Stockwinners Market Radar for June 03, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:57 EDT Founder of Velodyne Lidar reiterates call for Chairman, CEO to step down - David Hall, the beneficial owner of approximately 52.2% of the outstanding common stock of Velodyne Lidar, issued the following open letter to the Company's Board of Directors: "As I have made clear in recent months, I firmly believe that you have collectively fostered an anti-stockholder culture. I chose to resign from the Board earlier this year because I had numerous concerns about the strategic direction and current leadership of Velodyne Lidar. Today, I am writing to you to urge that the following Board members step down: Chairman Brad Culkin, Chief Executive Officer Anand Gopalan, director Michael Dee, and director Christopher Thomas. I believe that each of these individuals has breached stockholders' confidence and destroyed significant value in the Company. In my view, the only way to turn around Velodyne Lidar is to purge the Board of its seemingly self-interested and underqualified members. The Board should know it is not lost on stockholders that the Company's stock price has plummeted almost 50% since I was unjustifiably stripped of my role as Chairman in February. Pushing aligned and experienced directors off the Board has clearly been a recipe for disaster. At this point, the Company's failed directors should do the right thing and resign."

19:32 EDT Lyft CEO sells 36K shares of common stock - In a regulatory filing, Lyft disclosed that its CEO Logan Green sold 36K shares of common stock on June 1st in a total transaction size of $2.09M, reducing his stake by about 10%.

19:02 EDT Joint Corp. director Amos sells 54,000 common shares - In a regulatory filing, Joint Corp. director James Amos disclosed the sale of 54,000 common shares of the company on June 2 at a price of $71.9987 per share.

18:47 EDT Granite names Michael McNally board chair - Granite's board of directors has appointed three new directors and has elected Michael F. McNally as its new board chair. McNally has served on the board since 2016. The board also promoted Kyle T. Larkin to president and chief executive officer. At the conclusion of Granite's Annual Meeting of Shareholders held on June 2, 2021, former board chair, Claes G. Bjork, retired from the board. Louis E. Caldera, former United States Secretary of the Army, Laurie M. Mullen, retired partner at KPMG LLP, and Kyle T. Larkin have joined Granite's board of directors, effective Thursday, June 3, 2021. These appointments and retirement will increase the number of Granite directors from ten to twelve as part of the company's board succession plan.

17:58 EDT AMC Entertainment says has no plans to execute stock split - The company states that it "has received a number of inquiries regarding speculation about a potential split or reverse split of our stock. A stock split or reverse stock split is not a capital raising transaction and therefore does not achieve the aims of bolstering our liquidity or providing proceeds for other transactions. AMC has no plans to propose or take any actions regarding a stock split or reverse stock split, and in any event such actions would require shareholder approval."

17:36 EDT Motion Acquisition regains compliance with Nasdaq listing rules - Motion Acquisition previously received notice from The Nasdaq Stock Market that the company was not in compliance with Nasdaq Listing Rule 5250(c)(1) as a result of the company not having timely filed its Quarterly Report on Form 10-Q for the three months ended March 31, 2021. Upon filing this Form 10-Q with the Securities and Exchange Commission earlier today, the company regained compliance with this Nasdaq listing rule and the matter is now closed.

17:30 EDT AMC Entertainment says 507.8M shares outstanding to vote at shareholder meeting - The company states: "Fulfilling a commitment to release share count data, AMC Entertainment Holdings is today providing the following information: There were 501,780,240 AMC shares outstanding as of June 2, 2021, the record date for the Shareholder Meeting that is scheduled for July 29, 2021. Only the holders of these shares whose trades have settled as of June 2, 2021 are entitled to vote at the Shareholder Meeting. Trading or other transactions relating to the shares, such as share borrowing, derivatives or short selling, do not impact the number of shares entitled to vote at the Shareholder Meeting. Advance voting for the Annual Shareholder meeting is expected to begin on June 16 and will continue through July 28."

17:25 EDT Cohn Robbins receives noncompliance notification from NYSE - Cohn Robbins was unable to complete and file its quarterly report on Form 10-Q for the quarter ended March 31 by the required due date without unreasonable effort and expense. The company received a notice from NYSE indicating that, as a result of not having timely filed the Form 10-Q with the SEC, the company is not in compliance with Section 802.01E of the NYSE Listed Company Manual. The Listing Rule requires listed companies to timely file all required periodic reports with the SEC.

17:22 EDT Indus Realty Trust to acquire Charlotte, NC building for $42M - INDUS Realty Trust announced that it recently entered into an agreement to acquire, for a purchase price of $42M, an approximately 50% leased, 395,000 square foot industrial/logistics building in Charlotte, North Carolina. Under the terms of the agreement, INDUS expects to close on the acquisition by the end of Q2.

17:20 EDT Talos says 'Tornado Attic' well discovers pay in-line with expectations - Talos Energy provided an update regarding successful drilling operations on the company's Tornado 3 sidetrack well, or "Tornado Attic" well, which successfully discovered pay in-line with pre-drill expectations. Talos holds a 65.0% working interest in the Tornado field and is the operator with Kosmos Energy also holding a 35% working interest.

17:19 EDT Targa Resources to replace CoreLogic in S&P 400 at open on 6/9 - Stone Point Capital and Insight Partners are acquiring CoreLogic in a deal expected to be completed soon pending final closing conditions.

17:12 EDT e.l.f. Beauty CEO sells 82.2K shares of common stock - In a regulatory filing, e.l.f. Beauty disclosed that its CEO Tarang Amin sold 82.2K shares of common stock on June 1st in a total transaction size of $2.26M, reducing his stake by about 8%.

17:08 EDT Coherus Biosciences' toripalimab combination meets survival endpoint in NPC - Coherus BioSciences and Shanghai Junshi Biosciences announced positive results from the pivotal study "JUPITER-02", a Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma. The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival or PFS vs. chemotherapy alone. JUPITER-02 also met secondary endpoints of PFS assessed by the investigator and objective response rate assessed by BIRC. There was also a longer duration of response, a higher disease control rate and higher one- and two-year survival rates for the toripalimab arm. The safety profile of toripalimab was consistent with that observed in previously reported toripalimab clinical trials. The results will be presented at the 2021 annual meeting of the American Society for Clinical Oncology on June 6. More than 30 toripalimab abstracts were accepted for ASCO 2021. JUPITER-02 is the largest Phase 3 clinical study to evaluate a checkpoint inhibitor plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma. By the date of the interim analysis data cut, the median treatment duration was 39 weeks in the toripalimab arm and 36 weeks in the placebo arm. The 1-year PFS rates were 49% and 28%, respectively, for the toripalimab arm vs. the placebo arm. Although median overall survival (OS) analysis was not yet mature, a 40% reduction in risk of death was observed in the toripalimab arm compared to placebo.

17:03 EDT AstraZeneca, Merck say lynparza showed improvement in primary endpoint - AstraZeneca (AZN) and Merck (MRK) announced the first presentation of data from the Phase 3 OlympiA trial, in which LYNPARZA demonstrated a statistically significant improvement in its primary endpoint of invasive disease-free survival versus placebo in the adjuvant treatment of patients with germline BRCA1/2 mutations and high-risk human epidermal growth factor receptor 2-negative early breast cancer following definitive local treatment and neoadjuvant or adjuvant chemotherapy. Results will be presented during the Plenary Session at the 2021 American Society of Clinical Oncology Annual Meeting on June 6. Results were also published today in the New England Journal of Medicine. An estimated 2.3 million people were diagnosed with breast cancer worldwide in 2020, and germline BRCA mutations are found in approximately 5% of patients with breast cancer. OlympiA is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial. In the overall trial population of 1,836 patients, results showed LYNPARZA reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% versus placebo based on a pre-specified event-driven interim analysis with a median follow-up of 2.5 years. At three years following trial initiation, 85.9% of patients treated with LYNPARZA were alive and free of invasive breast cancer and second cancers versus 77.1% of patients treated with placebo.

17:01 EDT Merck says Keytruda reduced risk of disease recurrence in Phase 3 trial - Merck announced first-time results from the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, for the potential adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. After a median follow-up of 24.1 months, KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo. Additionally, a favorable trend in overall survival was observed with a 46% reduction in the risk of death with KEYTRUDA as compared to placebo. As previously announced, the trial will continue to evaluate OS, a key secondary endpoint. "With the results of KEYNOTE-564, pembrolizumab is the first immunotherapy to show a clinical benefit in the adjuvant setting in kidney cancer," said Dr. Toni K. Choueiri, director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School. "It took several decades to achieve this milestone. We hope to build on this important research and provide new treatment options to kidney cancer patients."

16:59 EDT EA says 'Knockout City' has had over 5M players since launch - Electronic Arts (EA) announced that its latest multiplayer game "Knockout City" has sene more than 5M players since its launch late last month. "THANK YOU, brawlers, for making the Knockout City game launch and Block Party an amazing ten-day event that surpassed expectations," the company said. "This party was unforgettable in many ways, and we're so excited to see the support and positivity pouring in from you, our community! Since launch, we've seen 5 million new brawlers join us in matches, there's been amazing- and unexpected- gameplay, hundreds of thousands of Crews were formed, over half a billion KOs landed, millions of hours of gameplay were watched, and-dare we say it?-thousands of friendships were made along the way. Who knew you could bond over hitting one another in the face with a dodgeball? It's been amazing to see everyone getting to check out the game during Block Party for free, and we know this is a game that you really need to play to appreciate how fun it is, so we wanted to keep the game free to try for anyone that didn't get to check it out before now. That's why we've decided to keep the fun rolling by giving new brawlers the ability to start playing for free and level up (currently to Street Rank 25) before having to purchase the game. That's also enough game time to teach them to pass the ball." The game is available on PC, Xbox One (MSFT), PlayStation 4 (SONY), Xbox Series X/S, PlayStation 5, and Nintendo Switch (NTDOY). Reference Link

16:46 EDT Caleres names Jennifer Olsen chief marketing officer - Jennifer "Jenny" Olsen has been named Chief Marketing Officer for Caleres, it was announced by Diane Sullivan, Chairman and CEO of Caleres. Olsen, who will begin on June 28, will oversee all brand marketing for Caleres including consumer analytics, media and creative. Olsen was most recently the CMO of UNTUCKit, where she led the marketing and creative teams.

16:36 EDT Triumph selected to support Boeing on AH-64 Apache - Triumph Group (TGI) announced that it has signed a repair and overhaul services agreement with Boeing (BA) for engine driven pumps on the AH-64 Apache. The long-term agreement supports the Boeing Vertical Lift Sustainment Depot Program, which provides the U.S. Army with lifecycle support of the Apache combat helicopter. "As the supplier of the Apache engine driven pump, Triumph's participation in the VLS Depot Repair Program helps improve operational readiness of the fleet while also reducing total ownership cost," said Scott Ledbetter, President of Triumph Actuation Products & Services operating company. "Triumph is a natural choice for customers who seek world class engineering expertise combined with in-house maintenance and repair capabilities. This agreement reflects a long-term commitment to our customer, and we are pleased that Boeing recognizes the continued value we can provide throughout the product lifecycle." The engine driven pumps that were designed and manufactured by Triumph supply hydraulic power to critical flight controls and utility functions on the aircraft. Triumph's in-house MRO business works hand-in-hand with the engineers who designed the pumps, providing the most reliable and cost-effective aftermarket support. The contract extends through 2024.

16:35 EDT America First Multifamily Investors announces sale of Vantage at Powdersville - America First Multifamily Investors announced that Vantage at Powdersville, a 288-unit market rate multifamily property located in Powdersville, South Carolina, was sold at the direction of the managing member of Vantage at Powdersville. The partnership's investment in the property was originated in November 2017 and the partnership previously contributed equity totaling approximately $10.7M. As a result of the sale, the partnership's equity investment in the property owner was redeemed. At closing of the sale, the partnership received net cash of approximately $19.4M and will recognize investment income of approximately $2.4M. The company will also recognize a gain on sale of approximately $4.8M, before final settlements of proceeds and expenses. The partnership will realize approximately 10c of net income per Beneficial Unit Certificate, basic and diluted, from the sale in Q2. Cash available for distribution is expected to be approximately 10c per BUC, basic and diluted, from the sale in Q2.

16:32 EDT Locust Walk Acquisition gets Nasdaq notice of deficiency - Locust Walk Acquisition, a blank-check company formed for the purpose of acquiring or merging with one or more businesses, announced that on May 28, 2021 it received a notice from Nasdaq Regulation indicating that, as a result of not having timely filed its Quarterly Report on Form 10-Q for the quarter ended March 31, the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of all required periodic financial reports with the Securities and Exchange Commission. The Nasdaq notice has no immediate effect on the listing or trading of the Company's units, Class A common stock or warrants on the Nasdaq Capital Market, and while the notice provides that the Company must submit a plan to regain compliance with Nasdaq Listing Rule 5250(c)(1) by July 26, the Company filed the Form 10-Q on June 3; accordingly, the Company believes that it is now in compliance with all applicable Nasdaq listing rules.

16:32 EDT National Health Investors reaches agrement to defer rent - National Health Investors "provided an update on a deferral agreement with Holiday Retirement, updated its May and second quarter contractual cash collections, and declared a second quarter dividend. NHI has reached an agreement with Holiday that defers rent of $600,000 per month for May, June, and July of 2021. The company also agreed to release $600,000 per month to be applied to rent for May, June, and July of 2021 from the Holiday security deposit which totaled $10.6 million prior to this deferral agreement. The remaining monthly base rent of $1.7 million will be paid in cash. Deferred payments under this agreement accrue interest at 8% and are expected to be repaid over 18 months commencing January 1, 2022. NHI continues to evaluate actions to optimize the Holiday portfolio which may include further deferrals, asset sales, and lease restructurings."

16:29 EDT DD3 Acquisition Corp. II receives noncompliance notification from Nasdaq - DD3 Acquisition Corp. II announced that it received a notice from the Listing Qualifications Department of Nasdaq indicating that the company is not in compliance with Nasdaq Listing Rule 5250 due to a delay in filing its quarterly report on Form 10-Q for the quarter ended March 31 with the Securities and Exchange Commission. The notice has no immediate effect on the listing or trading of the company's securities on the Nasdaq Capital Market. Nasdaq informed the company that, under Nasdaq's listing rules, the company has until July 26 to submit a plan to regain compliance with the rule, provided that the company will not be required to submit a plan if the Form 10-Q is filed before such date.

16:26 EDT Ion Geophysical commences second phase of North Sea 3D multi-client program - Ion Geophysical announced the commencement of a second, significantly larger phase of its approximately 11,000 sqyare kilometer North Sea 3D multi-client program. The company said the Mid North Sea High's proximity to shore and existing infrastructure translate to lower development costs, making the play particularly attractive to incumbents and new entrants alike. Phase two builds on a first phase last year, where Shearwater's acquisition technology and ION's imaging produced subsurface images that revealed insights into this underexplored UK province. ION has partnered with Shearwater again on phase two, which, upon completion in mid-October, will increase the program survey area six-fold.

16:24 EDT Apollo Global to acqurie EmployBridge, terms undisclosed - Apollo Global announced that funds managed by its affiliates have entered into a definitive agreement to acquire EmployBridge, the largest industrial staffing company in the United States. Subject to satisfaction of customary closing conditions including regulatory approvals, the transaction is expected to be completed by July. The terms and conditions of the transaction were not disclosed.

16:23 EDT Enviva sees FY21 net income to $29.4M-$49.4M - Raises FY21 adjusted EBITDA $250M-$270M vs. $230M-$250M prior view

16:21 EDT Preferred Apartment names Joel Murphy chairman of the board - Preferred Apartment Communities announced that its Board of Directors has unanimously appointed Joel Murphy to the additional position of Chairman of the Board. Murphy will continue to serve as President and Chief Executive Officer. The Board also unanimously appointed Howard McLure to continue to serve as its Lead Independent Director. Murphy has served as the Company's Chief Executive Officer since January 2020, and as a member of the Board of Directors since May 2019. "On behalf of the Board of Directors, we are pleased to announce that Joel Murphy has been named Chairman of the Board at PAC. Joel is a true leader in the real estate industry, which was proven most recently with his leadership in 2020. Under Joel's guidance, the Company's core business remained consistent through the pandemic, and at the same time, he has led and continues to lead the execution of the strategic transformation and simplification of our structure and balance sheet. Joel's leadership and experience are great assets for the Board as the Company continues to execute on its efforts to create long term value. We look forward to his expanded role in providing oversight, direction, and leadership to the full Board," commented Howard McLure, the Company's Lead Independent Director.

16:20 EDT DocuSign jumps 5% to $204.91 after Q1 results beat, FY22 revenue view raised

16:18 EDT Crowdstrike up 2% to $219.50 after Q1 earnings beat

16:17 EDT Broadcom CEO says 'strong demand from service providers and hypercloud' - "Due to the strength in demand for semiconductors across our multiple end markets, we delivered 20% year-over-year increase in semiconductor revenue," said Hock Tan, President and CEO of Broadcom. "Our third quarter outlook projects this year-over-year growth to sustain, as we continue to see strong demand from service providers and hypercloud." "Consolidated revenue grew 15% year-over-year and operating profit increased 25%," said Kirsten Spears, CFO of Broadcom. "We generated $3.4 billion in free cash flow or 52% of revenue in the quarter, and are expecting free cash flow to remain strong in the third quarter."

16:14 EDT Jaws Acquisition Corp closes business combination with Cano Health - Jaws Acquisition Corp. has completed its business combination with Cano Health, a primary care provider for seniors and underserved communities. The business combination, which was approved by Jaws' stockholders at its special meeting held on June 2, will enable Cano Health's shares of Class A common stock to begin trading on the NYSE under the symbol "CANO" beginning June 4. Dr. Marlow Hernandez will continue to lead Cano Health as CEO and Chairman of the Board of Directors. As a result of the business combination, Cano Health received approximately $1.49B of gross proceeds, including approximately $690M of cash held in Jaws' trust account and $800M from private placement investors and funds affiliated with Fidelity Management & Research as well as funds and accounts managed by BlackRock, Third Point and Maverick Capital.

16:12 EDT Strongbridge Biopharma issued patent from USPTO for Recorlev - Strongbridge Biopharma announced that the United States Patent and Trademark Office, or USPTO, has issued U.S. Patent No. 11,020,393 entitled, "Methods of Treating Disease with Levoketoconazole" which covers a method of treating Cushing's syndrome patients with Recorlev who also take metformin for Type 2 diabetes. The term of the U.S. patent will expire on March 2, 2040. This will be the third patent issued in the U.S. relating to Recorlev. The first, U.S. Patent No. 9,198,906, covers methods of reducing C-reactive protein levels and systemic inflammation through administration of a once-daily dose of Recorlev and will expire on December 29, 2030. The second, U.S. patent No. 9,918,984, covers methods of treating Cushing's syndrome with levoketoconazole and will expire on January 10, 2026.

16:09 EDT Vincerx Pharma announces first patient dosed in VIP152 study - Vincerx Pharma announced that the first patient has been dosed in the company's Phase 1b study of VIP152 in MYC-driven relapsed or refractory, or R/R, aggressive lymphomas and advanced solid tumors.

16:05 EDT CEOs of Canadian National, Kansas City Southern discuss benefits of combo - JJ Ruest, President and Chief Executive Officer of CN (CNI) and Patrick J. Ottensmeyer, President and Chief Executive Officer of Kansas City Southern ((KSU) presented today at Bernstein's 37th Annual Strategic Decisions Conference. In their prepared remarks and the fireside chat, both CEOs articulated how the combination of CN and KCS will create a fully end-to-end merger that will deliver significant public interest benefits for customers, ports, employees, communities and the environment. The CN-KCS combination will create an end-to-end merger with significant options for customers in the North-South corridor. With CN's commitment to divest KCS' 70-mile line between New Orleans and Baton Rouge, the proposed combination creates an end-to-end merger and provides no risk to competition. In fact, customers will now be able to access new markets that were not previously available to them via efficient single-line service. Customers will continue to have multiple options to move goods along this corridor, including the availability to use an improved new CN-KCS route, five other Class I railroad routings, the Mississippi River and two major interstate highways. Customers will not lose any existing routing options because CN and KCS are committed to preserving access to all existing gateways to enhance route choices and to ensure robust price competition. "The economy in North America, especially now post-COVID, really needs a network of the kind that we are talking about putting together especially as it relates to USMCA. There is something in it for shareholders. There is something in it for customers. There is something in it for employees - this is a growth project. It will create jobs. There is something in it for the port operators, which connect to us. It will give them better access to more cities, more importers, more exporters, so they too can do what they do best." JJ Ruest, president and chief executive officer of CN "This combination will create a truly end-to-end network that will provide a new single line service to go after the I-35 freight corridor and the market opportunity that exists there. I think this will clearly be of interest to a lot of shippers as demonstrated by the support we have seen already, as well as create new competitive options that simply don't exist today. We are combining two important segments that are already recognized as premium service segments, and this network is going to be unparalleled in terms of the access to markets, ports and the way we can participate in and help drive some of the economic growth we think will exist in the years ahead."

16:04 EDT IS&S receives flat panel display orders from online retailer - Innovative Solutions & Support (ISSC) was contracted by a premier on-line retailer for upgrades to its expanding air carrier operation, and is now retrofitting this operator's Boeing (BA) aircraft with their state-of-the-art Cockpit/IP Primary Flight/Navigation Flat Panel Display System. Initial orders are for 11 ship sets of the system. The IS&S flight deck upgrade replaces aging flight instruments on the Boeing 757/767, utilizing a common 10.4-inch LCD display architecture that IS&S developed and certified to increase operational performance, improve dispatch and on-time arrival, simplify maintenance, enhance situational awareness and improve safety for legacy aircraft. The IS&S retrofit decreases fuel consumption and aircraft weight, resulting in operational savings and reduced CO2 emissions. The system also achieves 3 and 10 day MMEL approval. Utilizing existing wiring, the installation can be completed in 24 hours while reducing the component count by 70% and removing approximately 180 pounds of legacy equipment, without the operator having to wait through heavy maintenance checks and extended aircraft downtime.

15:24 EDT VeriSign says domain name registrations down 0.9% year-over-year in Q1 - VeriSign announced that the first quarter of 2021 closed with 363.5M domain name registrations across all top-level domains, or TLDs, a decrease of 2.8M domain name registrations, or 0.8%, compared to the fourth quarter of 2020. Domain name registrations have decreased by 3.3M, or 0.9%, year over year. The .com and .net TLDs had a combined total of 168.0M domain name registrations in the domain name base at the end of the first quarter of 2021, an increase of 2.8M domain name registrations, or 1.7%, compared to the fourth quarter of 2020. The .com and .net TLDs had a combined increase of 7.3M domain name registrations, or 4.6%, year over year. As of March 31, 2021, the .com domain name base totaled 154.6M domain name registrations, and the .net domain name base totaled 13.4M domain name registrations, VeriSign stated.

14:11 EDT NIH researchers identify Adamis' Tempol as potential antiviral drug for COVID-19 - The experimental drug Tempol may be a promising oral antiviral treatment for COVID-19, suggests a study of cell cultures by researchers at the National Institutes of Health, the NIH announced. Tempol can limit SARS-CoV-2 infection by impairing the activity of a viral enzyme called RNA replicase, according to work led by researchers at NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development that appears in "Science," the NIH stated in a press release. Dennis Carlo, Ph.D., President and CEO of Adamis Pharmaceuticals, stated on June 1: "We have also been preparing to begin patient enrollment in a Phase 2/3 clinical trial to evaluate the use of Tempol in patients with COVID-19." Reference Link

13:49 EDT Tesla down 3% to $585.27 after Information report of China orders dropping

13:27 EDT Catalyst, KYE say Canadian Federal Court suit quashes NOC for Ruzurgi - Catalyst Pharmaceuticals and KYE Pharmaceuticals announced a decision in their lawsuit in Canadian Federal Court challenging Health Canada's approval of Medunik's New Drug Submission for Ruzurgi. The lawsuit sought judicial review of Health Canada's decision to approve the NDS for Ruzurgi and issue a Notice of Compliance on August 10, 2020, as unreasonable due to Ruzurgi's product monograph and NDS explicitly referencing data included in Firdapse's NDS, approved by Health Canada on July 31, 2020 and given data protection as an Innovative Drug as of that date. The Judge's decision quashes the NOC previously issued for Ruzurgi and remands the matter to the Minister of Health to redetermine its decision to grant marketing authorization to Ruzurgi in spite of Firdapse's data protection rights. This leaves Ruzurgi without marketing authorization in Canada.

13:17 EDT Provident Bancorp trading resumes

13:07 EDT MFA Financial names Laurie Goodman non-executive board chair - MFA Financial announced that its board of directors has appointed Laurie Goodman as non-executive chair of the board, effective immediately. Goodman assumes the role of board chair from George H. Krauss, who retired from the board after 24 years of service as a director of MFA following the company's annual meeting of stockholders held earlier in June.

12:24 EDT Ring's Neighbors App to require police to publicly request videos - In a blog post, Amazon's Ring announced the launch of Request for Assistance posts on the Neighbors App. The company said, "Beginning next week, public safety agencies will only be able to request information or video from their communities through a new, publicly viewable post category on Neighbors called Request for Assistance. Public safety agencies can use these posts to notify residents of an incident and ask their communities for help related to an investigation. All Request for Assistance posts will be publicly viewable in the Neighbors feed, and logged on the agency's public profile. This way, anyone interested in knowing more about how their police agency is using Request for Assistance posts can simply visit the agency's profile and see the post history. Request for Assistance posts can only be issued from verified public safety agency profiles. We have guidelines in place to prevent overly broad requests, and all public safety agencies must abide by our Request for Assistance Policy and Guidelines, which are publicly available in our Help Center... Request for Assistance posts are opt-in, nothing is shared with any agency unless you actively go through the steps of choosing to do so. You can also remove Request for Assistance posts from your feed. If you previously opted out of Video Requests, you will not be notified when public safety agencies post a Request for Assistance." Reference Link

12:06 EDT Fannie Mae extends protections for renters affected by COVID-19 - Fannie Mae announced the extension of its multifamily COVID-19 forbearance program through September 30, 2021. The program, which requires landlords to suspend all evictions for renters unable to pay rent during the forbearance period, was formerly set to expire on June 30, 2021. For any Fannie Mae-financed multifamily properties with a new or modified forbearance plan as the result of a financial hardship due to COVID-19, the property owner must inform tenants in writing about tenant protections available during the property owner's forbearance and repayment periods. In addition, the borrower is required to provide tenant protections. "Fannie Mae remains committed to supporting renters and multifamily property owners as COVID-19 continues to financially impact many people in the United States," said Michele Evans, Executive Vice President and Head of Multifamily. "By extending the forbearance program for Fannie Mae multifamily borrowers, we are also extending essential protections and flexibilities for renters, which will help keep people in their apartments as the economy continues to improve."

12:00 EDT Express falls -23.3% - Express is down -23.3%, or -$1.52 to $5.00.

12:00 EDT NGL Energy Partners rises 9.7% - NGL Energy Partners is up 9.7%, or 27c to $3.05.

12:00 EDT GTT Communications rises 42.8% - GTT Communications is up 42.8%, or $1.07 to $3.57.

11:57 EDT Ford to introduce all-new compact pickup called Ford Maverick - Ford said it is adding an all-new compact pickup to its Built Ford Tough lineup called Maverick. The ll-new Ford Maverick makes its debut on June 8 with the help of actress Gabrielle Union, who will show-off the all-new truck on her own Instagram and TikTok channels, on Ford's social channels as well as on Hulu. The Maverick will be Ford's first vehicle to debut on its new U.S. TikTok channel. Reference Link

11:25 EDT Grifols sees revenue from new launches growing to 20%-plus by 2030 - Grifols, in investor day presentation slides, said its revenue from new product launches will grow from 4% in 2020 and 20%-plus by 2030.

11:19 EDT Biden-Harris administration unveils vaccine sharing plan for first 25M doses - The Biden-Harris administration said in a statement that, " As we continue to fight the COVID-19 pandemic at home and work to end the pandemic worldwide, President Biden has promised that the United States will be an arsenal of vaccines for the world. To do that, the Administration will pursue several additional measures beyond our robust funding for COVAX: Donating from the U.S. vaccine supply to the world and encouraging other nations to do the same, working with U.S. manufacturers to increase vaccine production for the rest of the world, and helping more countries expand their own capacity to produce vaccines including through support for global supply chains... Today, the Administration announced its framework for sharing at least 80 million U.S. vaccine doses globally by the end of June and the plan for the first 25 million doses." Publicly traded COVID vaccine makers include Pfizer (PFE), BioNTech (BNTX), Moderna (MRNA), Johnson & Johnson (JNJ), AstraZeneca (AZN), and Novavax (NVAX). Reference Link

11:15 EDT DexCom announces publication and presentation of two new studies - DexCom announced the publication and presentation of two new studies during the 14th International Conference on Advanced Technologies & Treatments for Diabetes, or ATTD. The company said: "The MOBILE study, published in the Journal of the American Medical Association, is the first of its kind to find that people with Type 2 diabetes who use basal, or background, insulin, benefited from the use of CGM. With the publication of the MOBILE data, Dexcom has now demonstrated significant outcomes driven by its CGM technology in randomized controlled trials across the full spectrum of insulin use in people with diabetes... The randomized clinical trial led by HealthPartners Institute's International Diabetes Center and coordinated by The Jaeb Center for Health Research in Tampa, Fla. affirms Dexcom's belief in the power of CGM for all people with diabetes regardless of Type." David Price, MD, vice president of medical affairs at Dexcom, added: "The clinical benefits of Dexcom CGM were seen across all patient demographics regardless of age, education, numeracy or socioeconomic status. The MOBILE study design also affirms our ability to meet the needs of the diverse communities we serve."

10:45 EDT BriaCell Therapeutics Corporation trading resumes

10:31 EDT Coupa Software launches venture fund with $50M - Coupa Software announced the launch of Coupa Ventures, a $50M fund to "foster innovation" in business spend management. Coupa Ventures will invest in early- and growth-stage companies "breaking down inefficiencies in how businesses manage their spend, aligning processes and decisions across supply chain, procurement, and finance," the company said in a statement. Coupa unveiled the fund's first two portfolio companies: Zylo and SourceDay.

10:05 EDT Twitter launches subscription offering 'Blue' in Australia, Canada - Twitter announced that starting today, it will be rolling out a first iteration of Twitter Blue in Australia and Canada. The subscription offering is "meant to add enhanced and complementary features to the already existing Twitter experience for those who want it." Those who sign up for a Twitter Blue subscription will get bookmark folders, the ability to set a customizable timer of up to 30 seconds to click 'Undo' before a tweet, reply, or thread posts to your timeline, and a reader mode. "Subscribers will also get access to perks, such as customizable app icons for their device's home screen and fun color themes for their Twitter app, and will have access to dedicated subscription customer support," Twitter added. Twitter Blue will cost C$3.49 or A$4.49 per month. Reference Link

10:00 EDT C3.ai falls -15.0% - C3.ai is down -15.0%, or -$11.42 to $64.73.

10:00 EDT Express falls -20.3% - Express is down -20.3%, or -$1.32 to $5.19.

10:00 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares rises 8.6% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is up 8.6%, or 66c to $8.32.

09:55 EDT AMC Entertainment halted again after dropping over 30% - The stock resumed trading 9:54am.

09:55 EDT Sphere 3D trading resumes

09:47 EDT AMC Entertainment trading resumes

09:47 EDT AMC Entertainment falls -16.7% - AMC Entertainment is down -16.7%, or -$10.44 to $52.11.

09:47 EDT Elastic rises 9.1% - Elastic is up 9.1%, or $10.78 to $128.80.

09:47 EDT GTT Communications rises 43.6% - GTT Communications is up 43.6%, or $1.09 to $3.59.

09:42 EDT AMC Entertainment trading halted, volatility trading pause

09:33 EDT Zoom Telephonics changes name to Minim - Minim announced the completion of its corporate name change from Zoom Telephonics, Inc. effective as of June 3, 2021. The Company's trading symbol will remain "MINM". This news follows a prior announcement on May 17, 2021 that the company has submitted an application for listing on the Nasdaq Capital Market.

09:31 EDT BetMGM named exclusive sports betting partner of The Hockey News - BetMGM announced that it has been named the exclusive Sports Betting Partner of The Hockey News. Under the multi-year partnership, BetMGM and The Hockey News' journalists will collaborate on print and video content. "When looking for the best sports betting partner for our readership, trust and brand positioning were key factors," said W. Graeme Roustan, owner and publisher, The Hockey News. "BetMGM is a trusted, well-known operator and we couldn't be more excited to have found a long-term partner for our sports betting related content."

09:29 EDT Walmart unveils Me@Walmart app, offers all associates Samsung Galaxy smartphone - Walmart unveiled Me@Walmart, a new app built in-house by Walmart Global Tech for U.S. store associates that provides an exclusive destination filled with new features. The idea of this app started as a way to manage associates' schedules and has grown into an in-store app for U.S. associates. By the end of the year, Walmart plans to offer more than 740,000 associates a new Samsung Galaxy XCover Pro smartphone, case and protection plan to use - free of charge. Associates will only be able to access the app's work features while they're on the clock, but they can also use the smartphone as their own personal device if they want. Walmart will not have access to any personal data.

09:25 EDT Healthcare Services Acquisition to restate 2020 financial reports - Healthcare Services Acquisition has determined to restate its 2020 financial statements in light of the SEC's recently issued "Staff Statement on Accounting and Reporting Considerations for Warrants Issued by Special Purpose Acquisition Companies". The company currently expects that the reclassification of the warrants will have no impact on its historical liquidity, cash flows or revenues. The company is working with its auditors in order to finalize and to file an amendment to its Annual Report on Form 10-K for the year ended December 31, 2020 reflecting the reclassification of the warrants for the Non-Reliance Periods as soon as practicable. The company requires additional time to complete its customary quarterly review and reporting process and the filing of its Form 10-Q for Q1 and was unable to file the Form 10-Q by the May 17 deadline. The Form 10-Q will be filed as soon as is practicable after the filing of the Form 10-K/A.

09:23 EDT Tyler Technologies to acquire VendEngine for approximately $84M - Tyler Technologies announced that it signed an agreement to acquire VendEngine, a privately-held cloud-based software provider focused on financial technology for the corrections market. The purchase price is approximately $84M in cash, subject to certain customary adjustments at closing. Together, Tyler and VendEngine will be better able to respond to the evolving needs of local and state government agencies, and the residents they serve. Operating in more than 230 counties and 32 states, VendEngine is differentiated by its transparent approach and focus on making a positive impact on the corrections market by better supporting incarcerated individuals and their families. The company provides essential tools and services for incarcerated people and their families-such as trust accounting and digital messaging services-and their modular-based comprehensive suite of applications plugs into most facility management systems. Many key services are provided at no cost to incarcerated individuals or their families, including free inbound emails and texts, onsite video visitation, medical requests, access to education, certificates and legal research resources, and trust management and grievance management for incarcerated people.

09:21 EDT Lotto.com announces official launch - Lotto.com announced its official launch, starting in the state of New Jersey. The company is partnering with QuickChek. Both Lotto.com and QuickChek are experts on delivering official state lottery tickets and complement each other via the brick and mortar offering from QuickChek and the accessible and modern approach to the lottery from Lotto.com. As the exclusive retail partner of Lotto.com, QuickChek enables the New Jersey-based startup to reach consumers via awareness in the iconic fresh convenience market chain's 138 stores across the Garden State.

09:19 EDT Medigus says Eventer Technologies submitted public prospectus for IPO - Medigus announced that Eventer Technologies Ltd., Medigus' subsidiary and developer of advanced technology solutions for creating, marketing and managing events, including virtual events, submitted first public prospectus draft for the initial public offering of Eventer's shares on the Tel Aviv Stock Exchange. In April 2021, Eventer successfully completed a pre-IPO funding round of $2.25 million. The funding round included an investment of $1.5 million from Keshet, a leading Israeli broadcasting and media group. Medigus invested eight months ago $750,000 in Eventer for 58.77% of the company. Following $300,000 of additional investment by Medigus as part of the $2.25 million round, Medigus now owns 47.69% of Eventer, reflecting value of $6 million for Medigus in Eventer post money.

09:17 EDT ICE had record activity in the TTF natural gas and JKM LNG gas complexes - Intercontinental Exchange announced record activity in the TTF natural gas and JKM LNG benchmarks, which work together to provide the market with a global reference price for gas. TTF natural gas futures reached record open interest of approximately 1.94 million contracts on May 26, 2021 and is up 21% year over year , with open interest out to December 2028. Since 2016, Average Daily Volume in TTF futures and options has grown more than 40% on average every year. ADV has reached 155,000 contracts Year To Date, an increase of 5% versus the same period in 2020. The total number of participants trading TTF has grown by 83% from 2016 to 2020. Participants based outside of Europe have grown by 164% since 2016, with the highest growth coming from those based in the US. The strong growth in trading activity and participation in the ICE TTF contract reflects how TTF is being used as a global gas benchmark. JKM LNG futures reached record open interest of 108,210 contracts on May 13 and is up 10% y/y. ADV in JKM LNG futures and options YTD is 3,800 contracts, an increase of 14% versus the same period in 2020. The number of participants trading JKM LNG futures has increased 25% since May 2020, with a significant contribution to growth coming from participants based in East Asia, a region considered to be the largest LNG-importing region in the world. The TTF first line financial futures contract is a cash settled version of the benchmark TTF futures contract and trades in US Dollars per MMBtu.

09:16 EDT Casa Systems introduces Fiber Extension solutions portfolio - Casa Systems announced the introduction of Casa Systems' Fiber Extension solutions portfolio and recent deployments with leading top-tier service providers in the United States and Europe. Casa Systems' market-leading Fiber Extension solutions accelerate the delivery of high-quality, high-capacity broadband services and solve the "last mile" fiber problem, enabling service providers to deliver broadband services to homes and businesses previously deemed too difficult to connect.

09:15 EDT Broadcom announces expanded portfolio of electro-optics platform solutions - Broadcom announced the availability of its expanded portfolio of 100Gb, 200Gb, 400Gb and 800Gb electro-optics platform solutions for data center and cloud networks. Introducing the industry's first 100Gb PAM-4 VCSEL and multi-mode kit, proven 112Gb PAM-4 PHY with direct-drive technology, and uncooled 100Gb PAM-4 EML capability, the portfolio provides customers with a complete set of solutions to solve the industry's growing networking bandwidth requirements, including those based on Broadcom's 12.8-Tbps Tomahawk(R) 3 and 25.6-Tbps Tomahawk(R) 4 switch platforms. With Broadcom's full line of end-to-end solutions, data center operators and cloud providers can cost-effectively deploy 100Gb, 200Gb, 400Gb and 800Gb links to expand their network capacity and support growing bandwidth demands.

09:12 EDT Sam Alkharrat joins C3 AI as President and CRO - C3 AI announced that Sam Alkharrat has joined C3 AI as President and Chief Revenue Officer, CRO. Mr. Alkharrat will lead the global expansion of C3 AI's sales and customer service organizations. Before joining C3 AI, Mr. Alkharrat served as the Senior Vice President and Global Head of Sales for VMware's Tanzu portfolio of Modern Application Platforms, focused on bringing speed, stability, and security to multi-cloud software delivery. Prior to joining VMware, Mr. Alkharrat worked in a number of senior executive positions at SAP, including Global COO for SAP's Customer Experience line of business, with responsibility for SAP's CRM and Commerce solutions; SVP and Managing Director for North America West; and President, Middle East and North Africa.

09:11 EDT Lion Electric selects Mirabel, Quebec, as battery manufacturing plant location - Lion Electric's upcoming battery manufacturing plant and innovation center will be located at the YMX International Aerocity of Mirabel, Quebec. The facility will be located adjacent to Montreal-Mirabel International Airport on a 1.6 million square foot property, with development planned to begin in June. Lion selected the Mirabel location as it offers proximity to its current Saint-Jerome, Quebec, manufacturing plant and access to transportation infrastructure, such as highways and airport, to facilitate access to suppliers and customers. The company also plans to repurpose current airport facilities for use as a test track to aid in its vehicle development. Lion's battery manufacturing plant and innovation center represents an investment of approximately C$185M. The facility is expected to be completed in the second half of 2022, with a planned annual battery production capacity of 5 GW hours. The factory will be highly automated and is expected to be able to produce one battery module every 11 seconds and a full battery pack every five minutes.

09:09 EDT PDS Biotechnology expands VERSATILE-002 study of PDS0101, Keytruda - PDS Biotechnology Corporation announced the protocol amendment to expand its Phase 2 VERSATILE-002 study to include patients, in an additional arm, who have failed prior checkpoint inhibitor therapy. The VERSATILE-002 study is designed to evaluate PDS0101 in combination with KEYTRUDA in the treatment of advanced human papillomavirus-associated head and neck cancer and is currently being run at approximately 20 clinical sites in the US. VERSATILE-002 was initially opened to checkpoint inhibitor naive HPV16-associated head and neck cancer patients in first line treatment of recurrent or metastatic cancer. The trial is actively recruiting patients who have the option to receive the two immunotherapies rather than chemotherapy as their first line of treatment for recurrent disease. The additional study arm will evaluate the objective response to the combination among approximately 40 patients with advanced head and neck cancer who have failed multiple treatments, including checkpoint inhibitor therapy. Objective response is measured by radiographic tumor responses according to RECIST 1.1. In the expansion arm, the first 21 patients will be evaluated for safety and objective response before the arm progresses to full enrollment. The inclusion of CPI refractory patients in VERSATILE-002 follows the publication of an abstract and subsequent presentation of interim data in another Phase 2 trial being led by the National Cancer Institute evaluating the combination of PDS0101 (in combination with two investigational immunotherapies. That trial recently reported clinical responses with objective responses in 63% of HPV16-positive cancer patients who had failed chemotherapy, radiation, and checkpoint inhibitor therapy.

09:08 EDT General Motors sees 1H21 results 'significantly better' than prior guidance - As a result of GM's ongoing efforts to prioritize semiconductor usage, its success engineering solutions that maximize the utilization of chips as well as the pull-ahead of some projected semiconductor deliveries into the second quarter, the company now expects its first-half financial results to be significantly better than the first-half guidance previously provided. GM is optimistic about the full year and expects to share additional information during its second-quarter earnings conference call on Aug. 4. GM Chair and CEO Mary Barra and Chief Financial Officer Paul Jacobson will also participate in a Virtual Fireside Chat with Credit Suisse today, beginning at 1 p.m. EDT.

09:06 EDT Atos and Huma enter into five-year partnership - Atos and Huma announced a 5-year strategic global partnership to shift healthcare and clinical trials from hospital to home. The partnership will focus on Huma's modular platform which can power digital 'hospitals at home' up to national scale, as well as support pharmaceutical and research industries to run complex global decentralized clinical trials. The platform is already used in the US and across Europe for illnesses ranging from atrial fibrillation to diabetes to Covid-19. Atos will use its experience in implementing and scaling complex transformation projects to accelerate adoption of Huma's technology. This will include investment by Atos worth up to EUR20M split across R&D and go-to-market resources, including dedicated consulting and sales personnel. The investment in R&D will fast-track the integration of the Huma platform with other leading clinical platforms, as well as develop a dedicated video module. The 5-year partnership will begin with integration, enabling global go-to-market deployments, but will also combine Atos's expertise of driving digital adoption, support and infrastructure with Huma's digital care, clinical trials and biomarkers. The companies conservatively expect the combined service will reach EUR100M revenue per year within the first four years.

09:05 EDT Ping Identity names Jason Wolf as new Chief Revenue Officer - Ping Identity announced the addition of Jason Wolf as Chief Revenue Officer. Wolf is a highly accomplished sales leader holding his most recent role as chief revenue officer at SAP, overseeing the Spend Management and Network line of business. Wolf will oversee Ping Identity's global team of worldwide sales and revenue, channels, customer success, operations and enablement, leveraging his in-depth experience with go-to-market strategy, sales performance, customer success and operations of global field organizations. In addition to his global experience, Wolf has also worked closely to develop channel partners in prior roles, leading to successful transformation to cloud-based solutions. "Jason brings critical global experience to our sales organization, having managed and lived in multiple regions around the world," said Kris Nagel, COO of Ping Identity. "His unique background of global sales leadership and go-to-market strategy will help accelerate our cloud initiatives and channel priorities, helping to fuel international growth. Everyone here is excited to welcome Jason to the team."

09:05 EDT NanoVibronix provides business update - NanoVibronix provided an update on its business. Received CMS Approval for Reimbursement; Launched PainShield Plus; Expanded Distribution with UPPI; Refining Manufacturing Processes and Expanding Capacity; Sufficiently Capitalized. Near the end of 2020, the company launched the next generation of its PainShield device, PainShield Plus, which extends the functionality of its core product and broadens the opportunities for application. The PainShield Plus sells at a higher price point and expands the company's target market to increase opportunities for revenue growth. Delivery of the first devices is expected to be in Q2 2021. Subsequently, the company expanded and replaced its original distribution agreement with Ultra Pain Products to extend the term and increase minimum purchase requirements. UPPI is the exclusive distributor of PainShield and PainShield Plus devices to the Durable Medical Equipment distribution sector of the healthcare market in the United States. In doing so, the company increased the revenue opportunity significantly with UPPI. The company fulfilled the first order in the second quarter of 2021 and is working diligently to accelerate manufacturing and fulfill subsequent orders. Currently, the company is working to establish manufacturing capabilities both in the United States and Israel that will run parallel to its existing manufacturing operations located in Asia. In addition to providing expanded capacity for output, this will reduce operational risk from reliance on a sole manufacturer and positions the company to negotiate private-label agreements by complying with requirements of the Trade Agreements Act. The Centers for Medicare and Medicaid Services recently expanded its reimbursement approval for the company's PainShield product by adding the device to its DME schedule. PainShield is now reimbursable as an approved medical device under a unique reimbursement code assigned by CMS, K1004. The approval expands the original CMS approval to include reimbursement as a device for the many millions of beneficiaries enrolled in Medicare and paves the way for expanded distribution. UroShield, the company's urology therapy device, was added to the Federal Supply Schedule during the first quarter of 2021, making it easier for veterans being treated by the VA to secure and utilize the UroShield device and further expanding the company's addressable market. The company will be asking stockholders to approve a proposal to increase the number of common shares authorized for issuance from 24.1 million shares to 40 million shares at an Annual Meeting of Stockholders to be held on August 17, 2021. The increase is being requested to provide the company with a sufficient number of authorized shares to meet its existing preferred stock conversion obligations and warrant and option obligations and leave the company with an additional capacity to pursue a modest level of strategic transactions at the Board's discretion if such opportunities arise. As of March 31, 2021, the company had approximately 24.1 million shares of common stock authorized as well as issued and outstanding leaving no capacity to meet future potential needs for shares upon conversion of certain shares of Series C, Series D and Series E Preferred Stock or the exercise of outstanding warrants and stock options. The company did not receive sufficient votes to pass a proposal for an amendment to increase the authorized number of stocks of common stock to 45 million shares at the company's Special Meeting of Stockholders held on May 6, 2021. Accordingly, the company has responded with a more modest proposal that the Board believes will still meet the needs of the company. The proposal would amend the company's amended and restated certificate of incorporation to increase the number of authorized shares of common stock from approximately 24.1 million to 40 million.

09:05 EDT General Motors to increase vehicle deliveries to customers in U.S., Canada - General Motors outlined steps it is taking to increase deliveries to dealers and customers in the United States and Canada to meet strong consumer demand for Chevrolet, Buick, GMC and Cadillac vehicles. Production of the Chevrolet Silverado HD and GMC Sierra HD full-size pickups will increase by about 1,000 trucks per month beginning in mid-July as a result of production line efficiencies delivered by the team at Flint Assembly in Michigan. Shipments of Chevrolet Colorado and GMC Canyon mid-size pickups built at Wentzville Assembly in Missouri will increase by about 30,000 total units from mid-May through the week of July 5 as the team completes dynamic vehicle testing on units held at the plant due to semiconductor supply disruptions. Smaller volumes of vehicles held at other plants also will complete dynamic vehicle testing and ship to dealers during June and July. U.S. assembly plants that build GM's most capacity-constrained products will not take any dedicated vacation downtime this summer. As announced in May, GM will return full-size pickup production to Oshawa Assembly in Canada during the fourth quarter of 2021. The new accelerated timeline and incremental volume are expected to make an impact in 2022, as production ramps up. As a result of GM's ongoing efforts to prioritize semiconductor usage, its success engineering solutions that maximize the utilization of chips as well as the pull-ahead of some projected semiconductor deliveries into the second quarter, the company now expects its first-half financial results to be significantly better than the first-half guidance previously provided. GM is optimistic about the full year and expects to share additional information during its second-quarter earnings conference call on Aug. 4. Production at certain manufacturing facilities in North America, Asia and South America will continue to be impacted by the global semiconductor shortage through June and July. As global semiconductor supply recovers, the company expects to implement similar actions in markets around the world to resume production and increase deliveries to dealers through the second half of the year. GM continues to work with its suppliers and policy leaders to develop long-term solutions to the semiconductor supply issues that have impacted all automakers.

09:03 EDT Whirlpool migrates SAP Systems to Google Cloud - Whirlpool (WHR) announced that it has expanded its strategic collaboration with Google Cloud (GOOG, GOOGL) to deliver critical business systems and applications on Google Cloud's secure, reliable, and sustainable infrastructure. The company, which rolled out Google Workspace to its employees in 2014, has now deployed its enterprise-wide SAP (SAP) environment and applications on Google Cloud, providing its global teams with low-latency, secure access to SAP systems and data.

08:58 EDT WisdomTree launches BioRevolution Fund - WisdomTree Investments announced the launch of the WisdomTree BioRevolution Fund on the CBOE. WDNA seeks to track the price and yield performance, before fees and expenses, of the WisdomTree BioRevolution Index, and has an expense ratio of 0.45%.

08:56 EDT Align Technology releases iTero Workflow 2.0 software - Align Technology announced the new iTero Workflow 2.0 software release with advanced features that provide enhanced intraoral image sharpness for clearer hard and soft tissue details to aid in treatment diagnosis, while also driving practice efficiency, patient engagement, and a more seamless end-to-end digital treatment experience for doctors and their patients.

08:55 EDT EVO Payments to acquire Pago Facil e-commerce payment gateway in Chile - EVO Payments announced entry into an agreement to acquire Pago Facil, an e-commerce payment gateway in Chile, in partnership with its joint venture with Bci, Bci Pagos. The acquisition delivers approximately 3,000 merchants to the JV and expands its in-market integrated payment solutions and technology capabilities which will enhance EVO's acquiring services and attract new customers. Founded in 2018 by Cristian Tala Sanchez, Pago Facil offers an array of digital payment solutions, including acquiring services, e-commerce software integrations, and value-added solutions. EVO will also leverage Pago Facil's gateway capabilities to enhance its business in Mexico as well as other markets across Latin America EVO enters in the future. The acquisition is expected to close in early June.

08:53 EDT Alamos Gold releases 2020 Annual ESG Report - Alamos Gold has released its 2020 Environmental, Social, and Corporate Governance Report, which outlines the Company's progress on its ESG performance in 2020 across its operations, projects and offices, and provides direction on planned initiatives for 2021. Alamos' 2020 ESG Report, available at www.alamosgold.com/2020-ESG-Report-Final, highlights significant progress achieved by the Company during the past year including: Implemented stringent new health and safety protocols to protect the health and well-being of our employees and contractors during the COVID-19 pandemic, including medical screening and testing of all personnel prior to start of each rotation. Over 13,000 COVID-19 tests were completed on employees, contractors and visitors during the year. Improved workforce health and safety performance with a 28% reduction to the total recordable injury frequency rate and a 17% reduction to the lost time injury frequency rate over 2019. Reduced greenhouse gas emissions across operations by 3% since 2019 and 6% since 2018, and in 2021 all sites are developing Energy Management Plans to identify further opportunities for cost-effective emission reductions. 79% of water used at operations was recycled. Zero fines or sanctions for non-compliance with environmental laws and regulations, including zero reportable tailings-related incidents. $2.4 million invested in local community initiatives including donations, sponsorships, community programs and infrastructure. Announced the Island Gold mine Phase III expansion project that will increase production by 72% while reducing costs, significantly reduce fleet diesel usage by switching to cleaner grid electricity and lower life-of-mine carbon emissions by 35%. Progressed permitting at the Mulatos mine to replace diesel power with cleaner grid electricity. The Mulatos mine and El Chanate mine were named Socially Responsible Mining Companies by CEMEFI, the Mexican Center for Philanthropy. Mulatos also won the 2020 Ethics and Values in Industry Award from CONCAMIN, Mexico's Industrial Chambers Confederation. Progressed implementation of the World Gold Council's Responsible Gold Mining Principles including receiving independent assurance over Alamos' 2020 RGMP Progress Report. Advanced adoption of the recommendations of the Task Force on Climate-related Financial Disclosures including expanded reporting and completion of a climate risk assessment and scenario analysis that covered every Alamos operation and project. The 2020 ESG Report is guided by the Sustainability Accounting Standards Board Metals & Mining Industry Standard and the Global Reporting Initiative Standards for sustainability reporting "Core" requirements. It focuses on economic, environmental, social and corporate governance topics and indicators that are of the greatest interest to Alamos' stakeholders. Since 2013, Alamos has published an annual Sustainability Report to provide transparency on its sustainability initiatives and results from its operating mines. Since 2019, the Company has branded this publication as an ESG Report to reflect the depth of its content and the standards it now aligns to.

08:52 EDT 3M sees 2021 EPS impact from inflation of 30c-50c - Comments taken from Bernstein's 37th Annual Strategic Decisions Conference.

08:50 EDT Ciena sees 'somewhat' higher gross margin in 2H vs. 1H

08:48 EDT Corning introduces Corning SMF-28 Contour optical fiber - Corning Incorporated introduced its latest innovation, Corning SMF-28 Contour optical fiber, to help telecommunications operators address the ever-expanding number of connected devices, build-out of 5G networks, and advances in cloud computing. Networks perform at their best when errors are minimized during fiber installation and when existing infrastructure is used efficiently during upgrades. Corning engineered SMF-28 Contour fiber to meet those needs. This groundbreaking product will allow customers to seamlessly upgrade their optical infrastructures, enabling the cost-effective deployment of future-ready networks.

08:47 EDT Ciena: New wave of pandemic 'obviously slowing' recovery in India - Still sees revenue from India growing y/y in FY21 with any near-term challenges mitigated by the company's general geographic diversification.

08:41 EDT Ciena sees ability to manage supply chain challenges with no material impact - Ciena sees the ability to manage supply chain issues with no material impact to its revenue expectations for FY21. Comments taken from Q2 earnings conference call.

08:39 EDT Express down over 20% at $5.19 after Q1 results, at-the-market stock offering

08:37 EDT Recon Technology to invest in blockchain-based sustainable energy company - Recon Technology has entered into a share exchange agreement with Starry Blockchain Energy. Incorporated in Singapore, Starry seeks to leverage blockchain technology to drive sustainable energy solutions. Pursuant to the agreement, Recon will issue unregistered, restricted Class A shares to Starry's founding shareholders in exchange for 30% of the shares of Starry.

08:35 EDT Aon plc to sell U.S. retirement and Retiree Health Exchange businesses for $1.4B - Aon has signed definitive agreements to sell its U.S. retirement business to Aquiline and its Aon Retiree Health Exchange business to Alight for total gross consideration of $1.4B. The agreements are intended to address certain questions raised by the U.S. Department of Justice in relation to the combination with respect to the markets in which these businesses are active. Aon and Willis Towers Watson continue to work toward obtaining regulatory approval in all relevant jurisdictions. The U.S. retirement business Aquiline will acquire includes approximately 1000 colleagues and the agreement includes U.S. core retirement consulting, U.S. pension administration and the U.S.-based portion of Aon's international retirement consulting business. The agreement with Aquiline does not include Aon's non-U.S. actuarial, non-U.S. pension administration or international retirement businesses based outside of the U.S. Aquiline Capital Partners is a private investment firm based in New York and London with $6.4B in AUM. The Aon Retiree Health Exchange which Alight will acquire is an individual market solution. Alight leverages its proprietary AI and data analytics to optimize business process as a service. All of the announced regulatory divestitures are contingent on the completion of the pending Aon and Willis Towers Watson combination, as well as other customary closing conditions. While Aon and WTW are working toward completing the proposed combination as soon as possible in Q3, the completion remains subject to the receipt of required regulatory approvals and clearances, including with respect to U.S. antitrust laws.

08:28 EDT Canacol Energy says gas sales averaged 174 MMscfpd for May - Canacol Energy is pleased to provide the following information concerning its May 2021 natural gas sales and drilling program. In addition, the Corporation announces a significant new gas discovery with its Aguas Vivas 1 well. Realized contractual natural gas sales were 174 million standard cubic feet per day for May 2021. The Aguas Vivas 1 exploration well was spud on May 23, 2021 and reached a total depth of 7,852 feet measured depth on May 29, 2021. The well encountered 412 feet true vertical depth of net gas pay with an average porosity of 22% within the Cienega de Oro sandstone reservoir, the primary target. The gas column encountered within the CDO sandstone reservoir at Aguas Vivas 1 is the thickest yet encountered by the Corporation in its history and marks a significant and important new gas discovery. Prior to this well, the thickest net pay was encountered in the Clarinete 5 development well, which encountered 309 ft TVD of net gas pay. The Corporation is currently casing the Aguas Vivas 1 well in preparation of production testing and the well will be tied into existing production infrastructure within the next two weeks. The Corporation plans to immediately drill at least two appraisal wells back-to-back in order to prove up the extent of the new discovery. The Corporation will provide an update on drilling and testing results as they become available.

08:25 EDT NMI Holdings reports 9,387 loans in default at May 31 - NMI Holdings reported selected operating statistics for the month of May 2021. At May 31, 2021, the company reported 9,387 loans in default and a default rate of 2.04%.

08:24 EDT Beam Global: EV ARC charging systems to be deployed by Construction Art - Beam Global announced announced that EV ARC solar-powered EV charging systems will be deployed by Construction Art, a sustainable commercial design and construction company, at two locations in South Carolina. The EV ARC systems will power visitor, staff, service and transport electric vehicles at Eco Tourism Destinations focused on preservation and conservation.

08:24 EDT Aeterna Zentaris announces final settlement of previously disclosed class-action - Aeterna Zentaris announced the U.S. District Court for the District of New Jersey has given final approval of the settlement from the previously disclosed class-action lawsuit against the company. The settlement payment will be funded entirely by the company's insurers. Pending no action taken during the 30-day appeal period, this matter will be considered fully and finally settled. "The previously disclosed class-action lawsuit alleged that the company and certain of its current and former officers and directors violated the Securities Exchange Act of 1934 in connection with certain public statements made between August 30, 2011, and November 6, 2014, regarding the safety and efficacy of Macrilen and the prospects for the approval of the company's New Drug Application for the product by the FDA. Although Aeterna denies all of the alleged claims and all liability, it agrees that the settlement is appropriate to resolve the disputes, avoid further costs of litigation and avoid further distractions to management," the company stated.

08:22 EDT Guardion Health Sciences appoints Craig Sheehan as Chief Commercial Officer - Guardion Health Sciences announced the appointment of Craig Sheehan as its Chief Commercial Officer. Sheehan joins Guardion following the company's recent acquisition of Activ Nutritional. Sheehan was the senior executive responsible for the Viactiv brand as a member of the executive leadership team of Adare Pharmaceuticals for the last four years.

08:17 EDT Oyster Point Pharma announces preclincial study results, pipeline expansion - Oyster Point Pharma announced the expansion of its pipeline with the introduction of Enriched Tear Film Gene Therapy and proof-of-concept in vivo study results from its first gene therapy candidate, OC-101. ETF Gene Therapy is a proprietary adeno-associated virus based gene therapy approach where a target gene is delivered to human lacrimal gland cells via intralacrimal gland injection. Rather than replacing a gene that is defective or missing, a new target gene is delivered that may potentially produce a selected naturally occurring protein, enzyme, or other therapeutic gene product. The goal for this target gene is to produce a selected gene product to change cell behavior and function on the ocular surface. Oyster Point's investigational drug, OC-01 nasal spray, a highly selective cholinergic agonist, may play a role in ocular surface diseases treated with ETF Gene Therapy through its potential to modulate the secretion of a selected gene product. In this proof-of-concept in vivo study evaluating OC-101, a single, intralacrimal gland injection of an AAV containing the human NGF gene resulted in statistically significant levels of hNGF protein being expressed within the lacrimal gland and tear film of a rabbit model, as compared to control. hNGF was secreted into the tear film as early as Day 7, after the intralacrimal gland injection. No control animals showed evidence of hNGF in the lacrimal gland or tear film. Additionally, three weeks following OC-101 transduction of the lacrimal gland, cholinergic activation of the lacrimal gland with OC-01 nasal spray resulted in statistically significant increases in hNGF expression in the tear film, as compared to pre-cholinergic stimulation levels and as compared to control. After cessation of OC-01 nasal spray, hNGF tear protein levels returned to pre-cholinergic activation levels. During the 42-day study, there were no macroscopic or microscopic safety findings observed associated with the intralacrimal gland administration of OC-101 or OC-01 nasal spray.

08:15 EDT Histogen provides updates on development programs, pipeline focus - Histogen announced an update on its pipeline focus following a strategic evaluation of its regenerative medicine platform technology development programs with the goal of focusing on high value orthopedic indications, creating pipeline synergies and maximizing resources in an effort to further drive long-term shareholder value. The company said, " HST 001 - we completed our strategic evaluation of the HST 001 program taking into consideration the results from our Phase 1b/2a clinical trial of HST 001 as announced earlier this year, and as a result, we will suspend development of this program. While HST 001 has demonstrated a favorable safety and tolerability profile in androgenic alopecia in men, the development resources required to potentially achieve an acceptable efficacy threshold are substantial in terms of cost and time. Therefore, we believe the best business decision at this time, is to redirect these resources towards our high value orthopedic programs. HST 003 - we are on track to initiate our Phase 1/2 clinical study of HST 003 in June 2021. The upcoming study is designed to evaluate the safety and efficacy of human extracellular matrix implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. Patients will be enrolled at three sites: Oasis MD in San Diego, CA, The Steadman Clinic in Vail, CO, and Walter Reed Medical Center in Bethesda, MD. HST 004 - We recently initiated an investigational new drug application enabling activities for HST 004, a CCM solution intended to be administered through an intradiscal injection for spinal disc repair. Our initial preclinical research has shown that HST 004 stimulates stem cells from the spinal disc to proliferate and secrete aggrecan and collagen II, regenerate normal matrix and cell tissue structure, and restore disc height. HST 004 was also shown to both reduce inflammation and protease activity and upregulate aggrecan production in an ex vivo spinal disc model. We anticipate filing an IND in the second half of 2022. Emricasan - In May, we, along with our partner Amerimmune, completed enrollment of the Phase 1 study of emricasan for the treatment of mild-symptomatic COVID-19 patients. A total of 13 patients have been enrolled at our single site in New York City versus the initially targeted 40 patients. The decision to stop enrollment with a lesser number of patients was based solely upon the overall decline in COVID-19 cases in New York City and its negative impact on patient recruitment. To date, there have been no reports of serious adverse events, and we anticipate top-line safety, biomarker and patient reported outcomes data to be available in June 2021."

08:14 EDT Energy Focus teams with threeUV to market and distribute UV products - Energy Focus has formed a partnership with threeUV , a Med Solutions company, a UV product marketing and distribution company, to offer its UV by Energy Focus line of UV-C Air and Surface Disinfection solutions to institutional and government purchasing cooperatives that service 23,000 public and non-profit sector agencies including over 9,000 school districts, across all 50 states - to increase disinfection efficacy, reduce labor costs and protect the public spaces they serve.

08:12 EDT Hoth Therapeutics reports positive preclinical results of HT-KIT therapeutic - Hoth Therapeutics will share positive results from a preclinical trial during its shareholder presentation on the potential of HT-KIT, a new molecular entity under development for treatment of mast cell-derived cancers and anaphylaxis. HT-KIT is an mRNA frame-shifting therapeutic designed to specifically target the receptor tyrosine kinase KIT. Mutations in the KIT pathway have been associated with several human cancers, such as mast cell-derived cancers, systemic mastocytosis with associated hematologic neoplasm, or mast cell leukemia, gastrointestinal stromal tumors, and acute myeloid leukemia. Key findings of the mouse models found that HT-KIT reduces KIT expression and induces apoptosis of neoplastic human mast cells, inhibits tumor growth in humanized xenograft mast cell neoplasia models, reduces liver infiltration of neoplastic mast cells, reduces tumor growth in isograft models of mast cell neoplasia, reduces signs of mast cell leukemia in an isograft model of mutant mast cell neoplasia. This data will also be available at the company's ASCO Annual Meeting exhibit.

08:10 EDT Sanofi launches EUR3M Planet Mobilization fund - As part of a long-standing commitment to reduce the environmental footprint of the company's products and activities, Sanofi launched a EUR 3 million Planet Mobilization fund to support employee ideas and projects that will further contribute to a healthier environment. This year, three Sanofi teams will have their projects funded. For several years, Sanofi has been implementing a global environmental roadmap, Planet Mobilization, which is embedded in Sanofi's long-term strategy. The program covers all Sanofi activities and sites and the entire lifecycle of products, from raw materials used in production all the way to their disposal.

08:09 EDT Plug Power, Renault launch joint venture HYVIA - Renault Group (RNSDF) and Plug Power Inc. (PLUG) are launching their joint venture HYVIA, as outlined in the memorandum of understanding agreement signed on January 12th, 2021. The joint venture is equally owned by the two partners and is chaired by David Holderbach, with over 20 years of experience in strategic, product and international sales at the Renault Group. The name HYVIA is a contraction of "HY" for hydrogen and the Latin word "VIA" for road, embodying the ambition to open a new path towards low-carbon mobility. Commercial vehicles such as LCVs require greater range and shorter refueling time, operational demands where hydrogen fuel cells are the unparalleled energy solution. HYVIA's activities will be carried out at existing Renault facilities in France: 1. The head office of the joint venture as well as the R&D teams will be located at Villiers-Saint-Frederic, with the light commercial vehicle engineering and development center for Renault Group, to maximize synergy across teams. 2. The process, manufacturing and logistics teams will be based in Flins, as part of the Re-Factory project, and plan to begin the assembly of fuel cells and recharging stations by end of 2021. 3. The first vehicles, based on Renault Master, will be assembled at the Batilly plant. 4. The fuel cell integration will be carried out by PVI, a subsidiary of Renault Group since 2017, located in Gretz-Armainvilliers. The HYVIA integrated hydrogen technology complements Renault's E-TECH technology, increasing vehicle range to 500 km with rapid recharging time of 3 minutes. These advantages are particularly well-suited to certain uses of light commercial vehicles while simultaneously addressing the regulatory challenges of decarbonizing city centers. The first three fuel cell vehicles brought to market by HYVIA will be based on the Renault Master platform and should be available in Europe by end of 2021 and accompanied with the deployment of charging stations and the supply of green hydrogen: Transport of goods: Van version and Chassis cab version for large volumes. Transport of people: City bus version.

08:07 EDT Kratos Defense appoints Deanna Lund to board of directors - Kratos Defense & Security Solutions announced the appointment of Deanna Hom Lund to the Company's Board of Directors. Ms. Lund has served as Kratos' Executive Vice President and Chief Financial Officer since April 2009. Upon the unanimous recommendation of the Board's Nomination & Governance Committee, the Board of Directors also voted to increase the size of the Company's Board to nine members, with Ms. Lund filling one of the two vacancies. The Board of Directors expects to fill the second vacancy within the next 18 months when a suitable candidate is identified.

08:07 EDT Motus GI Holdings announces publication of Pure-Vu clinical data - Motus GI Holdings announced the publication of data from the REDUCE study in an article titled, "A multicenter, prospective, inpatient feasibility study to evaluate the use of an intra-colonoscopy cleansing device to optimize colon preparation in hospitalized patients: the REDUCE study" in the peer-reviewed journal BMC Gastroenterology. Among the important findings that the Company continues to emphasize since the data from the REDUCE study were first announced is the Pure-Vu system's 97% clinical success rate. The article covers clinical data from the REDUCE study. Prior to Pure-Vu, adequate cleansing were reported in 60%, 62%, and 47% for the left colon, transverse colon, and right colon segments, respectively. After intra-colonoscopy cleansing with the Pure-Vu System, adequate colon preparation was reported in 100%, 99%, and 97% of the left colon, transverse colon, and right colon segments, respectively.

08:05 EDT Kintara Therapeutics enrolls final patient in Phase 2 clinical trial of VAL-083 - Kintara Therapeutics announced it has enrolled the final patient in the adjuvant arm of its ongoing Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center. The adjuvant arm of the study investigates newly-diagnosed patients suffering from glioblastoma multiforme receiving VAL-083 in place of standard of care temozolomide as adjuvant therapy following surgery and chemoradiation TMZ. The trial was designed to enroll up to 36 patients to determine whether treatment with VAL-083 improves overall survival.

08:04 EDT Aspira Women's Health releases analytical, initial clinical data for OVASight - Aspira Women's Health released the analytical and initial clinical data for OVASight in an abstract titled "Serum-based Assay for Adnexal Mass Risk of Ovarian Malignancy". Registrants attending the American Society of Clinical Oncology 2021 virtual meeting gained access to the poster on May 19, 2021, and the on-demand presentation will be released to the ASCO virtual meeting registrants at 9:00 a.m. EDT on June 4, 2021 . OVASight is third-generation OVA technology and is a laboratory-developed, blood-based pelvic mass risk assessment test for ovarian cancer in a low prevalence population. It was developed to increase specificity, maintain high sensitivity with early-stage disease, and allow for conservative management of women with a suspected benign mass. A total of 596 samples collected from real-world patients were used to validate the OVASight diagnostic algorithm. Validation data demonstrated 89% Specificity, 91% Sensitivity and a Negative Predictive Value of 99.6% in a low prevalence population. In addition, overall sensitivity as well as sensitivity in early-stage disease were significantly better than CA-125 alone.

08:03 EDT One Group Hospitality reports quarter-to-date comparable sales up 35.2% - One Group Hospitality provided a business update in advance of the company's participation at three investor conferences. As of May 31, quarter-to-date comparable sales in 2021 compared to 2019 increased 35.2% on a consolidated basis, 49.2% for STK and 22% for Kona Grill. All of the company's domestic restaurants are operating with indoor dining rooms. On average, the company's domestic indoor dining capacity for May was 82%. All of the company's non-seasonal international venues are open, and STK Ibiza will open for the summer vacation season in June.

08:02 EDT Barfresh Food Group completes $6M financing - Barfresh Food Group announced that it has completed a private placement of approximately $6 million of common stock at $0.36 per share with no warrant coverage. In addition, the Company has negotiated the conversion of approximately $0.7 million and the retirement of approximately $0.8 million of existing debt and interest. This eliminates all prior convertible debt and related interest. After these transactions, the company now has approximately $7 million of cash and no debt except for a $0.56 million Paycheck Protection Program loan that is expected to be forgiven. The Company's first Paycheck Protection Program "PPP" loan of $0.56 million has been forgiven. The Company was granted a second PPP loan in January 2021 for $0.56 million and also expects this loan to be forgiven in Q3 2021. The Company expects to be debt free when the second PPP loan is forgiven.

07:59 EDT Bitfarms appoints Jeffrey Lucas as CFO - Bitfarms announces the appointment of Jeffrey Lucas as CFO, effective June 14, 2021, as well as two management promotions. Lucas will be responsible for the oversight of the finance, accounting, and reporting functions with the mandate to raise capital, enhance our corporate communications, expand our investor relations activities, increase analyst coverage, and support and integrate acquisitions as part of building a higher level of financial and operational excellence throughout the Company. Prior to his corporate roles, Mr. Lucas worked in high yield investment banking with L. F. Rothschild and in institutional money management as a securities analyst with Wells Capital Management. Further strengthening the executive team, Director of Mining Operations, Ben Gagnon, has been named as the Company's Chief Mining Officer and Nathaniel Port, Director of Finance has been named Senior Vice President of Finance and Accounting, both effective June 1, 2021. The Company has granted Mr. Lucas 364,050 incentive stock options, pursuant to the Company's Stock Option Plan. The Options are exercisable into one common share of the Company at a price of $5.45, for a period of five years from the date of grant and are subject to vesting conditions.

07:55 EDT Nabriva Therapeutics sees cah runway through 1Q22 - The company announced an extension of its cash runway. Based on its current operating plans and following the extension of the principal debt repayments under its loan agreement with Hercules, the company expects that its existing cash resources, including proceeds raised under its at-the-market offering facility since May 6, 2021, will be sufficient to enable the company to fund its operating expenses, debt service obligations and capital expenditure requirements substantially through the first quarter of 2022.

07:54 EDT BriaCell Therapeutics Corporation trading halted, news pending

07:52 EDT Lexagene Holdings partners with Ethos Discovery to expand test menu offerings - LexaGene Holdings announced it has partnered with Ethos Discovery to expand the test menu offerings that can be run on the MiQLab System. LexaGene's first validated panel, namely the MiQLab Bacterial and AMR Test, was developed specifically for aiding in the diagnosis of urinary tract infections, one of the most common causes for veterinary visits in companion animals. This panel detects 94% of the pathogens that cause UTI in cats and dogs and screens for 13 different antimicrobial resistance targets that are useful in determining the therapies best suited for treatment. Ethos Discovery was an early adopter of the MiQLab technology, and is now interested in expanding the use cases for the MiQLab to help in the diagnosis of other disease conditions. To address their needs, Ethos Discovery presented to LexaGene market opportunity assessments for sepsis, effusions, chronic/complicated wounds, pneumonia, diarrhea, joint diseases, seizures, hemangiosarcoma, and tick-borne infections. After in depth discussions, as a first step, LexaGene has decided to partner with Ethos Discovery on prioritizing the development of panels specific for severe pneumonia, diarrhea, and effusions. These were chosen due to the clinical importance of correctly identifying the cause of respiratory and gastrointestinal illnesses which can potentially be zoonotic, the sheer number of diarrhea cases in the US per year, and the pressing need for rapid differential diagnosis, respectively. These projects will be tackled in the stated order. As part of this collaboration, Ethos Discovery is providing consulting services for the identification of the relevant targets in each panel based on disease prevalence, the magnitude of the unmet need, and alignment with the MiQLab technology. These panels will include additional tests for species of bacteria not covered in the UTI panel, as well as new tests for viruses, protozoa, fungi and other disease targets. LexaGene will develop and validate these tests for each of the target organisms and antimicrobial markers, and use Ethos Veterinary Health's Wheat Ridge Animal Hospital in the greater Denver area for clinical validation studies, which are anticipated to start for the pneumonia panel in late summer/early fall.

07:48 EDT Altair appoints Jim Anderson to board of directors - Altair (ALTR) announced that Jim Anderson was elected to Altair's board of directors at the June 2, 2021 annual stockholder meeting. He is a managing director for Google Cloud (GOOGL) and is also a member of the Go-To-Market Advisory Board for CapitalG, Alphabet's independent growth fund.

07:45 EDT Evaxion Biotech reports proof-of-concept data for RAVEN platform - Evaxion Biotech announced new preclinical data from its Adaptive and Intelligent Vaccine for a Rapid Response against Corona Viruses program. The AICoV program aims to potentially develop the next generation of corona virus vaccines, utilizing RAVEN, Evaxion's AI powered vaccine design platform, along with Evaxion's proprietary Antigen Presenting Cell targeting DNA vaccine technology and novel manufacturing approaches. The RAVEN platform, an integral part of Evaxion's AICoV program, combines advanced algorithms from Evaxion's proprietary AI-immunology Core technology to identify optimal T and B cell antigen targets for the development of novel viral vaccines. Early data demonstrate that RAVEN identifies novel immunogenic T cell epitopes outside the spike protein, showing RAVEN's potential to rapidly support the design of novel SARS-COV-2 vaccines against current and future variants. This proof-of-concept for Evaxion's RAVEN platform and APC targeting DNA vaccine technology supports the potential development a next generation of SARS-COV-2 vaccines, which would aim to overcome challenges potentially encountered with the current vaccines including: Loss of effectiveness against variants of SARS-CoV-2 due to focus on a single target; Requirement for cold storage supply chains; Severe adverse events related to viral vector vaccines, which have not been observed in clinical trials relying on DNA vaccine technology. The application of Evaxion's proprietary targeted DNA plasmid vaccine technology for a SARS-CoV-2 vaccine, utilizing the receptor-binding domain from the spike protein, was shown to elicit a T cell response and neutralizing antibodies at comparable levels to those measured in convalescent human sera. Animal studies in mice immunized with EVX-APC-RBD revealed sera derived geometric mean endpoint-titers comparable to preclinical levels reported for spike protein based vaccines. The obtained live virus microneutralization geometric mean titers were comparable to that of human derived convalescent sera, supporting the induction of a functional immune response. Furthermore, mice immunized with EVX-APC-RBD showed induction of a T cell response measured by IFNgamma ELISpot covering the entire RBD fragment and a similar T-cell response was seen with epitopes selected by the RAVEN platform outside the spike protein. Evaxion's ongoing development work in the AI-CoV program is supported by funding from international investors and Innovation Fund Denmark.

07:42 EDT Adaptimmune included in over 20 abstracts at ASCO, EHA 2021 - Adaptive Biotechnologies will be included in more than 20 abstracts studying the use of Adaptive's clonoSEQ Assay for minimal residual disease assessment at the American Society of Clinical Oncology Annual Meeting from June 4-8, and the European Hematology Association Virtual Congress from June 9-17. clonoSEQ is the first and only U.S. Food and Drug Administration cleared assay for MRD assessment in chronic lymphocytic leukemia, multiple myeloma and B-cell acute lymphoblastic leukemia, and is widely available to clinicians and patients across the U.S. Assessment of MRD is a way to directly detect and quantify remaining disease, even in the absence of symptoms, across a spectrum of blood cancers. A patient's MRD status gives clinicians information about how a patient may be responding to treatment, so patients and providers can be in control when it comes to managing the disease and treatment decisions. Data at ASCO and EHA illustrates the relevance of MRD assessment post-CAR T cell therapy, in MM patients who are often heavily pretreated and who in the past might not have been expected to have such deep responses. Similarly, data showing the ability to achieve deep responses in high-risk patients supports the growing range of patient settings in which MRD assessment is valuable. Both meetings also include data showcasing the importance of serial monitoring of MRD using clonoSEQ as a primary endpoint. These data demonstrate that understanding the kinetics of low-level disease over time - which can only be ascertained using a highly sensitive and precisely quantitative MRD assay like clonoSEQ - is vital to clinicians' ability to accurately understand prognosis and even more clinically meaningful than a single point-in-time measurement.

07:41 EDT Edesa Biotech reports interim results from EB01 trial - Edesa Biotech announced that the company's drug candidate EB01 has met an interim study parameter. The company has now passed the initial inflection point of its Phase2b study and will continue enrolling the final cohort of patients. Edesa reported that interim study data from the first cohort met statistical thresholds previously approved by the FDA as part of an adaptive Phase 2b trial evaluating EB01 as a monotherapy for moderate to severe chronic Allergic Contact Dermatitis, or ACD. Though blinded to treatment assignment, the study's Data and Safety Monitoring Board, or DSMB, reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index, or CDSI, at day 29. Likewise, the DSMB reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA, a key secondary efficacy endpoint. Success on the ISGA is defined as a two-point reduction from baseline and a final ISGA score of '0' or '1' indicating clear or almost clear skin, respectively. A decrease in score relates to an improvement in signs and symptoms. For both the CDSI and ISGA endpoints, double-digit absolute differences were observed among the two treatment arms. No serious treatment-related adverse events were reported for either treatment group. Based on these findings, the DSMB has recommended progression to the second cohort of patients. Interim study data is preliminary and full study results are subject to change; and since the analysis remains blinded, it is not possible to definitively conclude if EB01 may be outperforming placebo or vice versa. The initial cohort analyzed consisted of a population of 46 subjects, of whom 36 completed the study follow-up and were used in the interim analysis. As of June 2, 66 total patients have been randomized in the Phase 2b study.

07:41 EDT Ocugen, Bharat Biotech enter amendment to COVAXIN agreement - Ocugen and Bharat Biotech announced that they have entered into an amendment to their Co-development, Supply, and Commercialization Agreement to expand Ocugen's exclusive territory to commercialize COVAXIN to now also include Canada, in addition to Ocugen's existing rights to commercialize COVAXIN in the United States. As consideration for Bharat Biotech's grant of the rights to commercialize COVAXIN in Canada, Ocugen will make an upfront payment and milestone payment upon first commercial sale in Canada to Bharat Biotech, in addition to sharing the profit from sales of COVAXIN in Canada. Similar to the US profit share arrangement, Ocugen will retain 45% of the profits from sales of COVAXIN in Canada.

07:38 EDT Polaris announces new partnership with National Forest Foundation - Polaris announced a new partnership with the National Forest Foundation, or NFF. Through this partnership, the Polaris Foundation will donate $5M to the National Forest Foundation over five years. The Polaris Fund for Outdoor Recreation will provide grants and project funding to support outdoor recreation and conservation work to help protect forests and surrounding lands for years to come.

07:36 EDT IGM Biosciences announces expansion of IgM platform into infectious diseases - IGM Biosciences announced the expansion of its IgM antibody platform into infectious diseases, with the anticipated advancement of a new pipeline candidate, IGM-6268, into the clinic in the third quarter of 2021. IGM-6268 is an IgM version of an anti-SARS-CoV-2 IgG monoclonal antibody being developed as an intranasally administered agent for the treatment and prevention of COVID-19. The announcement coincides with the publication in Nature of an article entitled "Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants," which is available now online and will be published in a future print issue of Nature. The article describes results from preclinical studies demonstrating significantly greater neutralization of SARS-CoV-2 with an IgM antibody compared to IgG antibodies, the potent neutralization of all evaluated mutant Variants of Concern and Variants of Interest, and the ability to provide effective preventative and therapeutic protection when delivered intranasally in mice. The work described in the paper was performed in collaboration with The University of Texas Medical Branch at Galveston, and The University of Texas Health Science Center at Houston. IGM has exclusively licensed the rights to the antibodies used to generate IGM-6268 and related intellectual property from the University of Texas System. Results from the study published in Nature found that, among the anti-SARS-CoV-2 IgG, IgA, and IgM antibodies screened, IgM antibodies were in all cases significantly more potent than IgG and IgA antibodies in neutralizing virus. IGM-6268, described as IgM-14 in the publication, was shown to be effective for prophylaxis and treatment in animal models when administered intranasally, and also demonstrated significantly increased potency against wild type SARS-CoV-2 and emerging natural viral variants, such as the current UK, South African and Brazilian VoC strains, VoIs, as well as the antibody escape mutants for the current Emergency Use Authorized antibodies.

07:35 EDT Auris Medical plans strategic repositioning on RNA therapeutics, name change - "Following a thorough review of various strategic options, we are very excited to enter with the Trasir acquisition the field of oligonucleotide delivery, which we believe will provide us with a new range of RNA-based therapeutics with disruptive potential", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "The global market for RNA therapeutics has been growing fast, exceeding $1 billion in 2020. However, appropriate delivery technologies have remained a key rate-limiting step for unlocking their potential. Trasir's groundbreaking OligoPhore technology allows for effective delivery of RNA payloads to tissues beyond the liver, which is inadequately addressed with current delivery approaches. We look forward to applying OligoPhore for the development of truly innovative RNA therapeutics and advancing them to clinical proof of concept." He added: "Although we continue to believe that our existing business holds great promise, we acknowledge investors' preferences for highly focused company strategies. Therefore, we will prepare for its separation either through a divestiture or a spin-off to shareholders within the next 12-18 months. Through the strategic repositioning and transformation of the Company, we aim to unlock and create significant shareholder value." Trasir was founded in 2014 by Dr. Wickline based on extensive NIH-sponsored research on technologies that enable safe and effective oligonucleotide delivery to extrahepatic tissues at Washington University, St. Louis MO. Its core technology is the proprietary peptide polyplex platform OligoPhore that can engage any type of RNA in rapid self-assembly. OligoPhore allows for safe and effective systemic delivery of oligonucleotide payloads with efficient cellular uptake and full endosomal release. Importantly, OligoPhore enables delivery to target tissues outside the liver, creating the potential for developing RNA-based therapies for a range of indications with substantial unmet need. In various murine models of disease, OligoPhore has been shown to protect the RNA payload from degradation in the circulation, while enabling pH-dependent nucleotide endosomal escape and cytoplasmic delivery. Proof-of-concept for efficient delivery and target knockdown has been demonstrated for targets in the NF-kB family, various members of the ETS transcription factor family, and targets in the JNK and TAM pathways, enabling a preclinical development pathway for several oncology indications, rare diseases, as well as rheumatoid and osteoarthritis and inflammatory pathologies such as atherosclerosis. Based on the extensive work of Dr Wickline and collaborators, the Company intends to initiate under project code AM-401 the preclinical development of the first pipeline program in an oncology or rare disease indication. The submission of an IND is targeted for the end of 2022. In parallel, the Company will explore further potential applications of the OligoPhoreTM platform for delivery of siRNA, mRNA and gene editing constructs, and seek to leverage the platform's potential through strategic partnering. To reflect the Company's strategic repositioning, the Board of Directors of Auris Medical Holding Ltd. intends to call an extraordinary general meeting of shareholders to propose to change its corporate name to Altamira Therapeutics Ltd. Upon approval of the proposed name change, the Company's shares will start trading under the ticker symbol "CYTO" - the word root for cell in ancient Greek - instead of "EARS". In addition, the Board intends to propose the election of Margrit Schwarz, PhD, MBA, as an additional Board member.

07:33 EDT Arrowhead doses first patient in AROAPOC3-2001 trial - Arrowhead announced that it has dosed the first patient in AROAPOC3-2001, a Phase 2b clinical study of ARO-APOC3, the company's investigational RNA interference, or RNAi, therapeutic being developed as a treatment for patients with severe hypertriglyceridemia, or SHTG. Arrowhead also intends to initiate a Phase 2b study and a Phase 3 study of ARO-APOC3 in two additional patient populations in 2021.

07:32 EDT Lizhi to provide in-car audio entertainment for Li Auto - Lizhi (LIZI) has been collaborating with Li Auto (LI) to integrate Lizhi Podcast in Li Auto vehicles. Lizhi Podcast will be available in Li Auto vehicles' in-car system in Q3.

07:29 EDT Aleafia Health completes medical cannabis export to Germany - Aleafia Health announced that dried flower grown at its Niagara greenhouse facility has been successfully exported to Germany. Gaining access to Europe's most mature legal cannabis market is an important breakthrough for Aleafia Health, with fulfilment of successive purchase orders to Germany currently underway. Germany represents the second major medical cannabis market to which the Company has successfully completed exports. Import and export permits have been secured for two additional orders to Australia, with the shipments expected to occur in June. The first shipment features Aleafia Health's signature THC cultivar Sour Kush. While dried flower currently available in Germany is largely irradiated, the product shipped exceeded stringent quality standards and did not require irradiation, offering a significant competitive advantage in product quality. The export was completed through the EU-GMP certified facility of a strategic partner.

07:28 EDT Gilat Satellite awarded $13M contract by Pronatel - Gilat Satellite Networks announced the award of a $13M contract by Pronatel for delivery of internet services to hundreds of sites in Peru. Gilat to supply Public Free WI-FI services over a two-year period to the regions of Ayacucho, Apurimac, Huancavelica and Cusco with a potential for significant extension and expansion to thousands of additional sites.

07:24 EDT Replimune Group announces data update from RP1, RP2 programs - Replimune Group announced updated interim data from the Phase 2 skin cancer cohorts combining RP1 with Opdivo and data from RP2 alone and in combination with Opdivo that continues to provide strong support for development in its lead indications. Additionally, Replimune announced plans to initiate a Phase 2 clinical trial program in tumor types that metastasize to the liver. A Updated clinical data from the Phase 2 cohort with RP1 in combination with Opdivo in patients with CSCC and other non-melanoma skin cancers continues to support the CERPASS registration-directed clinical trial of RP1 in combination with Libtayo in CSCC: The data continues to demonstrate that RP1 in combination with Opdivo is well tolerated and that it drives deep and durable responses in patients with CSCC with the number of complete responses, a dual independent primary endpoint in the CERPASS study, continuing to increase. At the current data cut off, seven of the nine responses are complete responses with a current CR rate of 46% and overall response rate of 60%. Another potentially eighth complete response will require biopsy confirmation. The Company believes this data provides clear differentiation versus anti-PD1 therapy alone and provides strong validation of Replimune's current registration-directed clinical development plan, with the initial readout of the CERPASS study expected in 2022. Updated clinical data evaluating RP1 in combination with Opdivo in anti-PD1 failed melanoma patients continues to strongly support the Company's registration-directed cohort in the IGNYTE clinical trial: Sixteen anti-PD1 failed cutaneous melanoma patients were enrolled into the previously reported 30 patient cohort in melanoma. The status of the anti-PD1 failed melanoma patients is as follows: Five of these patients have so far met the formal criteria for response; four of which had previously failed both anti-PD1 and anti-CTLA-4 therapies, with a current ORR of 31%. Of two further patients on study one remains a surgical complete response at 18 months from the start of treatment and the second patient with local progression following an extended period of stable disease has reinitiated RP1 treatment and is responding to therapy. Despite improvements in therapy, many melanoma patients treated with anti-PD1 therapy have primary resistance or acquire resistance to immune checkpoint blockade following initial response. The clear activity of RP1 in combination with Opdivo in anti-PD1 failed patients, including in patients with extensive visceral disease, represents a new potential therapeutic option for these patients. Based on the initial data with RP1 in melanoma, the Company initiated a registration-directed 125-patient cohort of anti-PD1 failed melanoma which is expected to read out in 2022. The signal with RP1 in anti-PD1 failed melanoma indicating that the Replimune series of product candidates may provide an effective therapy for these patients has also been further confirmed with RP2, although there are no current plans to independently develop RP2 in cutaneous melanoma. Based on the emerging data indicating that RP1 can be safely administered to tumors in the lung and the evidence of clinical activity in patients with lung metastases from other tumor types, including in patients with anti-PD1 failed disease, the Company has commenced dosing into a 30 patient cohort of patients with anti-PD1/L1 failed NSCLC. Updated RP2 monotherapy data continues to show compelling durability of response and new data in combination with Opdivo provides initial additional evidence of the clinical utility of RP2 in patients with hard-to-treat cancers: RP2 leverages Replimune's platform to express an anti-CTLA-4 antibody, in addition to GALV-GP R- and GM-CSF expressed by RP1. After fully enrolling patients in the RP2 monotherapy cohort in the Phase 1 clinical trial with RP2, 27 of the target number of 30 patients have now been enrolled in the cohort evaluating RP2 in combination with Opdivo. With limited follow up available, initial data shows: The data with RP2 combined with Opdivo in anti-PD1 failed cutaneous melanoma has further confirmed the signal previously seen with RP1 in this setting. Of the nine anti-PD1 failed cutaneous melanoma patients enrolled, four have so far achieved a partial response. The signal in uveal melanoma with RP1 combined with Opdivo and with single-agent RP2 has been further confirmed with RP2 combined with Opdivo, with clear evidence of anti-tumor activity. Signals of activity with RP2 combined with Opdivo have also been seen in patients with other tumor types beyond melanoma and uveal melanoma, including a partial response in anti-PD1 failed squamous cell head and neck cancer. RP2 single-agent activity had also previously been reported in a patient with anti-PD1 failed esophageal cancer and in a patient with salivary gland cancer where partial and complete responses respectively remain ongoing at 18 and 15 months from treatment initiation.

07:20 EDT Verano Holdings opens 34th MUV Dispensary in Florida - Verano Holdings announced the opening of its MundefinedV Dispensary located at 8103 Vineland Ave., Orlando, Florida, which is scheduled to open June 4, 2021 at 10:00am, pending all required approvals. Verano's 34th MundefinedV Dispensary in Florida is located just off Interstate 4 and International Drive near Orlando's world-famous theme parks, studios, and attractions. The new MundefinedV storefront is situated directly across the street from the Orlando Vineland Premium Outlets.

07:17 EDT Archer announces unveiling of eVTOL aircraft - Archer announced plans to unveil its inaugural aircraft, Maker. The unveiling of the company's 2-seat demonstrator aircraft marks a monumental milestone for Archer's journey toward commercial launch. On June 10th, Archer will host an intimate event in Los Angeles, in accordance with local COVID-19 guidelines and restrictions, to showcase its aircraft. Due to state-mandated limitations on event size, a livestream will also be available for a global audience of viewers. Archer's Urban Air Mobility platform will move people throughout cities in a fast, safe, sustainable, and cost-effective manner. The fully electric aircraft, designed to be 100x quieter than a helicopter, will travel distances of up to 60 miles at 150 mph using technology that is available today. Archer's aircraft will revolutionize the next era of travel and transform how people approach everyday life, work, and adventure -- all while benefiting the environment and working towards a zero-emissions future. Maker is the result of extensive development by Archer's world-class team who collectively have over 200 years in eVTOL experience.

07:16 EDT BioCryst launches ORLADEYO in Germany - BioCryst Pharmaceuticals announced that oral, once-daily ORLADEYO is now available for patients with a prescription in Germany. ORLADEYO was approved by the European Medicines Agency on April 30, 2021 for the prevention of recurrent hereditary angioedema attacks in HAE patients 12 years and older.

07:13 EDT Tonix Pharmaceuticals presents results from Phase 3 RELIEF study of TNX-102 SL - Tonix Pharmaceuticals announced the poster presentation of results from its Phase 3 clinical study, RELIEF, of TNX-102 SL for the management of fibromyalgia. The poster, titled, "Efficacy and Safety of TNX-102 SL for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Trial" shows that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo and was associated with a higher rate than placebo of greater than or equal to30% pain responders in participants with fibromyalgia. TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints measuring improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific functional recovery. In addition, TNX-102 SL was well tolerated and was not associated with side-effects seen with other approved oral fibromyalgia treatments, including weight gain, insomnia, nausea or sexual dysfunction. "We believe the results of the Phase 3 RELIEF trial validate the mechanism that improved sleep quality can lead to syndromal effects on fibromyalgia, improving not only pain but also sleep and fatigue. The sublingual formulation of TNX-102 SL for transmucosal absorption showed promise at the 2.8 mg dose in prior fibromyalgia studies, but we believe RELIEF provides evidence that 5.6 mg is the right dose for this patient population," said Seth Lederman, M.D., President and CEO. "We expect interim analysis results for the confirmatory Phase 3 study, RALLY, in the third quarter of this year, followed by topline data in the first quarter of next year."

07:13 EDT J.M. Smucker sees FY22 CapEx $380M - Sees FY22 adjusted effective tax rate 24.0%.

07:11 EDT OrthoPediatrics completes senior leadership transition to David Bailey as CEO - OrthoPediatrics announced the completion of the senior leadership transition, with David Bailey succeeding Mark Throdahl as CEO. Mark Throdahl will remain with the Company as Executive Chairman.

07:10 EDT Karyopharm's Xpovio now available in additional strength tablets - Karyopharm announced that three new strength tablets for Xpovio, the company's first-in-class, oral Selective Inhibitor of Nuclear Export medicine, are now commercially available. The availability of these additional strength tablets follows a FDA approval on April 15. In addition to the original 20 mg strength tablets, Xpovio is now available in 40 mg, 50 mg, and 60 mg strength tablets. Xpovio tablets are available in seven different package sizes to help healthcare providers individualize the dosing and administration of Xpovio based on patient needs.

07:10 EDT VBL Therapeutics adds PFS as secondary primary endpoint in OVAL study - VBL Therapeutics announced a primary endpoint amendment in the OVAL Phase 3 registration-enabling study of VB-111. The clinical trial amendment included a second, separate primary endpoint, of progression free survival, in addition to the original primary endpoint of the trial, overall survival. Based upon the changes that were reviewed by the U.S. Food and Drug Administration, successfully meeting either primary endpoint is expected to be sufficient to support BLA submission. Successful meeting of the PFS endpoint, with a readout anticipated in 2022, could accelerate BLA submission by approximately one year compared to original projections based on the readout of the OS primary endpoint that remains anticipated in 2023. The OVAL study amendment, along with an update on the number of patients enrolled, which as of April 30, 2021, exceeded 260 patients, will be presented tomorrow as part of a virtual Clinical Trial in Progress poster presentation at the 2021 ASCO Annual Meeting.

07:09 EDT Anavex announces notice of allowance for U.S. patent for ANAVEX 2-73 - Anavex Life Sciences announced it received a Notice of Allowance from the United States Patent and Trademark Office for its patent application number 16/166,732 expanding coverage of treatment methods for ANAVEX 2-73, to the treatment of a range of cardiac dysfunctions including cardiac arrhythmia, ventricular arrhythmia and atrial fibrillation among other indications. Data suggests that activation of the sigma-1 receptor is pivotal to restoring neural cell homeostasis and promoting neuroplasticity. Anavex's newest patent is expected to remain in force at least until 2038, not including any patent term extensions. The new patent will expand the use of ANAVEX 2-73 from neurodegenerative and neurodevelopmental disorders to a range of cardiac dysfunctions.

07:08 EDT Protagonist Therapeutics receives FDA BTD for rusfertide - Protagonist Therapeutics announced that the U.S. FDA has granted Breakthrough Therapy Designation for its lead investigational new drug candidate, rusfertide, for the treatment of patients with polycythemia vera for the reduction of erythrocytosis in those patients who do not require further treatment for thrombocytosis and/or leukocytosis.

07:07 EDT Sundial Growers, Tilray gain pre-market amid increased WSB mentions - Shares of Sundial Growers (TLRY) are up about 15% at $1.30 and Tilray (TLRY) up over 6% at $20.15 in early pre-market. The tickers have joined AMC Entertainment (AMC) and Gamestop (GME) in the top-5 most mentioned names on WallStreetBets message board over the past 24 hours.

07:06 EDT United Airlines to purchase aircraft from Boom Supersonic - United Airlines announced a commercial agreement with Denver-based aerospace company Boom Supersonic to add aircraft to its global fleet as well as a cooperative sustainability initiative - a move that facilitates a leap forward in returning supersonic speeds to aviation. Under the terms of the agreement, United will purchase 15 of Boom's 'Overture' airliners, once Overture meets United's demanding safety, operating and sustainability requirements, with an option for an additional 35 aircraft. The companies will work together on meeting those requirements before delivery. Once operational, Overture is expected to be the first large commercial aircraft to be net-zero carbon from day one, optimized to run on 100% sustainable aviation fuel. It is slated to roll out in 2025, fly in 2026 and expected to carry passengers by 2029. United and Boom will also work together to accelerate production of greater supplies of SAF.

07:03 EDT Kala Pharmaceuticals announces Eysuvis now covered by OptumRx - Kala Pharmaceuticals announced that OptumRx, one of the largest pharmacy benefit managers, or PBM, in the United States, has added Eysuvis 0.25% as a covered brand on its commercial formularies, effective May 21.

07:00 EDT Tellurian and Vitol sign 10-year liquefied natural gas agreement for 3 mtpa - Tellurian has finalized a liquefied natural gas sales and purchase agreement with Vitol. The SPA is for 3 million tons per annum, or mtpa, on a free on board basis at Driftwood LNG for a ten-year period, indexed to a combination of two indices: the Japan Korea Marker and the Dutch Title Transfer Facility, each netted back for transportation charges. At current prices, the agreement is valued at approximately $12B in revenue over ten years.

06:57 EDT Community Bankers Trust trading halted, news pending

06:54 EDT Express sees sequential comparable sales improvement through FY21 - Express provided a high level outlook for 2021. The company expects: sequential comparable sales improvement throughout the year; significant gross margin improvement for the year; Buying & Occupancy expense dollars to decrease double digits as a percent to 2019; SG&A expense dollars to decrease mid-single digits as a percent to 2019; net interest expense of $4M in Q2 and $16M for the full year; effective tax rate of approximately 16% for Q2 and approximately 20% for Q3, Q4 and for the year, excluding the impact of any valuation allowances recorded against deferred tax assets; positive EBITDA for Q3 and the second half of the year; positive operating cash flow for the year beginning in Q2; CapEx of approximately $35M.

06:52 EDT The Buckle reports May net sales up 75.4% to $89.7M - The Buckle announced that total net sales for the 4-week fiscal month ended May 29 increased 75.4% to $89.7M from net sales of $51.2M for the prior year 4-week fiscal month ended May 30, 2020. Compared to the same 4-week period in fiscal 2019, net sales increased 45.9% from net sales of $61.5M for the 4-week fiscal month ended June 1, 2019. Net sales for fiscal 2020 were significantly impacted by the company's closure of all brick and mortar stores due to the COVID-19 pandemic beginning March 18, 2020. As a result of the impact of the store closures on prior year reported net sales, the company will report total net sales each month compared to the past two years and does not plan to separately report comparable store sales for the months most affected by the store closures. The company plans to resume its regular monthly reporting with its August results.

06:50 EDT CEO says Elastic on its way to become $1B+ revenue company in FY23 - Consensus is $916.81M. Comments taken from Q4 earnings conference call.

06:49 EDT Gray Television raises offer for Meredith to $16.99 per share in cash - Gray Television (GTN) confirmed that Meredith (MDP) recently informed Gray that, after announcing the definitive agreement with Gray, it had received an unsolicited proposal to acquire its Local Media Group division, including all of Meredith's broadcast television stations, from another party. Gray subsequently offered to amend the parties' Merger Agreement to increase the total consideration payable by Gray from approximately $14.50 per share in cash, or $2.7B in total enterprise value, to $16.99 per share in cash, or $2.825B in total enterprise value; to increase certain fees due to the other party under certain termination events under the Merger Agreement; and to make certain other revisions. On June 2, Gray and Meredith entered into an amendment to reflect the revised terms. Meredith has informed Gray that its Board of Directors unanimously approved the revised Gray proposal, citing superior certainty of value, regulatory considerations, path to close and expected timing. Gray remains committed to moving forward with its pending acquisition of Meredith's local television stations. Gray continues to believe that the proposed Gray/Meredith transaction is in the best interests of the shareholders of both Gray and Meredith, as well as the companies' respective employees, business partners, and local communities. Meredith's Board continues to recommend that its shareholders approve the proposed transaction with Gray. In addition, Meredith shareholders with voting control of approximately 87% of the issued and outstanding Class B common stock of Meredith have entered into a voting and support agreement that generally requires that those shareholders vote their shares in favor of the adoption of the Merger Agreement and take certain other actions to support the transactions contemplated by the Merger Agreement (including voting against any competing proposal) as long as the Merger Agreement has not been terminated. Gray continues to expect that the Meredith transaction, even as amended, will be significantly accretive to free cash flow per share. To date, Gray has identified an estimated $55M in synergies annualized for the first full calendar year following the closing. Including these anticipated $55M of synergies, the revised purchase price for Gray's acquisition of Meredith represents a multiple of approximately 8.3 times a blended average of the Meredith television stations' 2019/2020 operating cash flow. The transaction is subject to approval by Meredith's shareholders and customary closing conditions and regulatory approvals, including certain consents necessary to effectuate the spin-off of Meredith's National Media Group immediately prior to the closing of Gray's acquisition of Meredith. Expected strong free cash flow generation through the closing of all pending transactions and throughout 2021 and 2022 is anticipated to allow Gray to deleverage its capital structure following the closing. Assuming a year-end 2021 closing, Gray anticipates that its total leverage ratio, net of all cash, would approximate 5.4 times on a trailing eight-quarter operating cash flow, including estimated annualized synergies from all announced transactions.

06:47 EDT Gray Television raises offer for Meredith to $16.99 per share in cash

06:38 EDT Vistra Energy reports results from PJM capacity auction for 2022/2023 - Vistra reported its results from the PJM capacity auction for planning year 2022/2023. The company cleared a total of 7,218 megawatts, or MW, at a weighted average clearing price of $66.89 per megawatt-day, equating to approximately $176M in capacity revenue for the 2022/2023 planning year. Including Vistra's incremental revenue of $55M-$60M from existing retail bilateral sales above the capacity auction clearing price, Vistra's total revenues for the period as of June 2 are approximately $231M-$236M.

06:32 EDT BJ's Wholesale Club adds new delayed payment option with Citizens Pay - BJ's Wholesale now offers Citizens Pay, a buy-now-pay-later payment option that allows members to finance purchases over $99. The new payment option is available for purchases made on BJs.com for delivery and with buy online, pick up in-club and curbside pickup.

06:17 EDT Cathie Wood's ARK Investment bought 157.2K shares of Etsy on Wednesday

06:11 EDT CleanSpark expands agreement with Pioneer Power - CleanSpark (CLSK) has extended and expanded its contract manufacturing agreement with Pioneer Power Solutions, (PPSI). The company also announced its membership in Think Microgrid, a group of Microgrid and Energy companies, organized to advance state and federal policies. The company also executed an updated Distribution Agreement with Pioneer Power Solutions that extends and expands the relationship between the two companies through the end of 2023. As part of the new agreement, Pioneer Power has been granted expanded rights to utilize CleanSpark's proprietary software products. Pioneer plans to bundle the solutions with PowerBloc, PPSI's integrated charging and power solution for EV infrastructure. In addition, CleanSpark has been granted expanded rights and opportunities to serve as a preferred distributor of the PowerBloc solution.

06:10 EDT United Therapeutics enrolls first patient in TETON study - United Therapeutics announced that the first patient has enrolled in the phase 3 TETON study, which is expected to evaluate approximately 396 adult patients with idiopathic pulmonary fibrosis, or IPF. This 52-week study will evaluate the impact of Tyvaso on a prognostic indicator for IPF known as forced vital capacity, or FVC. IPF is a progressive lung disease characterized by the loss of the ability of the lungs to absorb oxygen, ultimately resulting in respiratory failure and death. IPF is estimated to affect 100,000 people in the United States.

06:06 EDT Seagen's Tukysa combination shows improved survival in breast cancer - Seagen announced that improvements in overall survival and progression-free survival were maintained with long-term follow up from the pivotal HER2CLIMB trial evaluating the addition of Tukysa - tucatinib - to trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer with and without brain metastases. Data from the pre-specified exploratory analysis will be presented at the 2021 American Society of Clinical Oncology Annual Meeting. The overall survival benefit seen with Tukysa at the time of the primary analysis was maintained after an additional 15.6 months of follow-up - total of 29.6 months -, demonstrating a 5.5-month improvement in median OS for the Tukysa regimen vs. 19.2 months for capecitabine and trastuzumab alone. This benefit continued to be generally consistent across pre-specified patient subgroups. Median OS in the Tukysa arm was 24.7 months vs. median OS of 19.2 months in the control arm. Median PFS in the Tukysa arm was 7.6 months vs. median PFS of 4.9 months in the control arm. The safety profile was generally consistent with the primary analysis. Discontinuations due to adverse events were infrequent in both arms of the trial, with 5.9% in the Tukysa arm and 4.1% in the control arm. Tukysa in combination with trastuzumab and capecitabine was approved by the FDA in April 2020 for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

06:04 EDT Conn's CEO says 'extremely encouraged by the direction we are headed' - "Same store sales exceeded our expectations and increased 19.4% and total sales increased 26.5% as our team capitalized on robust consumer demand and the successful execution of our strategic growth initiatives. Strong first quarter sales were driven by a 70.0% increase in retail sales financed through cash, credit card, and third-party offerings, as our in-house credit underwriting strategy remained conservative during the quarter," stated Norm Miller, Conn's Chairman and CEO. "We generated the highest quarterly net earnings in our 131 year history as a result of strong operating performance from both our retail and credit segments. We significantly grew retail sales, while simultaneously managing credit risk demonstrating the power of our unique and hybrid business model, which we believe supports a meaningful and long-term opportunity to expand our platform and attract more consumers. Throughout fiscal year 2022, we are focused on building on the positive momentum underway and pursuing our strategic initiatives, which include increasing retail sales across our best-in-class financing options, executing on our digital transformation, and expanding our brick-and-mortar footprint. I am extremely encouraged by the direction we are headed, and proud of our team's resiliency and dedication over the past year," concluded Miller.

05:45 EDT Clorox increases quarterly dividend 5% to $1.16 per share - Clorox announced that its board of directors has declared a 5% increase in the quarterly dividend, from $1.11 to $1.16 per share on the company's common stock. The dividend is payable August 13 to stockholders of record as of the close of business on July 28.

05:36 EDT Organon launches as new women's health company - Organon has launched as a new women's health company. The company will be headquartered in the U.S., with offices across the globe including one in Shoreditch, London. Organon has more than 60 products across an international footprint that will serve people in more than 140 countries, with nearly 80% of its approximately $6.5B in annual revenue generated outside the U.S. Organon will be exploring new opportunities and partnerships across its three main pillars: women's health, biosimilars and established brands. The company said, "Organon has a dedicated team focusing on improving access to contraceptive and fertility products, and a comprehensive education and training programme to help women and healthcare professionals understand the choices available to them. There is a continued shift toward long-acting reversible contraceptives (LARCs) and a large fertility market with untapped potential driven by changing social demographics. Building on our current growth business, this is a dynamic market with multiple launch opportunities in the coming years. A core area of growth with the potential to deliver value to both Organon, the NHS and patients in the UK. The Established Brands portfolio will be reinvigorated to maximise market-leading, well-known brands that span key therapy areas such as cardiovascular, respiratory, pain, bone and dermatology."

05:27 EDT Enstar Group reinsures Hiscox portfolio - Enstar Group announced that one of its wholly owned subsidiaries has completed a loss portfolio transfer with Hiscox, pursuant to which Enstar's Syndicate 2008 has reinsured a diversified portfolio of legacy insurance business underwritten by Hiscox Syndicate 3624, including the majority of Hiscox USA's surplus lines broker business. Through the transaction, Hiscox has ceded net insurance reserves of approximately $520M at December 31, 2020 relating to 2019 and prior-year business.

05:22 EDT Amryt Pharma receives priority review from FDA for Oleogel-S10 NDA - Amryt announced that the FDA has granted priority review for Amryt's new drug application, or NDA, for Oleogel-S10 for the treatment of Epidermolysis Bullosa, or EB. Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Priority Review is granted by the FDA to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. In general, the FDA's Priority Review designation accelerates the review time from ten months to a goal of six months from the date of acceptance of the filing. The FDA has set a Prescription Drug User Fee Act, or PDUFA, target action date for the Oleogel-S10 NDA of November 30. Oleogel-S10 previously received fast track designation and rare pediatric disease designation from the FDA. If the NDA for Oleogel-S10 is approved, the company will apply for a priority review voucher.

05:12 EDT Eli Lilly, Innovent announce NMPA approval for Tyvyt combination sNDA - Innovent Biologics and Eli Lilly jointly announced that the National Medical Products Administration, or NMPA, of China has approved the supplemental new drug application, or sNDA, for Tyvyt in combination with gemcitabine and platinum chemotherapy as first-line therapy for people with unresectable locally advanced or metastatic squamous non-small cell lung cancer, or sqNSCLC,.