts or circumstances that indicate a likelihood of any material losses at this point during Q2. The company further reported that all buildings and parking facilities have remained open for business.
WRI

Hot Stocks

16:08 EDT Weingarten Realty says transformed portfolio 'very strong' - Weingarten Realty provided an update regarding the COVID-19 pandemic for the REITweek: 2020 Investors Conference. "The Company's transformed portfolio, which is 80% supermarket anchored, is very strong and diversified with 167 shopping centers located in 16 states primarily in the south and western United States. Additionally, approximately 75% of the average base rent of the portfolio comes from national and regional tenants," the company said. "Cash collections to-date for April rent have now reached 70%, as compared to 64% as reported in our first quarter press release. Further the Company negotiated deferral agreements for an additional 11% of April rent. Currently, May cash collections total 62% of rents. In addition, there are 15% of finalized May rent deferrals. The decreased collection rate for May has been significantly impacted by the timing, as payments continue to be received going forward, as well as the completion of additional deferral agreements. As May activity is finalized, it is expected that total cash collections plus deferrals for May and April will be similar. The Company's collection rates for April were among the highest in the shopping center sector." "We wish the best to all the first line responders, including the many associates at our retailers and our sympathies go out to those affected by this crisis. The dedicated team at Weingarten continues to work closely with all of our tenants to successfully navigate the reopening of the businesses in our shopping centers. We are excited that many of our tenants, most of which provide basic goods and services, have reopened and expect the vast majority of our tenants to resume operations shortly. We have been pleased with our performance through the pandemic thus far, though significant challenges remain," said Drew Alexander, Chairman, President and Chief Executive Officer.
RBNC

Hot Stocks

16:08 EDT Reliant Bancorp CFO James Dellinger steps down - Reliant Bancorp announced that James Daniel Dellinger has resigned as CFO of the company and Reliant Bank in order to pursue other personal business interests. The company also announced that Gerald Cooksey, Jr. has been appointed as CFO and Reliant Bank to succeed Mr. Dellinger. Prior to joining the company and Reliant Bank as Chief Administrative Officer following the company's acquisition of First Advantage Bancorp, Mr. Cooksey served as CFO of First Advantage Bancorp and First Advantage Bank.
ADC WMT

Hot Stocks

16:07 EDT Agree Realty receives May rent payments from 87% of its portfolio - As of May 29, Agree Realty (ADC) received May rent payments from 87% of its portfolio and entered into May deferral agreements with tenants representing approximately 4% of its portfolio. 100% of the company's investment grade tenants paid May rent. Total acquisition activity in the second quarter through May 29 amounted to $147.4M with six Walmart (WMT) stores acquired comprising approximately 39% of acquisition capital deployed. Walmart has accounted for approximately 37% of the company's year-to-date acquisition capital invested and remains the company's top tenant at approximately 7.5% of annualized base rent. Approximately 87.9% of annualized base rents acquired year-to-date are derived from investment grade retail tenants, increasing the company's exposure to investment grade retailers to 61.0% of annualized base rent as of May 29. The company sold seven properties quarter-to-date through May 29, 2020 for gross proceeds of approximately $16.6M. Notable disposition activity included the sale of six franchise restaurants, further reducing the company's franchise restaurant exposure to 1.6% of annualized base rent as of May 29. The company has executed a new twenty-year net lease for its former Art Van flagship location in Canton, Michigan with an anticipated recovery rate of 100% of the previous rent. Rent is expected to commence during the latter half of the third quarter. This was the only Art Van furniture location in the company's portfolio.
GTLS

Hot Stocks

16:07 EDT Chart Industries provides mid-Q2 business update - Chart Industries provided a mid-Q2 business update. Reportable April net cash provided by operating activities for continuing operations of $15.5M and corresponding free cash flow after including capital expenditures of $12.6M, driven by earnings, cash collections and supplier terms extensions. The company completed five-year long-term agreement with industrial gas customer for field service and repair. Also, the company signed an agreement with Risco Energy Solutions to provide LNG equipment to support the rapidly growing Indonesian gas-to-power infrastructure. Chart Industries booked orders with 67 new customers in April and May, executed on $11.9M of additional cost reductions on May 29 and brought year-to-date total annualized cost reductions to $60.7M. The company said, "While the current economic situation continues to be challenging for our oil related product lines, we continue to see demand for our equipment and solutions related to the transition to clean energy infrastructure and our specialty markets. With over $60 million of cost reductions taken year-to-date, we continue to expect margin expansion throughout 2020 and strong free cash flow for the year, with debt paydown a priority. April 2020 free cash flow of $12.6 million was driven by strong earnings, cash collections and supplier terms extensions. In the past two months, we have achieved payment term extensions with 311 suppliers with an average payment term extension of 38 days (new payment terms for those suppliers average 89 days).Through May 29, 2020, second quarter orders totaled approximately $135 million, with orders in-house that will be booked in the first days of June totaling an additional $14 million. In April and May, we received orders from 67 new customers, including 20 in China, where quarter to date orders and sales have exceeded our original 2020 plan.Demand for oxygen related critical care products was strong in the month of April and first two weeks of May, while quoting activity for traditional industrial gas applications has increased in the second half of May as the hyper-focus on oxygen delivery has subsided to pre-COVID-19 levels. We continue to see consistent and strong quoting and order levels for fueling stations, repair and service, small-scale LNG infrastructure and specialty markets, including the receipt of a $2.3 million order for a European country's Armed Forces. We also expect to receive a small-scale terminal order in North America in June 2020. E&C Cryogenics demand for quick turn refurbishment, repair and service-related product and services has increased over the past 8 weeks, with orders of $7.2 million associated with this type of work. Venture Global's Calcasieu Pass big LNG project continues on schedule, and in May, we booked an additional $1 million order related to the project.In addition to E&C Cryo, we continue to grow repair and service across our four segments, including hitting a major milestone today with the completion of a five-year long-term agreement with a major industrial gas customer for repair and service...Given the weak demand for air-cooled heat exchangers and the continued optimization of our cost structure, we took further reductions on May 29, 2020. The total cost reductions taken last Friday equaled $11.9 million in annualized cost savings, bringing the year-to-date total to $60.7 million of annualized cost savings. Of the $60.7 million, approximately $51 million are structural changes that can be maintained at volume levels above $1.6 billion."
NXGN

Hot Stocks

16:07 EDT NextGen to evaluate returning to guidance - In its business update on April 28, the Company announced that given the uncertainty going forward it will not be providing any forward-looking guidance either for FY21 or the years beyond. As things stabilize and there is more confidence in the macro environment, the Company will evaluate returning to guidance. "This year looks to be the tale of two halves. The first half ending in October impacted by the significant drop-off in volume due to the shutdown of care and the second half showing signs of returning to a new normal," said Frantz. "Based on our overall financial health and the opportunity in front of us, we made some important decisions on how to approach the next two quarters. In early May, we announced a go forward move to minimize our perpetual license revenue in favor of recurring subscription revenue. This will impact gross margin percentages as we will book less high-margin perpetual licenses than we have historically, but ultimately it will produce high-margin recurring revenue. In addition, we executed cost reductions with a goal of mitigating COVID-based impacts to earnings. Most of these cost reductions are temporary, as we believe that preserving our employee base, organizational momentum and robust capabilities for the near future will be a win for the company and our shareholders." Frantz continued, "The net effect of the aforementioned actions and decisions will result in earnings being down markedly and negative free cash flow in the first half of the fiscal year. However, our solid financial health, decisive action, and strong employee culture enablers us to both weather the initial storm and be well positioned for increasing earnings, revenue and opportunity as volume begins to return in the second half of the year.
REGN

Hot Stocks

16:05 EDT Regeneron's Goldstein sells 1,000 common shares - In a regulatory filing, Regeneron director Joseph L. Goldstein disclosed the sale of 1,000 common shares of the company on May 28 at a price of $578.94 per share.
DISH

Hot Stocks

16:04 EDT Dish expands senior leadership team - Dish Network announced an expansion of its senior leadership team to support and advance the company's wireless future. Industry veteran Dave Mayo has joined the team as EVP, Network Development, Jeff Blum has been promoted to EVP, External and Legislative Affairs, and John Swieringa has been named Group President, Retail Wireless, and will retain his duties as Dish COO. In addition, Michael Schwimmer has been named Group President, SLING TV, following the departure of Warren Schlichting. Andy LeCuyer, Dish SVP, Programming, will continue to lead the team responsible for acquisition and renewal of content for the company.
WRTC

Hot Stocks

15:53 EDT Wrap Technologies previews appearance of President on Fox Business Network - Wrap Technologies announced that Tom Smith, President of Wrap Technologies, and Richard Ross, retired Commissioner of Philadelphia Police Department and consultant for Wrap Technologies, are scheduled to be interviewed live at 11:15am ET tomorrow morning via Skype on Fox Business Network's "Varney & Co." Ross and Smith will be discussing BolaWrap and the current difficult climate of rioting across the United States, the company previewed in a press release.
JWN

Hot Stocks

15:44 EDT Nordstrom temporarily closed stores, looks forward to serving customers 'soon' - Nordstrom issued the following update on its stores via its website: "We continue to be heartbroken by the senseless deaths of George Floyd, Breonna Taylor, Ahmaud Arbery and too many others, and the deep pain and division we're seeing across the country...Our priority is always the health and well-being of our employees, customers and communities. To help keep everyone safe, we made the decision to temporarily close our stores yesterday. Some of our stores were impacted by gatherings in our cities this weekend, and we wanted to take the time to assess the damage, repair and reopen those stores so we can continue serving customers as soon as possible. The situation is evolving quickly, and we encourage you to check our website for the most up-to-date information on your store's hours. Thankfully, none of our employees were injured in these events, and we're communicating regularly with all of them on the actions we're taking and the ways we will continue to support them. We'll also pay employees for any shifts they may have missed as a result of these unexpected closures. We've heard from so many employees asking for ways they can help, and we're working to connect them to the nonprofits in their communities that are providing valuable resources, information and support in these difficult times. The events of this weekend are one more painful reminder that injustice remains in our world. We can fix the damage to our stores. Windows and merchandise can be replaced. We continue to believe as strongly as ever that tremendous change is needed to address the issues facing Black people in our country today. We strive to be a positive force for change in every community we serve. We look forward to serving you again soon." Reference Link
CASY DIN

Hot Stocks

15:32 EDT Casey's General Stores names Adrian Butler as chief information officer - Casey's General Stores (CASY) announced that Adrian Butler has joined the company as chief information officer. This is a newly created role that will lead the effort to advance next generation technology at the fourth largest convenience retailer. Butler will report to CEO Darren Rebelez. Butler most recently served as senior vice president and chief information officer at Dine Brands (DIN).
LBY

Hot Stocks

15:08 EDT NYSE American to suspend trading immediately in Libbey, seek delisting - NYSE American announced that the staff of NYSE Regulation has determined to commence proceedings to delist the common stock of Libbey - ticker symbol "LBY" - from the Exchange. Trading in the company's common stock on the NYSE American will be suspended immediately. NYSE Regulation has determined that the company is no longer suitable for listing and will commence delisting proceedings after the company announced that it has commenced voluntary petitions for a court-supervised reorganization under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware. NYSE Regulation noted the uncertainty as to the timing and outcome of the bankruptcy process, as well as the ultimate effect of this process on the value of the company's common stock. Reference Link
I EUTLF

Hot Stocks

14:59 EDT FCC says C-band spectrum to be made available on accelerated timeline - Federal Communications Commission Chairman Ajit Pai announced that the repurposing of C-band spectrum for 5G services will move forward on an accelerated timeline. In a public notice released today, the FCC's Wireless Telecommunications Bureau said it had secured commitments from all eligible satellite operators to meet an accelerated clearing timeline that will make way for faster 5G deployment in the 3.7 GHz band, also called the C-band. Chairman Pai said: "The acceptance of accelerated relocation by all eligible satellite operators vindicates the FCC's approach for making C-band spectrum available for 5G more quickly. Our initiative will enable this critical mid-band spectrum to be used for new and innovative wireless services that will be delivered to American consumers years ahead of schedule. The FCC's work on the C-band is an important part of its 5G FAST plan, a comprehensive strategy to promote American leadership in 5G. This is a national priority because it means millions of jobs, billions of dollars in investment, innovation on our shores, and stronger economic growth." Reference Link
SNE

Hot Stocks

14:49 EDT Sony postpones June 4 PlayStation 5 event - Sony said in a statement posted on its PlayStation Twitter account, "We have decided to postpone the PlayStation 5 event scheduled for June 4. While we understand gamers worldwide are excited to see PS5 games, we do not feel that right now is a time for celebration and for now, we want to stand back and allow more important voices to be heard." Reference Link
SRTS

Hot Stocks

14:14 EDT Sensus Healthcare says $4 per share takeover offer received and rejected - In a regulatory filing, Sensus Healthcare disclosed that on May 26 the company received an unsolicited offer to acquire all the outstanding shares of the company at a price of $4.00 per share, in cash. "Following consideration by and at the direction of its board of directors, the company has rejected the offer," the filing stated.
JBHT

Hot Stocks

14:13 EDT J.B. Hunt VP Nicholas Hobbs sold over $500K in company shares - J.B. Hunt VP Nicholas Hobbs sold 4,200 shares of company stock at $119.53 per share on May 29 for a total transaction value of $502,031.
WINR

Hot Stocks

14:01 EDT Simplicity Esports to offer play at home online tournaments in Brazil in June - Simplicity Esports and Gaming announced earlier that it will begin offering play at home online tournaments in Brazil in June. "Earlier this year, Simplicity Esports began offering online tournaments in the U.S. to its database of over 400,000 customers from its esports gaming centers. Capacity for the online tournaments in the U.S. had to be increased multiple times to accommodate an unexpectedly high number of registrations. The schedule of online tournaments in Brazil will not conflict with the upcoming split for Campeonato Brasileiro de League of Legends, the League of Legends top tier professional league in Brazil. Flamengo Esports returns to weekly CBLoL Brazil competition in June as one of the favorites to win the CBLoL Brazil championship and compete in the League of Legends World Finals," the company stated.
GILD BSGM

Hot Stocks

13:57 EDT ViralClear files protocol of study to evaluate merimepodib-remdesivir combo - According to a regulatory filing, on June 1, 2020, ViralClear Pharmaceuticals, a majority-owned subsidiary of BioSig Technologies, Inc., filed the protocol of its planned study to evaluate the safety and efficacy of merimepodib in combination with remdesivir in adult patients with advanced COVID-19 at clinical trials.gov.
AVEO

Hot Stocks

13:16 EDT Aveo Oncology announces FDA acceptance for NDA filing for tivozanib - AVEO Oncology announced that the U.S. Food and Drug Administration accepted for filing its New Drug Application seeking approval for tivozanib, the Company's next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor, as a treatment for relapsed or refractory renal cell carcinoma. The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee to discuss the application. The NDA submission is based on AVEO's pivotal Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC, including results recently presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program. The application is also supported by three additional trials, including an active comparator-controlled Phase 3 study, TIVO-1, comparing tivozanib to sorafenib in first line RCC, and two Phase 2 studies, Study 902, the open-label, crossover clinical study of tivozanib for patients who progressed on sorafenib in TIVO-1, as well as placebo-controlled Study 201 in first line RCC. In total, data from over 1,000 clinical trial subjects support the application.
RGR...

Hot Stocks

13:11 EDT FBI reports 3.09M NICS firearm background checks in May - The FBI reported that there were 3,091,455 firearm background checks initiated through the NICS system in May 2020. This compares to 2,349,309 checks in May of 2019 and 2,911,128 checks in April 2020. Companies in the gun space include Sturm, Ruger (RGR), American Outdoor Brands (AOBC), and Vista Outdoor (VSTO).
IBKR

Hot Stocks

12:38 EDT Interactive Brokers reports May DARTs up 84% y/y - Interactive Brokers Group reported its Electronic Brokerage monthly performance metrics for May. Brokerage highlights for the month included: 1,645 thousand Daily Average Revenue Trades, 84% higher than prior year and 4% lower than prior month. Ending client equity of $190.6B, 32% higher than prior year and 6% higher than prior month. Ending client margin loan balances of $23.3B, 10% lower than prior year and 13% higher than prior month. Ending client credit balances of $70B, including $3B in insured bank deposit sweeps, 32% higher than prior year and 1% higher than prior month. 839 thousand client accounts, 31% higher than prior year and 4% higher than prior month. 448 annualized average cleared DARTs per client account. Average commission per cleared Commissionable Order of $2.83 including exchange, clearing and regulatory fees.
EA

Hot Stocks

12:37 EDT EA delays 'Madden NFL 21' reveal event amid protests against racism - Electronic Arts released the following statement yesterday on Twitter: "Tomorrow, we had committed to celebrating Madden NFL 21 with you, but we're not going to do that now. We stand with our African American / Black community of friends, players, colleagues and partners. Our immediate attention is on actions we can take to drive change against the unjust treatment and systemic bias that is plaguing the nation and our world. We'll find another time to talk football with you. Because this is bigger than a game, bigger than sports, and needs all of us to stand together and commit to change." Reference Link
HFC

Hot Stocks

12:04 EDT HollyFrontier sees 2020 capital spending $525M-$625M - In 2020, HollyFrontier expects to maintain its total capital spending guidance of $525M-$625M. For Refining, the company expects to spend between $202M-$221M. This lower range reflects further optimization of refinery capital budgets and lower spending at the Cheyenne Refinery. For Renewables, HollyFrontier expects capital expenditures in 2020 of $150M-$180M, which includes capital costs for the Artesia renewable diesel unit, the Cheyenne conversion and the PTU. There is no change to the $30M-$45M capital spend for Lubricants & Specialty Products or the $85M-$110M for turnarounds & catalysts. Capital expenditures for Holly Energy Partners also remains unchanged at $58M-$69M.
HFC

Hot Stocks

12:02 EDT HollyFrontier announces expansion of renewables business - HollyFrontier announced that its Board of Directors has approved a plan to convert the Cheyenne Refinery to renewable diesel production and to construct a pre-treatment unit located at the Artesia Refinery. Including the previously announced renewable diesel unit at the Artesia Refinery, HollyFrontier is expected to have a combined capacity to produce over 200 million gallons per year of renewable diesel and pre-treat over 80% of its feedstock. HollyFrontier expects to invest between $650M-$750M in its renewables business, with an expected aggregate internal rate of return of 20-30%. With expected capital spending of $125M-$175M, HollyFrontier intends to repurpose Cheyenne's current footprint and a portion of its existing assets to produce approximately 90M gallons per year of renewable diesel. HollyFrontier expects the project will be completed in the first quarter of 2022 and generate an internal rate of return of 20-30%. HollyFrontier also plans to construct a PTU that will process over 80% of the feedstock for both of HollyFrontier's renewable diesel plants. The PTU is expected to provide feedstock flexibility, mitigating single feedstock risk and generating value through the use of lower carbon intensity feed. HollyFrontier estimates the capital cost of the PTU to be $175M-$225M and the in-service date to be in the first half of 2022. The PTU has an expected internal rate of return of 10-15% but is intended to protect the returns of HollyFrontier's renewables business against potential volatility in the feedstock markets. The conversion to renewable diesel production will result in HollyFrontier ceasing petroleum refining and reducing the workforce at the Cheyenne Refinery. This decision was primarily based on the expectation that future free cash flow generation in Cheyenne would be challenged due to lower gross margins resulting from the economic impact of the COVID-19 pandemic and compressed crude differentials resulting from dislocations in the crude oil market, coupled with forecasted uncompetitive operating and maintenance costs and the anticipated loss of the Environmental Protection Agency's small refinery exemption. Based on the initial review of its long-lived assets, over the second and third quarters of 2020, HollyFrontier expects to record non-cash charges of $225M-$275M million for impairment and depreciation charges and $3M-$12M for asset retirement obligations. Additionally, over the next twelve months, HollyFrontier anticipates pre-tax costs of $25M-$45M for decommissioning assets and $5M-$7M for severance obligations and proceeds of $50M-$70M from the liquidation of working capital.
CHNG

Hot Stocks

12:01 EDT Change Healthcare acquires pharmacy solutions provider PDX - Change Healthcare announced the acquisition of PDX, which it calls "a leader in providing patient centric and innovative technologies for pharmacies and health systems." "Their portfolio of solutions includes an Enterprise Pharmacy System software, a comprehensive suite of products and services that range from robust data analytics to revenue cycle management, and a flexible clinical services platform. Today's transaction complements Change Healthcare's recent acquisition of eRx Network and demonstrates the company's continued investment in core aspects of the business to fuel innovation and long-term growth. The combination of Change Healthcare, eRx Network, and PDX will result in faster, more integrated development and cross selling opportunities for Change Healthcare's combined portfolio of pharmacy network, software, and analytics solutions," the company said.
PFE

Hot Stocks

12:00 EDT Pfizer falls -8.4% - Pfizer is down -8.4%, or -$3.22 to $34.97.
THR

Hot Stocks

12:00 EDT Thermon Group falls -8.5% - Thermon Group is down -8.5%, or -$1.37 to $14.66.
EVH

Hot Stocks

12:00 EDT Evolent Health falls -26.9% - Evolent Health is down -26.9%, or -$2.39 to $6.49.
CIR

Hot Stocks

12:00 EDT Circor rises 21.3% - Circor is up 21.3%, or $3.43 to $19.51.
NVGS

Hot Stocks

12:00 EDT Navigator Holdings rises 25.7% - Navigator Holdings is up 25.7%, or $1.80 to $8.80.
MYOV

Hot Stocks

12:00 EDT Myovant Sciences rises 29.9% - Myovant Sciences is up 29.9%, or $3.66 to $15.91.
SSNLF

Hot Stocks

11:52 EDT Samsung launches Access upgrade plan for new Galaxy phones - Samsung announced the rollout of Samsung Access, a "simple" monthly subscription that gives users the company's latest phones, namely the Unlocked Galaxy S20 5G series, with the option to upgrade or cancel anytime. Customers will also receive premium care coverage, 1TB OneDrive cloud storage, and Premium Office apps. Subscribers can upgrade anytime, as well as cancel anytime, the company said. Reference Link
ABBV

Hot Stocks

11:42 EDT AbbVie submits regulatory applications to FDA, EMA for RINVOQ - AbbVie announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration and European Medicines Agency for RINVOQ, a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis. The applications are supported by data from two Phase 3 studies across a broad range of more than 2,000 patients with active psoriatic arthritis. In both studies, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo.RINVOQ 15 mg also achieved non-inferiority versus adalimumab in terms of ACR20 response at week 12. Patients receiving RINVOQ also experienced greater improvements in physical function and skin symptoms, and a greater proportion achieved minimal disease activity. Overall, the safety profile of RINVOQ in psoriatic arthritis was consistent with previously reported results across the Phase 3 rheumatoid arthritis clinical trial program, with no new significant safety risks detected.
GME

Hot Stocks

11:23 EDT GameStop recommends investors vote to support independent directors - GameStop issued a letter to stockholders affirming that GameStop "possesses a stable, comprehensively skilled and experienced Board that is successfully advancing the Company's innovative business transformation plan, GameStop Reboot, to enhance long-term value for all stockholders." The letter notes that Hestia Capital Partners, LP and Permit Capital Enterprise Fund, LP's campaign distracts from leadership's ability to continue to execute its strategic turnaround plan and deliver returns to all stockholders. The letter urges stockholders to use the BLUE proxy card to vote "FOR ALL" of GameStop's 10 director nominees in connection with the company's upcoming Annual Meeting of Stockholders to be held at 8:00 a.m. CT on June 12, 2020.
MRK

Hot Stocks

10:53 EDT Merck, Junshi Biosciences collaborate to explore head, neck cancer treatment - Junshi Biosciences announced their collaboration on a clinical trial program designed to investigate the efficacy and safety of anti-PD-1 mAb toripalimab in combination with Cetuximab as a treatment for recurrent and/or metastatic squamous cell carcinomas of the head and neck in China. Cetuximab is an IgG1 monoclonal antibody that specifically targets the EGFR. The inhibition of EGFR blocks the processes involved in tumor cell growth and progression. Cetuximab is also a potent inducer of antibody-dependent cell mediated cytotoxicity, inducing antitumor immune effect. In February 2020, Cetuximab was granted an approval by China's National Medical Products Administration for the first-line treatment of R/M SCCHN using a combination chemotherapy regimen. Developed by Junshi Biosciences, toripalimab is the first domestically marketed PD-1 monoclonal antibody in China. Anti-PD-1 mAb is an immunotherapy that can activate and direct the body's own immune system to attack tumor cells by inhibiting the PD-1 pathway. Over 30 toripalimab mono and combo clinical trials have been conducted globally for more than 10 tumor types, and show encouraging anti-tumor outcomes. Cetuximab and PD-1 inhibitors are believed to have a synergistic mechanism of action in SCCHN treatment. Preliminary data of early-phase studies have shown promising results from combining immune checkpoint inhibitors with cetuximab.
KZIA

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10:34 EDT Kazia Therapeutics presents interim paxalisib Phase II data - Kazia Therapeutics announced a poster presentation of interim data from the ongoing phase II study of paxalisib in glioblastoma, the most common and most aggressive form of primary brain cancer. Top-line data from this interim analysis was previously announced to ASX on 7 April 2020. Analysis of Stage 1 of the study shows median overall survival of 17.7 months. This compares very favourably with temozolomide, the existing standard of care, which has a reported median OS of 12.7 months in this patient population. Progression-free survival in Stage 1 was 8.4 months, which represents a clinically material advantage over the 5.3 months associated with temozolomide. The longest-treated patient remains on therapy and progression-free some 19 months after diagnosis. Safety profile is consistent with prior clinical experience. Rash, mucositis, and hyperglycemia are the most common toxicities, and 60mg, once daily, orally, was confirmed as the maximum tolerated dose. The Kazia data is presented in Abstract 2550. In addition to Kazia's paxalisib poster, abstracts are being presented by the Global Coalition for Adaptive Research on the GBM AGILE clinical trial, and by the Alliance for Clinical Trials in Oncology on their genomically-guided study in brain metastases, in which paxalisib is one of three participating drug candidates. The reported overall survival figure of 17.7 months represents a strong signal of clinical efficacy. The existing, FDA-approved standard of care, temozolomide, is associated with an OS of 12.7 months in this patient population. Comparison between different studies is always imprecise, but the magnitude of the numerical difference provides powerful evidence that treatment with paxalisib may extend life in this patient group. The reported progression-free survival figure of 8.4 months compares favourably with the PFS of 5.3 months that is associated with temozolomide in this patient population. In April 2020, Kazia reported an interim analysis showing a PFS of 8.5 months in the overall study population. This poster only reports the first stage of the study, and the figure in this part of the study was 8.4 months. Before losing patent protection, temozolomide achieved peak sales in excess of $1B per annum, which provides an indication of the commercial opportunity associated with a new treatment for glioblastoma. The Kazia study is being conducted in newly-diagnosed glioblastoma patients, following surgery and radiotherapy. Only those patients with an unmethylated MGMT promotor have been recruited. This genetic marker renders patients effectively resistant to temozolomide and is present in approximately two-thirds of patients. Thirty patients were enrolled to this study, comprising 9 in Stage 1 , and 21 in Stage 2. Data reported here are provisional figures from Stage 1 and from the entire study population, but may change as ongoing patients proceed through the study. The study has been conducted at leading centers of excellence in the United States. The safety of paxalisib remained broadly consistent with prior experience, with hyperglycaemia, oral mucositis, and low-grade rash among the most common drug-related toxicities. In addition to this phase II study in glioblastoma, four other studies are underway with paxalisib in different forms of brain cancer, and it is anticipated that several of these will provide initial efficacy data during CY 2020. The phase II study remains ongoing, with approximately half of the total enrolled patient population still receiving drug at the time of analysis and a number of additional patients still in follow-up. Kazia expects to complete the study in 1H CY2021. Kazia had previously had an abstract accepted the AACR Annual Meeting, which had originally been scheduled for April 2020.
AOBC SWBI

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10:21 EDT American Outdoor Brands changes name to Smith & Wesson Brands - Smith & Wesson Brands (SWBI), formerly American Outdoor Brands Corporation (AOBC), has changed its name from American Outdoor Brands Corporation to Smith & Wesson Brands and its ticker symbol from AOBC to SWBI. The name change reflects the company's preparation for the previously announced spin-off of its outdoor products and accessories business as a tax-free stock distribution to its stockholders in late summer 2020, a transaction that would create two independent publicly traded companies: Smith & Wesson Brands and American Outdoor Brands The company also unveiled the logo for the American Outdoor Brands, Inc. spin-off company. The company's common shares continue to be listed for trading on the Nasdaq Global Select exchange under the ticker symbol 'SWBI'. In conjunction with the name and ticker symbol change, the company's common shares have been assigned a new CUSIP number of 831754 106. The company also announced that it plans to release its fourth quarter and full fiscal 2020 financial results on Thursday, June 18, after the close of the market.
LINC

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10:01 EDT Lincoln Educational re-opens three Connecticut campuses - Lincoln Educational Services announced that it has re-opened its campuses, in East Windsor, New Britain, and Shelton, CT. On-site instruction will resume on a limited basis effective Monday, June 1st.
PFE

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10:00 EDT Pfizer falls -7.8% - Pfizer is down -7.8%, or -$2.98 to $35.21.
THR

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10:00 EDT Thermon Group falls -7.8% - Thermon Group is down -7.8%, or -$1.25 to $14.78.
EVH

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10:00 EDT Evolent Health falls -31.0% - Evolent Health is down -31.0%, or -$2.75 to $6.13.
VSTO

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10:00 EDT Vista Outdoor rises 14.3% - Vista Outdoor is up 14.3%, or $1.38 to $11.09.
CIR

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10:00 EDT Circor rises 14.4% - Circor is up 14.4%, or $2.32 to $18.40.
ITCB

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10:00 EDT Itau Corpbanca rises 24.7% - Itau Corpbanca is up 24.7%, or 75c to $3.79.
RWLK

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09:56 EDT ReWalk Robotics receives 510(k) Premarket Notification for P6.0 exoskeleton - A 510(k) Premarket Notification, with a decision date of May 26, was posted to the FDA website for the ReWalk P6.0 powered exoskeleton made by ReWalk Robotics, which was judged to be "substantially equivalent." Reference Link
OCGN

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09:50 EDT Ocugen Inc trading resumes
THR

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09:47 EDT Thermon Group falls -10.4% - Thermon Group is down -10.4%, or -$1.67 to $14.36.
UGAZ

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09:47 EDT VelocityShares 3x Long Natural Gas ETN falls -10.4% - VelocityShares 3x Long Natural Gas ETN is down -10.4%, or -$1.53 to $13.20.
EVH

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09:47 EDT Evolent Health falls -31.1% - Evolent Health is down -31.1%, or -$2.76 to $6.12.
DGAZ

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09:47 EDT VelocityShares 3x Inv Natural Gas ETN rises 10.3% - VelocityShares 3x Inv Natural Gas ETN is up 10.3%, or $29.47 to $316.47.
VSTO

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09:47 EDT Vista Outdoor rises 20.4% - Vista Outdoor is up 20.4%, or $1.98 to $11.69.
ITCB

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09:47 EDT Itau Corpbanca rises 29.9% - Itau Corpbanca is up 29.9%, or 91c to $3.95.
ORGS

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09:39 EDT Orgenesis to partner with The Edith Wolfson Medical Center for clinical study - Orgenesis announces that it has entered into a Clinical Study Agreement with The Edith Wolfson Medical Center, a public hospital in Israel. Under the agreement, the parties will conduct a clinical study with a goal of utilizing and validating a number of Orgenesis' proprietary POCare Technologies, including a novel, automated cell culturing system, designed to enable a faster, safer and metabolically optimized culturing and expansion process for the generation and expansion tumor infiltrating lymphocytes for use in adoptive T-cell therapies. The goal of the cell culturing system is to provide an innovative and simplified method for TIL generation and expansion in an automated and controlled system from the initial TIL production to final product with minimal human operation.
DLAKY

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09:31 EDT Lufthansa executive board accepts German stabilization package - Lufthansa announced that at its meeting today, the Lufthansa Executive Board decided to accept the commitments offered by Germany to the EU Commission for the stabilization package negotiated with the Economic Stabilization Fund of the Federal Republic of Germany. Lufthansa said: "The scope of the conditions required in the EU Commission's view has been reduced in comparison with initial indications. Lufthansa will therefore be obliged to transfer to one competitor each at the Frankfurt and Munich airports up to 24 take-off and landing rights, i.e. three take-off and three landing rights per aircraft and day, for the stationing of up to four aircraft. For one and a half years, this option is only available to new competitors at the Frankfurt and Munich airports. If no new competitor makes use of this option, it will be extended to existing competitors at the respective airports. The slots will be allocated in a bidding process. The slots can only be taken over by a European competitor that has not itself received any substantial state recapitalization as a result of the corona pandemic. The Supervisory Board must approve the stabilization package negotiated with the WSF, including the commitments to the EU Commission. Subsequent to the Supervisory Board's decision, the company intends to convene an Extraordinary General Meeting in the near future to obtain shareholder approval for the WSF stabilization measures."
ORRF

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09:28 EDT Orrstown Financial appoints Linford Weaver to board of direcrors - Orrstown Financial Services announced that Linford Weaver has been elected to the Boards of Directors of the Company and its principal subsidiary, Orrstown Bank, effective June 1, 2020. Mr. Weaver currently serves as Co-President of the Shady Maple Companies.
DSX

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09:27 EDT Diana Shipping announces direct continuation of contract for m/v Phaidra - Diana Shipping has entered into a time charter contract with Uniper Global Commodities SE, Dusseldorf, for one of its Post-Panamax dry bulk vessels, the m/v Phaidra. The gross charter rate is $9,400 per day, minus a 5% commission paid to third parties, for a period of minimum eleven months to maximum fourteen months. The new charter period commenced on May 29, 2020. The "Phaidra" is a 87,146 dwt Post-Panamax dry bulk vessel built in 2013. This employment is anticipated to generate approximately 3.1 million of gross revenue for the minimum scheduled period of the time charter.
FRG

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09:27 EDT Franchise Group amends term loan at the Vitamin Shoppe - Franchise Group announced that it has amended and acquired a portion of its term loan at The Vitamin Shoppe, a business line consisting of multiple wholly owned subsidiaries of the Company. Since closing the acquisition of The Vitamin Shoppe on December 16, 2019, the Company has now repaid, or acquired for its own account, more than $22 million of the original $70 million term loan. The Company's decision to prepay and acquire debt of The Vitamin Shoppe does not impact Franchise Group's ability to pay cash dividends to its shareholders. The Company is committed to paying a regular dividend based on its operating performance and availability of cash. All dividend payments are approved by the Board of Directors and will be announced when and if declared by the Board.
OCGN

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09:24 EDT Ocugen sees cash sufficient to fund operations into 4Q20
OCGN

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09:23 EDT Ocugen to discontinue Phase 3 oGVHD trial - Ocugen announced the decision to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. Host Disease. The decision to stop the trial is based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion. The study was not stopped based on safety concerns. "This is disappointing news, especially for those who suffer from oGVHD. Our hope was to provide the first treatment for this complex, orphan disease. We are grateful to the patients, their families and the investigators who participated in our clinical trial," said Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. "We are committed to advancing our transformative therapies and will shift our resources to focus on our breakthrough modifier gene therapy platform and novel biologic programs for patients suffering from blindness diseases. We remain on track to enter the clinic by next year with our first gene therapy product candidate, OCU400, which targets inherited retinal diseases. Our additional pipeline products, OCU410 and OCU200, which are focused on major retinal diseases, are targeted to enter the clinic by 2022. As a result of discontinuing this study and proceeds from our ATM program we believe that we have sufficient cash to fund our current operations into the fourth quarter of 2020. "
ECNCF FMCC

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09:22 EDT ECN Capital, Freddie Mac partner for affordable housing solutions - ECN Capital Corp. (ECNCF) announced that its wholly-owned subsidiary, Triad Financial Services, has been approved as a qualified mortgage seller and servicer by Freddie Mac (FMCC).
RLH

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09:21 EDT Red Lion Hotels appoints Gary Kohn as CFO - RLH Corporation announced the appointment of Gary Kohn as its EVP, CFO effective May 29, 2020. Mr. Kohn has been serving as a consultant to Red Lion since May 18, 2020. Mr. Kohn will be responsible for overseeing all financial aspects of the Company, including financial planning and analysis, accounting and reporting as well as managing the tax, internal audit, treasury and investor relations functions. Prior to joining Red Lion, Mr. Kohn was the founder and principal of GAK Advisors, an investor relations and financial consulting firm.
CERN HPE

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09:19 EDT Cerner appoints Jerome Labat as CTO - Cerner Corporation (CERN) announced that Jerome Labat has joined the company as CTO. As CTO, Labat will lead efforts to strengthen Cerner's technology focus and accelerate cloud-enabled SaaS platforms and solutions. Labat has extensive experience in cloud technology and will leverage that expertise to deliver integrated cognitive functionality based on artificial intelligence and machine learning. Prior to joining Cerner, Labat was CTO for HPE Software (HPE) and led the cloud automation business.
MATN

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09:18 EDT Mateon Therapeutics reports peer-reviewed publications on COVID-19 - Mateon Therapeutics reportd several peer-reviewed publications derived from its R&D effort against COVID-19. Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3: 1-3. Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-beta with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19. Clin. Invest. 2020; 10, 167-176. DOI: 10.4172/ Clinical-Investigation.1000166. "These publications validate the concept of COVID-19 being a TGF-beta disease and is demonstrated by its many different clinical presentations. Our IND for COVID19 is completed and we are rolling out clinical trials against COVID-19 in the coming weeks." said Dr Vuong Trieu, CEO of Mateon Therapeutics.
SIGA

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09:16 EDT Siga Technologies announces international delivery of oral TPOXX - SIGA Technologies announced its first international delivery of TPOXX, with 2,500 courses delivered to the Canadian Department of National Defence. On April 3, 2020, the Company previously announced that the CDND is expected to purchase up to 15,325 courses of oral TPOXX over four years for a total value of $14.3 million. Remaining purchases of 12,825 courses, at the option of the CDND, are expected to occur after regulatory approval of oral TPOXX by Health Canada. Meridian Medical Technologie, SIGA's partner for international promotion of TPOXX, is the counterparty to the Canadian Contract and SIGA is responsible for the manufacture and delivery of oral TPOXX. In addition to the Canadian product delivery, SIGA also expects to make deliveries of oral TPOXX to the U.S. Government this month. As previously disclosed, SIGA expects to deliver $101.3 million of oral TPOXX to the U.S. Government by April 2021, with deliveries starting this month. These deliveries will be in connection with the recent option exercises under its 2018 Biomedical Advanced Research and Development Authority contract. In addition to the options recently exercised, SIGA's full 19C BARDA Contract has up to $414 million of procurement-related options remaining for future exercise.
FCAU

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09:15 EDT Fiat Chrysler appoints Paolo Carmassi as CEO of Comau - Fiat Chrysler Automobiles announces that Paolo Carmassi has been appointed CEO of Comau in preparation for its future as one of the world's leading global providers of Industry 4.0 enabling systems, products and services and its stock market listing. Alessandro Nasi will become the Company's Chairman. Carmassi joins Comau with significant experience in global high-technology business management. For the past four years, he has led Malvern Panalytical. Alessandro Nasi joined the Fiat Group in 2005, having begun his career working in banking and finance. He has held senior roles at Fiat Powertrain Technologies, the Engine and Powertrain division of Fiat Group and CNH Industrial, which manufactures agricultural machinery and construction equipment, where he serves as a member of the Board and is also Chairman of Iveco Defence Vehicles. He is also member of the Board of EXOR. As previously announced by FCA on 18 December 2019, shortly following the merger of FCA and Groupe PSA, the shareholding in Comau will be distributed for the benefit of the shareholders of the newly merged company.
OCGN

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09:15 EDT Ocugen Inc trading halted, news pending
UPS

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09:13 EDT UPS Foundation commits $3M to Gavi to expand last mile delivery network - The UPS Foundation and Gavi, the Vaccine Alliance, announced a commitment of $3M in new funding and in-kind logistics support spanning two years, provided by UPS and The UPS Foundation to Gavi. The new support will enable Gavi to continue to strengthen supply chain networks that deliver life-saving vaccines to children in the world's poorest countries, and expand coverage of essential childhood vaccines with the mission of eliminating childhood deaths from avoidable diseases. The UPS Foundation's contribution of $2M in cash and $1M in UPS in-kind services, combined with a match of $2M from the Gavi Matching Fund, results in a total of $5M toward an expansion of previous shared efforts by the organizations. The contribution will apply to Gavi's 2021 to 2025 strategic period. The Gavi Matching Fund was created in 2011 to encourage businesses to invest in global immunization.
SGH...

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09:12 EDT AMD COVID-19 HPC Fund to deliver supercomputing clusters to researchers - AMD (AMD) and technology partner Penguin Computing Inc., a division of SMART Global Holdings (SGH) announced that New York University, Massachusetts Institute of Technology and Rice University are the first universities named to receive complete AMD-powered, high-performance computing systems from the AMD HPC Fund for COVID-19 research. AMD also announced it will contribute a cloud-based system powered by AMD EPYC and AMD Radeon Instinct processors located on-site at Penguin Computing, providing remote supercomputing capabilities for selected researchers around the world. Combined, the donated systems will collectively provide researchers with more than seven petaflops of compute power that can be applied to fight COVID-19.
WWE

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09:11 EDT WWE launches free version of WWE Network - WWE unveiled the free version of WWE Network, the company's digital streaming service, unlocking a vast portion of its content library with more than 15,000 action-packed WWE titles now available for free, no credit card required.
ATHOF

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09:10 EDT Athabasca Oil announces renewal of credit facility - Athabasca Oil announces that it has completed the annual review of its credit facilities. The Company's banking syndicate has renewed the reserve-based facility until November 30, 2020. The credit facility has been reduced to $42M which reflects the currently outstanding letters of credit for long term transportation commitments and is secured by the Company's cash balances. The Company continues to pursue opportunities to access credit support offered by the Government of Canada during this uncertain economic environment created by the COVID-19 pandemic. Athabasca remains focused on maximizing corporate funds flow and maintaining strong corporate liquidity. As at May 31, 2020 the Company has cash and cash equivalents of approximately $330M inclusive of restricted cash. Athabasca maintains long-term optionality across a deep inventory of high-quality Thermal Oil projects and flexible Light Oil development opportunities.
HJLI

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09:10 EDT Hancock Jaffe Laboratories Inc trading resumes
CMTL

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09:09 EDT Comtech awarded contract upgrade worth over $1.3M - Comtech Telecommunications announced that its Location Technologies group, a division of Comtech's Commercial Solutions segment, has finalized a contract upgrade worth over $1.3 million supporting 5G Location services and other enhancements with a major U.S.-based mobile network operator. "This mobile network operator continues to add state-of-the-art location technology to its service offerings, which enhance performance and public safety for their customers," said Fred Kornberg, Chairman of the Board and CEO of Comtech Telecommunications. "Comtech Location Technologies has been selected for its end-to-end solution, which greatly enhances the operations and ease of use for application developers and end users."
ATCX

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09:09 EDT Atlas Technical Consultants wins $8M contract from TxDOT - Atlas Technical Consultants announced the award of a $8M contract from the Texas Department of Transportation, or TxDOT, for Construction Engineering and Inspection, or CEI, services. The newly awarded contract will support the TxDOT's Odessa District in West Texas. Atlas has delivered CEI services for TxDOT since 2015 and will continue to do so for the next four years under the terms of this new contract. Under TxDOT's oversight, Atlas will provide the day-to-day management of construction inspection, material testing, record keeping and documentation and overall project management for construction activities on strategically selected projects.
HCHC

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09:09 EDT HC2 Holdings announces carraige of NBCUniversal's LX Network - HC2 Broadcasting announced the launch of NBCUniversal Owned Television Stations' LX Network in 15 of HC2 Broadcasting's free, over-the-air TV stations across the United States, including Atlanta, Seattle and Detroit. The LX channel is currently available in a total of 43 U.S.-based markets, including NBC/Telemundo owned station markets, and will rollout to additional HC2 Broadcasting stations in the coming weeks.
LEAF

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09:08 EDT Leaf Group 's Society6 sees 'strongest' Memorial Day sale in history - Society6 announced it saw its strongest Memorial Day sale in the brand's history. The artist-driven online marketplace, featuring made-to-order products in home decor, art, apparel and accessories, saw triple digit growth, compared to last year's Memorial Day weekend, in key categories, including wall art and home decor. In early 2020, Society6 optimized its promotions process through a revamped merchandising model, transforming from flash sales to more strategic seasonal and departmental promotions. For Memorial Day, the marketplace featured department-specific deals targeting popular products and designs, and recently launched categories, such as outdoor and lifestyle. The brand will continue to utilize this enhanced merchandising strategy for upcoming seasonal sales and holiday promotions, including Father's Day, a summer outdoor furniture sale and fourth of July.
FB

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09:07 EDT Facebook to commit $10M to groups working on racial justice, Zuckerberg says - In a post late Sunday, Facebook CEO Mark Zuckerberg said the company is committing "an additional $10 million to groups working on racial justice." The CEO added that "I know that $10 million can't fix this. It needs sustained, long term effort. One of the areas Priscilla and I have personally worked on and where racism and racial disparities are most profound is in the criminal justice system. I haven't talked much about our work on this, but the Chan Zuckerberg Initiative has been one of the largest funders, investing ~$40 million annually for several years in organizations working to overcome racial injustice. Priscilla and I are committed to this work, and we expect to be in this fight for many years to come. This week has made it clear how much more there is to do." Reference Link
NVUS

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09:07 EDT Novus Therapeutics announces OP0201 trial results, engages financial advisor - Novus Therapeutics announced topline results from the company's exploratory phase 2a clinical trial of OP0201 in acute otitis media. Study C-006 was a phase 2a, single center, double-blind, randomized, placebo-controlled, parallel group clinical trial to assess the safety, tolerability, and efficacy of 20 mg per day intranasal OP0201 as an adjunct therapy to oral antibiotic in the treatment of acute otitis media in infants and children six to 24 months of age. Subjects were treated twice-daily for 10 days and followed up to one month. Post-randomization visits occurred between days 4-6, days 12-14 and days 28-30. The primary efficacy endpoints included resolution of bulging tympanic membrane at visit 2 and resolution of middle ear effusion at visit 3. The company also today announced that the Board of Directors has initiated a process to explore strategic options intended to maximize shareholder value. The company has engaged financial advisors to assist in the review and evaluation of strategic options. Such options may result in a financing to continue development of the surfactant-based nasal aerosol, a company sale, merger, asset sale, in-license, out-license, or other business transaction. There can be no assurance that the exploration of strategic options will result in the company entering or completing any transaction. Novus does not intend to make any further disclosures regarding this process unless and until a specific course of action is approved by the board.
PVCT

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09:06 EDT Provectus presents data from metastatic uveal melanoma cohort of Phase 1 study - Provectus announced that updated data from the Company's expansion cohort of patients with uveal melanoma metastatic to the liver in its Phase 1 cancers of the liver "basket study" of investigational autolytic cancer immunotherapy PV-10 were presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program, held online May 29-31, 2020. Lead author, Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine of The University of Texas MD Anderson Cancer Center, is also the lead principal investigator of this single-center cohort at MDACC. Small molecule-based PV-10 is administered either by cutaneous intratumoral injection to superficial melanoma and non-melanoma skin cancer tumors or by percutaneous IT injection to visceral primary and metastatic hepatic tumors. By targeting tumor cell lysosomes, PV-10 treatment may yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells and a T cell mediated immune response against treatment refractory and immunologically cold tumors. Adaptive immunity can be enhanced by combining immune checkpoint blockade with PV-10.4 This ongoing, multi-center, open-label, Phase 1 study is evaluating the safety, tolerability, and efficacy of PV-10-based treatment in patients with solid tumors metastatic to the liver. PV-10 is administered to one or more designated hepatic tumors. Response assessments using European Association of the Study of the Liver (2D-EASL) criteria are performed at Day 28, and then every three months. Patients with additional injectable tumors and/or unresponsive injected tumors may receive additional PV-10 after Day 28. This study is now enrolling patients into a single-center cohort at MDACC of up to 25 uveal melanoma patients with hepatic metastases. Eligible patients may also receive standard of care CB during and after treatment with PV-10. Highlights from the Presentation at ASCO: Baseline characteristics: % men; median age of 62 years. Treatment summary: 3 patients received single-agent PV-10; 3 patients received the combination of PV-10 and an anti-PD-1; 8 patients received the triplet combination of PV-10, an anti-CTLA-4 agent and an anti-PD-1 agent. Safety: Adverse events were consistent with each agent's established pattern single agent and/or combination settings. AEs attributed to PV-10 were transient and included Grade 3/4 transaminitis that resolved within 72 hours, injection site pain, photosensitivity, and pink discoloration of skin, urine or feces. AEs attributed to CB included nausea, decreased white blood cell count, and fatigue. Injected target lesion efficacy. 8% complete response, 29% partial response, 37% overall response rate. 46% stable disease, 83% disease control rate. Overall survival: CB-naive: median OS of 11 months; 5 patients alive at 6.4-24.7 months. CB-refractory: OS of 11.4 months; 2 patient alive at 9.4 and 17.5 months. Single-agent PV-10: OS of 7.9 months; 1 CB-naive patient alive with PR at 24.7 months.
CMTL

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09:06 EDT Comtech awarded $1.6M in orders from U.S. Army - Comtech Telecommunications announced that during its third quarter of fiscal year 2020, its Mission-Critical Technologies group, which is part of Comtech's Government Solutions segment, was awarded orders consisting of $1.6 million of additional funding on the previously announced three-year $124.2 million contract to provide ongoing sustainment services for the AN/TSC-198A SNAP, and baseband equipment. The company said in a release, "SNAP terminals provide quick and mobile satellite communications capabilities to personnel in the field. The contract has been funded $88.6 million to date."
FFWM OPB

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09:04 EDT First Foundation appoints Kevin Thompson as CFO - First Foundation (FFWM) announced the appointment of Kevin Thompson as Executive Vice President, CFO. Prior to joining First Foundation, he was the Executive Vice President, CFO and Treasurer for Opus Bank (OPB).
MARK

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09:04 EDT Remark Holdings partners with Hanvon Technology - Remark Holdings announced its partnership with Hanvon Technology, a publicly listed Chinese systems integrator, won the Phase 2 implementation of China Mobile's contract for the transformation of its 17,800 corporate stores into smart retail stores. The project is expected to be delivered over the next two years. Phase 1 includes the upgrade of more than 17,800 stores across the entire country and is valued at $50M to Remark. The second phase of the project will deliver an additional several million dollars to Remark resulting from a multi-year recurring software license for the new software application modules.
FAT

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09:03 EDT Fatburger, Buffalo's Express debut in Texas - FAT Brands announces the opening of a co-branded Fatburger and Buffalo's Express in North Richland Hills, TX. The grand opening of the restaurant, the first to open in the Lone Star State, will be on Monday, June 1, 2020.
CI

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09:02 EDT Cigna expands, extends COVID-19 relief efforts - Effective immediately, Cigna is expanding its support for customers during this unprecedented COVID-19 pandemic by eliminating cost-sharing for all primary care, specialty care and behavioral health care in-office or telehealth visits for COVID-19 and non-COVID-19 care. This expansion applies to all U.S. customers enrolled in Cigna's Medicare Advantage and Individual and Family Plans, including those sold on the Individual Marketplace. Additionally, Cigna is making enhancements to its Medicare Advantage meal plan benefits to further protect customers during this pandemic and underscore the company's continued commitment to enabling access to simple, affordable and predictable health care.
EXPI

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09:02 EDT eXp World Holdings appoints Felicia Gentry to board of directors - eXp World Holdings announced the appointment of Felicia "Fee" Gentry to the company's board of directors, effective May 28, 2020. Gentry currently is an eXp Realty agent in Texas, and co-chair and one of the original founders of ONE eXp, eXp Realty's initiative for diversity and inclusion.
ITRM

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09:00 EDT Iterum Therapeutics PLC trading resumes
NVUS

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09:00 EDT Novus Therapeutics trading resumes
REKR

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08:55 EDT Rekor Systems announces venture to launch - Rekor Systems and Cygnet Infotech announced the launch of a standalone company, to be named ROKER, pronounced "rock-er," to automate parking enforcement and enable higher revenue recovery for both public safety institutions and private businesses alike. The companies said in a release, "Rekor and Cygnet are each contributing their respective technology stacks in exchange for equity in ROKER, with Rekor receiving 50% of the venture. The companies joined forces to develop and launch ROKER, a new approach that provides an end-to-end solution for simplified parking permitting, electronic citation management and parking enforcement for consumers, businesses and government. The solution is enabled by Rekor Systems' vehicle recognition solutions and Cygnet's blockchain and engineering solutions. Sachin Bedi, CEO of Cygnet Infotech, will transition to ROKER and serve as its CEO. ROKER will immediately begin raising a Series A round of funding, with the advisement of Cooley LLP, who also helped them finalize formation in mid-May. Cooley advises 6,000+ innovative, high-growth companies from pre-formation founder teams to many of the most sophisticated tech companies in the world."
GILD

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08:53 EDT Gilead slips 2% after announcing results of trial in moderate COVID-19 patients - Gilead Sciences shares are down $1.60, or 2%, to $76.23 in pre-market trading after the company announced earlier topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia.
IRT

Hot Stocks

08:52 EDT Independence Realty Trust provides business update - "IRT remains committed to working with our residents in order to support retention and sustain portfolio occupancy." said Scott Schaeffer, chairman and CEO of IRT. "As of May 31st, same store occupancy was 93.5% and we have collected 98.1% of May rent receipts, including 1.2% in deferred payment plans. These figures are a result of our efforts to actively engage with our current residents and attract new residents to our communities. In particular, we improved the quality and availability of virtual tours, which has translated into a 45% conversion rate to signed applications in May, representing a year-over-year increase of 15 percentage points." Schaeffer continued, "We have the financial flexibility to act decisively, as we are prepared to participate in an eventual market recovery. Our total liquidity position is approximately $248 million as of May 31st, which includes unrestricted cash, as well as additional capacity through our unsecured line of credit and remaining proceeds from the forward equity raise. IRT is well-positioned to manage the impact of this pandemic and continues to adhere to strict safety measures, as all of our states in which we have properties have begun to ease restrictions. We remain confident in our resilient portfolio and sustainable business model."
SIBN

Hot Stocks

08:51 EDT SI-Bone announces $40M debt re-financing - SI-BONE announced that it has re-financed its existing credit facility. Proceeds from the new $40M, five-year term loan will be used to repay SI-BONE's prior $40M term loan obligation in its entirety. SI-BONE's new term loan bears interest at a rate per annum equal to 9.40% plus the greater of the 1-month LIBOR Rate or 0.33%, or 9.73% in total based on current interest rates, payable monthly in arrears. The new loan has a 60 month term, with an interest-only period of 36 months, and 24 months of straight-line amortization. Furthermore, the terms of the re-financing, including the financial covenants of the new loan, will provide SI-BONE with additional operating flexibility going forward. The new facility was provided through Solar Capital Partners. Armentum Partners served as financial advisor to SI-BONE on the transaction.
LXXGF

Hot Stocks

08:50 EDT Lexagene Holdings provides update on commercializing pathogen detection system - LexaGene Holdings provided the following update on the Company's development plans of its flagship pathogen detection platform for the human clinical, veterinary diagnostics, and food safety sectors. As previously announced, LexaGene has recently placed a pre-commercial unit of its LX Analyzer in a major US hospital laboratory for the testing of COVID-19 and has submitted its plan to the FDA for Emergency Use Authorization. The Company also recently gave an interview to expand on this news. To support ramping up of final improvements to the pre-commercial system and manufacturing process, LexaGene has recently hired two additional members to the product development team in the areas of software and systems engineering. The Company also plans to hire sales staff in the summer in advance of the commercial launch in the fall. LexaGene is in the final stages of selecting a contract manufacturer to assist beyond the Company's in-house manufacturing capabilities in scaling up production of its analyzers in the fall to help meet the demand of testing needs in various markets. As is standard practice, until the FDA grants LexaGene's instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as Research Use Only and cannot be used for human clinical diagnostics. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 at this time.
UPS

Hot Stocks

08:49 EDT UPS matches offsets of carbon neutral shipments in June - UPS announced the company will commemorate World Environment Day on June 5 by matching the carbon offsets of all packages shipped via its carbon neutral program during the month of June. UPS carbon neutral counterbalances the estimated carbon impact of each shipment by purchasing certified carbon offsets. To participate, shippers pay a small fee to offset the carbon footprint of shipping their packages then UPS will match these offsets throughout June. This is essentially doubling the shipper's impact thereby allowing the shipper to potentially net out "carbon negative" in June. The per package flat rate price for the optional service is $0.05 for UPS ground services and $0.20 for UPS Next Day Air, UPS 2nd Day Air(R) and UPS 3 Day Select services.
CETX

Hot Stocks

08:48 EDT Vicon releases thermal body temperature measurement camera - Vicon, a subsidiary of Cemtrex, announced the release of its new Thermal Body Temperature Measurement Camera, the V1100B-THM-TEMP. The camera is designed to help organizations of all types to minimize the risk of reopening their facilities during the COVID-19 global pandemic. Designed to help businesses screen people for elevated temperatures, the V1100B-THM-TEMP thermal camera provides contactless body temperature detection for individual or multiple people with a stunning accuracy of +/-0.54 degrees F. The powerful, dual-spectrum camera alerts operators to critical events, such as a high-temperature detection or individuals who are not wearing a mask and takes a snapshot of the person's face so operators can quickly identify the individual for further screening and verification.
CVET

Hot Stocks

08:47 EDT Covetrus appoints Arman Samani as chief product officer - Covetrus has named Arman Samani to the role of chief product officer. The company said in a release, "Arman will be responsible for developing and driving the vision, roadmap and innovation strategy across Covetrus software products to fuel the company's future growth. Arman will lead global product teams, reporting into Georgia Wraight, executive vice president and president, Global Technology Solutions. Arman was most recently the chief operating officer of AdvancedMD."
MTBC

Hot Stocks

08:47 EDT Exscribe Orthopaedic Healthcare Solutions selects MTBC Force - MTBC announced the signing of a cooperative agreement with Exscribe Orthopaedic Healthcare Solutions. As part of the agreement, MTBC Force will provide custom software development services as well as give Exscribe clients the opportunity to access MTBC's sophisticated, end-to-end Revenue Cycle Management solutions. As part of this collaboration, MTBC Force will provide Exscribe clients with a dedicated team of orthopaedic-specific medical billers, specifically those trained in Exscribe's EHR software. In addition, MTBC's team of software developers will assist Exscribe's development team in bringing to market new and innovative solutions to complement their existing products and services. The marketing and sales teams of both companies will work together to co-launch this offering to Exscribe's physician client base.
CANN

Hot Stocks

08:45 EDT General Cannabis announces multi-million strategic equity investment - General Cannabis announced that it has reached an agreement that will bring up to $3M in strategic growth capital to the company. The investment will be funded by Hershey Strategic Capital LP and Shore Ventures III, LP, entities led by managing member Adam Hershey. The investment is another important step in General Cannabis' Colorado-based expansion strategy. Over the last two months, General Cannabis became only the second publicly traded cannabis company approved by the State of Colorado's Marijuana Enforcement Division to acquire licensed cultivation, manufacturing and retail cannabis operations throughout the state of Colorado. Shortly thereafter, the company closed its acquisition of Boulder, Colorado-based SevenFive Farm, a 17,000 square feet light deprivation greenhouse. Last week, General Cannabis was conditionally approved by the MED, subject to local approval, to close its next planned acquisition-Pueblo, Colorado-based Cannasseur, a vertically integrated company that commenced operations in 2013 and operates a recreational retail dispensary, a 12,000 square foot light deprivation greenhouse and a manufacturing facility that produces Dabtek, a product line of infused concentrates. General Cannabis' Next Big Crop division continues to operate as an industry leader in the application, design, buildout and operation of cultivation facilities, having worked with over 100 cultivation facilities across the country. Hershey Strategic Capital LP and Shore Ventures III, LP are purchasing, in two tranches, $2.185 million of common stock and warrants. The purchase price of the common stock is $0.3983 per share, representing a 10% discount to the 30-day volume weighted average price as of May 22nd. Along with the shares of common stock, the investors also are receiving warrants for a number of shares equal to 75% of the total number of shares purchased by the investors at an exercise price of $0.5565 per share, which is a 5% premium to the company's closing price on May 22nd. The first tranche of $800,000 closed on May 29th, 2020, and the second tranche of $1.385 million is expected to close on or before June 5th, 2020. The company anticipates that it will submit Mr. Hershey for approval as an individual suitable investor to the MED, and the company will close an additional $815,000 of capital with the investors on the same terms if Mr. Hershey is deemed suitable.
HJLI

Hot Stocks

08:45 EDT Hancock Jaffe Laboratories announces intent to merge with Catheter Precision - Hancock Jaffe Laboratories announced that the Company has signed a non-binding letter of intent to merge with Catheter Precision, a private medical device company focused on cardiovascular diseases, including heart arrythmias. The company said in a release, "Catheter Precision has developed a software imaging system called VIVO, an initial version of which is FDA cleared and CE marked, and that produces a 3-D virtual image of the heart on a computer monitor for the purpose of accurately identifying and targeting the anatomical location of ventricular arrhythmias for catheter ablation therapy. Ventricular arrhythmias are commonly associated with sudden cardiac death, which accounts for approximately 325,000 fatalities in the U.S. each year. Details of the proposed transaction and a time frame for completing the proposed merger will be announced if and when the parties execute a definitive agreement. The parties have entered into a period of exclusivity in order to negotiate the proposed transaction in good faith. Following the definitive merger agreement, the transaction will require approval by Nasdaq, and Hancock Jaffe shareholders."
GILD

Hot Stocks

08:44 EDT Gilead announces topline results from Phase 3 SIMPLE trial - Gilead announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. This open-label study evaluated 5-day and 10-day courses of the investigational antiviral remdesivir plus standard of care, versus standard of care alone. The study demonstrated that patients in the 5-day remdesivir treatment group were 65% more likely to have clinical improvement at Day 11 compared with those in the standard of care group. The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance. No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks. Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes COVID-19. Outside of Japan, remdesivir is an investigational, unapproved drug. The FDA granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19; the authorization is temporary and does not take the place of the formal new drug application submission, review and approval process. In this study, hospitalized patients with confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels were randomized to receive open-label remdesivir for five or 10 days or standard of care alone. The primary endpoint was the clinical status as assessed by a seven-point ordinal score at Day 11, ranging from hospital discharge to increasing levels of oxygen and ventilatory support to death. The secondary study objective was the rate of adverse events in each remdesivir treatment group compared with standard of care. At Day 11, a higher proportion of patients in the five-day treatment group achieved improvement in clinical status versus the standard of care group, achieving statistical significance for a one-point improvement in ordinal scale. In addition, non-statistically significant increases in clinical worsening or death were observed in the standard of care only group compared with the remdesivir groups. Remdesivir was generally well-tolerated in both the five-day and 10-day treatment groups. The most common adverse events occurring in more than 5% of patients in both treatment groups were nausea, diarrhea and headache.
CEI

Hot Stocks

08:44 EDT Camber Energy, Viking Energy amend merger agreement - Camber Energy and Viking Energy Group announced that they have entered into an amendment to the definitive Agreement and Plan of Merger signed by the parties on February 3. The companies said in a release, "Details regarding the Merger, along with a copy of the Merger Agreement, were included in Viking's and Camber's Current Reports on Form 8-K filed on February 5, with the Securities and Exchange Commission, and are available under "Investors" at www.vikingenergygroup.com and www.camber.energy. Terms were also summarized in press releases filed by each company on the same date. The amendment (i) modified and clarified the mechanisms pursuant to which Camber's and Viking's post-combination percentage of Camber would be determined; (ii) placed a cap of 5% (up or down) on the adjustment mechanism; (iii) corrected a prior error in the Merger Agreement relating to such calculation; and (iv) included a prohibition on either party raising capital from the other party's existing shareholders without prior written consent. As disclosed previously, the planned merger contemplates Camber issuing newly-issued shares of common stock to the equity holders of Viking in exchange for 100% of the outstanding equity securities of Viking by means of a reverse triangular merger in which a newly formed wholly-owned subsidiary of Camber will merge with and into Viking, with Viking continuing as the surviving corporation and as a wholly-owned subsidiary of Camber after the Merger. If the closing of the Merger occurs (the "Closing"), the Viking equity holders prior to the Merger will own approximately 80% of Camber's issued and outstanding common stock immediately after the Merger, and the Camber equity holders prior to the Merger shall own approximately 20% of Camber's issued and outstanding common stock immediately after the Merger, subject to adjustment mechanisms set out in the Merger Agreement, and in each case on a fully-diluted, as-converted basis as of immediately prior to the Closing (including options, warrants and other rights to acquire equity securities of Viking or Camber), but without taking into account any shares of common stock issuable to the holder of Camber's Series C Preferred Stock upon conversion of the Series C Preferred Stock. Completion of the Merger is subject to a number of closing conditions, as set out in the Merger Agreement. Specifically, the Merger Agreement, as amended, provides that the Camber Percentage is to be adjusted as follows: (i) for each (A) $500,000 in Camber unencumbered cash (without any associated debt) available for use by the combined company after the effective time of the Merger, which comes from equity sold by Camber for cash from February 3, 2020, through the Effective Time, which is not contingent or conditional upon the closing of the Merger, or (B) $500,000 in other unencumbered assets acquired by Camber prior to closing without increasing Camber's liabilities, the Camber Percentage will increase by an incremental 0.5%; and (ii) for each additional $500,000 in Viking unencumbered cash (without any associated debt) for use by the Combined Company after the Effective Time which is not contingent or conditional upon the closing of the Merger, in excess of $500,000, which comes from equity sold by Viking for cash from February 3, 2020 through the Effective Time, the Camber Percentage will decrease by an incremental 0.5%. The aggregate Camber Percentage Increase or Camber Percentage Decrease shall not exceed 5%."
RZLT

Hot Stocks

08:43 EDT Rezolute present RZ358 clinical data-validated in PK, glycemic response in HI - Rezolute announced that it has validated pharmacokinetic and pharmacodynamic models of its lead clinical asset, RZ358. Phase 2a data in adult and pediatric patients with congenital hyperinsulinism were shown to be predicted by the constructed models, and demonstrated that RZ358 raises glucose into a normal target range in a disease- and exposure-dependent manner, consistent with its known allosteric mechanism of action. The data were accepted as an oral presentation at the Pediatric Endocrine Society 2020 Annual Meeting, held virtually. A Population PK and subsequent empirical exposure-response model were constructed using pooled PK, PD, and continuous glucose monitoring data from all clinical studies conducted with RZ358. Pediatric simulations were performed using allometrically scaled PK parameters derived from adult data. The clinical data were well-described by the model, which was in turn used to characterize results from two completed Phase 2a open-label studies in adult and pediatric patients with congenital HI. In these studies, serial measurements of RZ358 and extended CGM were collected before and after intravenous administration of single and dual doses of RZ358, respectively. PK/PD modeling was performed to describe RZ358 levels and exposure-response relationships in the CHI population. Patient data was consistent with PK/PD models. First, empirical glucose levels were well-described in the model as a function of RZ358 levels, which were in turn dose-proportional and well-described by the PK model. RZ358's approximately 15-day half-life demonstrates the potential for once- to twice-monthly dosing. Observed pediatric PK fell within the ~90% prediction interval of simulated data, indicating that drug levels in children can be extrapolated from adults. Second, RZ358's exposure-response profile was disease state-dependent: RZ358 resulted in a sustained ~50% increase in glucose into a target range of 70-180 mg/dL in patients with pronounced baseline hypoglycemia, whereas the subset of patients with relatively normal overall baseline blood glucose remained within their starting normoglycemic range. Lastly, the model demonstrated an exposure-response relationship; importantly, target concentrations were well-characterized and are predicted to be achieved at clinically-relevant dose regimens that are being tested in an ongoing Phase 2b study in pediatric and adult patients with congenital HI.
GSM

Hot Stocks

08:41 EDT Ferroglobe announces 'unqualified' audit opinion including going concern - Ferroglobe filed its Annual Report on Form 20-F, the annual SEC filing required of foreign private issuers with securities listed on U.S. exchanges on May 29, 2020. The filing includes audited financial statements as of and for the year ended December 31, 2019 and is available at www.ferroglobe.com and www.sec.gov. As reflected therein, the Company had an operating loss of $355.6 million and a net loss of $285.6 million for the year ended December 31, 2019. As of that date, the Company had cash and cash equivalents of $123.2 million, of which $28.3 is restricted. The Company's financial statements are accompanied by an unqualified audit opinion from its independent auditors. However, the opinion does include a going concern explanatory paragraph. This is attributable in part to the uncertainty created by the COVID-19 pandemic and the limited visibility of the impact on the business. As of the date of the issuance of the financial statements, the COVID-19 pandemic has not had a material effect on the Company's liquidity or financial position. Management continues to monitor the impact the pandemic is having on the Company and the economies in which the Company operates. Based on current visibility and scenario testing, our analysis supports an expectation that the Company will have sufficient cash to continue to operate through the next twelve months. The audit opinion's going concern explanatory language is also due in part to provisions of the Indenture governing the Company's outstanding Senior Notes that, in the event of a change of control, would require the Company to offer to redeem its outstanding Senior Notes at 101% of par value plus any accrued and unpaid interest. Management believes a change of control as defined in the Indenture is unlikely to occur, yet the matter is beyond the Company's control. If such a change of control were to occur, the Company may not have sufficient financial resources available to satisfy all of its obligations.
XPER TIVO

Hot Stocks

08:41 EDT Xperi, TiVo announce completion of merger, TIVO no longer listed for trading - Xperi Holding announced that it has completed the merger of Xperi (XPER) and TiVo (TIVO), forming a "unique digital entertainment technology platform and one of the industry's largest and most diverse intellectual property licensing platforms." Xperi said in a release, "The combined company will operate a number of industry leading technology brands, including the TiVo brand for consumer-facing media and entertainment products. The scale achieved through the combined company will also enable the combined company to invent, develop and deliver technologies that enable extraordinary experiences, ultimately making entertainment more entertaining and smart devices even smarter for tens of millions of individual consumers. Additionally, the combined company will continue to invest in groundbreaking technologies that expand its leading intellectual property and bring new and exciting inventions to is licensing customers. With a shared track record of creating value through intellectual property licensing, the combined IP portfolio spans more than 11,000 patents and applications, with recurring subscriber-based IP revenue providing important stability and diversification for the business. Xperi Corporation and TiVo Corporation are now combined under Xperi Holding Corporation. From June 2, the shares of the combined company will continue to trade on the Nasdaq Global Select Market under the Xperi ticker symbol XPER. As previously announced, the shares held by of TiVo Corporation and Xperi Corporation stockholders will be converted into the shares of the new parent company, Xperi Holding Corporation, at their respective exchange ratios. TiVo common stock previously traded under the ticker symbol TIVO and, as of June 1, is no longer listed for trading."
REZI

Hot Stocks

08:41 EDT Resideo names Phillip Theodore as Chief Transformation Officer - Resideo Technologies announced that Phillip Theodore will join the company as chief transformation officer, effective June 1. Phillip Theodore is the founder and managing director of Ironhawk Advisory Group, a boutique investment advisory service firm. He previously served as interim CEO of the Consumer Division of Artesyn Embedded Technologies.
EQR

Hot Stocks

08:40 EDT Equity Residential provides quarter-to-date statistics for Q2 - Equity Residential provided various quarter-to-date, or QTD, statistics related to its residential same store operations for Q2. The company reports QTD new lease change down 4.8%, renewal rate achieved up 1.5% and blended rate down 0.7%. The company continues to experience a recovery in demand with initial leads, traffic and applications now in-line with the same period last year. This increased activity has led to improvements in physical occupancy, which is 94.9% quarter to date. During May, residential cash collections remained consistent with April .
ANIP

Hot Stocks

08:39 EDT ANI Pharmaceuticals provides update regarding Cortrophin Gel sNDA filing - ANI Pharmaceuticals announced that it continues to make progress toward addressing items identified in the Refusal to File letter received from the FDA relating to its Cortrophin Gel sNDA filing. "The most efficient path forward is to concentrate efforts on the preparation of the resubmission of the sNDA," commented ANI Pharmaceuticals Interim CEO Patrick Walsh. "As such, we decided to forego a request for a Type-A meeting with the FDA and respond to all observations as part of the comprehensive resubmission of the sNDA. To further support our efforts, we have retained a prominent regulatory consulting firm to support the company's re-filing plan, including a comprehensive review of the entire application before re-submission." The company plans on refiling its sNDA for Cortrophin Gel with the FDA upon completion of the review process.
SVMK

Hot Stocks

08:38 EDT SurveyMonkey announces return to work offering for enterprise customers - SurveyMonkey announced its latest return to work offering for enterprise customers, including leadership check-in survey templates, HIPAA-compliant features for health monitoring surveys, and professional services. The solution will give operational leaders a deeper and more comprehensive understanding of the health and well-being of employees, and help organizations turn feedback into an action plan for their employees' safe return to work.
ITRM

Hot Stocks

08:37 EDT Iterum Therapeutics evaluating corporate, strategic, financial alternatives - Based on the trial results, Iterum Therapeutics is evaluating its corporate, strategic and financial alternatives with the goal of maximizing value for its stakeholders while prudently managing its remaining resources. These alternatives could potentially include the licensing, sale or divestiture of the company's assets or proprietary technologies, a sale of the company, a merger or other business combination, another strategic transaction involving the company, restructuring activities, winding down of operations, dissolving and liquidating assets or seeking protection under bankruptcy laws. The evaluation of corporate, strategic and financial alternatives may not result in any particular action or any transaction being pursued, entered into or consummated, and there is no assurance as to the timing, sequence or outcome of any action or transaction or series of actions or transactions.
ITRM

Hot Stocks

08:37 EDT Iterum says Phase 3 trial of sulopenem did not meet primary endpoint - Iterum Therapeutics announced that sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae 2 clinical trial in complicated urinary tract infection. The primary U.S. Food and Drug Administration endpoint was overall clinical and microbiologic response on Day 21 in the micro-MITT population as evaluated using a 10% non-inferiority margin. The randomized, multi-center, double-blind SURE 2 clinical trial enrolled 1,395 patients to measure the efficacy, tolerability, and safety of IV and oral sulopenem for the treatment of cUTI in adults. Patients were randomized to receive either IV sulopenem once daily for a minimum of five days followed by oral sulopenem twice daily to complete seven to ten days of treatment, or IV ertapenem once daily for a minimum of five days followed by either oral ciprofloxacin or, for quinolone resistant isolates, amoxicillin-clavulanate twice daily. Responder rates at the test of cure visit for sulopenem were 67.8% and for ertapenem were 73.9% with a difference of -6.1%. The difference in response rates was driven almost entirely by higher rates of asymptomatic bacteriuria on sulopenem relative to ertapenem, only evident at the test of cure visit; the rates of patients receiving additional antibiotics or with residual cUTI symptoms was similar. Clinical response at the test of cure in the Modified Intent to Treat patient population and Clinically Evaluable patient population sulopenem vs ertapenem: 0.4% was similar. The outcome at other secondary endpoints was also similar, including the overall response at the end of therapy visit at Day 10.
ANIX

Hot Stocks

08:37 EDT Anixa Biosciences, OntoChem synthesize four potential COVID-19 compounds - Anixa Biosciences announced that the company, together with partner OntoChem GmbH, has synthesized four potential Covid-19 compounds that will advance to biological assay testing. Anixa and OntoChem announced their partnership on April 20 and announced discovery of its first potential Covid-19 candidate two weeks later on May 4.
ERI

Hot Stocks

08:36 EDT Eldorado Resorts to open 3 Missouri casinos, 2 Iowa casinos - Eldorado Resorts announced that it will resume operations at Isle of Capri Casino Hotel Boonville, Isle of Capri Casino Kansas City and Lumiere Place Casino & Hotels in Missouri and at Isle Casino Hotel Bettendorf and Isle Casino Hotel Waterloo in Iowa today, Monday, June 1. The company said in a release, "With today's reopenings in Missouri and Iowa, 11 of Eldorado's 23 casino entertainment facilities have resumed operations following the suspension of operations in March. Eldorado is implementing procedures that limit gaming capacity and ensure proper social distancing at its Missouri properties and is adhering to regulations imposed by Iowa Governor Kim Reynolds that limit gaming capacity to 50% of prior levels with proper social distancing regulations in place."
VJET

Hot Stocks

08:36 EDT EIB, Voxeljet expand partnership to bring 3D printing into series production - Voxeljet announced that the company has expanded its partnership with the European Investment Bank to bring 3D printing into series production. European Investment Bank, or EIB, and Voxeljet further expanded their partnership to bring, among other things, 3D printing into series production Next EUR5M under the venture debt deal signed with the EIB in 2017 now expected to be disbursed in June with a bullet repayment after five years. Without the commitment of the EIB, the development of VJET X would not have been possible in this form. A leading German car maker is the first customer and plans to use the systems to mass-produce new conformal cooling components to increase the efficiency of its vehicles. Voxeljet is currently developing a large, high-speed polymer sintering 3D printer for the series production of all kind of plastic polymer parts The finance covenants in the finance contract with the EIB were amended to replace the total net financial debt to EBITDA ratio with a minimum cash/cash equivalents requirement.
RVNC MYL

Hot Stocks

08:35 EDT Revance, Mylan to advance development program for Botox biosimilar - Revance Therapeutics (RVNC) and Mylan N.V. (MYL) announced Mylan's decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to BOTOX and BOTOX Cosmetic. The companies said in a release, "Feedback obtained from the FDA during a Biosimilar Initial Advisory Meeting, or BIAM, held in February 2019 indicated that the 351(k) regulatory pathway for an onabotulinumtoxinA product is viable. Based on this meeting, along with the results from additional characterization and analysis completed by Revance, the two companies are now moving forward with the development program. Mylan and Revance signed a collaboration and license agreement in February 2018 for the development and regulatory approval of a biosimilar to BOTOX, to be followed with commercialization by Mylan in the U.S., Europe and applicable markets throughout the rest of the world. The agreement included an upfront payment of $25 million to Revance. In August 2019, the companies amended the agreement to include an additional one-time payment of $5 million to extend the period in which Mylan could choose to continue its collaboration and license agreement to develop Revance's biosimilar to BOTOX. With Mylan's decision to move forward with the development program announced today, a payment of $30 million is now payable to Revance by Mylan. Furthermore, the collaboration and license agreement also provides for an additional $70 million in milestone payments, contingent upon the achievement of further clinical and regulatory milestones. Additionally, per the agreement, Revance is eligible to receive sales target milestone payments and royalties in all relevant markets."
TRWH

Hot Stocks

08:35 EDT Twin River Worldwide to open nearly entire portfolio of operating casinos - Twin River Worldwide announced the reopening of its Dover Downs Hotel and Casino in Dover, DE effective June 1st. The Company also announced that it plans to reopen its two casinos in Rhode Island, including its flagship Twin River Casino Hotel, on June 8th, at which time over 90% of the company's current portfolio will have resumed operations. This announcement follows the successful reopening of the Hard Rock Hotel and Casino Biloxi on May 21st. The company has been encouraged by the strong initial results of its operations at Hard Rock Biloxi, which points to strong pent-up demand in regional markets. Through the first ten days of operations, this property experienced slot and table win results that were up approximately 30% and 150% compared to the same period in the prior year, respectively. As part of Twin River's overall COVID-19 reopening plan, the company has committed to meeting or exceeding all guidelines established by the CDC. As such, the company has implemented property-specific comprehensive health and safety protocols, developed in close consultation with applicable state regulators and public health officials in local jurisdictions. At Dover Downs, the company reopened with 30% of capacity which will allow for approximately 950 VLT machines to be in operation. Table games and the hotel will not be opened in the first phase of reopening. In Rhode Island, the company will initially open to invited guests with 1,570 VLTs available at Twin River Casino, and approximately 375 VLTs at Tiverton Casino Hotel. Table games and the hotels will not be open in the initial re-opening phase; however, stadium gaming positions, with appropriate social distancing, will be open to provide customers with a live dealer experience. The company also announced today that it believes its previously announced acquisition of Isle of Capri Kansas City in Missouri and Lady Luck Vicksburg in Mississippi, both of which have resumed operations, will close in early July, pending Missouri regulatory approval.
CGIX

Hot Stocks

08:33 EDT Cancer Genetics: 'Substantial doubts' about ability continue as going concern - The company said, "The Company filed its Annual Report on Form 10-K for the year ended December 31, 2019 last Friday with the Securities and Exchange Commission. The 2019 audited financial statements contain an explanatory paragraph regarding the Company's ability to continue as a going concern in the audit opinion from its independent registered public accounting firm. See further discussion in Note 2 to the Company's consolidated financial statements included in the Annual Report on Form 10-K. The Company also disclosed in Item 9 to Form 10-K it had concluded that internal controls over financial reporting was ineffective for the year ended December 31, 2019 resulting in the Company reporting deficiencies that were considered material weaknesses." In the filing, the company said, "For the twelve month period ended December 31, 2019, the Company had a net loss from continuing operations of $6.9 million, had cash used in continuing operations of $3.2 million and $7.3 million in revenues from the Discovery Business. No assurances can be given as to whether the Company will ever be profitable, and there are substantial doubts about the Company's ability to continue as a going concern."
EQIX BCE

Hot Stocks

08:32 EDT Equinix acquires 13 data centers across Canada from BCE for $750M in cash - Equinix (EQIX) announced it has entered into a definitive agreement to purchase a portfolio of 13 data centers across Canada from BCE (BCE) for $750M in an all-cash transaction. The 13 data center sites, which represent 25 Bell data center facilities, are expected to generate approximately $105M annualized revenue which represents a purchase multiple of approximately 15x EV / adjusted EBITDA. The acquisition is expected to close in 2H 2020, subject to customary closing conditions including regulatory approval, and it is expected to be immediately accretive to Equinix's adjusted funds from operations per share upon close, excluding integration costs.
AYTU

Hot Stocks

08:32 EDT FDA grants EUA for COVID-19 test that Aytu BioScience distributes - Aytu BioScience announced the FDA has granted emergency use authorization, or EUA, for the COVID-19 IgG/IgM Rapid Test Cassette distributed by the company. This is only the fourth lateral flow COVID-19 rapid serology test authorized by the FDA. Additionally, more than 1.4 million COVID-19 IgG/IgM rapid tests have been delivered to the company's warehouse in San Diego and are available for distribution. EUA of the COVID-19 IgG/IgM Rapid Test Cassette was granted by the FDA on May 29 to Healgen Scientific, the U.S. subsidiary of manufacturer Zhejiang Orient. Aytu BioScience announced a U.S. distribution agreement to distribute the Zhejiang Orient rapid test on March 10.
AYTU

Hot Stocks

08:30 EDT Aytu BioScience announces Emergency Use Authorization of COVID-19 rapid test - Aytu BioScience announced the U.S. Food and Drug Administration has granted Emergency Use Authorization, or EUA, for the COVID-19 IgG/IgM Rapid Test Cassette distributed by the company. "This is only the fourth lateral flow COVID-19 rapid serology test authorized by the FDA. Additionally, more than 1.4 million COVID-19 IgG/IgM rapid tests have been delivered to the company's warehouse in San Diego and are available for distribution," said Aytu. Emergency Use Authorization of the COVID-19 IgG/IgM Rapid Test Cassette was granted by the FDA on May 29 to Healgen Scientific, the U.S. subsidiary of manufacturer Zhejiang Orient Gene Biotech, Limited. Aytu BioScience announced a U.S. distribution agreement to distribute the Zhejiang Orient Gene rapid test on March 10, the company noted.
TWST

Hot Stocks

08:29 EDT Twist Bioscience joins alliance to develop COVID-19 antibody therapy - Proteona announced that Twist Bioscience will join the international alliance led by Proteona to develop neutralizing antibody therapy against COVID-19 for vulnerable immunocompromised patients. Utilizing the highly parallel silicon-based DNA synthesis platform, Twist has the ability to manufacture millions of oligos of different lengths. This capability enables Twist Biopharma, a division of Twist Bioscience, to identify numerous neutralizing antibody sequences and use in house capability to generate and optimize IgG antibodies ready for analysis. The international alliance was initiated by Proteona in response to the need of patients most at risk facing the pandemic, such as those with blood cancers. Due to preexisting conditions, these patients have a higher risk of complications from infections. They may not respond well to vaccination once available because of their compromised immune system. The alliance aims to develop antibody therapies to provide a safe and targeted treatment for these vulnerable populations.
CPST

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08:29 EDT Capstone Turbine announces 10-year FPP service contract on 1 MW system in CA - Capstone Turbine announced that Cal Microturbine, the Capstone exclusive distributor for California, Washington, Oregon, Hawaii & Nevada signed a new Factory Protection Plan, or FPP, long-term service contract for a 1 megawatt Capstone C1000 Signature Series microturbine system installed at a Waste Water Treatment Plant, or WWTP, in Southern California. The company said in a release, "The 1 MW system has been placed under Capstone's industry-leading Factory Protection Plan long-term service product providing 10-years of comprehensive service coverage, including both scheduled and unscheduled maintenance. The wastewater treatment plant will operate the Capstone microturbines on biosolid-based renewable fuel for 24x7 electrical & thermal generation achieving over 75% overall system efficiency."
CGIX

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08:28 EDT Cancer Genetics continuing to evaluate 'all potential strategic opportunities' - Continuing to evaluate potential strategic options including collaborations, mergers or acquisitions, or other strategic transactions.
CTB

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08:26 EDT Cooper Tire restarts production at tire manufacturing plant in Mexico - Cooper Tire announced that its tire manufacturing plant in El Salto, Mexico will begin the process of restarting production on a limited basis. Cooper has put in place a set of procedures that include required employee health disclosures, increased cleaning and disinfecting of facilities and equipment, social distancing and physical barriers, visitor restrictions and other measures. Similar procedures have been in effect at Cooper plants in China, the United States and Serbia, all of which reopened after temporary closures, and are ramping tire production back up according to demand, which has been impacted industry wide by coronavirus. Throughout the global pandemic, Cooper's distribution centers around the globe have continued to operate and flow product to customers.
CE

Hot Stocks

08:26 EDT Celanese signs licensing agreement for acetic acid route to acrylic acid - Celanese announced that its subsidiary, Celanese Chemical Co. Ltd., has recently signed a tri-party agreement with SOUTHWEST INSTITUTE OF CHEMICAL, based in Chengdu, China, and YANKUANG LUNAN CHEMICAL, based in Teng Zhou, China, to build a Pilot Scale-up Unit, or PSU, in Teng Zhou, China, to test industrial scale production of acrylic acid using acetic acid as the principal raw material. The company said in a release, "Celanese and SWCHEM are jointly developing an innovative technology of producing acrylic acid with the process of acetic acid formaldehyde condensation based on Celanese's original proprietary research in this field. Under the terms of the agreement, LUNAN will build an industrial scale pilot plant to finish commercial production trials. Financial details of the agreement are not being disclosed at this time."
NERV

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08:25 EDT Minerva changes date of webcast on Phase 3 trial of roluperidone - Minerva Neurosciences announced that the company will hold a webcast on Friday, June 5, 2020 at 8.30 a.m. to present additional results and analyses from its Phase 3 trial in negative symptoms. This webcast replaces that previously scheduled for June 1 announced by the Company on May 29, 2020. Minerva management will be joined on the webcast by key opinion leaders Philip Harvey, Ph.D. and Brian Kirkpatrick, M.D. who will discuss these findings.
ITRM

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08:25 EDT Iterum Therapeutics PLC trading halted, news pending
HJLI

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08:25 EDT Hancock Jaffe Laboratories Inc trading halted, news pending
NVUS

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08:25 EDT Novus Therapeutics trading halted, news pending
ICAD

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08:24 EDT iCAD hosts virtual roundtable event on breast cancer surgery - iCAD announced it will host a free virtual roundtable event for clinicians, titled "The Impact of COVID-19 on Breast Cancer Surgery and Targeted Radiation Therapy," on June 4, 2020 at 7 pm ET/4 pm PT. Xoft breast IORT is a single-fraction therapy option that allows select early-stage breast cancer patients to replace weeks of daily radiation with one treatment, delivered at the time of surgery. This targeted treatment option offers a full course of radiation in just one day, which could contribute to a reduction in the healthcare system resources needed for breast cancer patients during the COVID-19 pandemic and reduce those patients' risk of exposure to the novel coronavirus by minimizing the number of visits required to a hospital or medical facility. Positive results from a long-term study involving Xoft breast IORT conducted at Hoag Memorial Hospital Presbyterian were published in the Annals of Surgical Oncology in 2019.2 Led by Melvin J. Silverstein, MD, Medical Director of the Hoag Breast Center, the prospective study, titled Intraoperative Radiation Therapy: A Series of 1000 Tumors, found breast cancer recurrence rates of patients who were treated with Xoft breast IORT were comparable to those seen in the cornerstone, randomized TARGIT-A and ELIOT trials, which evaluated IORT using different technology. This virtual roundtable event is a part of larger series of webinars hosted by iCAD in recent weeks, featuring leading experts in breast cancer detection and treatment. This series has examined various aspects of breast cancer care in the era of COVID-19, including risk adaptive tools and pragmatic solutions for both screening and treatment.
PRTS

Hot Stocks

08:23 EDT U.S. Auto Parts announces new Grand Prairie, Texas distribution center - U.S. Auto Parts announced it would open a new 210,000 square foot distribution center in Grand Prairie, Texas. The company said in a release, "the distribution center, slated to begin operations in late 2020, will create a minimum of 150 new jobs and $10 million in economic impact in its first 18 months alone. When operational, the facility will deliver new parts to customers across the South and Southwest servicing all of the brands U.S. Auto Parts Network has to offer, including CarParts.com and JC Whitney."
XPER TIVO

Hot Stocks

08:23 EDT Xperi shareholders approve merger agreement with TiVo - In a regulatory filing on Friday, Xperi (XPER) shareholders voted to approve the merger agreement with TiVo (TIVO).
AYI

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08:23 EDT Acuity Brands announces agreement with Ushio America - Acuity Brands announced it has entered into a strategic alliance agreement with Ushio America. Ushio has agreed to supply Acuity Brands with its Care222 UV disinfection module, which uses filtered excimer lamps to generate 222nm far-UVC light capable of inactivating viruses and bacteria on indoor surfaces. Acuity Brands plans to incorporate these lamps in a range of its products, including its ceiling and wall-mounted lighting fixtures that can operate in occupied or unoccupied spaces, to reduce pathogens. The agreement is exclusive to Acuity Brands for general illumination uses throughout North America. Acuity Brands also has non-exclusive rights to use the Care222 disinfection module worldwide for lighting and other uses. When incorporated in Acuity Brands products and used with its control systems, which are commonly installed in spaces such as offices, classrooms, restaurants, retail stores, restrooms and other public facilities, the Care222 lamp module will emit intermittent pulses of the 222nm UV light to reduce pathogens on surfaces. The mercury-free Care222 excimer lamps produced by Ushio feature a specially designed short pass filter, based on groundbreaking research and technology developed by Columbia University, which filters out from the lamp the longer UV wavelengths that are harmful to humans. The result is a narrow band 222nm wavelength of UV light that can inactivate viruses and bacteria, effectively preventing them from replicating. Results from laboratory testing and clinical studies suggest that the filtered UV light emitted from the Care222 lamp can reduce pathogens on surfaces without posing a health risk to human skin or eyes when used within appropriate parameters. In contrast, possible acute and chronic damage to eyes and skin may result from the more generally employed 254nm UV wavelength used in many germicidal lamps, although this UV wavelength can be used in interior spaces under certain conditions that sharply limit human exposure. In addition, although lamps in the 405-430nm wavelength range can also be used in occupied spaces, they are not as effective against viruses as lamps with lower-range UVC wavelengths.
PTE

Hot Stocks

08:23 EDT PolarityTE announces publication of two SkinTE manuscripts - PolarityTE reported the recent publication of two peer-reviewed manuscripts involving the application of SkinTE in a pilot study of diabetic foot ulcers and a 15-patient case series evaluating multiple wound types. A publication reporting results from the company's diabetic foot ulcer, or DFU, pilot study was published in the International Wound Journal. The primary endpoint of the pilot was the rate of closure at 12 weeks following SkinTE treatment. According to the abstract, "All 11 DFUs demonstrated successful graft take. Ten DFUs closed within 8 weeks. The median time-to-complete closure was 25 days." PolarityTE is currently conducting a multi-center randomized controlled trial to further evaluate the use of SkinTE in DFUs. Another publication was published in Plastic and Reconstructive Surgery - Global Open. The retrospective, noncontrolled, 15-patient case series evaluated various wound etiologies, including five acute and chronic, four acute traumatic, and six chronic wounds. According to the publication, "All wounds were closed with a single application of AHSC manufactured from a single tissue harvest."
TIVO XPER

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08:22 EDT TiVo shareholdres approve merger agreement with Xperi - In a regulatory filing on Friday, TiVo (TIVO) said its shareholders approved the merger agreement with Xperi (XPER).
CRBP

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08:22 EDT Corbus Pharmaceuticals publishes Phase 1b CF study patient demographics - Corbus Pharmaceuticals Holdings announced baseline patient demographics and disease characteristics in its Phase 2b study of lenabasum in cystic fibrosis. The information was published in an electronic supplement of the Journal of Cystic Fibrosis in connection with the 43rd European Cystic Fibrosis Conference. Topline results from the Phase 2b cystic fibrosis study are on track for the summer of 2020.
IMGN

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08:21 EDT ImmunoGen appoints Stacy Coen as Chief Business Officer - ImmunoGen announced that Stacy Coen has been appointed Senior Vice President and Chief Business Officer. The company said in a release, "Ms. Coen brings over 20 years of business and corporate development experience from leading oncology and rare disease companies. She joins ImmunoGen from Editas Medicine, where she served as Vice President, Business Development and was responsible for business development, strategy, transactions, and alliance management."
INFN

Hot Stocks

08:20 EDT Infinera appoints George Riedel, Christine Bucklin to board - Infinera announced the appointment of George Riedel and Christine Bucklin to its board of directors, effective immediately. Mr. Riedel has served as a Senior Lecturer in the General Management Unit at Harvard Business School since 2017. Ms. Bucklin served as Managing Director, Operations Group at Gryphon Investors, Inc., a private equity firm, from 2015 to 2018. In connection with Mr. Riedel's and Ms. Bucklin's appointments, Infinera's board of directors increased from nine to 11 members. Mr. Riedel will serve as a Class I director with a term expiring at the 2023 Annual Meeting of Stockholders and Ms. Bucklin will serve as a Class III director with a term expiring at the 2022 Annual Meeting of Stockholders. Ms. Bucklin is the Independent Designee as defined in the Letter Agreement between Infinera and Oaktree Optical Holdings L.P., dated April 13, 2020.
LCTX

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08:20 EDT Lineage Cell Therapeutics reports findings from OpRegen study - Lineage Cell Therapeutics announced that restoration of retinal tissue was observed in a patient enrolled in a Phase 1/2a study of its lead product candidate, OpRegen, a retinal pigment epithelium, or RPE, cell transplant therapy in development for the treatment of dry age-related macular degeneration, or AMD. This finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. The loss of RPE cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as dry AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which has led to a presumption that progression of geographic atrophy may someday be slowed or halted but cannot be reversed. The finding from the ongoing OpRegen clinical trial supports a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. The company reported evidence from a patient with atrophic end-stage disease who received a transplant of allogeneic RPE cells and showed substantial restoration of retinal tissue within the area of GA. Specifically, the area of GA assessed at 9 months was approximately 25% smaller than the patient's pre-treatment baseline and it grew approximately 50% slower than its historical rate during the subsequent six months. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging. OpRegen is currently being evaluated in a Phase 1/2a clinical study in patients with dry AMD with GA. Seventeen of twenty-one expected patients have been enrolled to date. The company has observed evidence of benefit in some patients, including increases in Best Corrected Visual Acuity, reduction in the growth of geographic atrophy and increases in reading speed.
OPK

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08:18 EDT Opko Health announces FDA authorization for trial evaluating RAYALDEE - OPKO Health announced that the U.S. Food and Drug Administration has authorized OPKO to undertake a Phase 2 trial with RAYALDEE as a treatment for patients with mild-to-moderate COVID-19. The trial, entitled "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2," is estimated to enroll 166 subjects, including many with stage 3 or 4 chronic kidney disease. The REsCue trial will have 4 weeks of treatment with RAYALDEE or placebo and 2 weeks of follow-up. The objective is to raise and maintain serum total 25-hydroxyvitamin D within the range of 50-100 ng/mL in order to mitigate COVID-19 severity.
LTBR

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08:17 EDT Lightbridge awarded patent in Eurasia for nuclear fuel assemblies - Lightbridge announced that it has received a patent from the Eurasian Patent Office for its innovative nuclear fuel assemblies. This is a divisional patent of the 2014 PCT application and covers an all-metal fuel assembly design with a mixed grid fuel rod arrangement inside the fuel assembly. Lightbridge is developing its advanced metallic fuel designed to make both existing and new nuclear power plants more efficient, more cost competitive, and even safer.
LIVX

Hot Stocks

08:16 EDT LiveXLive Media achieves triple-digit growth across core metrics - LiveXLive Media announced that it has achieved triple-digit growth across core metrics, including the numbers of events, artists and hours streamed on its platform. Since January 2020, LiveXLive has streamed 48 events, up 336%, and over 1,000 artist performances, up 821%. Its programming has generated more than 66M live stream views, an increase of 175% over the same time period last year. Total hours streamed increased by over 179%. Sponsorship revenues also climbed significantly over the same period last year. LiveXLive's technology enables artists to simulcast performances to fans worldwide across social media platforms, such as Facebook, Twitch, TikTok and YouTube. Engagements within its social media channels also garnered a triple-digit increase with total engagements up over 109% and average engagements per post saw 128%. LiveXLive has also added several additional revenue formats, including pay-per-view events, an artist ambassador program, a new video podcast format, tipping, merchandise and virtual gifts. The company is seeing promising trends in those categories as well.
COKE

Hot Stocks

08:16 EDT Coca-Cola bottlers dedicate production capability to support COVID-19 test kits - Coca-Cola Consolidated announced that Southeastern Container, a PET preform and bottle manufacturing co-operative funded and managed by a group of Coca-Cola bottlers, has begun producing test tubes for use in COVID-19 kits. Utilizing several injection molding preform tools, the manufacturing co-operative has already produced over 7 million tubes for testing kits. The U.S. Department of Health and Human Services collaborated with Oak Ridge National Lab to identify manufacturers who could address a supply chain gap of COVID-19 test collection tubes to support the increasing testing needs of States.
NG

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08:15 EDT NovaGold exploring legal options against J Capital Research - The company said, "NOVAGOLD RESOURCES confirmed that within a week it would provide a comprehensive and formal response to the catalogue of inaccuracies and falsehoods made by short-seller J Capital Research on May 28, 2020. NOVAGOLD, its Board of Directors, and management team are committed to operating with the utmost professionalism and integrity, which will be demonstrated in the Company's formal response in a meticulous manner. Additionally, NOVAGOLD is exploring all of its legal options in various jurisdictions against J Capital Research and any other parties who may be complicit in any effort to manipulate NOVAGOLD's share price through the dissemination of falsehoods and distortions. NOVAGOLD would like to extend sincere gratitude to its shareholders for their continued support and engagement with management."
NMIH

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08:14 EDT NMI Holdings reports 2,265 loans in default at May 31 - NMI Holdings reported selected operating statistics for the month of May 2020. In light of the COVID-19 crisis, the company will be releasing operating updates related to the credit performance of its insured portfolio and the risk characteristics of its new insurance written on a monthly basis going forward. At May 31, 2020, the company reported 2,265 loans in default and a default ratio of 0.61%. A loan is considered to be in default when a borrower has missed two or more consecutive monthly payments. Default ratio is calculated as total loans in default divided by total policies currently in force.
NMIH

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08:13 EDT NMI Holdings enters into quota share reinsurance arrangement - NMI Holdings has entered into a new quota share reinsurance arrangement, subject to customary approvals, with a broad panel of highly rated reinsurers. Under the new agreement, National MI will cede, subject to certain limitations, exclusions, and conditions, 10.5% of its primary new insurance written for the period from April 1, 2020 through December 31, 2020. The ceded percentage may be increased with additions to the reinsurance panel. The company will receive a ceding commission equal to 20% of ceded premiums, as well as a profit commission of up to 50% of ceded premiums, reduced by any losses ceded under the agreement.
HSTO

Hot Stocks

08:13 EDT Histogen doses first patient in Phase 1b/2a trial of HST 001 - Histogen announced the enrollment of the first patient in its Phase 1b/2a clinical trial of HST 001, the Company's lead therapeutic candidate for the treatment of androgenic alopecia in men. This blinded, randomized, placebo controlled, single site study will enroll 36 subjects with male pattern hair loss using a 2:1 randomization HST 001 to placebo. It is designed to assess the safety and tolerability of HST 001, as well as indicators of efficacy including non-vellus hair count, total hair count, and hair thickness density as measured by Canfield macrophotography. Building on prior clinical experience with HST 001, the Phase 1b/2a study will be the first company-sponsored trial to include a third dosing timepoint, with dosing taking place at week 0, week 6 and week 12. At each treatment timepoint, subjects will receive 20 injections focused on temporal recession and vertex scalp areas, the most common regions of hair loss in men with androgenic alopecia. Top-line data is anticipated to be available in the fourth quarter of 2020.
CLRB

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08:12 EDT Cellectar Biosciences granted SME status by EMA - Cellectar Biosciences announced that it has been granted Small and Medium-Sized Enterprise status by the European Medicines Agency's Micro, Small and Medium-sized Enterprise office. The newly granted SME status allows Cellectar to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities and fee waivers for selective EMA pre and post-authorization regulatory filings, including orphan drug and PRIME designations. Cellectar is also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other financial incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process.
ENPH

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08:10 EDT Enphase Energy collaborates with SmartX - Enphase Energy announced its expansion into Poland through a collaboration with SmartX Sp. z o.o., a solar distributor with headquarters in Bytom, Poland. Currently, Poland has one of the top five solar markets in Europe, with an estimated installed capacity of more than 1 GW. SmartX's installer network throughout Poland offers both residential and small commercial microinverter systems, utilizing Enphase IQ 7 family of microinverters including IQ 7, IQ 7+ and IQ 7X. In addition, SmartX's residential solar systems are outfitted with Enphase Envoy communications gateways, which connect an Enphase-based solar system to the Enphase Enlighten monitoring platform and helps make per-panel energy monitoring and insights for operations and maintenance easy.
FLXS

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08:10 EDT Flexsteel Industries announces $6M stock repurchase program - The board authorized a stock repurchase program under which the company may repurchase up to $6M of its outstanding common shares. The company said the board determined that a modest stock buy-back program could help mitigate undue pressure on the stock given the uncertainty of the Russell reconstitution, while not jeopardizing business plans and debt covenants. The repurchase program is authorized to last through June 9, 2021.
DFFN

Hot Stocks

08:09 EDT Diffusion Pharmaceuticals regains compliance with Nasdaq requirement - Diffusion Pharmaceuticals announces that on May 29, 2020 it received written notice from the Nasdaq Listing Qualifications Staff of the NASDAQ Stock Market, stating that the Company regained compliance with the applicable Nasdaq minimum bid price continued listing standard and the matter is now closed. The Company had previously been notified by Nasdaq on December 11, 2019 that it was not in compliance with the minimum bid price rule because its common stock failed to maintain a minimum bid price of $1.00 for 30 consecutive business days. In order to regain compliance with Listing Rule 5550(a)(2), the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved on May 28, 2020. The Company's last closing bid price on May 28 was $1.27. This development means that while the Company is still seeking authority from its stockholders for a reverse split of the Company's common stock, it is not currently anticipated that the board will implement a reverse split at this time, absent a change in the market price of the Company's common stock.
MUDS

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08:09 EDT Mudrick Capital Acquisition acquires Hycroft Mining - Mudrick Capital Acquisition and Hycroft Mining, a U.S.-based, gold and silver producer in Nevada, are pleased to announce the consummation of the purchase of Hycroft by MUDS. The shareholders of each of MUDS and Hycroft approved the transaction, which closed on May 29, creating a new world-class mining company named Hycroft Mining Holding that will trade publicly on the NASDAQ Capital Market under the ticker symbol "HYMC." Hycroft has sold all of the equity interests of Hycroft's subsidiaries and substantially all of its other assets to MUDS, and MUDS has discharged and paid or assumed all or substantially all of Hycroft's liabilities. HYMC has 50.2M common shares outstanding, as of the consummation of the transaction.
VRNDF

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08:09 EDT Delta 9 Cannabis completes transaction to acquire two Alberta stores - DELTA 9 CANNABIS announce dthat on May 29, 2020 it closed a transaction with Modern Leaf Group to acquire all or substantially all of Modern Leaf's assets located in the Province of Alberta relating to two retail cannabis stores located in Calgary, Alberta and Grande Prairie, Alberta. The acquisition is being completed through the Company's wholly-owned subsidiary, Delta 9 Cannabis Store Inc., and pursuant to the previously announced purchase agreement among Delta 9 Cannabis Store Inc., Modern Leaf and Mr. Preston Drummond dated November 21, 2019. Kronos Capital Partners advised Modern Leaf in regards to the transaction. The purchase price paid by Delta 9 Cannabis Store Inc. relating to the Transaction was $1,300,000, subject to customary adjustments. $1,000,000 of the Purchase Price was satisfied through the issuance of 1,250,000 common shares in the capital stock of the Company, a price per Common Share of $0.80 based on the closing market price of the Common Shares on the Toronto Stock Exchange on September 19, 2019, such date being the date that the Company and Modern Leaf entered into a previously announced binding letter of intent with respect to the Proposed Transaction. The balance of the Purchase Price was paid by way of the release of the $150,000 deposit in respect of the transaction, and the payment of $150,000, satisfied in cash. Upon the closing of the Transaction under the Agreement, Delta 9 Cannabis Store Inc. and Modern Leaf entered into additional agreements effective at the date of closing providing for, among other things, the granting of a right of first refusal by Modern Leaf in favour of Delta 9 Cannabis Store Inc. pertaining to the purchase of a retail cannabis store located in Olds, Alberta and the granting of certain restrictive covenants by Modern Leaf in favour of Delta 9 Cannabis Store Inc. The final closing of the Transaction remains subject to the approval of the Toronto Stock Exchange.
FLXS

Hot Stocks

08:08 EDT Flexsteel Industries implements conservative cash strategies amid COVID-19 - Flexsteel Industries announced that, in light of the continued economic uncertainty and dampened demand for furniture related to COVID-19, the company and its board have implemented conservative cash strategies to ensure the viability of the company and to maximize its financial flexibility until economic conditions stabilize. The company has extended 25% salary reductions for the CEO and CFO/COO and 50% cash compensation reduction for the board through October 1. Flexsteel is also evaluating and renegotiating company lease obligations where feasible. Lastly, the company has gained a commitment from Dubuque Bank & Trust for a new secured $45M credit facility with a two-year term. On April 28, the company announced its intent to exit the recreational vehicle seating and remaining hospitality businesses after determining they were no longer strategic to the future of the company. As a result of these planned actions, the company anticipates incurring pre-tax restructuring and related expenses between $25M and $28M, with a majority of expenses to be incurred in Q4. Cash charges are expected to be between $3M to $5M, and non-cash charges, including asset impairments, are expected to be between $22M and $23M.
HCI

Hot Stocks

08:07 EDT HCI Group headquarters to be acquired by State of Florida - Greenleaf Capital, LLC, the real estate division of HCI Group, has entered into an agreement with the Florida Department of Transportation by which the State of Florida will acquire HCI's headquarters property and a nearby right of way in connection with a planned road improvement project. The combined compensation to Greenleaf for the acquisitions is set at $47.5M. After transaction costs, Greenleaf expects to net approximately $44M. The property, known as "Cypress Commons," is located at 5300 West Cypress Street in Tampa. The transaction is expected to conclude by the end of July 2020. As part of the agreement, HCI has the option to occupy the headquarters property for up to three years after the acquisition. During this time, Greenleaf will continue to manage the property, which has numerous tenants.
NLTX

Hot Stocks

08:06 EDT Neoleukin Therapeutics appoints Erin Lavelle to board of directors - Neoleukin Therapeutics announced the appointment of Erin Lavelle to the company's Board of Directors. Ms. Lavelle has more than 20 years of strategic and operational leadership experience in the biopharmaceutical industry and most recently served as COO for Alder Biopharmaceuticals, Inc. She succeeds Sean Nolan, who will be stepping down from the Board. Mr. Nolan has served as a director of Aquinox Pharmaceutics since 2015 and remained on the Neoleukin Board after the merger in August 2019.
RCM

Hot Stocks

08:06 EDT Pinnacle Dermatology selects R1 RCM 's revenue cycle management solutions - R1 RCM announced Pinnacle Dermatology, one of the most prominent multi-state leaders in population skin health management, has selected R1's revenue cycle management solution to help improve performance, lower costs and increase patient satisfaction. Pinnacle Dermatology, based in Chicago, selected R1 to optimize the revenue cycle for its 50+ locations across five states and to support its significant long-term growth goals.
FLXS

Hot Stocks

08:04 EDT Flexsteel Industries lowers quarterly dividend to 5c per share - The board declared a Q4 dividend of 5c per share, payable July 6 to shareholders of record at the close of business on June 19. The decision to set the quarterly dividend at a lower level compared to previous quarters reflects the continued economic uncertainty and softer demand for furniture related to COVID-19.
NAOV

Hot Stocks

08:04 EDT NanoVibronix expands license agreement with Ideal Medical International - NanoVibronix announced that it has expanded its license agreement with Ideal Medical International Limited to include exclusive rights to distribute the company's UroShield and PainShield technologies in Canada and Turkey effective May 27. Under the terms of the 10 year, performance-based agreement, the company will receive an upfront license fee, payable immediately, and quarterly royalty payments based on a sliding scale of Ideal Medical's gross sales of the company's licensed technologies with minimum performance milestones beginning in year two of the agreement, and shall absorb costs associated with relevant regulatory approvals for Ideal Medical to market, distribute and sell the company's licensed technologies that are subject to the agreement.
OPY

Hot Stocks

08:02 EDT Oppenheimer & Co. to acquire Brandis Tallman, terms not disclosed - Oppenheimer & Co., a subsidiary of Oppenheimer Holdings, announced an agreement to acquire San Francisco-based Brandis Tallman, one of the top investment banks specializing in the underwriting and placement of municipal debt for California issuers. Completion of the transaction is subject to pending regulatory review and approvals.
MYOV

Hot Stocks

08:01 EDT Myovant Sciences submits NDA for relugolix combination tablet - Myovant Sciences announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for its once-daily relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids. The NDA submission in uterine fibroids is supported by positive results from the Phase 3 LIBERTY program, which included two multinational replicate studies and an open-label extension study through one year. The NDA is the third regulatory application Myovant has submitted this year, following a Marketing Authorization Application to the European Medicines Agency in uterine fibroids and an NDA in advanced prostate cancer. Myovant is also advancing the Phase 3 SPIRIT program, evaluating relugolix combination therapy in women with pain associated with endometriosis, with data from a second Phase 3 study expected this quarter. SPIRIT 2, the first of the two Phase 3 studies of once-daily relugolix combination therapy in women with pain associated with endometriosis, met its co-primary efficacy endpoints and six key secondary endpoints. In addition, relugolix combination therapy was generally well-tolerated including minimal bone mineral density loss over 24 weeks.
SAMA

Hot Stocks

08:00 EDT Schultze Special Purpose Acquisition Corporation trading resumes
CHUY

Hot Stocks

07:55 EDT Chuy's estimates positive EBITDA with average weekly sales above $54,000 - The company said, "In response to the business disruption caused by the COVID-19 pandemic, during the eight-week period ended May 24, 2020, we transitioned our restaurants to a more limited menu and a primarily off-premise operating model with reduced labor, operating expenses, marketing and corporate overhead expenses, along with the cancellation or postponement of all non-essential planned capital expenditures. At the end of the eight-week period ended May 24, 2020, we were operating 18 restaurants in to-go only format, 74 with limited dine-in seating and nine were temporarily closed. Based on our operations over this eight-week period, we estimate we achieve positive EBITDA with average weekly sales above approximately $43,000 after taking into account all restaurant operating costs, including rent, and G&A expenses. As we expand our operations by increasing our dine-in capacity and reducing the off-premise operating model for our restaurants, we expect to incur additional restaurant operating expenses and G&A expenses. With the increased expenses resulting from such expanded operations, we estimate we achieve positive EBITDA with average weekly sales above approximately $54,000."
CHUY

Hot Stocks

07:54 EDT Chuy's says 87 dining rooms in operation at varying levels of capacity - The company said, "As the Company has reopened its dining rooms, recent off-premise sales have continued at a rate of more than double pre-COVID-19 levels and the comparable restaurant sales have begun to show a significant improvement over immediately preceding weeks. As of today, 87 of the company's dining rooms were in operation in varying levels of capacity, while five restaurants continue to operate with enhanced off-premise service only, and nine restaurants remain temporarily closed. As of May 24, 2020, we had approximately $32M of cash and cash equivalents as compared to approximately $28 million of cash and cash equivalents as of March 29, 2020. During the eight-week period ended May 24, 2020, we remained current with all of our vendors but deferred a majority of our lease obligations and as allowed under the Coronavirus Aid, Relief, and Economic Security Act deferred the payment of our employer social security taxes. Had we fully paid these expenses during such period, we estimate that we would have had approximately $27M of cash and cash equivalents as of May 24, 2020."
CHUY

Hot Stocks

07:53 EDT Chuy's reports Q2 SSS down approx. 49.8% vs. last year - Chuy's Holdings provided a business update in light of the ongoing impact of COVID-19, including changes in the operating status of its restaurants as a result of changes in restrictions of in-restaurant dining. The company said, " With the safety of its employees and guests as its number one priority, the Company has re-opened a majority of its dining rooms as state and local municipalities have announced new guidelines regarding restaurant operations. For the second quarter through May 24, 2020 comparable restaurant sales decreased approximately 49.8% from the same period last year. As a result of the pandemic, the Company transformed its existing take-out and delivery business to a safe and efficient operation for its guests as well as employees and more than tripled its pre-COVID-19 off-premise sales entering the second quarter of 2020. Cinco de Mayo had a favorable impact on our comparable restaurant sales during the week ending May 10th, as it was celebrated a week prior in fiscal 2019."
SPRO

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07:51 EDT Spero Therapeutics announces inducement grants under Nasdaq listing rule - Spero Therapeutics announced that on May 29, 2020, the Compensation Committee of Spero's Board of Directors granted non-qualified stock option awards to purchase an aggregate of 29,500 shares of its common stock to four new employees under the Spero Therapeutics, Inc. 2019 Inducement Equity Incentive Plan, or the 2019 Inducement Plan. The stock options were granted as inducements material to the new employees becoming employees of Spero in accordance with Nasdaq Listing Rule 5635(c)(4). The 2019 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Spero, as an inducement material to such individuals' entering into employment with Spero, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The options have an exercise price of $11.82 per share, which is equal to the closing price of Spero's common stock on The Nasdaq Global Select Market on May 29, 2020. Each option will vest over a four-year period, with 25% of the shares vesting after 12 months and the remaining shares vesting monthly over the following 36 months, subject to each employee's continued employment with Spero on such vesting dates. The options are subject to the terms and conditions of the 2019 Inducement Plan and the terms and conditions of a stock option agreement covering the grant.
ACRGF

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07:50 EDT Acreage Holdings enters two funding agreements for up to $60M gross proceeds - Acreage Holdings announced it has entered into two definitive funding agreements for a total of up to $60,000,000 in gross proceeds. The two funding agreements include: A Standby Equity Distribution Agreement with an institutional investor, under which the Company may, at its discretion, periodically sell to Investor, and pursuant to which the Investor may, at its discretion, require the Company to sell to it, up to $50,000,000 of the Company's Class A Subordinate Voting Shares, no par value, and Completion of a private placement offering, in which it issued $11,000,000 in principal amount under a secured convertible debenture, with gross proceeds to the Company of $10,000,000 before transaction fees. For each Subordinate Voting Share purchased under the SEDA, the Investor will pay the Company the greater of 95% of the lowest daily volume weighted average price of the Subordinate Voting Shares on the Canadian Securities Exchange or other principal market on which the Subordinate Voting Shares are traded for the five consecutive trading days immediately following the date the Company or the Investor delivers notice requiring the Investor to purchase or the Company to sell the Shares under the SEDA; or the lowest price allowable under the rules of the Principal Market. The Investor's obligation to purchase, and the Company's obligation to sell, the Shares under the SEDA is subject to certain conditions, including obtaining requisite relief from applicable Canadian securities regulators in respect of transactions of this nature, the Company filing and maintaining the effectiveness of a registration statement, and a supplement to the Company's Canadian shelf prospectus, qualifying the issue and resale of the Shares and the 200,000 Subordinate Voting Shares to be issued to the Investor as consideration under the SEDA, and is limited to $500,000 per advance, and no more than $5,000,000 in the 30 days following May 29, 2020. Acreage expects to use the proceeds for working capital and general corporate purposes The Convertible Debentures will bear interest at 15% per annum and are secured by the Company's medical cannabis dispensaries in Connecticut. The Convertible Debenture is convertible by the holder in whole or in part after September30, 2020. Prior to September30, 2020, the holder may convert only $550,000 of principal amount. The Convertible Debenture is convertible into Class A Subordinate Voting Shares of the Company at $1.68 per share, subject to the conversion limitations described above. The Company has the right to redeem up to 95% of the principal amount on or prior to September 29, 2020 without penalty.
BMRA

Hot Stocks

07:48 EDT Mayo Clinic joins Biomerica's InFoods IBS diagnostic-guided therapy trial - Biomerica announced they have signed definitive agreements with Mayo Clinic to join the clinical trial for Biomerica's new InFoods diagnostic-guided therapy, designed to alleviate Irritable Bowel Syndrome symptoms. Mayo Clinic is joining Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, Houston Methodist and the University of Michigan as primary enrollment centers for this study. Mayo Clinic can now begin enrollment of patients in this trial. Biomerica has added several new, large medical centers and groups to assist with accelerating completion of the endpoint trial and to participate in the subsequent pivotal trial needed for final FDA clearance. Biomerica continues to add leading gastrointestinal physicians operating in world-renowned centers to the InFoods IBS clinical study, who are potential users and advocates for this product once cleared by the FDA. Biomerica also announced today that the Japanese Patent Office has issued Biomerica' s first Japanese patent pertaining to the Company's InFoods family of products that allow for a revolutionary new treatment option for patients suffering from IBS and several other disease states. Specifically, this patent contains numerous claims that broadly cover a product that enables physicians to identify patient-specific foods, that when removed from the diet, may alleviate or improve an individual's IBS symptoms including, but not limited to, constipation, diarrhea, bloating, pain and indigestion. It is estimated that about 19 million people in Japan suffer from IBS. It is estimated that over 45 million Americans suffer from IBS and the symptoms are often triggered by consumption of specific foods. The total cost of IBS has been estimated at $30 billion annually in the United States. IBS is a common condition that can substantially impair physical and mental well-being of a patient and a person's ability to function both at home and in the workplace. A clinical lab version of the product is being used in this clinical trial. However, the Company is also developing InFoods IBS DGT as a point-of-care product that allows physicians to perform the test in-office using a finger stick blood sample. A billable CPT code that can be used by both clinical labs and physicians' offices is already available for the InFoods IBS products. Market research conducted by a leading, independent pharmaceutical marketing research firm, determined that seventy percent of physicians surveyed would utilize the InFoods DGT without reimbursement and over 90% would utilize it with reimbursement. Importantly, the InFoods DGT can be used without or in conjunction with current pharmaceuticals to potentially improve patient outcomes. Since the InFoods product is a diagnostic-guided therapy and not a drug, it has no drug-type side effects. The clinical trials are randomized, double-blinded, and placebo-controlled. Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, has completed its enrollment of patients for this endpoint study but will continue to participate in the final pivotal trial once that commences. This clinical endpoint trial is expected to be completed in approximately 6 months. However, due to the novel coronavirus' impact on the U.S.'s healthcare system, it may take longer. If all goes as expected, Biomerica plans to commence the final pivotal trial several months thereafter, which is needed for submission to the FDA for final clearance. The endpoint trial stratifies enrollment by the three main IBS subclasses. There is currently no FDA cleared therapy for IBS-Mixed. The study design has already received a non-significant risk determination from FDA.
SAMA

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07:44 EDT Schultz Special Purpose reports LOI for combination with Clever Leaves - Schultze Special Purpose Acquisition and Clever Leaves International announced that they entered into a non-binding letter of intent pursuant to which SAMA and Clever Leaves would enter into a business combination, with the combined company becoming a publicly-traded company on NASDAQ. The parties intend to execute a definitive agreement in June with a closing expected in the third quarter of 2020. No assurances can be made that the parties will successfully negotiate and enter into a definitive agreement, or that the proposed transaction will be consummated on the terms or timeframe currently contemplated, or at all. Any transaction would be subject to the approval of the two companies' boards, regulatory and shareholder approvals, as well as other customary conditions. Under the terms of the LOI, SAMA and Clever Leaves intend to enter into a definitive agreement pursuant to which SAMA and Clever Leaves would combine, with Clever Leaves' shareholders owning a majority of the equity in the combined public company which will be listed on NASDAQ. SAMA's cash balances, currently in excess of $130M, would be used primarily to fund the combined company's near-term operating expenses, capital expenditures, working capital, and potential M&A opportunities. George J. Schultze, Chairman and CEO of SAMA, said, "We are confident Clever Leaves represents a tremendous partner for SAMA and an attractive public market story through its thoughtfully constructed, vertically integrated international platform and outstanding management team. Clever Leaves has earned its industry-leading market position through its high-quality genetics capability and highly scalable cultivation, and extraction capacity. Moreover, the leveragability of its pre-existing distribution infrastructure, unique GMP certification, and disruptive low-cost model bring us great enthusiasm about its future prospects. We have enjoyed working with Clever Leaves' outstanding management team to announce this transaction, and we look forward to achieving success together for the combined company's shareholders."
CBWTF

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07:42 EDT Auxly Cannabis says established foundation to move towards positive cash flows - The company said, "With the launch of the Company's Cannabis 2.0 Products in December 2019, Auxly has established the foundation the Company plans to build on in 2020 to increase revenues and move towards positive cash flows. Auxly's objectives for 2020, which may be impacted by the COVID-19 pandemic, continue to be concentrated on its Canadian operations, with a view to international opportunities that may be profitable in the near to long term. Broadly, the Company's objectives for the year ahead are as follows: Be a leader in the Canadian Cannabis 2.0 Products market. Complete remaining construction and licensing of all Canadian operations to leverage existing assets and increase revenues. Work with the Sunens team to secure supply of input materials for use in the Company's product offerings in 2020. Collaborate with the Company's strategic partners to move towards commercialization of a small number of products for sale internationally or, if and when permitted, as part of the Cannabis 3.0 Products market. The Company looks forward to continuing its success over the year ahead as it gets closer to realizing on its vision of being a global leader focused on branded cannabis products that deliver on Auxly's consumer promise of quality, safety and efficacy"
PRIM

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07:38 EDT Primoris announces solar award with initial value of $10M - Primoris Services Corporation announced the award of a Limited Notice to Proceed for a new solar project with an initial value of $10M and an anticipated final contract value of over $100M. The contract was secured by Primoris Renewable Energy, part of the Power, Industrial, & Engineering segment. The LNTP is for the initial engineering work on a utility-scale solar facility in the Southwest. It is very typical for clients in the solar industry to issue LNTPs to support initial engineering, site investigation, long lead procurement items, and cost optimization activities at the beginning of utility-scale projects. Historically, Primoris' LNTPs for solar projects have resulted in contracts for the execution of the entire project. We should note that Primoris has only taken the value of the LNTP into backlog and will not place the entire contract value into backlog until the final contract is fully executed. The initial phase of work will commence in the third quarter of 2020. It is anticipated that construction on the entire project will be completed in the third quarter of 2021.
BDRBF MHVYF

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07:36 EDT Bombardier completes sale of CRJ program to Mitsubishi Heavy Industries - Bombardier (BDRBF) confirmed the closing of the previously announced sale of the CRJ Series aircraft program to Mitsubishi Heavy Industries, Ltd (MHVYF) for a cash consideration of approximately $550M, subject to post-closing adjustments and the assumption of liabilities by MHI related to credit and residual value guarantees and lease subsidies amounting to approximately $200M. Under the agreement, the Corporation's net beneficial interest in the Regional Aircraft Securitization Program, which is valued at approximately $170M, has been transferred to MHI. Through this sale, MHI acquires the maintenance, support, refurbishment, marketing, and sales activities for the CRJ Series aircraft, including the related services and support network located in Montreal, Quebec, and Toronto, Ontario, and its service centres located in Bridgeport, West Virginia, and Tucson, Arizona, as well as the type certificates. Bombardier will continue to supply components and spare parts and will assemble the remaining 15 CRJ aircraft in the backlog as of March 31, 2020 on behalf of MHI until the complete delivery of the current backlog, expected in the second half of 2020. Bombardier retains certain liabilities representing a portion of the credit and residual value guarantees totalling $288M as of March 31, 2020. This amount is largely fixed and not subject to future changes in aircraft value and is mainly payable by Bombardier over the next four years.
PLPRF

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07:34 EDT Plus Products re-launches limited edition gummies for Pride 2020 - Plus Products announced the return of its limited edition Rainbow Sherbet cannabis-infused gummies for Pride 2020. As part of its commitment to strengthening and supporting the communities in which it operates and sells products, the Company is collaborating with the SF Queer Nightlife Fund to donate $1 per tin sold to provide direct financial relief to workers in queer nightlife in San Francisco who have been affected by the COVID-19 pandemic. PLUS Rainbow Sherbet gummies are made with an blend of cannabinoids and contain 5mg of THC in each precisely dosed gummy. Rainbow Sherbet gummies are available for a limited time across select licensed retailers and cannabis delivery platforms throughout California.
SPAR SHYF

Hot Stocks

07:34 EDT Spartan Motors changes corporate name to The Shyft Group - Spartan Motors (SPAR) announced its corporate name change to The Shyft Group (SHYF), following the divestiture of its Emergency Response business. As part of the name change, the company has released a new company logo and has launched a new corporate website at www.theshyftgroup.com. The Shyft Group is headquartered in Novi, Michigan. The company begins trading under the NASDAQ ticker symbol "SHYF", effective June 1.
GRIL

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07:32 EDT Muscle Maker to open four locations at Northern Virginia Community College - Muscle Maker Grill announced that it has signed a lease for four Muscle Maker Grill locations at Northern Virginia Community College. The expansive menu offerings will vary from campus to campus and include traditional Muscle Maker Grill fare, MMG Meal Plans, Healthy Joe's signature menu offerings, Grab & Go and healthier snacks. Individually packaged boxed lunches that include a wrap or salad, side and beverage will be available and can be distributed in a group setting with minimal contact to accommodate social distancing practices. The Company plans to kick off construction on the four campuses this summer with the anticipation to open for the fall 2020 semester. Muscle Maker will open the four NOVA campus restaurants in addition to the recently announced five dual branded Muscle Maker Grill and Healthy Joe's delivery-only ghost kitchens in the downtown Chicago market this summer. The four NOVA community college restaurants and five delivery-only ghost kitchens add to the Company's growing non-traditional portfolio.
BBBY

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07:31 EDT Bed Bath & Beyond names Harriet Edelman independent Chair of Board - Bed Bath & Beyond announced that Harriet Edelman has been appointed as independent Chair of the Board, effective immediately. Patrick Gaston has stepped down as Chairman of the Board and, after 13 years as a director of the company, has notified the Board that he does not plan to stand for re-election at the company's 2020 Annual Meeting of Shareholders. In connection with Ms. Edelman's appointment as Chair of the Board, she has stepped down as Chair of the Audit Committee. The Board has appointed Joshua Schechter as Chair of the Audit Committee, effective immediately.
AMRN

Hot Stocks

07:23 EDT Amarin says cannot predict outcome of Vascepa generic appeal - The company said in a statement, "If Amarin wins on its patent litigation appeal the benefits of Amarin's planned increased promotion and education efforts should accrue to both improved patient care and to increased sales of Vascepa by Amarin. If Amarin loses on the patent litigation appeal, increased Vascepa usage as a result of increased promotion and education efforts should still benefit patient care. The larger market would potentially be split among branded Vascepa, a potential authorized generic version of Vascepa, if then launched by Amarin (which Amarin could launch rapidly if warranted), and generic versions of Vascepa from third-parties. As noted, Amarin believes any launch of generic versions of Vascepa by such third parties would be subject to supply limitations. Amarin reiterated that it believes that it has strong arguments in its patent litigation appeal but that it cannot predict the outcome. Amarin is progressing its plans for international expansion. Those plans are not directly impacted by increased promotion in the United States but could benefit from the company's anticipated expanded educational initiatives."
ALT

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07:22 EDT Altimmune launches clinical trial of T-COVID intranasal immune modulator - Altimmune announced the U.S. Food and Drug Administration has authorized the Company to proceed with a clinical trial of T-COVID, an investigational agent for the treatment of early COVID-19. Patient enrollment in the Phase 1/2 clinical trial is expected to commence in June, with data readout anticipated in Q4 2020. T-COVID is based on the same replication-deficient adenovirus 5 vector technology behind Altimmune's intranasal vaccine candidates, which include NasoVAX for influenza, NasoShield for anthrax, and AdCOVID for COVID-19, but it acts through a different mechanism. In preclinical studies sponsored by the National Institute of Allergy and Infectious Diseases, intranasal administration of RD-Ad5 vectors modulated the innate immune response to lethal challenge with a respiratory virus in mice and protected them from death. The immunomodulatory effects resulted in significantly decreased cellular inflammation and lower concentrations of IL-6 and other inflammatory cytokines in the lungs of treated animals compared to controls. Excessive production of inflammatory cytokines like IL-6 has been associated with the lung pathology and death in COVID-19. The protective effects were independent of any specific immunity or vaccine effects against the challenge virus. These protective effects were only observed with intranasal administration of RD-Ad5, and intramuscular administration provided no survival benefit. The Company believes that treatment with T-COVID administered as a single intranasal dose to patients with an early onset of symptoms and recent diagnosis of COVID-19 may prevent the progression to severe lung inflammation and thereby decrease the development of severe COVID-19 and the need for hospitalization. The FDA has agreed that the Company may use its existing lot of RD-Ad5-based NasoVAX influenza vaccine for the planned T-COVID clinical trial allowing the Company to immediately initiate the study. The planned clinical trial will evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19. The double-blind trial is expected to enroll approximately 100 patients who are 35 years and older randomized 1:1 to receive either intranasal T-COVID or placebo administered in an outpatient setting within 48 hours of onset of symptoms and 24 hours of diagnosis. The study will be enrolled in 3 cohorts of increasing risk factors for severe COVID-19, with the final cohort enrolling patients of all ages and risk factors. The primary efficacy endpoint is the proportion of patients with clinical worsening, defined as a 4% decrease in pulse oxygen saturation, or need for hospitalization. The Company believes this approach is differentiated from other COVID-19 therapeutics currently in development as it is focused on non-hospitalized patients prior to the development of pulmonary dysfunction or the need for hospitalization. T-COVID is being studied as a single intranasal dose, not requiring the use of needles or infusions, and has the potential to be self-administered. Additionally, based on the current stability profile at ambient temperatures, T-COVID has the potential to be widely distributed without the need for refrigeration. The Company's intranasal RD-Ad5 vectors have been studied in five clinical studies in healthy subjects and appeared to be safe and well-tolerated. Pending a successful trial readout, Altimmune anticipates future discussions with FDA about additional clinical trials and Emergency Use Authorization. The Company believes the mechanism of action underlying T-COVID has the potential to be studied for both pre- and post-exposure prophylaxis for higher-risk individuals, such as frontline healthcare workers, making it attractive as a potential first-line defense for other viral pathogens for which vaccines are not yet available, such as in an influenza pandemic or new strains of coronavirus. This therapeutic intervention complements the Company's development of AdCOVID, a single-dose, prophylactic intranasal vaccine candidate designed to specifically protect against COVID-19, which is also based on the RD-Ad5 vector. It is expected that AdCOVID, which expresses the spike antigen of SARS-CoV-2 virus, will promote mucosal and systemic immunity including IgA in the nasal cavity, neutralizing antibodies and T cell responses as previously demonstrated in a clinical study with the Company's intranasal adenoviral vector technology. Stimulation of nasal mucosal immunity may be especially important in the prevention and control of COVID-19 as the nasal cavity is a key site for SARS-CoV-2 replication.
ABMD

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07:21 EDT FDA issues EUA for Impella RP to include COVID-19 related right heart failure - The FDA has issued an emergency use authorization, or EUA, for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism, or PE. Abiomed manufactures Impella RP. Impella RP is a temporary heart pump that provides circulatory support for patients who develop right side ventricular failure. Five years of pre- and post-market clinical studies support Impella RP's safety and efficacy.
AMRN

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07:20 EDT Amarin to increase Vascepa promotion and education initiatives - Amarin announced that it intends to increase the level and breadth of its promotion and education initiatives regarding Vascepa. "As early signs emerge of patients returning to physicians' offices, Amarin plans to emphasize its key marketing messages including positioning Vascepa as the only FDA-approved drug for lowering the persistent cardiovascular risk beyond statin therapy for millions of high-risk patients...Most healthcare professionals and at-risk patients are unaware that Vascepa is the first and only drug with this important new indication. For this reason, and the emerging return of patients, Amarin believes the opportunity exists for increasing awareness of Vascepa and its potential to provide an important healthcare solution to reduce cardiovascular risk in high-risk patients," the company said in a statement. Amarin plans to adjust its level of promotion and educational activities upward or downward based on various factors, including whether any generic company takes the risk of launching a generic version of Vascepa during the patent litigation appeal process and the amount of any product launched. Amarin "does not believe generic companies have made the investment of resources, know-how and time to develop sufficient quantities of quality supply to meet current and growing demand. Accordingly, Amarin believes that if any generic determines to launch its product after an FDA approval that any such launch would be limited in scope."
BXRX

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07:19 EDT Baudax Bio secures $50M credit facility - Baudax Bio announced that it has closed on a credit facility of up to $50M from funds managed by Marathon Asset Management, a global credit solutions partner. Proceeds from the facility will generally be used to support the commercial launch of ANJESO injection, and for working capital purposes. This financing is in the form of a five-year term loan bearing interest at a fixed rate of 13.5%. Baudax will pay interest only for the first 24 months of the loan. The funds are structured in five tranches, to provide financial flexibility as needed, while balancing debt leverage and managing interest expense, with $10M available immediately upon closing of the transaction. The additional four tranches will be available upon achieving certain minimum net revenue thresholds within set periods of times from the closing date. If Baudax achieves $10M trailing 12-month EBITDA within 24 months of closing, then the term of the loan can be extended to six years with an interest only period of 36 months. In connection with the credit facility, Baudax issued to Marathon warrants to purchase 527,100 shares of Baudax common stock at an exercise price of $4.59 per share. Further information with respect to the credit facility and the warrants is set forth in the Form 8-K which will be filed by the Company with the Securities and Exchange Commission.
TNXP FUJIY

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07:18 EDT Tonix selects Fujifilm Diosynth Biotechnologies as manufacturing partner - Tonix Pharmaceuticals Holding Corp. (TNXP) announced an agreement whereby FUJIFILM Diosynth Biotechnologies (FUJIY) will provide contract manufacturing and development services to support the manufacturing of Tonix's COVID-19 vaccine candidate, TNX-1800, for clinical trial supply. Under the agreement, FUJIFILM Diosynth Biotechnologies will develop a manufacturing process, manufacture, and stock a supply of TNX-1800 at FDB's College Station, Texas site for Tonix's clinical development. FDB's manufacturing site in College Station, Texas is a state-of-the-art facility designed to operate as a flexible, responsive contract manufacturing facility to support production on multiple scales as candidates move through the clinical process from clinical stages into commercialization. In February, Tonix announced a strategic collaboration with Southern Research to support the development of TNX-1800 to protect against the new coronavirus disease, COVID-19, based on Tonix's proprietary horsepox vaccine platform. Tonix is developing TNX-801 as a potential smallpox preventing vaccine for the U.S. strategic national stockpile and as a monkeypox preventing vaccine. The Company believes that its proprietary horsepox virus has the potential to serve as a vector for vaccines to protect against other infectious agents.
KIM

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07:17 EDT Kimco Realty explores sponsoring separate investment vehicle - Kimco Realty announced that it is exploring the opportunity to sponsor a separate investment vehicle. The initiative is focused on raising capital to invest in retail real estate-related opportunities arising from market disruptions affecting retailers and the retail real estate sector, including the ongoing disruption caused by the COVID-19 pandemic. Kimco intends to invest approximately $50M-$100M in the separate investment vehicle upon the closing of its initial private capital raise. A subsidiary of Kimco intends to manage the new vehicle and will have the opportunity to receive income from managing the vehicle. The separate investment vehicle is expected to commence its operations upon completion of its private capital raise. Kimco cannot provide any assurances that the separate investment vehicle's capital raise, nor Kimco's investment in the separate vehicle, will be completed on successful terms, or at all.
AMRN

Hot Stocks

07:17 EDT Amarin says Q2 Vascepa prescription growth 'considerably slower' than Q1 - Amarin said in a press release, "As the United States reopens from the COVID-19 epidemic, Amarin intends to resume field-based face-to-face interactions with healthcare providers by its sales force, commencing on a pilot scale basis before the end of June 2020, based on current expectations. Assuming that these interactions prove to be helpful and other parts of the country reopen, the company plans to expand such interactions on a phased basis across select geographies. Prescription growth on a year-over-year basis in Q2'20 has, as expected due to COVID-19, been considerably slower than in Q1'20. However, Amarin believes that there are early signs that patient care for chronic conditions, such as treating the risks of cardiovascular disease, is increasing with more patients returning to their healthcare providers for routine medical visits."
IPI

Hot Stocks

07:15 EDT Intrepid Potash sells record volume of Trio to domestic customers in April - Intrepid Potash announced it safely sold a record volume of Trio to domestic customers during April. "Most importantly, our team accomplished this work safely and under mandated COVID-19 safety guidelines and procedures, including social distancing." said Mark McDonald Intrepid's Vice President of Sales. "With cooperative weather for most of the spring, we saw customers move their purchases into earlier in the season and our team was up to the challenge. Achieving a record month takes daily cooperation and communication across all lines of our business, and we want to thank our customers, the transportation industry, production and loadout staff, and our sales and marketing team for their hard work and dedication to following the COVID-19 safety guidelines during this pandemic. We are grateful and fortunate to be able to keep our workforce employed during this uncertain time. As the spring season slows down significantly in May and June, we are reminded of the value our customers place on this specialty fertilizer and we are proud to serve the American farmer working so hard through the COVID-19 pandemic to keep the agricultural food chain alive and well and feeding Americans."
XEBEF

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07:14 EDT Xebec Adsorption, Fonds de solidarite FTQ launch investment fund - Xebec Adsorption and Fonds de solidarite FTQ announced the creation of the GNR Quebec Capital L.P. investment fund. With an initial capitalization of $20M, this new investment vehicle aims to increase renewable natural gas production in Quebec. Partners, particularly from the agricultural and municipal sectors, will have access to the capital and expertise needed to develop and operate efficient facilities to treat organic waste. The creation of a fund of this type for renewable natural gas projects is a first in Quebec. Xebec and the Fonds will each initially invest $10less than into the partnership. Over time, Xebec and the Fonds expect that the partnership could receive an aggregate $100M in equity capital from Xebec, the Fonds and other investors. Xebec and the Fonds' initiative could, with a 75:25 debt to equity ratio, fund 12 to 15 renewable natural gas projects in Quebec with an aggregate investment of $400M over the next decade. The general partner, GNR Quebec Capital Management Inc., overseen by a Board of Directors nominated by Xebec and the Fonds will be managing the partnership.
CNC

Hot Stocks

07:14 EDT Centene: WellCare of Kentucky to continue serving Medicaid managed care program - Centene announced its subsidiary, WellCare of Kentucky, has been selected by the state of Kentucky to continue serving the commonwealth's Medicaid managed care program statewide. The new four-year contract is anticipated to begin on Jan. 1, 2021 running through Dec. 31, 2024 with the option for six, two-year renewal extensions.
ZNGA

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07:13 EDT Zynga up 4.5% after announcing acquisition of Peak, updating guidance
CLI

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07:13 EDT ISS, Glass Lewis recommend Mack-Cali Realty shareholders vote gold proxy card - Bow Street announced that Institutional Shareholder Services, or ISS, and Glass Lewis have recommended that Mack-Cali Realty shareholders vote the gold proxy card for Bow Street's independent director nominees in connection with the company's annual meeting on June 10. ISS recommended that Mack-Cali shareholders elect all eight of Bow Street's nominees to the Mack-Cali board. Akiva Katz and Howard Shainker, managing partners of Bow Street, said, "We are gratified that both ISS and Glass Lewis recognize that Mack-Cali shareholders deserve better, including a meaningful refreshment of the Board comprised of truly independent directors who will provide robust oversight of management, reestablish accountability, and deliver value to shareholders. We strongly encourage all Mack-Cali stakeholders to review ISS's and Glass Lewis's independent, third-party reports, which detail a systemic pattern of governance abuses that is amongst the worst we have witnessed throughout our careers as investors and fiduciaries. ISS and Glass Lewis, for a second year in a row, have confirmed our long-held belief that ending Mack-Cali's underperformance and governance woes is only achievable by resetting the broken culture in the Mack-Cali Boardroom. We urge shareholders to follow ISS's recommendation and vote the GOLD proxy card today to elect ALL EIGHT of Bow Street's nominees, who, as directors, will be fierce shareholder advocates and execute a plan to permanently usher in a new era of corporate responsibility, operational oversight, credibility and value creation at Mack-Cali."
PVCT

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07:12 EDT Provectus publishes updated data from metastatic NET Phase 1 PV-10 study - Provectus announced that updated data from the first cohort of the Company's neuroendocrine tumors metastatic to the liver Phase 1 study of investigational autolytic cancer immunotherapy PV-10 were published as an abstract as part of the American Society of Clinical Oncology 2020 Virtual Scientific Program, held online May 29-31, 2020. Small molecule-based PV-10 is administered either by cutaneous intratumoral injection to superficial melanoma and non-melanoma skin cancer tumors or by percutaneous IT injection to visceral primary and metastatic hepatic tumors. By targeting tumor cell lysosomes, PV-10 treatment may yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells and a T cell mediated immune response against treatment refractory and immunologically cold tumors. Adaptive immunity may be enhanced by combining immune checkpoint blockade with PV-10. This single-center Phase 1 study is being conducted at The Queen Elizabeth Hospital in Adelaide, Australia to evaluate the potential safety, tolerability, and preliminary efficacy of single-agent PV-10 treatment in symptomatic mNET patients refractory to systemic somatostatin analogues and peptide receptor radionuclide therapy. The primary endpoint of the trial is safety; secondary endpoints include objective response rate of injected target and measurable bystander lesions, target lesion somatostatin receptor expression, and biochemical response. Response assessments were conducted using Response Evaluation Criteria in Solid Tumors criteria and by independent review. Six patients in the first cohort each received one percutaneously-administered IT injection of PV-10 to one target lesion per treatment cycle. Patients in the second cohort can receive PV-10 injection of multiple lesions per cycle; enrollment of this cohort is nearing completion. Highlights from the mNET Presentation at ASCO: Baseline characteristics: 67% male; median age of 65 years. Disease characteristics: Primary tumor site: small bowel, pancreas, and caecal. NET grades: Grade 1 and Grade 2. All patients were refractory to SSA and PRRT. PV-10 treatment summary: Median of 1 cycle. Safety: Post-procedure pain, carcinoid flare, and nausea. Injected target lesion efficacy: 50% partial response, 50%ORR. Patient-level efficacy. 83%a disease control rate. Progression-free survival: Not reached by computerized tomography scan; 6.1 months by positron emission tomography scan. Overall survival: greater than22.5 months; 50% ongoing response follow-up at the January 2020 data cut-off.
AKCA IONS

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07:12 EDT Akcea Therapeutics: INFARMED grants approval for reimbursement of TEGSEDI - Akcea Therapeutics (AKCA), a majority-owned affiliate of Ionis Pharmaceuticals (IONS), announced the Portuguese Medicine Regulatory Authority (INFARMED) has granted approval for reimbursement of TEGSEDI for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis.
CTIC

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07:10 EDT CTI BioPharma: First patient enrolled in Phase 3 PRE-VENT trial - CTI BioPharma announced that it has enrolled the first patient in the Phase 3 PRE-VENT trial of pacritinib in hospitalized patients with severe COVID-19. PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care versus placebo and standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer. The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or die by Day 28.
PTI

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07:09 EDT Proteostasis announces in vitro data for PTI-129 as potential COVID-19 treatment - Proteostasis announced results from in vitro studies evaluating the use of PTI-129 as a treatment for COVID-19. PTI-129 is a pre-clinical, once-daily, oral small molecule originally designed to treat protein misfolding disorders involving the unfolded protein response. Upon infection, coronaviruses hijack the host cell endoplasmic reticulum to quickly produce a larger quantity of misfolding-prone viral glycoproteins. The accumulation of misfolded and unfolded proteins in the ER causes ER stress and induces the UPR. In in vitro studies conducted at Calibr, the drug discovery division of Scripps Research, PTI-129 demonstrated the potential to reduce viral protein production in host cells by activating the adaptive branches of the UPR pathway and reducing the levels of misfolded proteins.
CIGI

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07:08 EDT Colliers International completes acquistion of Dougherty - Colliers International has completed its previously announced acquisition of a controlling interest in Dougherty Mortgage, Dougherty Funding, Dougherty & Company and Dougherty Insurance Agency. Under Colliers' unique partnership model, Dougherty's senior leadership team will continue to drive operations and will remain significant shareholders. Headquartered in Minneapolis, with more than 250 professionals operating from nine offices, Dougherty provides mortgage banking, loan servicing, mortgage brokerage and investment banking services across 21 U.S. states. Dougherty originates $2.5B of real estate loans annually, services $7B in real estate loans and generated revenue in excess of $100M in 2019. Dougherty's mortgage banking operations have rebranded as Colliers Mortgage and will continue to provide specialty real estate debt financing for multifamily, healthcare and senior housing real estate through U.S. Government-Sponsored Enterprises. This includes origination, underwriting, asset management and loan servicing for Fannie Mae, the Federal Housing Administration/U.S. Department of Housing and Urban Development and for the U.S. Department of Agriculture. In addition, Colliers Mortgage will originate and service a broad range of other commercial real estate loans for real estate owners and developers nationwide. Going forward, all brokerage, investment banking, capital markets and public finance services will be carried on through newly branded Colliers Securities which is licensed under the Securities and Exchange Commission and is a member of the Financial Industry Regulatory Authority.
AZN

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07:08 EDT AstraZeneca announces FDA approval for Brilinta - AstraZeneca's Brilinta has been approved in the U.S. to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease, or CAD, the most common type of heart disease. The approval by the FDA was based on results from the Phase III THEMIS trial. The trial showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular, or CV, events at 36 months with aspirin plus Brilinta 60mg versus aspirin alone in patients with CAD and type 2 diabetes at high-risk of a first heart attack or stroke. The primary composite endpoint was driven by a reduction in heart attack and stroke. This is the first regulatory approval for aspirin plus Brilinta dual antiplatelet therapy in patients who have a high CV risk, but without a history of heart attack or stroke.
CGEN BMY

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07:07 EDT Compugen: FDA clears IND for Phase 1/2 study of COM701/Opdivo/BMS-986207 - Compugen (CGEN) announced that the U.S. FDA has cleared the investigational new drug application for its Phase 1/2 study evaluating the triple combination of COM701, Compugen's first-in-class anti-PVRIG antibody, Opdivo, Bristol Myers Squibb's (BMY) PD-1 immune checkpoint inhibitor and BMS-986207, Bristol Myers Squibb's investigational anti-TIGIT antibody, in patients with advanced solid tumors. The triple combination study is designed to evaluate the simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1, and will accelerate the clinical evaluation of Compugen's DNAM axis hypothesis and biomarker-driven approach in patients with advanced solid tumors, including those that may be refractory or non-responsive to standard-of-care immune checkpoint inhibitors. The study is expected to commence in the second half of 2020.
ZNGA

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07:06 EDT Zynga to acquire Peak for $1.8B in cash, stock deal - Zynga announced it has entered into a definitive agreement to acquire Peak for $1.8 billion. Zynga said in a release, "Peak brings a 100-person strong team and two Forever Franchises, Toon Blast and Toy Blast, that have consistently ranked in the top 10 and top 20 U.S. iPhone grossing games for over two years, respectively. These franchises add significant scale to Zynga's live services and will be an additional driver of margin expansion over the coming years. Peak also enhances Zynga's new game pipeline with additional projects in early development. Zynga will acquire 100% of Peak for $1.8 billion, comprised of approximately $900 million in cash and approximately $900 million of Zynga common stock (issued at the volume-weighted average closing price per share over the thirty-day trading period ended May 29). The final upfront transaction consideration will also include customary closing adjustments, and the transaction is expected to close in the third quarter of 2020."
AXGN

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07:06 EDT Axogen general counsel Greg Freitag retires - Axogen announced the appointment of Brad Ottinger as general counsel and chief compliance officer. He will assume the duties of Greg Freitag who retired from his position as general counsel. Freitag will continue as a member of the Company's Board of Directors and assume the role of Special Counsel during a transition period expected through October 2020. Ottinger's appointment is effective June 1, 2020. He will report directly to CEO Karen Zaderej and be responsible for all legal and compliance activities for Axogen. Prior to joining Axogen, Ottinger served as VP, general counsel, CAO and secretary of MicroPort Orthopedics.
ZNGA

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07:05 EDT Zynga to acquire Peak for $1.8B in cash, stock deal
REGN NTLA

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07:05 EDT Regeneron, Intellia Therapeutics expand pact to develop CRISPR/Cas9 treatments - Regeneron (REGN) and Intellia Therapeutics (NTLA) announced an expansion of their existing collaboration to provide Regeneron with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B. Regeneron also receives non-exclusive rights to independently develop and commercialize ex vivo gene edited products. Intellia will receive an upfront payment of $70M, and Regeneron will make an additional equity investment in Intellia of $30M at $32.42 per share. Under the amended agreement, the term of the companies' existing collaboration is extended until April 2024, with Regeneron having an option to renew for an additional two years. Regeneron will have rights to discover and develop CRISPR/Cas9-based therapeutic products for an additional five in vivo liver targets, for a total of up to 15 targets. As currently set forth in the existing collaboration, the parties will jointly research these in vivo targets, and thereafter certain targets may be developed by Regeneron or Intellia, or co-developed under certain conditions. Per the terms of the original agreement, Regeneron will pay potential royalties and milestone payments for the in vivo products it independently develops. In addition, Regeneron will receive a royalty-bearing, non-exclusive license to certain Intellia intellectual property to develop and commercialize up to 10 ex vivo CRISPR/Cas9 products in defined cell types.
CUB

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07:04 EDT Cubic awarded over $35M contract to support British Army training - Cubic announced Cubic Defence U.K. was awarded a contract worth more than $35M, to continue its support for the training of the British Army. The three-year contract is for support and repair of the area weapons effects simulator, or AWES, system at Salisbury Plain Training Area in the United Kingdom and at British Army Training Unit Suffield in Alberta, Canada.
EE

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07:04 EDT El Paso Electric, IIF agree to extend termination date for proposed acquisition - El Paso Electricand the Infrastructure Investments Fund, or IIF, announced that they have mutually agreed to extend the termination date for the transaction under the terms of the previously announced Agreement and Plan of Merger to September 1. As previously announced, the proposed acquisition is pending final approval from the Federal Energy Regulatory Commission, or FERC. On April 15, EPE and IIF filed proposed mitigation options with the FERC as requested by the FERC in its March 30 order conditionally approving the proposed acquisition. The FERC's approval of the parties' mitigation plan is the last regulatory approval needed to close the proposed acquisition. EPE and IIF continue to expect to close the transaction in the first half of 2020.
VBLT

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07:04 EDT VBL Therapeutics presents interim data from OVAL Phase 3 study - VBL Therapeutics announced the presentation of the outcome of pre-planned interim analysis results from the OVAL Phase 3 pivotal clinical trial in platinum-resistant ovarian cancer at the American Society of Clinical Oncology 2020 virtual annual meeting. The analysis compared the CA-125 objective response rate according to GCIG criteria in the treatment and control arms among the first 60 evaluable patients. The CA-125 ORR in those patients was 53%. Assuming a balanced randomization, the response rate in the treatment arm was 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate was 69%. The CA-125 response rate observed in the Phase 3 interim analysis is at least as good as the response rate seen in the prior Phase 2 study, which enrolled a similar patient population and showed overall survival benefit. In the previously reported Phase 2 study of VB-111 in platinum resistant ovarian cancer, 58% of the patients treated with VB-111 and paclitaxel demonstrated a CA-125 response. Those patients with a CA-125 response demonstrated a median overall survival of 808 days, versus 351 days for those patients without a CA-125 response.
SBT

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07:03 EDT Sterling Bancorp to hire Thomas O'Brien as CEO - Sterling Bancorp announced that the company and the Bank have agreed to hire Thomas O'Brien as the Chairman, President and CEO of the company and the Bank, subject to prior receipt of regulatory non-objection from the Office of the Comptroller of the Currency. O'Brien currently serves as a consultant to the Board of Directors of the Bank and will not assume the duties and responsibilities of President and CEO until such regulatory non-objection is received. Steve Huber, current CFO and Treasurer of the company, will continue to serve as Interim President and CEO until the time O'Brien becomes an employee of the company. O'Brien most recently he served as Vice Chairman of New York City-based Emigrant Bancorp and Emigrant Bank from October 2018 to March 2020.
ALRN

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07:02 EDT Aileron announces interim results from Phase 1b/2 trial of ALRN-6924 - Aileron Therapeutics announced interim data from the open-label Phase 1b dose optimization part of its ongoing Phase 1b/2 clinical trial. In this trial, ALRN-6924 is being evaluated as an agent to protect patients against chemotherapy-induced toxicity, a concept known as chemoprotection. Patients in the trial have advanced, p53-mutated small cell lung cancer and are being treated with second-line topotecan following administration of ALRN-6924. 18 patients were enrolled across three ALRN-6924 dose levels in the dose optimization part of the trial of which 17 patients completed the first treatment cycle and therefore met protocol-defined criteria for evaluability. A protective effect against severe chemotherapy-induced anemia and thrombocytopenia was observed across all dose levels as compared to historical controls. In addition, patients treated with 0.3 mg/kg ALRN-6924 met the protocol-defined criteria for reduction of NCI CTC Grade 3/4 neutropenia to less than or equal to50% in the first treatment cycle. Key findings from the interim analysis of the Phase 1b dose optimization part of the trial are as follows: Patients treated with 0.3 mg/kg ALRN-6924 showed the lowest rate of NCI CTC Grade 3/4 hematological adverse events, including 17% with anemia, 33% with thrombocytopenia and 67% with neutropenia, across all treatment cycles. None of the patients treated with 0.3 mg/kg ALRN-6924 required transfusions of red blood cells or platelets. The expansion of the 0.3 mg/kg ALRN-6924 dose level from six to a total of 14 patients is underway. Across all three dose levels, patients showed NCI CTC Grade 3/4 hematological adverse events, including 24% with anemia, 35% with thrombocytopenia and 88% with neutropenia. Across all three dose levels, no patients experienced febrile neutropenia or NCI CTC Grade 3/4 nausea, vomiting, diarrhea or fatigue, which are severe toxicities commonly observed with topotecan-treatment in this patient population. The Phase 1b portion of the study is designed to identify a dose and a schedule of ALRN-6924 administration to reduce chemotherapy-induced toxicities such as severe anemia and thrombocytopenia, as well as other toxicities resulting from topotecan. In the ongoing dose optimization part of the study, ALRN-6924 is administered 24 hours before each dose of topotecan, which is administered daily on days 1 through 5 of every 21-day treatment cycle. The Company is enrolling patients into the expansion cohort of its 0.3mg/kg dose level and plans to initiate enrollment in the schedule optimization part of the Phase 1b/2 trial in June 2020. As previously reported, the Company plans to report the top-line final data for the dose optimization and schedule optimization parts of the trial in the fourth quarter of 2020. The Company expects that these results will determine a recommended ALRN-6924 dose and schedule for subsequent trials. The Company is carefully monitoring the effect of the coronavirus pandemic on its clinical trial sites and the healthcare system, which may impact the future timing of the trial and the Company's planned data announcements.
BMY

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07:01 EDT Bristol-Myers announces commercial launch of ZEPOSIA - Bristol Myers announced that ZEPOSIA 0.92 mg, a new once-daily oral medication for adults for the treatment of relapsing forms of multiple sclerosis, or RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, is now commercially available in the U.S. ZEPOSIA was approved by the FDA on March 25.
ASM

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06:59 EDT Avino Silver & Gold Mines announces phased ramp-up to resume mining operations - Avino Silver & Gold Mines announces it is starting a phased ramp-up of operational activities at its Avino Mine near Durango, Mexico. The company said in a release, "on May 15, the Mexican Federal Government authorized the resumption of mining activities as of June 1, 2020, for municipalities that present low or no known cases of COVID-19, subject to criteria defined by the Secretariat of Health. The Company is pleased to announce that it received acceptance by the Secretariat of Health and has been granted approval to recommence regular production mining activities in an orderly, gradual and cautious manner, as of today."
CYDY

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06:59 EDT CytoDyn files request with FDA seeking Priority Review for leronlimab BLA - CytoDyn announced that it has filed with the U.S. FDA a request seeking Priority Review designation for the company's Biologics License Application for leronlimab as a combination therapy for HIV indication.
LLY

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06:58 EDT Eli Lilly announces FDA approval for Taltz sBLA to treat nr-axSpA - Eli Lilly announced the FDA has approved a supplemental biologics license application, or sBLA, for Taltz injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis, or nr-axSpA, in patients with objective signs of inflammation. This approval makes Taltz the first IL-17A antagonist to be approved by the FDA for nr-axSpA. This approval is based on the results from the Phase 3 COAST-X trial, which evaluated improvement in signs and symptoms of nr-axSpA as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 response criteria compared to placebo. ASAS40 measures disease signs and symptoms such as pain, inflammation and function.
MNK

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06:57 EDT Mallinckrodt to appeal District Court ruling - Mallinckrodt announced that it will appeal a ruling by the U.S. District Court for the District of Columbia in a lawsuit filed by its subsidiary, Mallinckrodt ARD LLC, against the U.S. Department of Health and Human Services, or HHS, and the Centers for Medicare and Medicaid Services, or CMS, regarding the Medicaid drug rebate calculation for Acthar Gel. "The District Court denied the Company's request to reconsider its previous decision that declined to declare unlawful an action by CMS to effectuate a change in the base date average manufacturer price used to calculate those rebates. The Court also denied the company's request that it temporarily block CMS' action pending an appeal. The Company will immediately appeal to the U.S. Court of Appeals for the D.C. Circuit, where it will seek to overturn the lower court decision and temporarily block CMS action during the appellate process," the company said in a release. "We are disappointed by the Court's unwillingness to reconsider its previous decision. We believe the Court has misinterpreted the statute that governs the Medicaid drug rebate program and failed to hold the government accountable to a bedrock principle of administrative law that the government must give fair notice and a clear, legal basis for a change in policy, particularly when that policy has been relied upon by a regulated entity such as Mallinckrodt," said Mark Casey, Executive Vice President and Chief Legal Officer of Mallinckrodt. "We plan to immediately appeal to the U.S. Court of Appeals for the D.C. Circuit. Mallinckrodt remains committed to ensuring Medicaid patients have access to Acthar Gel therapy for the long term." The company added, "In asking the Court to temporarily block CMS' action, the Company described the risk that allowing CMS to move forward could inhibit the Company's ability to fund research and development activities, including COVID-19 related activities, and effectuate its opioid settlement, among other issues. As previously announced, in the absence of court intervention, the company would pay roughly $640 million in retroactive non-recurring charges from January 1, 2013 to March 27, 2020, and the annualized prospective change to the Medicaid rebate calculation would reduce Acthar Gel net sales by roughly $90 million to $100 million. Under a previous agreement with the government, CMS has agreed to not enforce a change in the Medicaid drug rebate calculation for Acthar Gel until at least June 14."
BSX

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06:54 EDT Boston Scientific announces U.S. launch of Directsense Technology - Boston Scientific announced the U.S. launch of the Directsense Technology, a tool for monitoring the effect of radiofrequency, or RF, energy delivery during cardiac ablation procedures. Available on the Rhythmia HDx mapping system, the Directsense Technology, which received FDA approval in April, is the only tool to monitor changes in local impedance around the tip of the Intellanav MiFi Open-Irrigated ablation catheter, offering physicians an additional measurement of therapy effect during an ablation.
TXMD

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06:52 EDT TherapeuticsMD CFO Daniel Cartwright retires, James D'Arecca to succeed - TherapeuticsMD announced the appointment of James D'Arecca as the company's CFO, effective June 1. D'Arecca succeeds Daniel Cartwright, who has retired from his position as the company's CFO, also effective June 1. Cartwright will remain with the company as an advisor for a transitional period. D'Arecca joins TherapeuticsMD with broad experience in corporate and operational finance, most recently as Senior Vice President and Chief Accounting Officer of Allergan.
LVS...

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06:51 EDT Macau reports May casino revenue down 93.2% to 1.76B patacas - Macau's gaming bureau reported May gross revenue from games of fortune in the region decreased 93.2% year-over-year to 1.764B patacas. Publicly traded companies in the Macau gaming space include Las Vegas Sands (LVS), MGM Resorts (MGM), Wynn Resorts (WYNN) and Melco Resorts (MLCO).
MRK AZN

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06:47 EDT Merck, AstraZeneca: LYNPARZA receives positive opinion from EU CHMP - AstraZeneca (AZN) and Merck (MRK) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending LYNPARZA for approval as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. The CHMP based its positive opinion on results from the Phase 3 POLO trial, which were previously published in The New England Journal of Medicine. The trial demonstrated LYNPARZA nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo.
HEXO

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06:43 EDT Hexo's Belleville facility receives Health Canada sales license - HEXO is pleased to announce it has received its Health Canada licence amendment for the sale of dried and fresh cannabis, cannabis extracts, cannabis topicals and edible cannabis products for its cannabis manufacturing and processing facility in Belleville, Ontario. The updated licensing also encompasses the expansion of the licensed area to include the beverage production area dedicated to the Truss/HEXO beverage division. The Belleville facility will act as the main development, processing and distribution facility for HEXO's cannabis products. Located along primary shipping routes in Ontario, the facility further delivers on HEXO's national expansion strategy and ensures necessary capacity for the manufacturing and distribution of advanced cannabis products to fulfil purchase orders across the country.
EBS

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06:41 EDT Emergent BioSolutions issued task order for COVID-19 vaccine development - Emergent BioSolutions announced that it has been issued a task order under an existing contract with the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services, to deploy its contract development and manufacturing capacities, capabilities, and expertise to support the U.S. government's efforts to accelerate delivery of COVID-19 vaccines. This task order, valued at approximately $628M, is being issued under the company's 2012 contract with BARDA that established Emergent's Baltimore Bayview facility as a Center for Innovation in Advanced Development and Manufacturing for pandemic preparedness, and expands the partnership to include investments in Emergent's Baltimore Camden and Rockville facilities, creating a U.S.-based manufacturing supply chain for pharmaceutical and biotechnology innovators of COVID-19 vaccine candidates. Under the task order, Emergent will deploy its molecule-to-market CDMO offering, committing manufacturing capacity, valued at approximately $542.7M, for production of COVID-19 vaccine candidates through 2021. This award secures, on behalf of leading COVID-19 vaccine innovators that are supported by the U.S. government, capacity for drug substance manufacturing at the company's Baltimore Bayview facility and for drug product manufacturing at the Baltimore Camden and Rockville locations. The task order also includes an investment of approximately $85.5M for the rapid expansion of Emergent's viral and non-viral CDMO drug product fill/finish capacity at the Baltimore Camden and Rockville facilities.
COTY

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06:37 EDT Coty founder, Chairman Peter Harf to assume additional role of CEO - The founder of today's Coty, Chairman Peter Harf, will assume the additional role of CEO. Harf is an entrepreneur and builder of world-class businesses. He is Founder and Managing Partner of JAB Investors, an investment firm with more than $100B of assets under management. He has extensive industry experience, including through his previous roles as Chairman and CEO of Benckiser N.V. and then Deputy Chairman of Reckitt Benckiser, which he formed through the merger of Benckiser N.V. with Reckitt Coleman in 1999. While leading Benckiser, Harf built modern-day Coty and spent more than 20 years with direct executive responsibility for the business, as Chief Executive from 1990-2001 and then Chairman until 2011, during which time Coty again became an independent company with almost 14 times revenue growth. Harf has also served as Chairman of AB InBev.
KKR COTY

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06:35 EDT KKR to make $1B investment in Coty via convertible preferred shares - KKR (KKR) is making a $1B investment into Coty (COTY) via convertible preferred shares. These shares carry a coupon of 9% and will be convertible into Coty shares at $6.24, equating to a 20% premium to Coty's closing stock price on May 8, 2020 of $5.20, the last trading day before entry into the investment agreement. The initial $750M of this investment was completed on May 26, 2020, with the remaining $250M expected to be completed in the next two months. Assuming full conversion, JAB will remain Coty's largest shareholder, with 50% ownership in the company. KKR will be the second largest shareholder, with a 17% stake. KKR's majority investment in Wella values the business at $4.3B on a cash- and debt- free basis. This equates to 12.3x FY19 adjusted EBITDA of ~$350 million on a fully-allocated basis, which includes approximately $160M of central costs which will not transfer as part of the transaction. At the closing of the deal, expected in the next six to nine months, the Wella business is anticipated to issue approximately $1B of debt and distribute the proceeds to its respective shareholders. This will result in total net cash proceeds to Coty of approximately $2.5B, including $2.6B relating to 60% of Wella's enterprise value and $0.4 billion from the dividend distribution, net of $0.2B relating to debt items and $0.3B of tax and transaction fees. Based on Coty's FY19 results ended June 30, 2019, this two-pronged transaction lowers Coty's net debt/adjusted EBITDA leverage from ~5.6x to ~4.5x on a pro forma basis, adding meaningful stability.
LLY

Hot Stocks

06:34 EDT Eli Lilly doses first patients in LY-CoV555 study for COVID-19 treatment - Eli Lilly announced patients have been dosed in the first study of a potential antibody treatment designed to fight COVID-19. This investigational medicine, referred to as LY-CoV555, is the first to emerge from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists developed the antibody in three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, or NIAID, identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. LY-CoV555 is the first potential new medicine specifically designed to attack SARS-CoV-2, the virus that causes COVID-19. The first patients in the study were dosed at medical centers in the U.S., including NYU Grossman School of Medicine and Cedars-Sinai in Los Angeles. Should Phase 1 results show the antibody can be safely administered, Lilly expects to move into the next phase of testing, studying LY-CoV555 in non-hospitalized COVID-19 patients. The company also plans to study the drug in a preventative setting, focusing on vulnerable patient populations who historically are not optimal candidates for vaccines. Lilly is researching multiple approaches to treating COVID-19. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with two biotech companies to discover novel antibody treatments for COVID-19.
COTY KKR

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06:32 EDT Coty announces definitive agreement with KKR on Wella - Coty (COTY) announced the signing of a definitive agreement with KKR (KKR) as part of a strategic transformation that will deleverage its balance sheet, streamline its operations and strengthen its leadership team. Under the definitive agreement, Coty and KKR have entered into a strategic transaction for Coty's Professional and Retail Hair business, including the Wella, Clairol, OPI and ghd brands, valuing the businesses at $4.3B on a cash- and debt-free basis. KKR will own 60% of this separately managed entity and Coty will own the remaining 40%. As previously announced, KKR is investing $1B directly into Coty through the issuance of convertible preferred shares.
AUY

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06:23 EDT Yamana Gold confirms filing of technical report for Jacobina gold mine in Brazil - Yamana Gold confirms that a National Instrument 43-101 technical report for the Jacobina gold mine in Brazil, called 'NI 43-101 Technical Report, Jacobina Gold Mine, Bahia State, Brazil', with an effective date of December 31, 2019, has been filed with Canadian securities regulators. The Jacobina gold mine is a long life, low cost mine with estimated current production of 170,000 ounces per year which would increase to an average of 230,000 ounces per year pursuant to a low capital cost expansion, all as more fully described in the NI 43-101 report.
TGT

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06:16 EDT Target temporarily closing or shortening hours at 200 stores - Target said in a statement this weekend: "We are heartbroken by the death of George Floyd and the pain it is causing communities across the country. The safety of our team and guests is our top priority. At this time, we are making the decision to adjust store hours or close stores temporarily. We recognize the important role we play in helping our communities shop for the food, medicine and other essentials they need. We apologize for the inconvenience and will reopen our stores on their normally scheduled hours as soon as it is safe to do so. We're providing community support and prioritizing the rebuilding of our Lake Street store, which is near where George Floyd was killed. We have teams working to provide basic first aid supplies, water and essentials through partnerships with local nonprofits. We appreciate members of the community and our team who have assisted in cleaning in and around that location. We are now boarding the store up until we can survey the location and begin recovery efforts. Team members are receiving direct communications updates from leaders regarding any store impact where they work. Additionally, team members impacted by store closures will be paid for up to 14 days of scheduled hours during store closures, including COVID-19 premium pay. They will also be able to work at other nearby Target locations." Reference Link
MESO

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06:02 EDT Mesoblast: Remestemcel-L improves respiratory, functional outcomes in COPD - Mesoblast announced that treatment with its lead mesenchymal stem cell product candidate remestemcel-L in patients with chronic obstructive pulmonary disease and an elevated state of inflammation resulted in improved respiratory and functional outcomes. The results were presented as a virtual oral presentation delivered to the 2020 International Society for Cell & Gene Therapy annual meeting held May 28-29, 2020. The post-hoc analysis from a randomized, placebo-controlled 60-patient Phase 2 trial in patients with COPD showed that remestemcel-L, given in four monthly intravenous doses of 100M cells, significantly improved respiratory and functional clinical outcomes in patients with elevated levels of the inflammatory biomarker C-reactive protein. Significantly elevated CRP levels are predictive of increased hospitalization and death in patients with COPD1, and are seen in various acute lung diseases, including acute respiratory distress syndrome, a life-threatening complication of COVID-19. These results support the potential of remestemcel-L to effectively treat inflammatory lung diseases, such as acutely decompensated COPD and ARDS.
SYBX

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05:51 EDT Synlogic announces publication in Nature Communications highlighting SYNB1891 - Synlogic announced the publication in Nature Communications of preclinical data supporting its first clinical immuno-oncology program, SYNB1891, which is being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors or lymphoma. Data described in the publication demonstrate that SYNB1891 treatment cleared tumors and stimulated antitumor immunity in preclinical models of cancer. "The targeted delivery and dual immune stimulatory activity of SYNB1891 offer distinct advantages over other approaches," said Aoife Brennan, M.B., Ch. B., Synlogic's president and CEO. "The preclinical data published today highlight the transformative potential of SYNB1891. Together with the early experience in the clinic demonstrating feasibility and tolerability in the initial cohorts of the clinical trial, these data provide support for the continued development of SYNB1891 as a potential therapeutic option to expand the benefits of immunotherapy to more patients with cancer." The company said in a release, "The publication titled, 'Immunotherapy with an engineered bacteria by targeting the STING pathway for anti-tumor immunity,' details the engineering and characterization of SYNB1891. The work describes preclinical studies that demonstrate anti-tumor activity and generation of immunological memory by SYNB1891 in mouse models of cancer, as well as its robust activation of human antigen presenting cells, or APCs, that are key to the generation of an anti-tumoral immune response."
YUMC BYND

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05:41 EDT Yum China to introduce Beyond Burger at select restaurants - Yum China (YUMC) announced that it is partnering with Beyond Meat (BYND) to introduce the Beyond Burger as a limited time offering at select KFC, Pizza Hut and Taco Bell locations in mainland China starting June 3. The company said in a release, "This partnership marks the introduction of Beyond Meat's Beyond Burger in mainland China. Launching on June 3, KFC will offer the Beyond Burger as a 3-day limited time offer at five locations in Beijing, Chengdu, Hangzhou and Shanghai. The Beyond Burger will provide Chinese consumers an exciting and delicious plant-based twist on the iconic beef burger patty. Pizza Hut is also launching its first-ever burger offerings by testing a combo set that includes both a Beyond Burger and an Australian sirloin steak burger at six stores in Shanghai from June 8 to 11. Pre-sale coupons are required for participating in the test and are available only for Pizza Hut's members starting June 1. Meanwhile, Taco Bell will offer a taco made with the plant-based Beyond Burger patty at three stores in Shanghai from June 3-10. The taco combines Taco Bell's classic taco recipe with a crispy corn taco, signature Mexican spices and ingredients such as chipotle and black beans, vegetables and unique sauce."
HCM

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05:38 EDT Chi-Med plans to submit NDA for surufatinib following pre-NDA meeting with FDA - Hutchison China MediTech, or Chi-Med, announces that it has held its pre-New Drug Application, or NDA, meeting with the FDA for surufatinib for the treatment of patients with advanced neuroendocrine tumors, or NET. The company said in a release, "Chi-Med has reached an agreement with the FDA that the completed SANET-ep, non-pancreatic NET, and SANET-p, pancreatic NET, studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support a U.S. NDA submission. The FDA granted Fast Track Designation status to surufatinib for the non-pancreatic and pancreatic NET development programs in April 2020. Chi-Med has initiated preparatory work for the U.S. NDA and intends to utilize a rolling submission under Fast Track Designation Status. The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. Filing acceptance of the NDA is subject to FDA review of the complete application. The planned start of the NDA submission is late 2020."
ERYP

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05:36 EDT Erytech Pharma announces poster presentation ast ASCO - Erytech Pharma announces the presentation of two posters at the American Society of Clinical Oncology, or ASCO, 2020 Virtual Meeting. The company said in a release, "TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is planned to enroll approximately 500 patients in approximately 100 clinical sites in Europe and the U.S. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab paclitaxel or an irinotecan based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival, or OS. The trial is designed to identify a OS hazard ratio, or HR, of 0.72 with close to 90% power. An interim efficacy analysis is planned for when approximately two- thirds of events have occurred. To date, approximately 80% of the patients have been enrolled. Eryaspase is composed of L-asparaginase encapsulated in erythrocytes and has demonstrated significant efficacy in a randomized Phase 2 trial. Prognostic and predictive value of circulating tumor DNA, or ctDNA, investigated in this trial. The analysis from this prospective randomized trial confirmed that the presence of ctDNA at baseline is a strong prognostic factor, and that the early change of ctDNA correlates with treatment outcome. ctDNA could therefore be a potential predictive biomarker of eryaspase efficacy."
ABBV

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05:33 EDT AbbVie enters strategic collaboration with Jacobio Pharmaceuticals - AbbVie and Jacobio Pharmaceuticals announced a global, strategic collaboration to develop and commercialize SHP2 inhibitors, which target a key node in cancer and immune cells. The companies said in a release, "SHP2 is an important protein mediator of cellular signaling through RAS/MAP kinase pathway. Many tumors have genetic mutations, driving abnormal cancer cell growth which relies on SHP2 activity. SHP2 also plays a key role to control cytokine production and immune cell response. Therefore, inhibition of SHP2 is believed to have dual effects by potentially reducing cancer cell growth and modulating immune responses to generate anti-tumor activities. Jacobio's early clinical stage SHP2 assets, JAB-3068 and JAB-3312, are oral small molecules designed to specifically inhibit SHP2 activity. Under the terms of the agreement, AbbVie will be granted an exclusive license to the SHP2 portfolio. Jacobio will continue to conduct early global clinical trials of JAB-3068 and JAB-3312 with AbbVie covering R&D expenses. Upon completion, AbbVie will assume global development and commercialization responsibilities. Jacobio has an option, exercisable before the initiation of registrational trials, to exclusively develop and commercialize the SHP2 program in mainland China, Hong Kong, and Macau. Financial terms were not disclosed and the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act."
CYAD

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05:32 EDT Celyad presented updates on Phase 1 alloSHRINK trial at ASCO - Celyad announced updates from the company's allogeneic programs, including additional data from the Phase 1 alloSHRINK trial evaluating the T cell receptor, or TCR, inhibitory molecule, or TIM,-based, non-gene edited allogeneic CAR-T candidate, CYAD-101, for the treatment of metastatic colorectal cancer, or mCRC, and the company's short hairpin RNA, or shRNA, platform underpinning the next-generation, non-gene edited CYAD-200 series of CAR-T candidates. These data were presented at the 2020 American Society of Clinical Oncology, or ASCO, Virtual Scientific Program from May 29-31,. Dr. Frederic Lehmann, VP of Clinical Development at Celyad, commented, "The latest safety and clinical activity data from the alloSHRINK trial in metastatic colorectal cancer patients further demonstrate CYAD-101's differentiated profile as an allogeneic CAR-T candidate. The absence of clinical evidence of graft-versus-host-disease, or GvHD, for CYAD-101, which co-expresses the NKG2D receptor with our novel, TIM technology used to knockdown signaling of the TCR complex, confirms the potential of non-gene edited approaches for the development of allogeneic CAR-T candidates. Taking these positive clinical data into account, we have decided to broaden the program to include evaluating CYAD-101 following FOLFIRI chemotherapy in refractory patients as an expansion cohort of the alloSHRINK trial. Overall, treatment of advanced metastatic colorectal cancer patients beyond second line regimens remains a high unmet medical need, and we believe CYAD-101 could offer a unique immunotherapeutic approach to treat this incurable disease." Dr. David Gilham, CSO of Celyad, stated, "CYAD-101 has pioneered the potential for non-gene edited approaches for the development of allogeneic CAR-T candidates, and we are excited to build upon this strong position with our shRNA technology platform. Preclinical data reported during ASCO over the past few days confirm the ability of a single shRNA hairpin to provide prolonged TCR knockdown, which our first shRNA-based allogeneic candidate, CYAD-211. In addition, the data demonstrated the breadth and depth of the shRNA platform, including the concurrent knockdown of up to four genes. We believe combining the knockdown potential of the platform with additional construct enhancements provides tremendous therapeutic optionality to our non-gene edited CYAD-200 series of CAR-T candidates."
LBY

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05:12 EDT Libbey files voluntary petitions under Chapter 11 - Libbey announced that the Company and its U.S.-based subsidiaries have filed voluntary petitions for a court-supervised reorganization under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware. The company said in a release, "Libbey's international subsidiaries in Canada, China, Mexico, the Netherlands and Portugal are not included in the Chapter 11 proceedings and are operating in the normal course of business. Libbey expects to use the court-supervised restructuring process to strengthen its balance sheet to navigate the effects of the COVID-19 pandemic and better position the Company for the future. Libbey is continuing constructive discussions with its lenders and other stakeholders regarding the terms of a consensual financial restructuring plan and is focused on moving through the process as efficiently as possible. Certain of Libbey's existing lenders have agreed to provide up to $160 million in debtor-in-possession ("DIP") financing, including a $100 million revolving credit facility and a $60 million term loan. Following court approval, the Company expects this financing, together with cash flow from operations, to support the business during the court-supervised process. The Company is continuing to serve customers and end users globally, and will continue to evaluate the operating environment and make adjustments, as necessary, to adapt to the impact of COVID-19. Libbey is filing customary first day motions that, once approved by the Court, will allow the Company to smoothly transition its business into Chapter 11, including, among other things, granting authority to pay employee wages and benefits and honor customer commitments in the ordinary course of business. The Company will also pay vendors in the ordinary course for all goods and services provided on or after the Chapter 11 filing date."