Stockwinners Market Radar for September 30, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

CMRX

Hot Stocks

19:34 EDT Chimerix enters up to $180M license deal with SymBio Pharma for Brincidofovir - Chimerix announces an exclusive global license agreement with SymBio Pharmaceuticals, under which SymBio has exclusively licensed the worldwide rights to develop, manufacture and commercialize brincidofovir in all human indications, excluding the prevention and treatment of smallpox. Moving forward, SymBio will be responsible for all future development and commercialization as well as manufacturing costs associated with brincidofovir in the licensed indications. Under the terms of the agreement, Chimerix will receive an upfront payment of $5M plus potential clinical, regulatory and commercial milestones of up to $180M. In addition, Chimerix is eligible to receive double digit royalties on net sales of brincidofovir worldwide.
GBCI

Hot Stocks

19:32 EDT Glacier Bancorp to acquire State Bank for $135.3M - Glacier Bancorp announced the signing of a definitive agreement to acquire State Bank Corp, the bank holding company for State Bank of Arizona, a community bank headquartered in Lake Havasu City, Arizona. The combined entity will operate as Foothills Bank, continuing its over 20 years of serving Arizona communities. As of June 30, 2019, State Bank of Arizona had total assets of $678.6M, total loans of $413.6M and total deposits of $592.0M. The boards of Glacier and SBC unanimously approved the transaction. The definitive agreement provides that upon closing of the transaction, SBC shareholders are to receive 0.3706 shares of Glacier stock and $1.69 in cash for each SBC share. Based on the closing price of $40.43 for Glacier shares on September 27, 2019, the transaction would result in an aggregate value of $135.3M, or $16.67 per share. Upon closing of the transaction, which is anticipated to take place late in Q4 of 2019 or early in Q1 of 2020, State Bank of Arizona will merge into Glacier's Foothills Bank Division and will expand Glacier's franchise footprint in Arizona. The transaction will be immediately accretive to Glacier's earnings per share, excluding one-time transaction-related expenses.
MSA

Hot Stocks

19:26 EDT MSA Safety's SCBA gets NIOSH approval - MSA Safety announced that its next generation G1 Self-Contained Breathing Apparatus, or SCBA, has received U.S. government approval from the National Institute for Occupational Safety and Health, or NIOSH),and certification from the Safety Equipment Institute as compliant to the 2018 Edition of the National Fire Protection Association's 1981 performance standards. With this approval, the company can begin shipping the new NFPA-compliant SCBA immediately.
MNOV

Hot Stocks

19:02 EDT MediciNova receives notice of allowance for MN-001 from Chinese Patent Office - MediciNova announced that it has received a Notice of Allowance from the Chinese Patent Office for a pending patent application which covers MN-001, or tipelukast, for the treatment of idiopathic pulmonary fibrosis, or IPF. Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than May 2035. The allowed claims cover the use of MN-001 for treating a patient diagnosed with idiopathic pulmonary fibrosis. The allowed claims also cover the inhibition of pulmonary scarring, the reduction or inhibition of elevated lung hydroxyproline levels, the reduction of elevated lung density, and the reduction of elevated total cell count in bronchoalveolar lavage fluid using MN-001. The allowed claims cover oral administration, including tablets and capsules, as well as liquid dosage forms.
LEU

Hot Stocks

18:48 EDT Centrus Energy names Philip Strawbridge as CFO, CAO, Treasurer - Centrus Energy announced that Philip Strawbridge has been appointed Senior Vice President, CFO, Chief Administrative Officer, and Treasurer of the company effective September 30. From 2010 to 2013, he served as an executive adviser at Court Square Capital. Strawbridge served in various executive positions including CFO at EnergySolutions from 2006 to 2010.
GERN...

Hot Stocks

18:46 EDT Fly Intel: After Hours Movers - HIGHER: Geron (GERN) up 19.6% after FDA granted imetelstat Fast Track designation in MF treatment...NewLink Genetics (NLNK) up 6.9% after buyig Lumos Pharma. LOWER: AnaptysBio (ANAB) down 17.1% after disclosing Phase 2 data for ANB019... Reed's (REED) down 9.2% after announcing restructuring and naming a new CEO... Five Prime (FPRX) down 1.2% after being downgraded to Neutral at Guggenheim. Movers as of 18:30ET.
ERJ

Hot Stocks

18:24 EDT Embraer's Praetor 500 receives EASA and FAA approval - Embraer announces that the company's new Praetor 500 midsize business jet was granted its Type Certificate by EASA, or European Union Aviation Safety Agency, and by the FAA. The Praetor 500 received regulatory approval from Brazil's Civil Aviation Authority in August, less than a year after having been announced in October 2018 at NBAA-BACE.
AWK

Hot Stocks

18:19 EDT American Water awarded $519M West Point water and wastewater treatment contract - American Water announced its Military Services Group has been awarded a contract for ownership, operation and maintenance of the water and wastewater systems on one of the nation's most storied institutions, the United States Military Academy at West Point, N.Y. American Water was selected for both water and wastewater utility privatization contracts awarded by the Department of Defense in fiscal year 2019, following a prior announcement on securing the contract for Joint Base San Antonio. The total contract value as awarded is approximately $519M over a 50-year period. The contract will be subject to an annual economic price adjustment.
TTEK

Hot Stocks

18:11 EDT Tetra Tech names Leslie Shoemaker as President - Tetra Tech announced the promotion of Dr. Leslie Shoemaker to President. In this role she will lead our strategic planning and operating segments. Dr. Shoemaker joined Tetra Tech 28 years ago, and has held positions including project manager, chief strategy officer, and most recently executive vice president and business segment president.
CE

Hot Stocks

18:00 EDT Celanese announces price increases in China on POM grades - Celanese announced price increases on its Amcel, Celcon, and Hostaform polyacetal grades, as well as other functionalized grades in China. The price increases will be effective October 1, 2019, or as contracts otherwise allow.
LMT

Hot Stocks

17:48 EDT Lockheed Martin awarded $494.88M Navy contract modification - Lockheed Martin was awarded a $494.88M fixed-price-incentive, cost-plus-incentive-fee and cost-plus-fixed-fee modification to a previously awarded and announced un-priced letter contract for TRIDENT II missile production and deployed systems support. Work is expected to be completed September 30, 2024. The maximum dollar value of the modification, including the base and all option items, if exercised, is $1.23B. FY19 weapons procurement funds in the amount of $38.34M and United Kingdom funds in the amount of $4.17M are being obligated on this award, none of which will expire at the end of the current fiscal year. This contract is being awarded to the contractor on a sole source basis under 10 U.S. Code 2304 and was previously synopsized on the Federal Business Opportunities website. Strategic Systems Programs is the contracting activity.
PBR

Hot Stocks

17:47 EDT Petrobras starts opportunity disclosure stage regarding E&P asset sale - Petrobras reports that it has started the opportunity disclosure stage regarding the sale of the totality of its interests in eight onshore exploratory blocks located in the Reconcavo Basin, State of Bahia. Subsequent stages of the project will be reported to the market in due course.
GLD

Hot Stocks

17:45 EDT SPDR Gold Shares holdings fall to 920.83MT from 922.88MT - This is the second consecutive decrease in holdings.
S

Hot Stocks

17:44 EDT Sprint awarded $993.5M Navy contract for wireless services, devices - Sprint was awarded an estimated $993.5M indefinite-delivery/indefinite-quantity, firm-fixed-price contract for wireless services and devices in support of the Navy, Marine Corps, Army, Air Force, other Department of Defense agencies, and federal agencies. The contract will include a base period, September 30-November 7, due to an on-ramp to the existing Spiral 3 wireless services multi-agency contracts with three one-year option periods which if exercised, the total value of this contract will be $993.5M. The program ceiling amount is $993.5M. The contract line item numbers amounts are not firm individual ceilings, but are rather representative of the program amount for administrative purposes. Therefore, if the amounts stated are not utilized in a given year, they shall be available for subsequent option periods if exercised. The whole unobligated program ceiling amount remains available throughout the life of the contract until such time as the amount becomes obligated. Work is expected to be completed by November; if all options are exercised, work will be completed by November 2022. Work will be performed at various locations throughout the U.S. and percentage of work cannot be determined at this time. Annual fiscal year operations and maintenance funds in the amount of $10,000 will be obligated and funds will expire at the end of the current fiscal year. This contract resulted from a full and open competitive solicitation, with two offers received. Naval Supply Systems Command is the contracting activity.
SAIC

Hot Stocks

17:41 EDT SAIC director John Hamre sold over $864K in company shares - SAIC director John Hamre disclosed in a filing that he had sold 10,000 shares of company stock at an average price of $86.43 per share on September 27. The total transaction value of the sale was $864,263.
UTX

Hot Stocks

17:38 EDT United Technologies awarded $2.2B Navy contract modification - United Technologies was awarded a $2.2B modification to a previously awarded advanced acquisition contract. This modification definitizes the production and delivery of 112 F135-PW-100 propulsion systems for the Air Force, 46 F135-PW-600 propulsion systems for the Marine Corps, and 25 F135-PW-100 propulsion systems for the Navy. In addition, this modification definitizes award of long lead components, parts and materials associated with 129 F135-PW-100 and 19 F135-PW-600 propulsion systems for non-U.S. Department of Defense, or DoD, participants and foreign military sales, or FMS, customers. Work is expected to be completed in February 2023. FY18 and FY19 aircraft procurement; non-U.S. DoD participant; and FMS funds in the amount of $3.56B are being obligated at time of award, none of which will expire at the end of the current fiscal year. This modification combines purchases for the Air Force; the Marine Corps; the Navy; non-U.S. DoD Participants and FMS customers. The Naval Air Systems Command is the contracting activity.
AES

Hot Stocks

17:28 EDT AES Corp. announces approval from Vietnam to develop a CCGT power plant - AES Corp. announced it was granted approval by the government of Vietnam to develop a 2.2 GW combined cycle gas turbine, or CCGT, power plant, which will be located in the south-central province of Binh Thuan, Vietnam. The Son My 2 plant will have a 20-year contract with the government of Vietnam, and is expected to achieve financial close in 2021 and begin commercial operations in 2024. Son My 2 complements AES' investment plans in gas infrastructure in the country with its previously announced 450 TBtu Son My LNG terminal, which received approval from the government of Vietnam in August. Together, the plant and terminal will play a major role in shaping Vietnam's energy future by diversifying the energy mix with imported LNG as well as meeting the country's increasing demand for sustainable and affordable electricity. This approval represents a significant milestone in the development of the CCGT plant and the LNG terminal, enabling the company to move forward with the necessary permitting and associated project agreements.
NVT

Hot Stocks

17:08 EDT nVent Electric names Sara Zawoyski as CFO - nVent Electric announced that Sara Zawoyski was appointed Executive Vice President and CFO, effective November 1, 2019. She currently serves as Senior Vice President Finance and Treasurer at nVent. Zawoyski previously held CFO roles for several businesses at Pentair, which spun off nVent as an independent, public company in April 2018.
NLNK

Hot Stocks

17:00 EDT NewLink Genetics trading resumes
NLNK

Hot Stocks

16:40 EDT NewLink to acquire Lumos Pharma, to change symbol to LUMO - NewLink Genetics and Lumos Pharma announced that the companies have entered into a definitive merger agreement. Under the terms of the agreement, NewLink will issue Lumos Pharma stockholders NewLink common stock in exchange for their shares in Lumos such that Lumos Pharma stockholders will own approximately 50% of NewLink. Immediately following the closing of the merger, Lumos Pharma will become a wholly-owned subsidiary of NewLink, and NewLink will be renamed "Lumos Pharma, Inc." and will trade on Nasdaq under the symbol "LUMO." The combined company is expected to have offices in Austin, TX and Ames, IA. The boards of directors of both companies have approved the transaction. Major stockholders of Lumos Pharma have also approved the transaction, and the largest stockholder of NewLink has signed a support agreement in favor of the merger transaction. The transaction is anticipated to close in the first quarter of 2020. The proposed merger would create a biopharmaceutical company focused initially on the development of Lumos Pharma's lead candidate, LUM-201, a potential oral therapy for pediatric growth hormone deficiency and other rare endocrine disorders. The merger would combine the Lumos management team's deep experience in rare diseases and endocrinology with NewLink's expertise in drug development and its solid financial position. This merger is expected to provide the financial support necessary to expedite the clinical development of LUM-201 for PGHD, for which the next step is the anticipated initiation of a Phase 2b clinical trial in mid-2020. The planned Phase 2b clinical trial will evaluate LUM-201 for children with PGHD compared to the current standard of care: daily injections of recombinant human growth hormone. Under the terms of the merger agreement, at the effective time of the merger, the outstanding shares of Lumos Pharma capital stock will be converted into the right to receive a number of newly issued shares of NewLink common stock at exchange ratios applicable to each series of capital stock. The conversion of all Lumos Pharma capital stock will result in former Lumos Pharma and NewLink stockholders each owning approximately 50% of the combined company's outstanding common stock. In conjunction with the transaction, the combined company plans to effect a reverse stock split. The transaction has been approved by the Boards of Directors of both companies and the majority of Lumos Pharma stockholders, which include Deerfield Management, a fund managed by Blackstone Life Sciences, Roche Venture Fund, New Enterprise Associates, and Sante Ventures. The largest stockholder of NewLink, Stine Seed Farm, Inc., has also pledged to support the agreement. The transaction is expected to close in the first quarter of 2020, subject to the satisfaction of customary closing conditions, including approval by the stockholders of NewLink Genetics.
TGE

Hot Stocks

16:34 EDT Tallgrass Energy announces binding open season for Pony Express Pipeline - Tallgrass Energy, through its affiliate Tallgrass Pony Express Pipeline, announced a binding open season soliciting shipper commitments for crude oil transportation for near-term expansion on the Pony Express system from origin points in Wyoming to Cushing, Okla. The open season begins at noon on Oct. 1.
ELAN

Hot Stocks

16:32 EDT Elanco to undergo $50M business restructuring, eliminate 250 jobs - Since its September 2018 IPO, Elanco has continued to evaluate its capabilities, structure and staffing to meet its goal of being an agile, standalone company, focused exclusively on animal health and delivering on its Innovation, Portfolio and Productivity strategy. As part of this effort, Elanco is implementing actions to "enhance productivity and drive efficiency." The company is announcing its intent to eliminate approximately 250 positions across multiple locations and functions. This includes exiting R&D operations in Prince Edward Island, Canada; ceasing certain operations at the company's Wusi, China site; and streamlining operations at the Speke, England location. The cost of this restructuring will be approximately $50M with approximately $30M relating to non-cash asset write downs. Elanco expects to realize at least $12M of savings in 2020 from this restructuring. An estimated restructuring charge of $38M will be incurred in Q3 2019 with the remaining $12M to be incurred in 2020.
COLB

Hot Stocks

16:32 EDT Columbia Banking CEO CEO Hadley Robbins to retire - Columbia Banking System and Columbia Bank announced that president and CEO Hadley Robbins will retire on December 31 after nearly seven years of service with the company and nearly forty years in banking. Columbia's board has appointed Clint Stein, Columbia's current COO, to succeed Robbins as CEO.
NLNK

Hot Stocks

16:30 EDT NewLink Genetics trading halted, news pending
GERN

Hot Stocks

16:23 EDT FDA grants Geron's imetelstat Fast Track designation in MF treatment - Geron announced that the FDA has granted Fast Track designation to imetelstat for the treatment of adult patients with Intermediate-2 or High-risk myelofibrosis, or MF, whose disease has relapsed after or is refractory to janus kinase inhibitor treatment, or relapsed/refractory MF. The Fast Track designation includes patients with primary MF and MF developed after essential thrombocythemia or polycythemia vera. This is the same patient population that was studied in Geron's IMbark Phase 2 clinical trial. There are currently no marketed drugs specifically approved for relapsed/refractory MF, representing a significant unmet medical need. Geron plans to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020 to determine if there is a regulatory path forward for imetelstat in relapsed/refractory MF.
RRTS

Hot Stocks

16:20 EDT Roadrunner to downsize dry van business, cut 10% of total workforce - Roadrunner announced it will downsize its unprofitable dry van business, which is part of the company's truckload segment. The downsizing includes reducing dry van company tractor and trailer fleets by over 50%, closing five terminal locations and eliminating approximately 450 positions. Employees subject to the workforce reduction will receive either severance or a 60-day notice. In conjunction with the downsizing activities, the company expects to incur one-time pretax operations restructuring costs of $12M-$16M, excluding the gain or loss on the sale of equipment and the write-down of assets. The downsizing activities are expected to reduce lease obligations and debt and be substantially complete by year-end 2019, with workforce reductions effective over the next 60 to 90 days. The reduction in force represents approximately 10% of the company's total workforce.
UEPS

Hot Stocks

16:18 EDT Net 1 UEPS says SCA of South Africa rules against SASSA, CPS - Net1 UEPS Technologies announced that the Supreme Court of Appeal of South Africa has dismissed the Cash Paymaster Services Ltd application. CPS petitioned the SCA to grant it leave to appeal the March 2018 High Court order, which set aside the agreement between CPS and SASSA and the subsequent payment of ZAR317M, and ordered CPS to refund the amount with interest from June 2014 to date of payment. As previously disclosed by the company in June 2014, CPS received approximately ZAR277M from SASSA related to the recovery of additional implementation costs it incurred during the beneficiary bulk re-registration process in fiscal 2012 and 2013. After the award of the tender in January 2012, SASSA requested CPS to biometrically register all social grant beneficiaries and collect additional information for each child grant recipient, materially higher than what was originally cited in the Request For Proposal. CPS agreed to SASSA's request, and as a result CPS performed approximately 11M additional registrations beyond those that it tendered to register for as part of the quoted service fee. Accordingly, CPS claimed a cost recovery from SASSA, supported by a factual findings certificate from an independent auditing firm. SASSA agreed to pay CPS the ZAR277M as full settlement of the additional costs incurred by CPS. "We are disappointed with the SCA judgment and will study the judgment to determine our next course of action," said Herman Kotze, CEO of Net1. "We reiterate our view that the additional registrations we performed based on SASSA's specific request, resulted in the identification and removal of a significant number of ghost beneficiaries and duplicate grants, and had the direct result of saving the South African government more than ZAR 2 billion per year. The cost incurred for the additional registrations was recovered without any profit component. CPS performed the work requested by SASSA on a bona-fide basis, and it is unfortunate that it once again finds itself being prejudiced by apparent shortcomings in SASSA's procurement processes," he concluded. This ruling is expected to temporarily delay the filing of the company's Form 10-K for the year ended June 30, 2019, which was originally scheduled to be filed today, as the company has to assess the potential impact, if any, of this ruling on the company's financial statements.
SGMO CYTK

Hot Stocks

16:17 EDT Sangamo names Bettina Cockroft, MD as Chief Medical Officer - Sangamo (SGMO) announced the appointment of Bettina Cockroft, MD, MBA, as Senior Vice President and Chief Medical Officer. Dr. Cockroft will oversee all clinical development activities and operations and will report to the Executive Vice President of Research and Development. Dr. Cockroft has 23 years of experience in the biopharmaceutical industry and joins Sangamo from Cytokinetics (CYTK).
ROYT

Hot Stocks

16:17 EDT Pacific Coast Oil says there will be no October cash distribution - Pacific Coast Oil Trust, a royalty trust formed by Pacific Coast Energy Company, announced that there will be no cash distribution to the holders of its units of beneficial interest in October 2019. The trust's distribution calculation relates to net profits and overriding royalties generated during August 2019 as provided in the conveyance of net profits and overriding royalty interest.
ANAB

Hot Stocks

16:16 EDT AnaptysBio reports 'positive' data from interim analysis of GALLOP Phase 2 - AnaptysBio announced "positive" topline data from an interim analysis of its Phase 2 clinical trial of ANB019 in moderate-to-severe generalized pustular psoriasis patients, also known as the GALLOP trial. Enrollment is ongoing and AnaptysBio anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during 2020. Moderate-to-severe GPP is a chronic, life-threatening, rare inflammatory disease with no approved therapies. "Patients with GPP are urgently in need of safe and effective therapeutic options," said Hamza Suria, president and chief executive officer of AnaptysBio. "We are pleased with the benefit observed to date in this trial and look forward to data from additional patients as the GALLOP trial continues. In addition to GPP and palmo-plantar pustulosis, we believe excess IL-36 signaling may be involved in additional orphan dermatological indications, which represent potential future development opportunities for ANB019."
AMK

Hot Stocks

16:15 EDT AssetMark Financial to acquire OBS Financial - AssetMark Financial Holdings announced that it has reached an agreement, through its subsidiary AssetMark Financial, with Canandaigua National Corporation to acquire OBS Financial, an established turnkey asset management platform delivering academically constructed, structured investment strategies to independent advisors, bank Trust officers and their clients, in an all-cash transaction. The transaction is expected to close in early 2020, subject to customary closing conditions.
REED

Hot Stocks

16:12 EDT Reed's announces restructuring, appoints John Bello as interim CEO - Reed's announced a restructuring of its executive leadership team to accelerate its continued business transformation to an efficient and effective asset-light model. The leadership changes include the appointment of John Bello, currently Chairman of the Board of Directors, as Interim Chief Executive Officer and the appointment of Norman E. Snyder, Jr. as Reed's Chief Operating Officer. Additionally, the Company has announced preliminary third quarter 2019 net sales. "Today's announcement reflects the Board's decision to adjust our leadership team to align with the stage of our business development. The Company has executed the initial stages of its business transformation to a brand platform business model centered on Healthy Refreshment. With the divestiture of manufacturing, Reed's will focus on building world class brands through on-trend product innovation, effective sales and powerful marketing. We have now entered a key next stage of our business transformation, where we are focused on executing the further development of our outsourced supply chain to support the anticipated growth of our core brands as we expand our sales and marketing efforts," said John Bello, Chairman and Interim CEO of Reed's, Inc. "As we enter this next phase in our growth, it is crucial to develop a team with the experience and skills to execute our new business model. I will leverage my beverage industry experience to provide the guidance to drive these important business activities while partnering with and building our talented team to support our expanding sales, marketing and product development efforts."
FANG

Hot Stocks

16:10 EDT Diamondback Energy announces resignation of COO Hollis - In a regulatory filing, Diamondback Energy disclosed that Michael Hollis resigned from his positions as President, Chief Operating Officer and a director of Diamondback Energy, effective immediately. "Hollis' resignation was due to personal reasons and not because of a disagreement on any matter relating to Diamondback's operations, policies or practices," the company stated. Daniel Wesson, who has been with Diamondback since February 2012, will continue to oversee Diamondback's operations in his current position as Senior Vice President of Operations, the company noted.
INFU

Hot Stocks

16:09 EDT InfuSystem announces up to $5M stock repurchase program - InfuSystem announced the company's board has approved a stock repurchase program authorizing the company to repurchase up to $5M of the company's outstanding common stock through 2020.
QGEN

Hot Stocks

16:08 EDT Qiagen launches enhanced GeneGlobe Design & Analysis Hub - Qiagen announced the launch of its newly enhanced GeneGlobe Design & Analysis Hub, bringing next-level experiment planning, execution and follow-up to life science researchers. GeneGlobe integrates Qiagen's knowledge base on over 10,000 biological entities with the industry's most comprehensive portfolio of tools for next-generation sequencing, polymerase chain reaction and functional analysis. GeneGlobe users can quickly explore pathways and targets of interest in their scientific context and order the right tools. User-friendly custom product builders enable experiment design with full flexibility on target regions, configuration and format. Embedded analysis pipelines provide quick insights and support the planning of follow-up studies.
BXG

Hot Stocks

16:07 EDT Bluegreen Vacations names Ahmad Wardak as CMO - Bluegreen Vacations announced that Ahmad Wardak, who has been with the company for 16 years, has been appointed Executive Vice President and Chief Marketing Officer, and that Susan Saturday is returning to the company as Executive Vice President and Chief Administrative Officer. Mr. Wardak joined Bluegreen Vacations in 2003 and most recently served as EVP of Corporate Development and Innovation, where he led the company's strategic and corporate development as well as the business intelligence and analytics functions.
SENS

Hot Stocks

16:07 EDT Senseonics completes U.S. patient enrollment in PROMISE 180-day clinical study - Senseonics Holdings announced the completion of patient enrollment in the Eversense PROMISE 180-day sensor Clinical Study. The PROMISE Clinical Study is intended to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes over a 180-day period for the pre-market application submission to the U.S. Food and Drug Administration. This system has previously received its CE Mark and is currently commercially available across Europe. The 181 study participants at 8 sites across the United States had the Eversense CGM System inserted subcutaneously as part of the study. "I am thrilled to be able to offer a long-term implantable sensor to my patients through the Eversense 180-day clinical study," said Satish Garg, MD, Professor of Medicine and Pediatrics at the Barbara Davis Center, University of Colorado Health. "This long-term CGM could be a game changer for people with diabetes. At the Barbara Davis Center, we actively participate in clinical trials that bring the latest diabetes technology and treatments to patients which change the way they manage their diabetes - now and in the future. The PROMISE study promises to do so."
FLEX

Hot Stocks

16:07 EDT Flex names Lynn Torrel chief supply chain and procurement officer - Flex announced that Lynn Torrel has been named chief supply chain and procurement officer, responsible for direct and indirect materials, transportation and logistics, business operations, materials management, and strategic supply chain management. "Having a supply chain and procurement expert of Lynn's caliber join our team will help Flex continue to innovate our real-time supply chain and procurement solutions," said Francois Barbier, president, global operations. "With her extensive experience managing supply chains, delivering improved financial performance, maximizing process efficiencies and productivity, and maintaining strong relationships with vendors and distributors, we know she'll be a valuable asset to Flex and our customers." Torrel joins Flex from Avnet where she was president, Avnet United and Velocity, and was responsible for maintaining and growing Avnet's largest and most strategic customers and supply chain programs globally.
CTRN

Hot Stocks

16:06 EDT Citi Trends names Lisa Powell as new CMO - Citi Trends announced that it has hired Lisa Powell as Executive Vice President and Chief Merchandising Officer. Ms. Powell will oversee the merchandising, planning and allocation functions of the company. She has extensive off-price retail experience, serving TJX, Inc. for 20 years in various merchandising and planning/allocation positions.
CATB

Hot Stocks

16:05 EDT Catabasis completes enrollment for Phase 3 PolarisDMD trial of edasalonexent - Catabasis Pharmaceuticals announced the completion of enrollment for the Phase 3 PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy. The target enrollment of 125 boys was exceeded due to strong interest from our 40 clinical sites in 8 countries and the support of patient advocacy organizations. Top-line results from the Phase 3 PolarisDMD trial are expected in the fourth quarter of 2020 and the trial is anticipated to support an NDA filing in 2021. "We are thrilled to reach this important milestone. The interest and feedback from families and trial sites has been overwhelmingly positive. At a time when there are multiple trials for Duchenne, we are very pleased that physicians and families chose the Phase 3 PolarisDMD trial for edasalonexent," said Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Catabasis. "Edasalonexent has the potential to be a foundational therapy, providing benefit to boys, regardless of their underlying mutation, with the potential to benefit muscle function, as well as cardiac function and bone health. We look forward to completing the trial next year and are working diligently toward the goal of making edasalonexent available to patients."
SOHO

Hot Stocks

16:03 EDT Sotherly Hotels acquires hotel commercial unit in Florida - Sotherly Hotels announced that the company has acquired the hotel commercial unit of the Hyde Beach House Resort & Residences located in Hollywood, Florida for $5.35M. In connection with the closing, the company acquired the hotel commercial unit, which consists of the designated lobby and front desk area, offices, and other spaces. The company also entered into a 20-year management agreement for the parking garage and poolside cabanas of the resort, as well as an agreement to operate and manage the condominium association. Pursuant to a pre-opening services agreement, the company received a fee of $1.0M in connection with certain pre-opening preparations. Also in connection with the closing, the company's DoubleTree Resort by Hilton Hollywood Beach received a construction disruption fee of $1.2M and the company acquired commercial unit 3 of the Resort, a +/- 3,000 square foot ballroom that was constructed and conveyed as required pursuant to an existing covenant and easement agreement.
SKAS

Hot Stocks

16:02 EDT Saker Aviation Services announces special cash dividend - Saker Aviation Services announced that its board has declared a special cash dividend of 50c per share, payable over the next four quarters, 12.5c per share each quarter.
NBIX

Hot Stocks

16:01 EDT Neurocrine names David Boyer as Chief Corporate Affairs Officer - Neurocrine Biosciences announced that David Boyer has joined the company's executive management team as Chief Corporate Affairs Officer. Boyer joins Neurocrine Biosciences from BGR Group, where he served as a Principal and Head of the Health & Lifesciences Practice, leading the firm's healthcare advocacy, policy and strategy development, and strategic consulting team. In his new role at Neurocrine Biosciences, Boyer will be responsible for patient advocacy and engagement, corporate communications, government relations, and public policy.
APTV...

Hot Stocks

15:19 EDT Aptiv, Apple, Navistar announcements highlighted in Trump tweets - President Donald Trump, in a series of tweets this afternoon, has highlighted news recently announced by Aptiv (APTV), Apple (AAPL) and Navistar (NAV) regarding plans for U.S. factories and manufacturing. On September 23, Apple confirmed that its newly redesigned Mac Pro will be manufactured in Austin, Texas. Also on September 23, Aptiv and Hyundai Motor Group (HYMTF) announced that they will be forming an autonomous driving joint venture. The same day, Navistar announced plans for a truck factory in San Antonio, Texas. All three announcements have been highlighted in tweets in this afternoon by President Trump. Reference Link
GOOG GOOGL

Hot Stocks

15:05 EDT Alphabet hires former FDA commissioner to supervise health strategy and policy - Duke Forge Director Robert M. Califf, MD, will be stepping down from his leadership roles at Duke University in November to accept a full-time position as Head of Strategy and Policy for Verily Life Sciences and Google Health, divisions of Google's parent company Alphabet. "Dr. Califf has deep roots at Duke, where he first arrived as a student 50 years ago. A graduate of Duke University and Duke Medical School, he returned to the university for a cardiology fellowship after completing a residency in internal medicine at the University of California, San Francisco. As a Duke faculty cardiologist and clinical investigator, he helped create the Duke Clinical Research Institute, which would grow into the nation's largest academic clinical research organization under Califf's leadership," said Duke Forge in a blog post. Reference Link
AAPL

Hot Stocks

14:59 EDT Apple says App Store prices to increase in Kazakhstan, Sweden due to forex - Apple stated in a post to its Developer news site: "When taxes or foreign exchange rates change, we sometimes need to update prices on the App Store. In the next few days, prices of apps on the App Store and in-app purchases (excluding auto-renewable subscriptions) will increase in Kazakhstan and Sweden due to changes in foreign exchange rates. Your proceeds will be increased accordingly." Reference Link
INTC CSCO

Hot Stocks

14:01 EDT Intel appoints Karen Walker Chief Marketing Officer - Karen Walker will join Intel (INTC) as senior VP and Chief Marketing Officer, effective October 23. Walker will oversee Intel's global marketing group and be responsible for building and strengthening Intel's brand, supporting growth strategies, cultivating opportunities in new and existing markets, and increasing demand for Intel's products and solutions globally. Walker joins Intel from Cisco (CSCO), where she was Chief Marketing Officer since 2015.
AMZN

Hot Stocks

13:43 EDT Amazon announces availability AWS IQ - Amazon Web Services, an Amazon.com company, announced the general availability of AWS IQ, a new service that "helps customers quickly find, engage, and do business with AWS-Certified third party experts for on-demand project work."
NFLX

Hot Stocks

13:40 EDT Netflix renews Stranger Things, signs deal with Duffer brothers - Netflix announced that it has renewed the series "Stranger Things" for a fourth season and signed series creators and showrunners The Duffer Brothers to a multi-year film and series overall deal. "The Duffer Brothers have captivated viewers around the world with Stranger Things and we're thrilled to expand our relationship with them to bring their vivid imaginations to other film and series projects our members will love. We can't wait to see what The Duffer Brothers have in store when they step outside the world of The Upside Down," said Ted Sarandos, Chief Content Officer, Netflix. Reference Link
TSLA

Hot Stocks

13:39 EDT Tesla's director of Central Europe announces resignation - Jochen Rudat, Tesla's director of Central Europe announced via LinkedIn that today will be his last day at the company. "After 10y and so many great memories it is time for me to say Goodbye now. Today is my last day at Tesla but I am staying a friend of the Company and the Management," Rudat said in a post.
DUK

Hot Stocks

13:37 EDT Duke Energy announces request for rate review in North Carolina - Duke Energy Carolinas asked North Carolina regulators in a filing to review its rates as the company continues working to reduce carbon emissions, strengthen the grid and improve the customer experience, the Duke Energy subsidiary announced. The filing with the North Carolina Utilities Commission requests to increase annual revenues by about $291M, for an overall average rate increase across all customer groups of 6.0%. The company's request has been reduced by customer savings of 3.2% resulting from federal and state tax reform, the company said.
AEGN

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13:04 EDT Aegion's Insituform awarded $15.7M wastewater pipeline rehabilitation contract - Aegion Corporation announced that its subsidiary, Insituform Technologies, has been awarded a $15.7M contract in Georgia to rehabilitate more than 22 miles of small-, medium- and large-diameter wastewater pipelines using Insituform cured-in-place pipe, primarily in residential areas. Insituform expects to begin the work in October 2019 and complete the project within 12 months.
DISCA...

Hot Stocks

13:03 EDT Discovery, Comcast's FreeWheel announce multiyear partnership agreement - Discovery (DISCA) and FreeWheel, a Comcast company (CMCSA), announced a multiyear agreement under which FreeWheel will provide their unified decisioning platform to enable holistic advertising management for Discovery's full roster of cable networks. "As we are building the advertising solutions of the future, the industry needs to accelerate the innovation around technology, measurement and targeting. There is too much value being left on the table and Discovery is committed to supporting the next generation of innovators across the industry. FreeWheel has been a strong partner over the years, and their work to integrate the tech stacks of our expanded portfolio, while complicated, has been seamless," said Keith Kazerman, EVP Digital Sales, Advanced Advertising and Research, Discovery, Inc. "The resulting, combined Discovery platform offers advertisers the necessary scale and intelligence to reach their customers across the array of data-enabled delivery channels that are redefining the way television is bought and sold."
PSN

Hot Stocks

12:38 EDT Parsons awarded $590M COCOM cyber mission contract - Parsons Corporation has been awarded the Combatant Commands Cyber Mission Support contract by the U.S. General Services Administration. The contract is a one-year base with four one-year options for a total potential value of $590M. Under the contract, Parsons will support multi-domain operations across cyber, space, air, ground, and maritime -- researching, developing, testing, and evaluating tailored cyber solutions for cyberspace operations, advanced concepts and technologies, and integrating operational platforms. The company will also provide operational support for developed cyber capabilities, including joint command and control and multi-domain platforms, for the Department of Defense, combatant commands, and interagency partners.
BA

Hot Stocks

12:34 EDT Boeing CEO says 737 MAX accidents 'will always weigh heavily on us' - "Safety is at the core of who we are at Boeing, and the recent 737 MAX accidents will always weigh heavily on us. They have reminded us again of the importance of our work and have only intensified our commitment to continuously improve the safety of our products and services," said President and CEO Dennis Muilenburg. "My team and I embrace our board's recommendations and are taking immediate steps to implement them across the company in partnership with our people, while continuing and expanding our ongoing efforts to strengthen safety across Boeing and the broader aerospace industry. We thank our board and the committee members for their thorough work and ongoing support. Boeing is committed to always being at the forefront, proactively leading and advocating for continuous improvements in global aerospace safety."
BA

Hot Stocks

12:33 EDT Boeing CEO says 'must take an expanded leadership role' with focus on safety - "At this defining moment, Boeing must take an expanded leadership role with a heightened focus on safety - and reach even higher," said President and CEO Dennis Muilenburg. "In addition to our focus on a common safety management system, we're creating new leadership positions with the authority, accountability and transparency needed to make measurable progress; addressing the growing need for talent, pilot and maintenance technician training, and STEM education; as well as investing in areas such as product design, future flight decks, infrastructure, regulation and new technologies. We will have more to share on these additional efforts soon. Ensuring the safety of the flying public, pilots and crew is our top priority as we work to return the 737 MAX to service. We'll keep learning from the recent accidents, share what we learn with the broader aviation community, and emerge better and stronger as a company and industry."
BA

Hot Stocks

12:32 EDT Boeing establishing design requirements program - The company also is establishing a Design Requirements Program to strengthen a culture of continuous improvement, learning and innovation; enhancing the Continued Operation Safety Program to raise visibility and transparency of all safety and potential safety reports; partnering with commercial and defense customers, and other stakeholders, to ensure flight deck designs continue to anticipate the needs of future pilot populations; and expanding the role and reach of the company's Safety Promotion Center to reinforce Boeing's long-standing safety culture. Concurrently and in addition to the board's recommendations, Muilenburg announced further steps Boeing is taking to strengthen how it manages safety across the company and its supply chain, focusing on operational excellence, investing in its people and, in partnership with others across the aerospace community, working to improve global aviation safety. That includes expanding companywide use of a comprehensive safety management system and safety review boards to standardize safety policy and objectives, share best practices, manage risk, assess performance, increase visibility and further strengthen the company's safety culture. An anonymous reporting system, born in Commercial Airplanes and expanded across the company, is encouraging employees to bring forward potential safety issues that will be reviewed by the Product and Services Safety organization. Also, safety review boards have been expanded and are now led by senior company leadership, including Boeing's chief engineer and business unit CEOs, resulting in enhanced visibility. Early gains and lessons learned are being applied-today-across a range of development and established programs. Additionally, investments in enhanced flight simulation and computing capabilities have increased the company's ability to proactively test a wide range of scenarios, resulting in improved product safety. For example, over the past several weeks, software engineers have run 390,000 flight hours on the 737 MAX-the equivalent of flying 45 years. Advanced R&D efforts in future flight decks also are underway, leveraging leading-edge work in human factors science and design.
BA

Hot Stocks

12:32 EDT Boeing announces new product and safety services organization - Boeing Chairman, President and CEO Dennis Muilenburg announced several immediate actions he is taking to strengthen the company's enduring commitment to product and services safety. The actions follow recent recommendations from the Boeing Board of Directors that were the result of a five-month independent review of the company's policies and processes for the design and development of its airplanes by a specially appointed committee, initiated by Muilenburg following the Lion Air Flight 610 and Ethiopian Airlines Flight 302 737 MAX accidents. Recommendations from the Committee on Airplane Policies and Processes-supported by extensive outreach to internal and external experts-focused on further improving safety throughout the company and the broader aerospace ecosystem. In addition to the previously announced permanent Aerospace Safety Committee of the Boeing Board of Directors, Muilenburg shared that Boeing is standing up a new Product and Services Safety organization that will further strengthen the company's safety-first focus. This organization will unify safety-related responsibilities currently managed by teams across several Boeing business and operating units. The team will be led by Vice President of Product and Services Safety Beth Pasztor, who will report jointly to the Boeing Board of Directors Aerospace Safety Committee and Greg Hyslop, Boeing chief engineer and senior vice president of Engineering, Test & Technology. The organization will bring together teams across Boeing-and external talent where needed-to elevate awareness and reporting of, and accountability for, safety issues within the company, further improving enterprise-wide product and services safety. The organization is responsible for reviewing all aspects of product safety, including investigating cases of undue pressure and anonymous product and service safety concerns raised by employees. Pasztor also will oversee the company's Accident Investigation Team and safety review boards, in addition to the enterprise Organization Designation Authorization-the company's engineering and technical experts who represent the Federal Aviation Administration in airplane certification activities.
BA

Hot Stocks

12:30 EDT Boeing announces changes to sharpen company focus on products, services safety
MO CRON

Hot Stocks

12:04 EDT Altria puts Begley on Cronos board with Crosthwaite stepping down for Juul - Cronos Group (CRON) announced that, in connection with its investment in the company, Altria Group (MO) has appointed Jody Begley to the Cronos Board of Directors. Begley is currently Senior Vice President, Tobacco Products for Altria. Altria's appointment replaces one of its previous director designees, K.C. Crosthwaite, who has resigned from the Cronos board "to devote more time to his new position as CEO of JUUL Labs."
VZ

Hot Stocks

12:04 EDT Verizon acquires Jaunt XR's technology - Jaunt XR announced the acquisition of its software, technology, and certain other assets by Verizon Communications for an undisclosed amount. Jaunt XR is a player in the immersive industry with a focus on the scalable creation and distribution of volumetric video of humans. "We are thrilled with Verizon's acquisition of Jaunt's technology," said Mitzi Reaugh, President & CEO of Jaunt XR. "The Jaunt team has built leading-edge software and we are excited for its next chapter with Verizon." Jaunt will be assisting Verizon with the transition of select portions of the software and technology for a brief period of time.
SXC

Hot Stocks

12:00 EDT SunCoke Energy falls -9.0% - SunCoke Energy is down -9.0%, or -57c to $5.73.
JNUG

Hot Stocks

12:00 EDT Direxion Daily Jr Gld Mnrs Bull 3X Shrs falls -10.7% - Direxion Daily Jr Gld Mnrs Bull 3X Shrs is down -10.7%, or -$6.84 to $57.17.
RCUS

Hot Stocks

12:00 EDT Arcus Biosciences falls -14.1% - Arcus Biosciences is down -14.1%, or -$1.44 to $8.74.
JDST

Hot Stocks

12:00 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares rises 11.6% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is up 11.6%, or $1.84 to $17.75.
GTT

Hot Stocks

12:00 EDT GTT Communications rises 12.9% - GTT Communications is up 12.9%, or $1.01 to $8.81.
THO

Hot Stocks

12:00 EDT Thor Industries rises 20.3% - Thor Industries is up 20.3%, or $9.93 to $58.85.
JNJ

Hot Stocks

11:26 EDT J&J ordered to pay California woman $40M in latest talc case, law firm says - A California woman suffering from mesothelioma prevailed in a talc trial against Johnson & Johnson, following six days of jury deliberation that ended Friday when the jury awarded her $40M in damages, law firm Simon Greenstone Panatier announced in a statement. The firm explained, "Nancy Cabibi, 71, of Hasuer, Idaho, and her husband Phil sued Johnson & Johnson, makers of Johnson's Baby Powder, following her pleural mesothelioma diagnosis in 2017. Since then, Mrs. Cabibi has undergone a variety of medical procedures including radical surgical intervention, chemotherapy, radiation and immunotherapy. Testing of her body tissue showed the presence of tremolite and anthophyllite asbestos, known contaminants of Johnson's Baby Powder and Shower to Shower, both of which were manufactured by Johnson & Johnson and both of which Mrs. Cabibi used. The jury in the case found Johnson's Baby Powder defective because it contained asbestos. It also found the powder caused Mrs. Cabibi's mesothelioma, which is an invariably fatal form of cancer."
JNJ...

Hot Stocks

11:11 EDT J&J's Acuvue introduces brand's first contact lens solution - Johnson & Johnson (JNJ) Vision earlier today announced what it called "the first-ever extension of the Acuvue brand name beyond contact lenses" with the launch of Acuvue RevitaLens Multi-Purpose Disinfecting Solution, which the company said "delivers exceptional disinfection and all-day comfort for reusable contact lens wearers." Thomas Swinnen, President, North America, Johnson & Johnson Vision, said, "I believe it's a pivotal time in the eye health space, and we have amazing potential as we boldly innovate to expand our best-in-class portfolio of products and services. The addition of Acuvue RevitaLens MPDS to our portfolio is an exciting advancement. It's the first contact lens solution progressive enough to carry the Acuvue brand name." Other companies that market contact lenses and related products include Alcon (ALC) and Cooper Companies (COO).
JKHY

Hot Stocks

11:04 EDT Jack Henry announces retirement of CTO Mark Forbis - Jack Henry & Associates announced that its EVP and CTO Mark Forbis, will retire on November 15, 2019. Effective with Forbis' retirement, the company will appoint Ted Bilke as its CTO and elevate Greg Adelson to a new COO position on its executive team. Ted Bilke, VP of Jack Henry & Associates and President of Symitar, will serve as the company's CTO upon Forbis' retirement.
AZN MRK

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11:03 EDT AstraZeneca, Merck present detailed results from Phase 3 PROfound trial - AstraZeneca (AZN) and Merck (MRK) presented detailed results from the Phase 3 PROfound trial in 387 men with metastatic castration-resistant prostate cancer, or mCRPC, who have a mutation in their homologous recombination repair genes and whose disease had progressed on prior treatment with new hormonal agent treatments. Results showed a statistically significant and clinically meaningful improvement with LYNPARZA in the primary endpoint of radiographic progression-free survival, or rPFS, improving the time men with BRCA1/2- or ATM-mutated mCRPC lived without disease progression or death to a median of 7.4 months vs. 3.6 months for those treated with abiraterone or enzalutamide. LYNPARZA reduced the risk of disease progression or death by 66% for these men. The trial also met the key secondary endpoint of rPFS in the overall HRRm population, where LYNPARZA reduced the risk of disease progression or death by 51% and improved rPFS to a median of 5.8 months vs. 3.5 months for abiraterone or enzalutamide. The results were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology congress, or ESMO.
MRK AZN

Hot Stocks

10:39 EDT AstraZeneca, Merck presents results from Phase 3 PROfound trial of LYNPARZA - AstraZeneca (AZN) and Merck (MRK) presented detailed results from the Phase 3 PROfound trial in 387 men with metastatic castration-resistant prostate cancer who have a mutation in their homologous recombination repair genes and whose disease had progressed on prior treatment with new hormonal agent treatments e.g. abiraterone or enzalutamide. The trial was designed to analyze men with mCRPC harboring HRR-mutated genes in two cohorts: the primary endpoint was in those with mutations in BRCA1/2 or ATM genes and then, if LYNPARZA showed clinical benefit, a formal analysis was performed of the overall trial population of men with HRRm genes. Results showed a statistically-significant and clinically-meaningful improvement with LYNPARZA in the primary endpoint of radiographic progression-free survival in BRCA1/2 or ATM-mutated tumors reducing the risk of disease progression or death by a median of 7.4 months versus 3.6 months for those receiving abiraterone or enzalutamide. LYNPARZA reduced the risk of disease progression or death by 66% for these men. The trial also met the key secondary endpoint of rPFS in the overall HRRm population, where LYNPARZA reduced the risk of disease progression or death by 51% and improved rPFS to a median of 5.8 months vs. 3.5 months for those receiving abiraterone or enzalutamide. In the key secondary endpoint of time to pain progression, median TTPP was not reached with LYNPARZA and was 9.92 months with abiraterone and enzalutamide in patients with BRCA1/2 or ATM mutations. Results also showed a trend at this interim analysis time point for improvement in overall survival, another key secondary endpoint. LYNPARZA extended OS to a median of 18.5 months versus 15.1 months for abiraterone or enzalutamide in men with BRCA1/2 or ATM-mutated tumors, of which 81% started on abiraterone or enzalutamide and, following confirmed disease progression, then switched to LYNPARZA. At this interim analysis, the OS endpoint did not meet statistical significance. In an exploratory analysis, a similar trend in OS was observed at this interim analysis in the HRRm population with a median of 17.5 months for men treated with LYNPARZA vs. 14.3 months for those receiving abiraterone or enzalutamide. The trial showed a confirmed overall response rate a key secondary endpoint of 33.3% for LYNPARZA vs. 2.3% for abiraterone or enzalutamide in patients with BRCA1/2 or ATM mutations. In an exploratory analysis of patients in the overall HRRm population, confirmed ORR was 21.7 % for LYNPARZA vs. 4.5% for patients receiving abiraterone or enzalutamide. The safety and tolerability profile of LYNPARZA in the PROfound trial was in line with that observed in prior clinical trials. The most common adverse events greater than or equal to20% for LYNPARZA compared to abiraterone or enzalutamide were anemia, nausea, fatigue and asthenia, decreased appetite, and diarrhea. Grade 3 or above AEs were anemia, fatigue and asthenia, vomiting, dyspnea, urinary tract infection, nausea, decreased appetite, diarrhea, and back pain. AEs led to discontinuation of treatment in 16% of patients on LYNPARZA vs. 9% on abiraterone and enzalutamide. AstraZeneca and Merck are also exploring additional trials in prostate cancer, including the ongoing Phase 3 PROpel trial, evaluating LYNPARZA as a first-line therapy in mCRPC for patients with or without HRR mutations, in combination with abiraterone acetate.
SNY

Hot Stocks

10:36 EDT Sanofi reports CARD study results presented at ESMO, published in NEJM - Data published in the New England Journal of Medicine showed that patients with metastatic castration-resistant prostate cancer, mCRPC, previously treated with docetaxel and who progressed within 12 months on an androgen receptor-targeted agent experienced significantly longer radiographic progression free survival, or rPFS, with Jevtana plus prednisone compared with abiraterone plus prednisone or enzalutamide, Sanofi announced. Overall survival with Jevtana was also significantly longer, the company said. These findings from the CARD study were presented today in the Presidential Symposium of the 2019 European Society of Medical Oncology Congress, or ESMO. The study's primary endpoint was rPFS, which more than doubled with Jevtana treatment compared to abiraterone or enzalutamide. Patients treated with Jevtana experienced an improvement in rPFS in all pre-specified subgroups, irrespective of the timing of the previous alternative AR-targeted agent, before or after docetaxel. Jevtana also significantly improved a key secondary endpoint, OS, reducing the risk of death from any cause by 36% compared with abiraterone or enzalutamide. Other key secondary endpoints all favored Jevtana, the company said.
AGIO

Hot Stocks

10:33 EDT Agios data from Phase 3 ClarIDHy trial shows significant improvement in PFS - Agios Pharmaceuticals presented data from the global Phase 3 ClarIDHy trial of TIBSOVO in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 mutation in a Presidential Symposium at the European Society for Medical Oncology Congress. Results from the ClarIDHy trial demonstrated a statistically significant improvement in progression-free survival by independent radiology review of 2.7 months among patients randomized to TIBSOVO compared with 1.4 months among placebo patients. The safety profile observed in the study was consistent with previously published data. "Advanced cholangiocarcinoma is an aggressive disease oftentimes characterized by rapid progression following multiple lines of therapy, and there are no currently approved treatments," said Ghassan Abou-Alfa, M.D., medical oncologist at Memorial Sloan Kettering Cancer Center, who presented the data at ESMO. "The ClarIDHy study is the first randomized trial in previously treated IDH1 mutant cholangiocarcinoma patients and demonstrates that TIBSOVO provides significant improvement in PFS compared to placebo, while also showing a favorable trend in overall survival. These critical data also provide strong justification for genomic testing in cholangiocarcinoma patients where a targeted therapeutic approach may provide benefit."
RGLD

Hot Stocks

10:33 EDT Royal Gold names William Heissenbuttel to succeed Tony Jensen as CEO - Royal Gold announced that William Heissenbuttel, CFO and VP, Strategy, has been named as president and CEO and a member of the Board of Directors. Heissenbuttel's appointments will be effective upon the retirement of Tony Jensen from the role of president and CEO, and member of the Board of Directors, on January 2, 2020 after 16 years of service to the Company, 13 of which were as president and CEO. An announcement on the replacement for the CFO will be made in due course.
BMY

Hot Stocks

10:32 EDT Bristol-Myers reports results from Phase 3 ATTRACTION-3 trial - Bristol-Myers Squibb and Ono Pharmaceutical announced results from the Phase 3 ATTRACTION-3 trial evaluating Opdivo versus chemotherapy for the treatment of patients with unresectable advanced or recurrent esophageal squamous cell carcinoma, or ESCC, refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs. For the primary endpoint of overall survival, Opdivo demonstrated a statistically significant improvement over chemotherapy, with a 23% reduction in risk of death and a 2.5-month improvement in median OS compared to patients treated with chemotherapy. The safety profile of Opdivo in this trial was consistent with previously reported studies in ESCC and other solid tumors. These data will be featured in the Presidential Symposium on Monday, September 30 from 4:30-6:15 PM CEST at the European Society for Medical Oncology, or ESMO, and simultaneously published in The Lancet Oncology. "These are very promising results for patients with advanced esophageal squamous cell carcinoma for whom prognosis is typically poor and are particularly important given Opdivo improved survival regardless of PD-L1 status. We are encouraged to see important progress being made in this tumor type and look forward to broadening our research in gastrointestinal tumors," said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb.
RHHBY

Hot Stocks

10:32 EDT Genentech says Tecentriq, chemotherapy shows improvement in PFS in trial - Genentech, a member of the Roche Group, presented results from the Phase III IMvigor130 study evaluating Tecentriq plus platinum-based chemotherapy versus chemotherapy alone for the first-line treatment of people with previously untreated locally advanced or metastatic urothelial carcinoma eligible and ineligible for cisplatin chemotherapy. In the study, Tecentriq plus chemotherapy showed a statistically significant improvement in progression-free survival compared with platinum-based chemotherapy alone. Encouraging overall survival results were observed for Tecentriq plus chemotherapy compared with chemotherapy alone in the intention-to-treat population, however these data did not reach statistical significance at this interim analysis. Safety in the Tecentriq plus chemotherapy arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. "We are pleased with these positive results from the IMvigor130 study, which show Tecentriq plus chemotherapy may provide a meaningful benefit for people newly diagnosed with advanced bladder cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "There remains a high unmet need for people with advanced bladder cancer, where chemotherapy alone is the current standard of care. These results reinforce the role of immunotherapy in treating this aggressive disease."
TBPH GSK

Hot Stocks

10:31 EDT Theravance announces arbitrator decision in Trelegy royalty litigation - Theravance Biopharma disclosed this morning that on September 26, an arbitrator ruled that, while Innoviva breached the LLC Agreement by failing to provide quarterly financial plans to the company as required, the withholding of funds by Innoviva with respect to certain Trelegy development and commercialization initiatives proposed by Innoviva was not in breach of the LLC Agreement. The arbitrator also found that Innoviva had not breached its fiduciary duties to the company. The arbitrator awarded injunctive relief to give more certainty to future dealings between the parties and to clarify certain terms of the LLC Agreement, and imposed additional obligations on Innoviva to obtain the consent of GSK for any proposed investment of TRC funds that requires the consent of GSK under the Collaboration Agreement dated November 14, 2002, as amended. Under the arbitrator's ruling, Innoviva is currently permitted to continue to withhold approximately $8M of TRC funds for certain Trelegy development and commercialization initiatives proposed by Innoviva. These initiatives must be presented to GSK in Q4 of 2019 and they cannot be implemented without GSK's approval, which approval must be obtained no later than during the first quarter of 2020. To the extent GSK's approval is not received, Theravance expects distribution to the TRC members of the withheld funds. To the extent the initiatives are timely approved by GSK and proceed, TRC may withhold additional amounts in subsequent quarters through to the completion of these initiatives, the company added.
SPX SPY

Hot Stocks

10:18 EDT Fitch downgrades Saudi Arabia to A; outlook Stable - Fitch Ratings has downgraded Saudi Arabia's Long-Term Foreign-Currency Issuer Default Rating to 'A' from 'A+'. The Outlook is Stable. The downgrade reflects rising geopolitical and military tensions in the Gulf region, Fitch's revised assessment of the vulnerability of Saudi Arabia's economic infrastructure and continued deterioration in Saudi Arabia's fiscal and external balance sheets.
MITO

Hot Stocks

10:13 EDT Stealth BioTherapeutics Corporation (ADS) trading resumes
RDS.A

Hot Stocks

10:10 EDT Shell sees Q3 Integrated Gas production of 930-960K boepd - Royal Dutch Shell plc introduced earlier the publication of a quarterly update, starting with the third quarter. Jessica Uhl, CFO of Royal Dutch Shell said: "In response to feedback from our investor community we are introducing this new quarterly process. This is a further step in Shell's ongoing journey to enhance disclosures and increase transparency". In Integrated Gas, production is expected to be between 930 and 960 thousand barrels of oil equivalent per day. LNG liquefaction volumes are expected to be between 9.00 and 9.30 million tonnes. "For the third quarter, we expect to deliver strong trading and optimisation performance," Shell said. In Upstream, production is expected to be between 2,600 and 2,650 thousand barrels of oil equivalent per day. "During the third quarter there have been additional well write-offs in the range of $250-$350M compared to Q3 2018, for which no cash impact is expected," Shell said. In Downstream, refinery availability is expected to be between 90% and 92%. Oil Products sales volumes are expected to be between 6,700 and 7,350 thousand barrels per day. Chemicals manufacturing plant availability is expected to be between 90% and 92%. Chemicals sales volumes are expected to be between 3,900 and 4,000 thousand tonnes. "We expect chemicals cracker and intermediate margins to be materially unchanged from Q2 2019," Shell said. Corporate earnings excluding identified items are expected to be a net charge between $700M-$850M, which excludes the impact of currency exchange rate effects. Currency exchange rate movements, including a weakening of the Brazilian Real, is expected to have a negative earnings impact on top of the provided range. As per previous disclosures, price sensitivity at Shell group level is $6B per annum per $10 per barrel Brent price movement.
MITO

Hot Stocks

10:08 EDT Stealth BioTherapeutics Corporation (ADS) trading halted, volatility trading pause
TGNA

Hot Stocks

10:00 EDT Tegna shareholder Standard General to become actively engaged, plans talks - In a regulatory filing, Standard General disclosed a 9.8% stake in Tegna and noted that the firm originally acquired, and continues to hold, the securities for investment purposes. Standard General said in the filing that it has "continually reviewed" the investment "in light of the [company's] published financial results and disclosures, changes in the trading price of shares of common stock, conditions in the securities market, and general economic and industry conditions and other factors." Standard filed a Schedule 13G on August 14 but is now filing a Schedule 13D to supersede their previously filed Schedule 13G, indicating the firm's intent to be actively engaged. Standard has "experience as significant shareholders and directors of publicly-listed television broadcasting companies [and] a successful track-record of overseeing acquisitions, mergers, and sales processes of publicly-listed television broadcasting companies. Accordingly, the [investors] now intend to become actively engaged with the [company]. These activities may include speaking with management, the board, other shareholders, and third parties to gather information and share the Reporting Persons' views on the Issuer's strategic alternatives, including the previously disclosed offers for the Issuer as well any other proposals that may be made to the [company]."
GME

Hot Stocks

10:00 EDT GameStop rises 4.3% - GameStop is up 4.3%, or 23c to $5.57.
DGAZ

Hot Stocks

10:00 EDT VelocityShares 3x Inv Natural Gas ETN rises 6.2% - VelocityShares 3x Inv Natural Gas ETN is up 6.2%, or $7.74 to $132.28.
THO

Hot Stocks

10:00 EDT Thor Industries rises 12.6% - Thor Industries is up 12.6%, or $6.15 to $55.07.
JNJ

Hot Stocks

09:52 EDT Janssen licenses oncology multispecific product from Teneobio - Teneobio, Inc., a clinical-stage biotechnology company developing engineered bispecific antibodies for the treatment of cancer, announced that as a result of its work with scientists from Janssen Research & Development, LLC, Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has elected to exercise a commercial option to license and advance an undisclosed multispecific product for development in an oncology indication. Under the terms of the collaboration agreement, which was first announced in Q3 of 2018, Janssen will receive exclusive global licensing rights to the multispecific product for clinical development and commercialization. Teneobio will receive a milestone payment from Janssen for the commercial license and is eligible for additional development and commercial milestones as well as royalties on world-wide net sales of the multispecific product.
JNJ

Hot Stocks

09:51 EDT Janssen says FDA approves Invokana to treat DKD - The Janssen Pharmaceutical Companies of Johnson & Johnson announced earlier that the U.S. Food and Drug Administration approved a new indication for INVOKANA to reduce the risk of end-stage kidney disease, worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease with a certain amount of protein in the urine. INVOKANA is now the only type 2 diabetes medicine indicated to both treat diabetic kidney disease and reduce the risk of hospitalization for heart failure in patients with T2D and DKD. With the approval of these new uses, INVOKANA(R) is now the only diabetes medicine indicated to help type 2 diabetes patients reduce the risks associated with diabetic kidney disease, including hospitalization for heart failure," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "This significant advancement addresses serious unmet needs and could change the trajectory of care for the many millions of patients living with type 2 diabetes and diabetic kidney disease." The new indication is based on results from the landmark Phase 3 CREDENCE study in patients with T2D and DKD, which was stopped early because it met the prespecified criteria for efficacy.
UXIN

Hot Stocks

09:48 EDT Uxin to divest loan facilitation related business in cash and stock deal - Uxin Limited announced it entered into definitive agreements with Golden Pacer, a financial technology platform in China, to divest its loan facilitation related business. Previously on July 12, the company announced that it had entered into a binding term sheet with Golden Pacer relating to the divestiture. Pursuant to the definitive agreements, the Company will divest its entire 2C intra-regional business to Golden Pacer, and cease to provide guarantee services in connection with its 2C cross-regional business going forward, and thus divest the corresponding assets and liabilities. In return, the company will receive an aggregate of $100M cash from Golden Pacer and certain preferred shares of Golden Pacer representing approximately 18.4% of the share capital of Golden Pacer on a fully diluted basis. The company will have the right to appoint one director on Golden Pacer's board of directors. The transactions contemplated under the definitive agreements are subject to certain closing conditions, and are currently expected to close by the end of 2019.The company's board of directors, acting upon the unanimous recommendation of its Audit Committee consisting of independent and disinterested directors, approved the definitive agreements and the transactions contemplated thereunder. The Audit Committee reviewed and considered the terms of the definitive agreements and the transactions with the assistance of its financial and legal advisors.
TGP

Hot Stocks

09:47 EDT Teekay LNG falls -7.5% - Teekay LNG is down -7.5%, or -$1.13 to $14.00.
UGAZ

Hot Stocks

09:47 EDT VelocityShares 3x Long Natural Gas ETN falls -7.5% - VelocityShares 3x Long Natural Gas ETN is down -7.5%, or -$1.21 to $14.85.
TK

Hot Stocks

09:47 EDT Teekay Corp. falls -8.5% - Teekay Corp. is down -8.5%, or -36c to $3.87.
JDST

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09:47 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares rises 7.0% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is up 7.0%, or $1.11 to $17.02.
DGAZ

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09:47 EDT VelocityShares 3x Inv Natural Gas ETN rises 7.8% - VelocityShares 3x Inv Natural Gas ETN is up 7.8%, or $9.74 to $134.28.
THO

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09:47 EDT Thor Industries rises 13.3% - Thor Industries is up 13.3%, or $6.49 to $55.41.
RGRX

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09:38 EDT RegeneRx: Phase 3 ARISE-3 trial 'progressing smoothly' according to plan - RegeneRx Biopharmaceuticals announced that GtreeBNT, its Korean partner in the U.S. development of RGN-259 for the treatment of dry eye disease, issued an update on the U.S. phase 3 clinical trial. The following translation was provided to RegeneRx by GtreeBNT, with certain clarifications made by RegeneRx: "The ongoing clinical trial of dry eye -- ARISE-3 -- is progressing smoothly according to the plan. In the second and third quarters of 2019, we made significant effort to select appropriate clinical study sites, and we have identified and selected around 15 eye hospitals as study sites and started clinical trials sequentially. In addition, by actively utilizing databases held by hospitals to select patients that meet the criteria for recruiting clinicians, and by proactively asking questions to better identify patient status learned from ARISE-1 and ARISE-2, we are becoming more efficient and accurate with patient screening in this ARISE-3 clinical trial. In addition, since we are focusing more fully on clinical management based on know-how that we have learned from the two previous clinical trials, we expect that we will be able to control the risk of clinical trial failure. Furthermore, in the FDA approval process for new dry eye products, we believe that all data from previous trials as well as this ongoing study will be analyzed and included in the Data Totality concept. When you combine the results of two already completed clinical studies and the data from the currently ongoing ARISE-3 clinical trial, it is expected that all three Phase 3 studies will show the same consistent effect and trend. We also expect the pace of patient recruitment will be accelerated in the fall and winter, when the dry eye season comes, so we believe it will be easier to achieve our goal of completing the treatment of patients by the end of 2nd quarter of 2020. In the future, we will be able to talk more often about our ARISE-3 situations in order to address the interests of shareholders and related parties."
RCEL

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09:31 EDT AVITA Medical announces listing on Nasdaq - AVITA Medical announced that its American Depositary Shares have been approved to list on the Nasdaq Capital Market. Trading is to begin on Tuesday, October 1, under the ticker symbol "RCEL." "Our listing on Nasdaq is an exciting next step for AVITA Medical. It builds on our established ASX shareholder base and provides broader access to investors in the United States and worldwide," said Dr. Michael Perry, AVITA Medical's CEO. "Following the robust uptake and adoption of our RECEL System by U.S. burn centers, we view the trading of our American Depositary Shares on the Nasdaq as a natural extension of our growth plan."
BBU

Hot Stocks

09:28 EDT Brookfield Business Partners to invest in BrandSafway - Brookfield Business Partners, together with its institutional partners and Clayton, Dubilier & Rice announced a definitive agreement for Brookfield to acquire half of CD&R's ownership interest in Brand Industrial Services. As a result of the investment, Brookfield and funds managed by CD&R will each own approximately 45% of the Company. BrandSafway management will continue to own a minority interest in the business. Brookfield's investment will be funded with approximately $1.3B of equity. Brookfield Business Partners intends to fund approximately $400M, with the balance being funded by institutional partners. Prior to or following closing, a portion of Brookfield Business Partners' commitment may be syndicated to other institutional investors. The transaction is subject to customary approvals and is anticipated to occur in the first quarter of 2020.
NRE

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09:18 EDT Northstar Realty Europe announces completion of AXA acquisition, shares delisted - Northstar Realty Europe announced the completion of the previously announced acquisition of NRE by AXA Investment Managers, acting as manager of one of its funds, through a merger of NRE with and into a wholly-owned subsidiary of such fund. The merger was approved at a special meeting of NRE stockholders. Each share of NRE common stock outstanding as of the merger was cancelled and converted automatically into the right to receive an amount in cash equal to the sum of $1.68 plus the U.S. dollar equivalent of EUR9.26 plus the U.S. dollar equivalent of GBP3.82. After the settlement of the previously disclosed forward exchange contracts to hedge the non-U.S. dollar portions of the merger consideration, the U.S. dollar consideration to be paid for each share of NRE common stock is approximately $17.01. In connection with the completion of the merger, NRE's common stock will be delisted from the New York Stock Exchange.
FNMA FMCC

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09:16 EDT Fannie Mae permitted to maintain capital reserves of $25B, Freddie Mac $20B - The U.S. Department of the Treasury and the Federal Housing Finance Agency announced that they had agreed to modifications to the Preferred Stock Purchase Agreements, or PSPAs, that will permit Fannie Mae (FNMA) and Freddie Mac (FMCC) to retain additional earnings in excess of the $3B capital reserves currently permitted by their PSPAs. Under the modifications announced today, Fannie Mae and Freddie Mac will be permitted to maintain capital reserves of $25B and $20B, respectively. These changes to the PSPAs were recommended in the Treasury Housing Reform Plan released on September 5, Treasury noted. To compensate Treasury for the dividends that it would have received absent these modifications, Treasury's liquidation preferences for its Fannie Mae and Freddie Mac preferred stock will gradually increase by the amount of the additional capital reserves until the liquidation preferences increase by $22B for Fannie Mae and $17B for Freddie Mac. Reference Link
ESEA

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09:12 EDT Euroseas announces charter for container vessel M/V Akinada Bridge - Euroseas announced its container vessel, M/V "Akinada Bridge", with capacity of about 5,600 teu and built in 2001, has entered into a charter contract of minimum duration of ten months and maximum duration of thirteen months at a daily rate of $16,500. The charter will commence upon completion of the vessel's special survey and drydocking and the installation of a water ballast treatment plant at a total cost of about $2.5M. The Company expects to fully recover the above-mentioned cost over the duration of the charter and will finance it via a loan from an entity affiliated with the Company's CEO. The loan ranks below the other indebtedness of the Company, is convertible to equity under certain conditions at the option of the Company or the lender, and will be repaid within a year after the completion of the drydocking. The terms of the loan have been approved by an independent committee of the Board of Directors of the Company.
DOVA...

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09:10 EDT Fly Intel: Pre-market Movers - HIGHER: Dova Pharmaceuticals (DOVA), up 39% after entering into an agreement and plan of merger with Swedish Orphan Biovitrum, or Sobi. Under the terms of the agreement, an indirect subsidiary of Sobi will commence a tender offer for all outstanding shares of Dova, whereby Dova stockholders will be offered an upfront payment for $27.50 per share in cash, along with one non-tradeable contingent value right that entitles them to an additional $1.50 per share in cash upon regulatory approval of DOPTELET... Bed Bath & Beyond (BBBY), up 7% after Wedbush analyst Seth Basham upgraded the stock to Outperform from Neutral and raised his price target for the shares to $16 from $14. Bed Bath & Beyond has a "good chance of stabilization" in earnings over the next two years as its changes take hold, Basham tells investors... Calithera Biosciences (CALA), up 9% after presenting new data from the investigational oral arginase inhibitor INCB001158 as a monotherapy and in combination with the checkpoint inhibitor pembrolizumab in microsatellite stable colorectal carcinoma patients... Mallinckrodt (MNK), up 5% after executing a definitive settlement agreement and release with Cuyahoga and Summit Counties in Ohio in connection with lawsuits pending in multidistrict opioid litigation in the U.S. District Court for the Northern District of Ohio... Colony Capital (CLNY), up 3% after entering into definitive agreements for Blackstone Real Estate Partners IX to acquire Colony Industrial, the industrial real estate assets and affiliated industrial operating platform of Colony Capital, for an aggregate purchase price of $5.9B. LOWER: Immunomedics (IMMU), down 7.5% after presenting interim data from the 100-patient cohort of cisplatin-eligible patients of the company's TROPHY-U-01 open-label Phase 2 study. In this interim report, sacituzumab govitecan produced an overall response rate of 29% in 35 patients with metastatic urothelial cancer who have relapsed or are refractory to immune checkpoint inhibitors and platinum-based chemotherapy... Teekay LNG (TGP) and Teekay Corp. (TK), down 7% and 5%, respectively, after postponing their group investor day.
REG

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09:09 EDT Regency Centers acquires Circle Marina Center in Long Beach, California - Regency Centers Corporation announced the off-market acquisition of 120,000-square feet of premier retail located in the heart of Long Beach, CA known as Circle Marina Center. It is currently 95% leased and includes 33,000-square feet of a three-story office building and above-retail office. Originally built in 1959, this property sits on the Pacific Coast Highway in a high density submarket in close proximity to three other Regency shopping centers, and has become the fifth property Regency owns in Long Beach. The surrounding demographics consist of a population of nearly 250,000 with an average home value of $952,000.
AESE

Hot Stocks

09:09 EDT Allied Esports Entertainment appoints Anthony Hung as CFO - Allied Esports Entertainment announced the appointment of Anthony Hung as CFO of the company, effective September 24. Kenneth DeCubellis stepped down from his role as CFO and Treasurer on September 24. DeCubellis will remain with the company through the end of the year as a consultant to help ensure a smooth transition. Before joining the company, Hung served as the CEO and CFO of Audio Design Experts.
AMEH

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09:08 EDT Apollo Medical names Brandon Sim as Interim Chief Technology Officer - Apollo Medical announced the appointment of Matthew Mazdyasni to its Board of Directors and Brandon Sim as its Interim Chief Technology Officer. Prior to joining ApolloMed, Sim served as Quantitative Researcher at Citadel Securities since 2015. From 2012 to 2014, Sim served as Chief Technology Officer at Theratech, a medical device company focused on developing a low-cost, simple-to-use patch for automated drug delivery.
MU XLNX

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09:08 EDT Micron works with Xilinx for configuration performance of Versal platform - Micron Technology (MU) announced that it is working with Xilinx (XLNX) to boost the boot and dynamic configuration performance of Xilinx's Versal platform, the industry's first adaptive compute acceleration platform. ACAP, a new category of heterogeneous compute devices, will use Micron Xccela flash and other Micron memory solutions to reduce system startup times and increase system responsiveness in automotive, industrial, networking and consumer applications that use artificial intelligence.
TLYS JWN

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09:08 EDT Tilly's appoints Tricia Smith as CMO - Tilly's (TLYS) announced that Tricia Smith has been appointed to serve as the company's executive VP, chief merchandising officer, or CMO, effective September 30. Smith will oversee all aspects of the company's merchandising operations, including buying, sourcing and product development, along with coordinating consistency in merchandising experiences both in-store and online. Prior to joining the company, Smith served as executive VP, general merchandise manager of women's, young contemporary, designer and specialized apparel at Nordstrom (JWN) since 2016.
AMD

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09:05 EDT AMD announces global availability of AMD Ryzen Pro 3000 Series processors - AMD announced the global availability of its new AMD Ryzen PRO 3000 Series desktop processor lineup, along with new AMD Ryzen PRO processors with Radeon Vega Graphics and AMD Athlon PRO processors with Radeon Vega Graphics. The AMD Ryzen PRO and Athlon PRO desktop processors combine powerful performance, built-in security features, and commercial-grade reliability to get the job done. Starting in Q4 2019, robust enterprise desktops from HP and Lenovo powered by AMD Ryzen PRO and Athlon PRO desktop processors are slated to be available.
NRE

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09:05 EDT Northstar Realty Europe Corp. trading halted, news dissemination
DSX

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09:04 EDT Diana Shipping announces extension, increase of tender offer - Diana Shipping announced that the Company is amending its previously announced tender offer to purchase up to 1,408,450 shares of its outstanding common stock at a price of $3.55 per share. Under the amended terms, the Company is now offering to purchase up to 2,816,900 shares of its common stock at the same price of $3.55 per share. The Company is also extending the expiration date of the tender offer. The tender offer, which was previously set to expire at 5:00 P.M., Eastern Time, on October 4, 2019, is now set to expire at 11:59 P.M., Eastern Time, on October 11, 2019, unless further extended or withdrawn. The tender offer otherwise remains subject to all previously announced terms and conditions. Computershare Trust Company, N.A., the depositary for the Offer, has advised the Company that as of the close of business, New York City time, on September 27, 2019, the last business day prior to the announcement of the extension of the Offer, 1,937,943.1053 shares have been validly tendered pursuant to the Offer and not properly withdrawn.
BRFH

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09:03 EDT Barfresh Food Group adds 45 U.S. Armed Forces dining facilities - Barfresh Food Group announced that it has approval for international expansion into an initial 26 U.S. Armed Forces Locations in South Korea and Turkey. The Company will be serving multiple product offerings in dining facilities in 25 South Korean facilities and 1 facility located in Turkey. In addition, the Company increased its domestic U.S. Armed Forces Dining Facility locations to 169 from 150 locations at end of second quarter, 2019. Barfresh is well positioned to continue international and domestic expansion beyond the current 195 dining facilities which include today's newly announced locations. The Company's smoothies will be available in military food service programs supporting dining facilities and its solutions for all meal periods are designed to support a large number of personnel in a short period of time. The Company expects these new 45 locations announced today will be pouring product within 60-90 days. There are multiple facilities at each military base location creating many expansion opportunities at current and new bases. The Company is actively pursuing engagement with all U.S. military facilities and expects to gain greater penetration throughout the remainder of 2019 across the United States' 800 bases, which serve 1.3 million active troops.
ADAP

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09:01 EDT Adaptimmune presents updated data from Phase 1 trial with ADP-A2M4 - Adaptimmune Therapeutics presented updated data from patients with synovial sarcoma who were treated in the ongoing Phase 1 trial with SPEAR T-cells targeting MAGE-A4. The oral presentation by Brian Van Tine, MD, PhD of Washington University in St. Louis, occurred earlier today at the European Society for Medical Oncology Congress. This is a Phase 1 dose escalation, multi-tumor trial to assess the safety, tolerability, and antitumor activity of ADP-A2M4 in HLA-A2+ patients. As of Sep. 03, 2019, data from 12 patients with synovial sarcoma treated in the expansion phase of this trial demonstrated a best overall response rate of 58%. There was a disease control rate of 92%, defined as objective overall response and stable disease. Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies. Fatal aplastic anemia was reported in 1 patient with synovial sarcoma in this trial. This event was previously described and reported to the US Food and Drug Administration. The median age of these patients was 54 years and they had received a median of 2 prior lines of systemic therapy. The median dose received was 9.7 billion SPEAR T-cells. Data from patients with synovial sarcoma treated in the expansion phase of this trial were previously reported in May of this year. At that time 8 patients had been assessed, with 6 showing a decrease in tumor size, of which 3 patients had confirmed partial responses and 1 patient had an unconfirmed partial response. Detailed summary of response data presented at ESMO for ADP-A2M4 in patients with synovial sarcoma. Twelve patients received treatment in the expansion phase of this trial and had post-baseline scans to assess efficacy by time of data cutoff: Of the 12 patients with post-baseline scans to assess efficacy: 11/12 showed clinical benefit with best overall responses of PR or stable disease; this represents a disease control rate of 92%; 7/12 had clinical responses representing a best overall response rate of 58% with 5 confirmed PRs by RECIST criteria; 3 of which remain ongoing at the time of data cutoff; 2 of which developed progressive disease and 2 unconfirmed PRs that remain ongoing at the time of data cutoff;Higher peak SPEAR T-cell expansion was associated with decreases in target lesions from baseline.
JAGX

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08:58 EDT Jaguar Health unit receives notice of allowance from CIPO for patent application - Jaguar Health announced that the company's wholly-owned, human-health focused subsidiary, Napo Pharmaceuticals, has received a Notice of Allowance from the Canadian Intellectual Property Office for Canadian Patent Application No. 2,816,416, titled Methods and Compositions for Treating HIV-Associated Diarrhea. "We are very pleased to receive this Notice of Allowance from the Canadian Intellectual Property Office for this patent," Steven King, PhD, Jaguar's executive vice president of sustainable supply, ethnobotanical research and intellectual property, commented. "Jaguar, through Napo, holds extensive global rights for crofelemer, comprising a valuable and significant barrier to entry. At the present time we hold approximately 141 issued worldwide patents, with coverage in many cases that extends until 2031. These issued patents cover multiple indications including HIV-AIDS diarrhea, IBS, IBD, manufacturing, enteric protection from gastric juices, among others. We also have approximately 24 pending patent applications worldwide in the human health areas that are being prosecuted." The patent covers methods for treating diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort and other symptoms associated with diarrhea. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.
CLAR

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08:54 EDT Clarus creates Performance Sports division, appoints Taylor West as GM - Clarus Corporation has created its Performance Sports division to accelerate the development of sport-enhancing products like skincare, supplements, nutrition and other personal health products for performance-driven athletes. To lead the new division, Clarus appointed consumer brand and marketing industry executive Taylor West as general manager, effective September 30, 2019. Most recently, he served as VP of marketing and e-commerce for KT Tape.
ESE

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08:51 EDT Esco Technologies announces new credit facility - ESCO Technologies announced that it has finalized a commitment with its lenders to enter into a new, extended and increased credit facility. The new five-year agreement, which replaces the previous credit facility dated December 21, 2015, extends the maturity date through September 27, 2024, and lowers the total costs by reducing the outstanding borrowing rates and commitment fees. The new facility includes a $500M revolving line of credit as well as provisions allowing for the increase of the credit facility commitment amount by an additional $250M, if necessary, with the consent of the lenders. Proceeds from the new facility will be used to provide liquidity for general corporate purposes, including working capital, research and development spending, capital expenditures, and acquisitions.
SMED ANIK

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08:50 EDT Sharps Compliance appoints Susan Vogt to board of directors - Sharps Compliance (SMED) announced the appointment of Susan Vogt to its Board of Directors. Vogt replaces F. Gardner Parker who has resigned his board membership. Vogt currently serves as an independent director and member of the audit committee for Anika Therapeutics (ANIK).
LH

Hot Stocks

08:49 EDT LabCorp publishes study of cfDNA screenings in multifetal pregnancies - LabCorp recently published results of the largest study to date of cell-free DNA, or cfDNA, screenings in multifetal pregnancies. The study, published in PLOS ONE, determined that non-invasive cfDNA screening using the MaterniT21 PLUS test offered by LabCorp's Integrated Genetics provided results that compare favorably to those for singleton pregnancies. A woman's age-related risk for aneuploidy in most multifetal pregnancies is elevated compared to that of a woman of the same maternal age carrying a singleton pregnancy, and reliable cfDNA screening can provide valuable information to help guide care decisions. The study, conducted by leading LabCorp geneticists, assesses the reliability and accuracy of cfDNA screening in multifetal pregnancies by examining four areas: current experiences with biochemical screening in twins, the observed performance of cfDNA screening in multiples, the cfDNA screening positivity rate and total non-reportable rate in all multifetal gestations. Of the 750,000 samples received by LabCorp for MaterniT21 PLUS screening during the study period of October 2011 to December 2017, 4% were from multifetal pregnancies. Previous clinical validation studies in singleton pregnancies have established the high sensitivity and specificity of cfDNA screening, as well as increased detection rates, lower false-positive rates and higher positive-predictive values over that of conventional prenatal screening methods. This study found that cfDNA screening in patients with multifetal gestations meets or exceeds performance from original clinical validation studies on singleton pregnancies. The collective positivity rate of resulted samples in the study was 2.19%. Positive rates for trisomy 21, 18 and 13 were 1.5%, 0.48% and 0.21% respectively. The average fetal fraction was 12.33% in twins and 13.20% in triplets. The quantity-not-sufficient, or QNS, non-reportable rate was higher in multifetal vs singleton pregnancies, which is related to more stringent fetal fraction requirements for multiple gestations as compared to singletons. The study is the largest published sample of the use of non-invasive prenatal cfDNA screening on twins, triplets and higher-order multiples. The data on 709 triplets is particularly significant because there are currently no other non-invasive prenatal laboratory screening options available in these pregnancies. In addition, current clinical practice guidelines do not recommend the use of cfDNA in aneuploidy screening in women with multiple gestations. This study increases the body of evidence supporting cfDNA as an alternative to traditional prenatal screening methodologies in multifetal pregnancies.
DGLY

Hot Stocks

08:48 EDT Digital Ally signs contract extension with cruise line company - Digital Ally announced that a global leader in the cruise line industry has agreed to a contract extension for its continued use of the Company's FirstVu HD body-worn cameras and back-office solution, VuVault.com. The contract extension will provide the Company with a recurring service revenue stream for multiple years to come. Since 2016, the Company's FirstVu HD body-worn cameras have been deployed on security personnel during cruises to reduce frivolous claims and capture interactions between staff and guests.
ACST

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08:47 EDT Acasti Pharma 'on track' to report topline results for TRILOGY 1 in December - Acasti Pharma reported additional milestones reached and provided a business update on its clinical trials. COO and CSO Pierre Lemieux commented, "Our TRILOGY Phase 3 trials in patients with severe hypertriglyceridemia continue to progress, and we remain on track to report topline TRILOGY 1 results in December 2019, and topline TRILOGY 2 results in January 2020. Importantly, both of our TRILOGY studies have achieved 100% patient randomization, and nearly 80% of the patients in both studies combined have now completed their 6-month plan. It is important to note that data clean up is approximately 90% complete in TRILOGY 1, bringing us closer to database lock. We have also progressed TRILOGY 2 and anticipate database lock as planned in January 2020." Jan D'Alvise, president and CEO of Acasti, further noted, "Given the positive results we saw from our Phase 2 trials in a total of 675 patients, we eagerly await the completion of the results from our two TRILOGY clinical studies. It is also important to note: patients enrolled in the Phase 3 TRILOGY trials have higher baseline triglyceride levels versus our Phase 2 studies, where most had baseline triglycerides significantly below 500 mg/dl; patients randomized to CaPre in the Phase 3 TRILOGY trials all received 4 grams per day and will remain on drug for 6 months, while our Phase 2 studies included patients receiving a range of doses from 1 gram, 2 grams and 4 grams per day for only 8 to 12 weeks with a favorable dose response; the Phase 2 trials also indicated that CaPre may have a positive effect on other major lipid markers such as VLDL, LDL-C, and HDL-C, as well as HbA1c in patients with diabetes." As previously disclosed, topline results will include a readout of the primary endpoint, which is intended to show CaPre's overall impact on lowering triglycerides after 12 weeks compared to placebo. The placebo used in the TRILOGY trials is cornstarch, which is inert, and consequently is expected to have a neutral effect on key biomarkers of patients in the placebo group. The TRILOGY studies are designed to provide at least 90% statistical power to detect a difference of at least a 20% decrease from baseline in TGs between CaPre and placebo. The Company has shared the statistical analysis plan for the analysis and reporting of the TRILOGY results with the FDA, and expects to finalize the SAP prior to final database lock. Subject to any input from the FDA, Acasti is currently planning that the topline TRILOGY results will include the primary endpoint of TG reduction at Week 12 compared to placebo. Safety and tolerability will also be reported. The Company currently expects that topline results will not include any secondary or exploratory endpoints. The important secondary and exploratory endpoint results are expected to follow shortly after the release of the topline results of TRILOGY 2, currently anticipated in late January, 2020. According to the SAP, the primary endpoint must first be positive with statistical significance prior to analyzing the secondary and exploratory endpoints. These endpoints will then be analyzed in the following order: 1) additional TG secondary endpoints, including TG reduction at Week 26, which is intended to show CaPre's persistence of effect, TG reduction in various subgroups to show consistency of effect (such as patients stratified with baseline qualifying TG levels of less than or equal to750 mg/dL vs. greater than750 mg/dL), and a comparison of TG reduction in patients using and not using statins at baseline; 2) Non-HDL-C; 3) VLDL-C; 4) HDL-C; 5) LDL-C and HbA1c. Physician investigators determined if patients with high LDL-C and/or high HbA1c levels at screening needed to be put on standard therapy, and if so, they were stabilized prior to being randomized into TRILOGY. Results for both LDL-C and HbA1c will then require subgroup analyses, which are done by combining diabetic patients and separately patients with high LDL-C from both studies at baseline to reach adequate statistical power to detect a difference if one exists, and therefore potentially show any incremental benefit of CaPre above and beyond the standard of care. Acasti expects that the remaining secondary and exploratory endpoints along with various additional subgroup analyses should be completed before the end of March 2020. In addition to the preliminary topline data, the Company will seek to present the full data set, which will include results for key secondary and exploratory endpoints of interest such as Non-HDL-C, LDL-C, VLDL, HDL-C and HbA1c at key scientific meetings in 2020. The Company will communicate more information in the months ahead on how and when all of the TRILOGY results will be reported once the SAP is finalized.
TKAMY

Hot Stocks

08:45 EDT ThyssenKrupp names Martina Merz as CEO, Guido Kerkhoff terminated - Martina Merz will take over as CEO of thyssenkrupp AG on October 1, the company said in a statement. This was unanimously decided by the Supervisory Board of thyssenkrupp AG in an extraordinary meeting last Friday. The current Chairwoman of the Supervisory Board will be delegated to the Group Executive Board for a maximum period of twelve months, after which she will return to the Supervisory Board. With Guido Kerkhoff, the current CEO, the Supervisory Board agreed on the mutual termination of his mandate on the Executive Board. With the delegation of Martina Merz, the Supervisory Board followed the recommendations of the Personnel Committee. In addition, the Supervisory Board appointed Dr. Klaus Keysberg to the Executive Board of thyssenkrupp AG effective October 1. Keysberg, who will be responsible for the materials businesses on the Group Executive Board, has held various positions at thyssenkrupp since 1996 and has been CEO of the Business Area Materials Services since the beginning of the year. He will continue to hold this position until a successor is appointed. Martina Merz's successor at the head of the Supervisory Board will be Prof. Dr. Siegfried Russwurm. The former Siemens Executive Board member has been a member of the Supervisory Board since April 2019. Reference Link
KNDI

Hot Stocks

08:43 EDT Kandi Technologies completes equity transfer of JV company - Kandi Technologies Group announced that to accelerate the growth of Kandi Electric Vehicles Group, Kandi's wholly-owned subsidiary, Zhejiang Kandi Vehicles signed an Equity Transfer Agreement in March of 2019 with Geely Technologies Group to transfer certain equity interests. The equity transfer was for the JV Company to utilize Geely's competitive strength and recognition in the automotive industry to unlock the JV Company's potentials in branding, manufacturing capability, sales & marketing network, and after-sales service to enhance its competitiveness for greater success. Pursuant to the Transfer Agreement, the parties have agreed that Kandi Vehicles shall sell 21.47% of its equity interests in the JV Company to Geely for a total amount of RMB516M. Upon the completion of the transfer, Kandi Vehicles shall own 22% of the equity interests of the JV Company while Geely shall own 78%. The JV Company has completed the transfer of 21.74% of its equity interests in the JV Company to Geely on September 29, 2019. Following the modifications of the JV Company's business development plan in the past six months, the two parties have renegotiated and agreed the payment method of RMB516M for the equity transfer. As of September 29, Kandi Vehicles received cash payment of RMB220M and the remaining RMB296M in commercial acceptance notes, of which RMB140M's note maturity date is January 20, 2020 and RMB156M's note maturity date is March 29, 2020. Additionally, the two parties also agreed on the payment installments of the accounts receivable and accounts payable between Kandi Vehicles and the JV Company. The JV Company has the total amount of RMB311.5M in accounts payable to Kandi Vehicles which will be paid in three installments. The first payment of RMB150M was received on September 10, 2019; the second payment of RMB80M is expected to be received by December 10, 2019, and the remaining RMB81.5M is expected to be received after the JV Company receives its 2017/2018 national subsidy payment.
ATOS

Hot Stocks

08:39 EDT Atossa Genetics announces preliminary results from Phase 1 study of Endoxifen - Atossa Genetics reported preliminary results from its Phase 1 study of its proprietary modified-release tablet form of oral Endoxifen. All objectives were successfully met: There were no unexpected and serious adverse events; no clinically significant adverse safety signals; and no clinically significant adverse events in participants receiving the tablet form of oral Endoxifen. No participants withdrew or were removed from the study due to skin rashes and irritation or other adverse events. The tablet form of oral Endoxifen was well tolerated by each participant throughout the study. "This was an important study because the results support advancing our modified-release tablet into a Phase 2 study to reduce mammographic breast density, which we plan to begin in the fourth quarter by contracting with a CRO," said CEO Steven Quay. "We will continue our analysis of the Phase 1 data and plan to announce additional results in the coming weeks. We also recently completed a successful Phase 2 study of our topical form of Endoxifen in which a significant reduction of MBD was achieved among study participants who applied the stronger dose of topical Endoxifen. Our success with the topical Phase 2 study and now the successful Phase 1 study of the tablet, supports our plan to advance our proprietary tablet into a Phase 2 study to reduce MBD."
RARE

Hot Stocks

08:37 EDT Ultragenyx, Kyowa Kirin announce FDA approval for label update for Crysvita - Ultragenyx Pharmaceutical and Kyowa Kirin announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Crysvita. The label has been updated to include new clinical data demonstrating superiority of treatment with Crysvita versus oral phosphate and active vitamin D in pediatric patients with XLH, and improvement in stiffness, and maintenance of efficacy of Crysvita in adult patients with longer-term treatment. The indication has also been expanded to include infants as young as six months of age. Crysvita is an antibody that binds to and inhibits the biological activity of fibroblast growth factor 23, restoring renal phosphate reabsorption and increasing the serum concentration of 1,25 dihydroxy vitamin D. It was first approved in the U.S. in April 2018 for the treatment of XLH in adult and pediatric patients one year of age and older. For the pediatric XLH population, the U.S. label update is based on 64-week efficacy and safety data from the randomized active-controlled Phase 3 study of Crysvita compared with oral phosphate and active vitamin D in 61 children with XLH. The results showed that Crysvita was superior to conventional therapy for all key efficacy endpoints, showing a meaningful improvement in rickets severity, lower limb deformity and growth. The 64-week safety profile was similar to that observed at 40 weeks and in other Crysvita pediatric XLH studies. For the adult XLH population, the label update incorporates results from the open-label treatment period of the Phase 3 study in 134 adult patients with XLH through week 48, demonstrating that serum phosphorus levels were maintained with no evidence of loss of effect. The updated label also includes results demonstrating the continued healing of fractures and pseudofractures at week 48 and improvement in the patient-reported outcome of stiffness at week 24. The safety profile is consistent with what has been previously observed in this study, with no new adverse reactions identified during the extended treatment period.
OAK

Hot Stocks

08:36 EDT Oaktree Capital trading halted, news dissemination
MYE

Hot Stocks

08:35 EDT Myers Industries announces Tom Harmon as CHRO - Myers Industries announced that Tom Harmon has joined the company as VP, chief human resources officer, or CHRO. In this role, he will be responsible for leading all aspects of human resources, including talent acquisition, talent development and learning, business partnerships, compensation and benefits, employee engagement and culture. Harmon joins Myers from Gryphon Investors where he was managing director, human resources.
CLRB

Hot Stocks

08:35 EDT Cellectar Biosciences presents data from DLBCL cohort of Phase 2 CLOVER-1 study - Cellectar Biosciences announced Jarrod Longcor, CBO of Cellectar, presented data from the diffuse large B cell lymphoma cohort in the company's Phase 2 CLOVER-1 study of CLR 131 in relapsed or refractory select B-cell malignancies at the European Society for Medical Oncology Congress 2019. The oral presentation, entitled: "Interim Evaluation of a Targeted Radiotherapeutic, CLR 131, in Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients," featured data from 6 subjects who received a single 30-minute intravenous dose of 25mCi/m2 of CLR 131. Data showed durable responses, including a 33% overall response rate, a 16.6% complete response rate and a 50% clinical benefit rate. All patients enrolled in the study received an average of 3 prior lines of systemic therapy, 5 of 6 patients were refractory to at least one prior line of therapy. Importantly, CLR 131 showed activity against both germinal center and activated DLBCL. In a patient for whom cytogenetics was available, CLR 131 showed activity against c-Myc and BCL-2 mutation positive patients. As required by the Lugano Criteria for Response, the patient who experienced a CR had a total reduction in tumor volume of greater than 99% and continues to be a CR at 510+ days post dosing. This patient was refractory to two prior treatment lines, which included the combination regimen RICE. Analysis of dosing showed that the disease control rate and progression free survival were markedly improved in patients receiving a dosing ratio of 1.2% or greater versus those receiving below a 1.2% dosing ratio. Finally, the most frequent adverse events in DLBCL patients were consistent with prior studies of CLR 131; the majority of AEs being hematologic in nature and predominately Grades 1 and 2. CLOVER-1 is a Phase 2 study of CLR 131 being conducted in approximately 10 leading cancer centers in the United States in patients with relapsed or refractory B-cell hematologic cancers. The hematologic cancers being studied in the trial include multiple myeloma, chronic lymphocytic leukemia/small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, mantle cell lymphoma, and diffuse large B-cell lymphoma. The study will enroll up to 80 patients. Its primary endpoint is clinical benefit response, with additional endpoints of overall response rate, progression free survival, median overall survival and other markers of efficacy following a fractionated dose of 37.575mCi/m2 of CLR 131 administered in two 30-minute infusions of 18.75mCi/m2 of CLR 131 administered on day 1 and day 8, with the option for a second dose cycle approximately 75-180 days later. The company expects to report topline data in 2019.
EGHT

Hot Stocks

08:33 EDT 8x8, Inc. awarded NASPO ValuePoint contract - 8x8, Inc. announced that it has been awarded a place on a cooperative government contract by the National Association of State Procurement Officers, or NASPO, ValuePoint for state, local, education and special district, or SLED, agencies, becoming the only UCaaS provider to be directly listed on the contract. A consortium of procurement professionals from across the public sector, NASPO assesses and evaluates potential vendors on behalf of government agencies. By awarding 8x8 a cooperative contract, NASPO confirms that 8x8 meets the stringent regulatory and systems standards for agencies looking to replace their legacy, on-premises technology with a single cloud contact center and communications solution such as the 8x8 X Series.
TGP...

Hot Stocks

08:33 EDT Teekay Group to postpone investor day - Teekay Corp. (TK), Teekay LNG (TGP) and Teekay Tankers (TNK) announced that they have decided to postpone the Teekay Group investor and analyst meeting previously scheduled to take place in New York City on October 2. In order to focus on avoiding undue disruption to Teekay LNG's business from certain complex issues that have recently emerged, the Teekay Group has determined that it would be prudent to postpone the New York event at this time. The company is working with its joint venture partner to resolve this issue and will provide further updates on the situation as and when appropriate. The Teekay Group will provide details on the rescheduled investor and analyst meeting once a solution has been reached. On September 25, the United States Government, by an Executive Office of Foreign Assets Control, or OFAC, order, imposed sanctions on two subsidiaries of Chinese state-owned shipping and logistics company COSCO, for allegedly trading oil with Iran with their owned vessels. COSCO Dalian is a direct 50% shareholder in China LNG Shipping, or CLNG. CLNG was not listed on the recent OFAC order or otherwise directly implicated in any sanctioned activity, but by virtue of being 50%-owned by COSCO Dalian, CLNG currently qualifies as a "Blocked Person" under OFAC rules. CLNG, in turn, owns a 50% interest in Teekay LNG's Yamal LNG joint venture, which owns four on-the-water ARC7 LNG carriers and two ARC7 LNG carrier newbuildings. As a result of CLNG's 50% interest, the Yamal LNG Joint Venture also currently qualifies as a "Blocked Person" under OFAC rules. Management has been advised by CLNG that it is actively engaged in seeking a prompt resolution to this issue. The Teekay Group has not traded and will not trade with Iran and will not act in contravention of any trading sanctions. With respect to Teekay Tankers' business, given the significant size of COSCO Dalian's tanker fleet, these same COSCO sanctions are having a pronounced positive impact on spot tanker rates.
TPTX

Hot Stocks

08:32 EDT Turning Point announces FDA clearance of IND application for TPX-0046 - Turning Point Therapeutics announced clearance by the U.S. Food and Drug Administration of its investigational new drug application for TPX-0046, a novel therapy targeting solid tumors with abnormal RET genes by inhibiting RET and SRC kinases. Under the IND, the company plans to initiate a Phase 1/2 first-in-human, open-label clinical study later this year. The phase 1 portion will have a dose-finding design, including intra-patient dose escalation to assess the safety, tolerability, and preliminary clinical activity of TPX-0046 in patients with advanced or metastatic solid tumors harboring oncogenic RET fusions or mutations. The phase 2 portion will evaluate the preliminary efficacy of TPX-0046 in multiple cohorts of patients with advanced or metastatic sold tumors harboring oncogenic RET fusions or mutations. Preclinical studies of TPX-0046 demonstrate potent inhibition of wildtype and mutated RET kinases as compared to proxy chemical compounds for investigational RET inhibitors, LOXO-292 and BLU-667. In cellular assays, TPX-0046 showed comparable potency against wildtype KIF5B-RET and stronger potency against the G810R solvent front mutation. These studies were presented on Sept. 28 at the 2019 congress of the European Society for Medical Oncology. TPX-0046 is a multi-targeted RET and SRC kinase inhibitor with a novel three-dimensional macrocyclic structure. Activation of RET-- a receptor tyrosine kinase --through gain-of-function mutations and fusions has been found in multiple tumor types, including lung and thyroid cancers. Dual inhibitor of RET and SRC represents a novel therapeutic strategy to target abnormal RET signaling in cancers. Inhibition of SRC family kinases has the potential to reduce recruitment of multiple receptor tyrosine kinases involved in bypass resistance and therefore has the potential to increase the therapeutic effect of TPX-0046.
MGI

Hot Stocks

08:32 EDT MoneyGram names Kamila Chytil as COO, effective September 30 - MoneyGram announced the appointment of Kamila Chytil to the position of COO, effective September 30. Chytil recently served as MoneyGram's Chief Global Operations Officer. Prior to MoneyGram, Chytil spent 11 years at FIS.
CPST

Hot Stocks

08:32 EDT Capstone Turbine partner lands 1 MW 10-year service contract - Capstone Turbine announced that Supernova, Capstone's exclusive distributor for Colombia and Venezuela, sold a new 1.0 megawatt 10-year Capstone Factory Protection Plan while concurrently reporting that their Capstone microturbine fleet has exceeded 1,000,000 successful hours of operation in Colombia.
BAM OAK

Hot Stocks

08:28 EDT Brookfield Asset Management completes acquisition of 61.2% of Oaktree Capital - Brookfield Asset Management (BAM) and Oaktree Capital Group (OAK) announced the completion of Brookfield's acquisition of approximately 61.2% of Oaktree's business. In connection with the transaction, Brookfield acquired all of the outstanding Oaktree class A units and approximately 20% of the units of Oaktree Capital Group Holdings held by the founders, senior management, and current and former employees of Oaktree. The purchase price per unit was, at the election of such unitholders, $49.00 in cash or 1.0770 class A shares of Brookfield. OCGH is the holder of all outstanding class B units of Oaktree as well as a direct interest in certain of Oaktree's operating entities. Oaktree class A unitholders' and OCGH unitholders' elections were made on a per unit basis and subject to proration such that the total consideration paid by Brookfield was 50% cash and 50% Brookfield class A shares. Based on the elections received, the share consideration was oversubscribed and former holders of class A units and participating OCGH units who elected to receive share consideration with respect to all or a portion of their units will instead receive approximately 0.6173 class A shares of Brookfield and $20.92 in cash with respect to each such unit. The election results remain subject to the limitations and proration procedures described in the consent solicitation statement/ prospectus of Brookfield and Oaktree delivered to Oaktree unitholders in connection with the transaction. The aggregate amount of cash payable to Oaktree class A unitholders and OCGH unitholders in the transaction is approximately $2.4B. Approximately 52.8 million class A shares of Brookfield were issued in the transaction. In connection with the closing of the transactions, Oaktree class A units were delisted from the New York Stock Exchange.
BKYI

Hot Stocks

08:26 EDT Florida County Election Boards select BIO-key solutions for security - BIO-key International announced two additional County Election Boards in Florida have selected BIO-key solutions to enhance the security of their identification and authentication process for staff members and volunteers involved in managing the voting process. The Election Boards are acting to enhance security for the upcoming 2019 regional elections and the 2020 presidential election.
KLDO

Hot Stocks

08:21 EDT Kaleido Biosciences appoints Jean Mixer to board of directors - Kaleido Biosciences announced that Jean Mixer has been appointed to its Board of Directors. Mixer has more than 25 years of experience in healthcare and is currently Chief Digital Transformation Officer and VP, Strategy at Boston Children's Hospital. Mixer will assume the seat of Jonathan McIntyre, Ph.D., who is stepping off the Board to focus on his role as CEO of Motif FoodWorks.
INFN TELDF

Hot Stocks

08:18 EDT Telefonica Deutschland selects Infinera DRX Series to modernize network - Infinera (INFN) announced that Telefonica Deutschland (TELDF) selected the Infinera DRX Series to modernize its nationwide mobile transport network. The Infinera DRX Series, a disaggregated router family that combines a carrier-class white box portfolio with the field-proven and scalable Infinera CNOS software, enables Telefonica Deutschland to prepare its nationwide mobile transport network for 5G mobile services with scale, efficiency, and automation.
KAR

Hot Stocks

08:18 EDT KAR Auction rebrands as 'KAR Global' - KAR Auction Services announces that it has rebranded and will begin doing business as "KAR Global." The move comes after several years of rapid geographic expansion across North America and Europe and the company's acquisition and development of new technology and data-driven products, services and capabilities. KAR Global will continue to trade on the New York Stock Exchange under the ticker symbol "KAR."
TROV

Hot Stocks

08:17 EDT Trovagene: Positive data from Phase 1b/2 study of onvansertib presented at ESMO - Trovagene announced that results from the company's Phase 1b/2 study of onvansertib in patients with relapsed/refractory acute myeloid leukemia were presented in an oral plenary session at the 2019 European Society for Medical Oncology Conference in Barcelona, Spain, on Saturday, September 28th. The presentation highlighted the favorable safety profile and clinical efficacy of onvansertib, as well as correlative biomarker data from the recently completed Phase 1b trial. "These data from this ongoing clinical trial in patients with relapsed/refractory AML support that the combination of onvansertib with either low dose cytarabine or decitabine appear to be feasible, safe and well tolerated up through the 60mg/m2 dose of onvansertib," said Dr. Amer Zeidan, lead investigator and assistant professor of Medicine at the Yale School of Medicine, and Hematology expert at Yale Cancer Center. "While the recently completed dose escalation part of the study focused on evaluating the safety of the combinations, we see evidence of clinical activity, particularly with onvansertib in combination with decitabine. We hope to better understand the efficacy profile of this combination as we go into the Phase 2 expansion part of the trial."
TOWR

Hot Stocks

08:13 EDT Tower International trading halted, news dissemination
SPWH DKS

Hot Stocks

08:13 EDT Sportsman's Warehouse to acquire 8 Field & Stream stores for $28M - Sportsman's Warehouse (SPWH) announced that it has entered into agreements with DICK'S Sporting Goods, Inc. (DKS) to acquire 8 Field & Stream locations. The acquired stores will be operated as Sportsman's Warehouse stores and are located in Pennsylvania, New York, North Carolina and Michigan. The total purchase price of $28M for inventory and assets will be funded through borrowings under Sportsman's revolving credit facility. Sportsman's will sublease the eight locations from DICK'S. The transaction is expected to close on October 11, 2019 subject to customary closing conditions. This acquisition is consistent with Sportsman's strategy to return to a more typical store growth pattern, following a period of investment in omni-channel capabilities, technology, and debt reduction over the last two years. Excluding non-recurring costs and non-cash purchase accounting adjustments, this transaction is expected to be neutral to EPS in fiscal year 2019, and accretive to EPS in fiscal year 2020. The acquired stores, both individually and collectively, meet or exceed the investment hurdle rates that Sportsman's has established for opening any new store.
VRTX

Hot Stocks

08:13 EDT Vertex, Ribometrix establish strategic collaboration - Vertex Pharmaceuticals and RNA therapeutics developer Ribometrix, announced today that the companies have entered into a strategic collaboration to discover and develop novel RNA-targeted small molecule therapeutic candidates for serious diseases. The collaboration will combine Ribometrix's proprietary discovery platform for identifying and optimizing small molecule therapeutics that modulate RNA function by targeting three-dimensional RNA structures with Vertex's scientific, clinical and regulatory capabilities for up to three therapeutic programs, including one ongoing discovery program from Ribometrix. Under the terms of the agreement, Vertex will pay Ribometrix approximately $20M upfront, which includes an equity investment in the company. Initially, Ribometrix will undertake two discovery programs with Vertex, and Vertex has an option to add a third program. Following discovery and optimization of novel therapeutic molecules, Vertex has the option to take an exclusive global license for the development and commercialization of molecules for that program. Ribometrix is eligible to receive more than $700M in total potential payments based upon the successful achievement of specified research, development, regulatory and commercial milestones as part of the collaboration. In addition, Vertex will pay tiered royalties on future net global sales on any products that result from the collaboration.
MRNA

Hot Stocks

08:13 EDT Moderna announces FDA allowance of mRNA-3927 IND to proceed to clinic - Moderna announced the FDA has completed their review of the investigational new drug, or IND, application for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia, or PA, and allowed it to proceed to clinic. Moderna plans to initiate an open-label, multi-center, dose escalation Phase 1/2 study of multiple ascending doses of mRNA-3927 in primarily pediatric patients with PA in the United States and Europe. The objectives of this study are to evaluate the safety and tolerability of mRNA-3927 administered via IV infusion, characterize the pharmacokinetic profile of mRNA-3927 and assess the pharmacodynamic response as assessed by changes in plasma biomarkers.
CUE

Hot Stocks

08:11 EDT Cue Biopharma initiates patient dosing in Phase 1 study of CUE-101 - Cue Biopharma announced today that on September 23, 2019 it dosed the first patient in a Phase 1 clinical trial of CUE-101 at Washington University, Alvin J. Siteman Cancer Center, St. Louis, Missouri for the treatment of HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma. Enabled by the company's proprietary Immuno-STAT platform, CUE-101 is the company's lead biologic drug candidate from the IL-2 based CUE-100 series, designed to directly engage and activate T cells in the body to target HPV-driven cancers. The trial is a multi-center, open-label, Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 as a monotherapy in patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype. The study is designed to enroll approximately 50 patients. Based on translational analysis/data from the trial, the company may expand the study to test CUE-101 both as a neoadjuvant therapy and potentially in combination with checkpoint inhibitors in patients with HPV16-driven recurrent/metastatic HNSCC.
FLIR

Hot Stocks

08:11 EDT Flir Systems awarded $35.1M contract by U.S. Army - FLIR Systems announced it has won an indefinite-delivery/indefinite-quantity, or IDIQ, contract worth up to $35.1M with the United States Army to deliver a new version of the company's Agentase C2 chemical agent disclosure spray to detect sulfur mustard, a highly toxic chemical warfare agent. FLIR Agentase C2 spray quickly changes color on a surface if a chemical warfare agent is present. With faster and more targeted detection, military decontamination experts can locate trace levels of contamination on surfaces and precisely mitigate the threat. The IDIQ award consists of a 30-month engineering and manufacturing development phase, followed by an 18-month low-rate initial production phase, and a 72-month full-rate production phase. Shipments are expected to begin in Q1 of FY20. This is the second award issued to FLIR by JPEO-CBRND to support fielding of the Agentase C2 product line to the Joint Services under CIDAS. FLIR already is engaged on a $30M contract to deliver its disclosure spray formulated for nerve agents such as VX and sarin. That effort is scheduled to enter full-rate production in Q1 of FY20.
ICE MSCI

Hot Stocks

08:11 EDT IntercontinentalExchange, MSCI extend license agreement - IntercontinentalExchange (ICE) and MSCI (MSCI) announced they have expanded their existing relationship. This expansion includes a long-term extension of ICE's existing license agreement for listed futures based on MSCI Indexes. In addition, MSCI will license ESG data to ICE Data Services for index construction, while ICE Data Services' fixed income pricing and reference data will be integrated into MSCI's platform. Additionally, ICE plans to launch futures on the MSCI EAFE ESG Leaders Index, MSCI Emerging Markets ESG Leaders Index, MSCI Europe ESG Leaders Index, MSCI USA ESG Leaders Index, MSCI World ESG Leaders Index and the MSCI USA Climate Change Index on ICE Futures U.S. during Q4. Since migrating to the ICE platform in 2014, average daily volume and open interest in futures contracts on MSCI indexes have grown at an annual rate of 30% and 21% respectively.
FATE

Hot Stocks

08:09 EDT Fate Therapeutics announces opening of cGMP manufacturing facility - Fate Therapeutics announced that the company has opened its current Good Manufacturing Process compliant manufacturing facility for the clinical production of its off-the-shelf natural killer cell and chimeric antigen receptor T-cell product candidates. The Company's cGMP facility, located in San Diego, California, is custom designed for the manufacture of off-the-shelf allogeneic cell products using clonal master induced pluripotent stem cell lines as a starting cell source. The new state-of-the-art facility has been commissioned and qualified, and the Company has been issued a drug manufacturing license by the State of California, Department of Health Services, Food and Drug Branch.
TYME

Hot Stocks

08:08 EDT Tyme Technologies presents data from TYME-88-Panc Phase II study - Tyme Technologies announced that its open-label Phase II TYME-88-Panc study evaluating SM-88 as an oral monotherapy in patients with advanced pancreatic cancer continues to demonstrate encouraging overall results and has a well-tolerated safety profile. TYME also announced encouraging Quality of Life data for this challenging patient population. The supporting data from the study were presented at the European Society of Medical Oncology Congress being held on September 27- October 1, 2019 in Barcelona, Spain. As a result of these clinical outcomes, TYME recently launched the multi-center randomized controlled pivotal stage of the TYME-88-Panc trial for use of SM-88 in patients with third-line pancreatic cancer. TYME's lead CMBT candidate, SM-88, was designed to leverage innate changes in cancer metabolism that are fundamental to support the cancer's proliferation. The Warburg Effect, a process that helps most cancer cells adapt to changing conditions, is prevalent across most solid and hematological malignancies impacting energy production and the uptake of non-essential amino acids for cancer growth. SM-88 is a modified dysfunctional form of the amino acid tyrosine. Tyrosine is required for cancer cell growth and as a result, SM-88 is selectively consumed by the cancer cell, causing a disruption of protein synthesis that leads to catastrophic failure and cancer cell death. The results from the multicenter open-label Phase II TYME-88-Panc study involved 49 heavily pretreated patients with radiographically progressive metastatic pancreatic cancer who had significant disease related morbidity before receiving TYME's investigational agent SM-88. More than 80% of patients had received at least two prior lines of therapy. Of the 49 patients, 38 patients were evaluable for efficacy as defined in the protocol. This study is being performed under a TYME IND with input from the FDA prior to study initiation. In this study, based on information available as of April 25, 2019, the median overall survival of the 38 evaluable patients was 6.4 months. Certain efficacy indicators correlated with greater OS, including achieving stable disease or better and decreases in circulating tumor cells. Notably, patients achieving stable disease or better demonstrated a statistically significant improvement in survival with a 92% reduction in risk of death.The clinical benefit response was durable with the majority of these patients remaining in stable disease or better at more than 7 months after receiving treatment with SM-88. In the TYME-88-Panc study, baseline CTCs were an average of 142 cells/4ml. Of the 24 evaluable patients treated with SM-88 who had CTC readings available, 66.7% of those patients showed a median decrease of 63% in CTC levels falling from baseline CTCs to a median of 21 cells/4ml. 42% of those patients with available results reaching an 80% reduction or greater in CTCs demonstrated a 60% decrease in risk of death. A novel radiomics analysis was also conducted. The radiomic analysis of tumor texture correlated with CTCs at baseline. In addition, tumor texture was closely associated with the percentage change in CTCs on treatment and OS. Quality of life assessments were conducted as part of the TYME-88-Panc study. Generally, patients maintained their QOL throughout their treatment with SM-88. Patients reported low levels of GI-related symptoms, which are commonly reported in patients undergoing other treatments for pancreatic cancer. Score for pain and fatigue related questions showed that patients reported generally low levels of these symptoms also. Overall stability of weight was also reported. This is a key finding as patients with pancreatic cancer typically experience noticeable, but unintentional weight loss, which is a clinically meaningful indicator of poor prognosis. As of April 25, 2019, the study reported that SM-88 was well tolerated with only 4.0% of patients who experienced serious adverse events deemed at least possibly related to SM-88. One patient with reported SAEs continued on treatment.
AABA

Hot Stocks

08:08 EDT Altaba shares to halt trading on Nasdaq - Altaba announced that Nasdaq has advised the fund that it intends to halt trading in the fund's shares of common stock, par value $0.001 per share, on Nasdaq following the close of regular trading in anticipation of the fund's filing of a certificate of dissolution with the Secretary of State of the State of Delaware on October 4. Nasdaq has further advised the fund that it intends to maintain the halt in trading in the shares until confirmation of the filing of the certificate of dissolution, and that upon confirmation, Nasdaq intends to indefinitely suspend trading in the shares prior to the opening of trading on Nasdaq. The fund previously announced that it plans to file the certificate of dissolution immediately following the close of regular trading on Nasdaq on October 4 and that, upon the filing of the certificate of dissolution, the fund will close its stock transfer books, after which record holders of the fund's shares will be prohibited from transferring record ownership of their shares, except by will, intestate succession or operation of law.
PATK

Hot Stocks

08:05 EDT Patrick Industries sees G.G. Schmitt acquisition 'immediately accretive' - Patrick Industries announced that it has completed the acquisition of G.G. Schmitt & Sons. Schmitt's trailing 12-months revenue through August was approximately $20M and the company expects the acquisition to be immediately accretive to net income per share.
TOT

Hot Stocks

08:04 EDT Total Energy Services plans to repurchase shares - Total Energy Services announced that it has filed a Notice with the Toronto Stock Exchange to undertake a normal course issuer bid that will expire on October 1, 2020. Total Energy has been informed that the TSX has accepted its notice to make the normal course issuer bid. All purchases of common shares will be effected through the facilities of the TSX and one or more of the Canadian alternative trading systems and all Shares purchased will be cancelled by Total Energy. As of September 23rd, there are 45,436,000 Shares issued and outstanding. In connection with the normal course issuer bid, which will commence on October 2, 2019, Total Energy may purchase up to 1,000,000 Shares, being 2.2% of the total number of outstanding Shares, during the period from October 2, 2019 to October 1, 2020, subject to a maximum daily purchase limit of 8,531 Shares based on an average daily trading volume for the last six calendar months of 34,124 Shares. From time to time, purchases of Shares may be undertaken at prices that represent an attractive investment opportunity for Total Energy. Total Energy expects that the purchase of Shares will benefit the remaining shareholders of Total Energy by increasing their proportionate equity investment in Total Energy. On September 28, 2018, Total Energy announced its intention to undertake a normal course issuer bid, which remains in effect during the 12-month period ending October 1, 2019. Under that normal course issuer bid, as of the date hereof, Total Energy purchased a total of 650,000 Shares, at an average price of $8.72 per Share.
UFAB

Hot Stocks

08:03 EDT Unique Fabricating announces resignation of CFO Tom Tekiele - Unique Fabricating announced that CFO Tom Tekiele has tendered his resignation to pursue another professional opportunity. Tekiele will continue to serve the company until October 11, 2019 to facilitate a smooth transition. The Board of Directors of Unique Fabricating has engaged an executive search firm to lead the process of identifying a permanent replacement. In the interim, Doug Cain, the company's new CEO, will fill the role on a temporary basis.
CE

Hot Stocks

08:03 EDT Celanese updates status of Clear Lake operations - Celanese is progressing in restarting on-site production units after experiencing an emergency incident on Saturday, September 21, at its Clear Lake facility in Pasadena, Texas. The Fairway Methanol unit has restarted and is approaching full operating rates. The acetic acid and vinyl acetate monomer production units are planned for restart at reduced rates during October, with full operating rates expected for all production units at Clear Lake within the fourth quarter of 2019. Shipping operations at Clear Lake and associated terminals continue to operate without interruption. Celanese is assessing the potential impact of the incident on available product volumes. As part of its ongoing commitment to provide reliable supply, Celanese is utilizing its global network capabilities to provide product to its contract customers and will keep its customers updated on any developments. The company will provide further updates on the status of its Clear Lake operations as well as financial impact to 2019 when it reports third quarter results.
ECOR

Hot Stocks

08:02 EDT electroCore appoints Daniel Goldberger as CEO - electroCore announced the appointment of Daniel Goldberger as CEO, effective October 1. Prior to joining electroCore, Goldberger served as executive chairman of Repro Med Systems.
VSAT

Hot Stocks

08:02 EDT ViaSat awarded sole-source contract by Navy - Viasat announced it was awarded an ID/IQ contract by the Naval Information Warfare Systems Command for the purchase of supplemental units for Viasat's KOR-24A Small Tactical Terminal. The KOR-24A STT is the world's only multi-channel radio capable of performing Link 16 communications in a small form factor, and includes interoperable functionality to improve communications between U.S. and international coalition partners' military agencies requiring critical information from multiple networks.
BSGM

Hot Stocks

07:55 EDT BioSig Technologies to present clinical observations at Venice Arrhythmias - BioSig Technologies announced the PURE EP System will be highlighted in a poster presentation at the Venice Arrhythmias conference. The poster titled, "Use of a Novel Intracardiac Signal Processing System during Mapping of Complex Cardiac Arrhythmias" is authored by Amin Al-Ahmad, M.D., Carola Gianni, M.D., Domenico G. Della Rocca, M.D., J. David Burkhardt, M.D., Rodney P. Horton, M.D., G. Joseph Gallinghouse, M.D., Patrick M. Hranitzky, M.D., Javier E. Sanchez, M.D., Luigi Di Biase, M.D. and Andrea Natale, M.D. from Texas Cardiac Arrhythmia Institute in Austin, TX. The clinical data presented in the poster was collected during two atrial fibrillation cases conducted with PURE EP System in February 2019. After conducting first clinical cases at Texas Cardiac Arrhythmia Institute in February 2019 BioSig successfully carried out further patient cases using its PURE EP System at Greenville Memorial Hospital in Greenville, SC and Indiana University School of Medicine. BioSig was recently added to the Russell 3000 Index and allowed 33 patent claims covering its PURE EP System.
CKPT

Hot Stocks

07:48 EDT Checkpoint Therapeutics announces interim results for anti-PD-L1 cosibelimab - Checkpoint Therapeutics announced that positive interim results for cosibelimab, a potentially differentiated high affinity anti-PD-L1 antibody with functional Fc domain, were presented on Saturday, September 28th, at the European Society for Medical Oncology Congress 2019 in Barcelona, Spain. The poster presentation provided updated interim efficacy and safety results from Checkpoint's ongoing multicenter Phase 1 clinical trial, including expansion cohorts in cutaneous squamous cell carcinoma and non-small cell lung cancer. Checkpoint continues to enroll CSCC patients to support an initial Biologics License Application submission for cosibelimab based on this ongoing clinical trial. The Phase 1, open-label, multicenter trial is evaluating the safety, efficacy and pharmacokinetics of cosibelimab in checkpoint therapy-naive patients with selected recurrent or metastatic cancers. Following dose escalation, the trial initiated multiple disease-specific expansion cohorts, including in CSCC and NSCLC, evaluating a fixed dose of 800 mg cosibelimab dosed intravenously every two weeks. As of August 5, 2019, 81 patients with diverse tumor types have been treated with cosibelimab. Sixty-eight patients were evaluable for efficacy at the time of data cutoff, having at least two tumor assessments or discontinued treatment prior. Key efficacy results were as follows: 50% objective response rate in CSCC patients per RECIST v1.1. One patient achieved a complete response and six patients achieved partial responses. All seven responses are confirmed and ongoing with the longest duration at 11.4 months at the time of analysis. 40% ORR in first-line NSCLC patients with high expression of PD-L1 per RECIST v1.1. Ten patients achieved partial responses. Nine of 10 responses are ongoing with the longest duration at 11 months at the time of analysis. Cosibelimab appeared to be safe and well-tolerated with a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies. Treatment-related adverse events occurred in 48/81 patients, most commonly rash, fatigue, hypothyroidism, anemia, alanine aminotransferase increase, diarrhea, and infusion-related reaction. Treatment-related grade greater than or equal to3 AEs occurred in 5/81 patients, with only two patients discontinuing treatment due to a treatment-related AE.
TTOO

Hot Stocks

07:43 EDT T2 Biosystems' T2Resistance Panel available as RUO test in U.S. - T2 Biosystems announced that its T2Resistance Panel, which received Breakthrough Device Designation from the Food and Drug Administration earlier this year, is now available as a research use only test in the United States. The T2Resistance Panel also remains on track to receive CE-Mark for commercial availability in Europe by the end of 2019.
IDRA

Hot Stocks

07:38 EDT Idera Pharmaceuticals announces initiation of ILLUMINATE-206 trial - Idera Pharmaceuticals announced the initiation of a phase 2 trial, ILLUMINATE-206 which will evaluate tilsotolimod, a toll-like receptor 9 agonist, in combination with nivolumab, a programmed death receptor-1 blocking antibody, and ipilimumab, a human cytotoxic T-lymphocyte antigen 4 blocking antibody for the treatment of solid tumors. The primary objective of this phase 2, open-label, global, study is to demonstrate efficacy. Secondary and exploratory objectives include safety, tolerability, immunogenicity and translational data evaluations. The initial cohort of the trial will be patients with immunotherapy-naive Microsatellite Stable Colorectal Cancer. The second planned cohort of ILLUMINATE-206 will focus on treating patients with anti-PD-1 refractory Squamous Cell Carcinoma of the Head and Neck, which will initiate in the fourth quarter of this year. The basis for this trial is supported by data generated from the ILLUMINATE-101 trial, which studied intratumoral tilsotolimod monotherapy in 45 evaluable patients with a variety of solid tumor types in which 33% achieved stable disease. Translational research in ILLUMINATE-101, demonstrated that tilsotolimod increased dendritic cell activation and upregulated MHC class II and IFN-alpha signaling which suggests improved antigen presentation. These findings are consistent with those observed in the ILLUMINATE-204 trial in anti-PD-1 refractory metastatic melanoma patients. Therefore, the mechanism of action for tilsotolimod may be tumor-type agnostic and potentially beneficial in combination with checkpoint modulation in a variety of tumor types.
LMB CPST

Hot Stocks

07:37 EDT Limbach Holding appoints Jayme Brooks as CFO - Limbach Holding (LMB) announced the appointment of Jayme Brooks as executive VP and CFO, effective October 1. Brooks replaces John Jordan and will report directly to CEO Charlie Bacon while also serving as a member of the executive committee. She will be responsible for overseeing all financial aspects of the company, including financial planning and analysis, accounting and financial reporting, as well as managing the tax, internal audit and treasury functions. Brooks previously held a number of positions at Capstone Turbine (CPST), most recently serving as executive VP and CFO.
TGTX

Hot Stocks

07:35 EDT TG Therapeutics announces publication of data from Phase I/Ib trial of U2 - TG Therapeutics announced the publication of results from the multicenter first-in-human Phase I/Ib combination trial of ublituximab, the Company's anti-CD20 monoclonal antibody, and umbralisib, the Company's oral once-daily PI3K delta inhibitor in Blood, the Journal of the American Society of Hematology. The paper includes safety and efficacy information from patients with chronic lymphocytic leukemia and non-Hodgkin Lymphoma, including 22 patients with CLL or small lymphocytic lymphoma and 53 patients with NHL treated with the combination of ublituximab and umbralisib, referred to as "U2". Dose-escalation was performed with a 3+3 design evaluating fixed doses of ublituximab and escalating doses of umbralisib to establish the maximum tolerated dose. Safety data was available from all 75 patients and demonstrated that the U2 combination was well tolerated with the majority of adverse events being grade 1 or 2 in severity and no maximum tolerated dose achieved in either CLL or NHL. Importantly, U2 exhibited low rates of immune-mediated toxicities typically associated with other PI3K-delta inhibitors including colitis, pneumonia/pneumonitis, or hepatic toxicity, and discontinuations due to AEs were limited. Efficacy data was available from 69 patients and showed the combination to be highly active with a 72.5% clinical benefit rate across all subtypes of B-cell cancers enrolled in the study. Of note, a median PFS of 27.57 months was observed in patients with relapsed/refractory CLL treated at therapeutic dose levels of umbralisib and a 65% overall response rate was observed in patients relapsed/refractory indolent NHL, including a 100% ORR amongst MZL patients.
ENDP

Hot Stocks

07:33 EDT Endo: Successful culmination of litigation regarding FDA compounding policy - Endo announced the successful culmination of two litigation matters before the U.S. District Court for the District of Columbia regarding the unlawful compounding of vasopressin from bulk drug substances. In October 2017, Endo initiated a lawsuit against the U.S. FDA challenging the FDA's interim policy authorizing the bulk compounding of drugs. That policy relied on "enforcement discretion" to allow bulk compounding of vasopressin, the active ingredient in Vasostrict, which is manufactured by Endo's subsidiary Par Sterile Products. Endo's lawsuit alleged that the FDA's interim policy violated Section 503B of the Drug Quality and Security Act and other provisions of the Federal Food, Drug, and Cosmetic Act which allow bulk compounding only if FDA first makes a determination that there is a genuine "clinical need" for compounding from a particular bulk drug substance. Shortly after Endo filed its lawsuit, the FDA began to take significant steps to implement the requirements of the DQSA, and in particular issued proposed guidance regarding the statutory "clinical need" requirement which was consistent with the claims in Endo's Complaint. At FDA's and the Department of Justice's request, Endo stayed its lawsuit to allow FDA time to complete this process. FDA ultimately finalized its new guidance and issued a thorough, well-reasoned administrative decision that bulk compounders of vasopressin competing with Vasostrict could not satisfy the statutory "clinical need" requirement. Soon thereafter, a bulk compounder of vasopressin, Athenex, and two related entities, sued the FDA-also in the U.S. District Court in the District of Columbia-seeking to invalidate the FDA's decision regarding vasopressin. Endo intervened in the Athenex lawsuit to defend the case alongside the FDA and the Department of Justice. The defense was successful, with the Court concluding on August 1, 2019 that the "FDA's exclusion of vasopressin from the 'clinical need' list was not arbitrary and capricious," a decision that "forecloses [Athenex] from selling their product." The Court also denied Athenex's subsequent motion for a stay of its ruling pending appeal. Although Athenex initially appealed the Court's ruling, it recently filed a motion to withdraw that appeal. Given FDA's determination removing bulk compounded vasopressin from the market, and FDA's and Endo's success in the Athenex litigation, Endo has agreed with the FDA and the Department of Justice to voluntarily dismiss without prejudice its initial lawsuit against the FDA. That case has been stayed since February 2019, and Endo has now filed with the Court a stipulation to voluntarily dismiss the suit.
MNRO

Hot Stocks

07:33 EDT Monro appoints Robert Rajkowski as COO - Monro announced that Robert Rajkowski has been appointed to the position of COO, effective immediately. In his role as COO, Rajkowski will oversee and spearhead the integration of Monro's operations, marketing and merchandising functions. In addition, he will be responsible for all aspects of the Company's store operations, including the ongoing execution of its Monro.Forward operational excellence initiatives. Rajkowski will report to Brett Ponton, President and CEO. Rajkowski most recently serving as the COO of AAMCO Transmission and Total Car Care.
CLNY BX

Hot Stocks

07:33 EDT Colony Capital to sell Colony Industrial to Blackstone for $5.9B - Colony Capital (CLNY) and Blackstone Real Estate Partners IX, an affiliate of Blackstone (BX), announced that they have entered into definitive agreements for Blackstone to acquire Colony Industrial, the industrial real estate assets and affiliated industrial operating platform of Colony Capital, for an aggregate purchase price of $5.9B. The Colony Industrial last-mile light industrial portfolio represents the substantial majority of the total transaction and comprises approximately 60 million square feet of infill, logistics assets across 465 light industrial buildings in 26 U.S. markets, with significant concentration in Dallas, Atlanta, Florida, northern New Jersey, and California. The transaction also includes Colony's 51% ownership interest in a 4 million square foot portfolio of bulk distribution assets and the affiliated operating platform which manages the properties of both portfolios. The aggregate net sales proceeds to Colony are expected to be in excess of $1.2B. This transaction comprises one of the highest quality portfolios of last-mile logistics assets in the U.S. Colony Industrial was formed in December 2014 through Colony Capital's acquisition of Cobalt Capital Partners, founded and led by Lewis Friedland. Since then, the portfolio has doubled in size and produced strong and consistent operating results. Each of the agreements is subject to customary closing conditions, including third party consent for the sale of the 51% interest in the bulk industrial portfolio, and is expected to close in Q4.
CLNY BX

Hot Stocks

07:31 EDT Colony Capital to sell Colony Industrial to Blackstone for $5.9B
HUSKF

Hot Stocks

07:27 EDT Husky Energy receives approval to begin Superior Refinery rebuild - Husky Energy continues to make steady progress towards a return to full operations at the Superior Refinery. The Company has received the required permit approvals to begin reconstruction activities at the site and work is expected to begin immediately. Demolition of damaged equipment resulting from a fire in April of 2018 is now largely complete and the rebuild will take place over the next two years with an expected return to full operations in 2021.
AKTS

Hot Stocks

07:24 EDT Akoustis ships pre-production BAW filters to tier-1 SoC customer - Akoustis Technologies announced it has shipped pre-production 5.2 GHz and 5.6 GHz tandem BAW filters to a multi-billion dollar, tier-1 SoC customer, targeting tri-band WiFi customer premise equipment. This customer is the third announced SoC maker evaluating use of the 5.2 GHz and 5.6 GHz coexistence XBAW filters for MU-MIMO reference designs in tri-band WiFi applications. Akoustis' 5.2 GHz and 5.6 GHz filters operate in tandem to create the world's first BAW coexistence solution for tri-band WiFi equipment, offering a significant size advantage over existing dielectric resonator filters with up to 23 times smaller footprint. The filters provide low insertion loss, meet the demanding coexistence rejection specifications and can be surface mounted.
WSR

Hot Stocks

07:22 EDT Whitestone REIT announces 100% lease up at pad site at Fulton Ranch Towne Center - Whitestone REIT announced the 100% lease up completion of a pad site at Fulton Ranch Towne Center property in Chandler, Arizona. Producing attractive financial rewards for Whitestone shareholders, the development results in a stabilized NOI of $263,000, an unlevered return on total cost of 8.8%, and contributes a 16.7% increase of NOI to the center.
HCM

Hot Stocks

07:19 EDT Hutchison China MediTech offers 1.3% of Chi-Med's share capital - Hutchison China MediTech Limited announces that its shareholder CK Hutchison Holdings is launching an offering to sell approximately 1.3% of the total outstanding share capital in Chi-Med's through an underwritten public offering, which would reduce its stake in Chi-Med from 51.1% to 49.9%. CK Hutchison has announced that, upon completion of the Offering, it has no intention of selling additional Chi-Med shares for the foreseeable future. CK Hutchison plans to maintain its shareholding in Chi-Med as a strategic investment for the long term as it continues to strive to become a global biopharmaceutical company.
FGEN

Hot Stocks

07:14 EDT FibroGen announces publication of results from Phase 2 study of pamrevlumab - FibroGen announced publication in The Lancet Respiratory Medicine of results from the company's PRAISE Phase 2 clinical study of the efficacy and safety of pamrevlumab, a fully human recombinant monoclonal antibody against connective tissue growth factor, for treatment of idiopathic pulmonary fibrosis. The publication, entitled, "Pamrevlumab, an anti-connective tissue growth factor therapy for idiopathic pulmonary fibrosis: a randomized, double-blind, placebo-controlled trial," is available online. In the Phase 2 randomized, placebo-controlled PRAISE study, the decline in percentage of predicted forced vital capacity was significantly lower in the pamrevlumab group than in the placebo group. Specifically, the mean change from baseline to Week 48 in percentage of predicted FVC was -2.9% in the pamrevlumab group compared with -7.2% in the placebo group, which corresponded to a relative reduction in percentage of predicted FVC decline of 60.3% in patients treated with pamrevlumab. Further, the proportion of patients with disease progression was lower in the pamrevlumab group than in the placebo group. The difference between treatment groups was significant at Week 48. The results of this trial indicate that pamrevlumab reduced progression of idiopathic pulmonary fibrosis over a period of one year. Other findings included positive results on multiple efficacy outcomes, including lung function and, for the first time, quality of life and chest imaging with a quantitative high-resolution computed tomography score. Pamrevlumab was well tolerated in this study. Pamrevlumab is currently in Phase 3 clinical development for the treatment of IPF. The ZEPHYRUS study is a randomized, double-blind, placebo-controlled, multi-center trial designed to evaluate the efficacy and safety of pamrevlumab over a 52-week period. The primary endpoint of this global study is the change in FVC from baseline. Approximately 565 subjects will be enrolled. Subjects who complete the 52-week study may be eligible for rollover into a separate study offering open-label, extension treatment with pamrevlumab. For more information about the ZEPHYRUS study, please visit https://clinicaltrials.gov/ct2/show/NCT03955146.
AQST

Hot Stocks

07:11 EDT Aquestive Therapeutics announces completion of Phase 1 trial for AQST-108 - Aquestive Therapeutics announced the completion of its Phase 1 dose escalation proof-of-concept study in healthy subjects for AQST-108. AQST-108 is an oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive's proprietary PharmFilm technologies. Importantly, the data demonstrated that AQST-108: achieved similar ranges of mean values of maximum concentration and time to reach maximum concentration to that reported for injectables EpiPen and Auvi-Q; provided a greater total exposure than that reported for EpiPen and Auvi-Q; had less interpatient variability when compared to degree of variation data reported for EpiPen and Auvi-Q ; was well tolerated, with no study participants discontinuing participation due to an adverse event. Based on the results of this proof-of-concept study, Aquestive is in the process of scheduling a pre-IND meeting with the U.S. FDA.
ORTX

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07:08 EDT Orchard Therapeutics announces presentation of clinical data for OTL-200 - Orchard Therapeutics announced the presentation of new clinical data at the upcoming European Society of Gene & Cell Therapy Annual Congress in Barcelona, Spain, October 22-25, 2019. The poster presentation will highlight initial results from the ongoing clinical trial with a cryopreserved formulation of OTL-200 for metachromatic leukodystrophy that is being conducted at the San Raffaele-Telethon Institute for Gene Therapy in Milan, Italy. Poster presentation details for OTL-200: Lentiviral haematopoietic stem cell gene therapy for metachromatic leukodystrophy: Preliminary results from a clinical trial with a cryopreserved formulation of OTL-200. Metachromatic leukodystrophy is a rare and life-threatening inherited disease of the body's metabolic system occurring in approximately one in every 100,000 live births. MLD is caused by a mutation in the arylsulfatase-A gene that results in the accumulation of sulfatides in the brain and other areas of the body, including the liver, the gallbladder, kidneys, and/or spleen. Over time, the nervous system is damaged and patients with MLD will experience neurological problems such as motor, behavioral and cognitive regression, severe spasticity and seizures, finding it more and more difficult to move, talk, swallow, eat and see. Currently, there are no effective treatments for MLD. In its late infantile form, mortality at 5 years from onset is estimated at 50% and 44% at 10 years for juvenile patients.1 OTL-200 is an ex vivo, autologous, hematopoietic stem cell-based gene therapy being studied for the treatment of MLD.
EIDX

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07:06 EDT Eidos Therapeutics to present interim analysis of Phase 2 OLE study of AG10 - Eidos Therapeutics announced that an interim analysis of its ongoing Phase 2 open-label extension study of AG10 in subjects with symptomatic ATTR cardiomyopathy will be presented in a late-breaking featured science oral presentation at this year's American Heart Association Scientific Sessions. Daniel Judge, M.D., professor in the division of cardiology at the Medical University of South Carolina, will discuss the data in a presentation entitled "Long-term Safety and Efficacy of AG10 in Patients with Transthyretin Amyloid Cardiomyopathy: Interim Analysis of the Ongoing Phase 2 Open-Label Extension Study" at 5:30 PM ET on November 16, 2019 as part of the Early Phase Science oral session. In addition, Eidos will present several posters at AHA. The following summarizes Eidos' presentations at the conference: Long-term Safety and Efficacy of AG10 in Patients with Transthyretin Amyloid Cardiomyopathy: Interim Analysis of the Ongoing Phase 2 Open-Label Extension Study. ATTRibute-CM: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Global Phase 3 Study of AG10 in Patients with Transthyretin Amyloid Cardiomyopathy. Differential Transthyretin Binding, Kinetic Stability and Additive Ex Vivo Stabilization by AG10 Compared to Tafamidis. Differential Ex Vivo Stabilization of Transthyretin by AG10 and Tafamidis in Samples from Patients with Moderate or Severely Destabilizing Mutations. AG10 is an investigational, orally-administered small molecule designed to potently stabilize tetrameric transthyretin, or TTR, thereby halting at its outset the series of molecular events that give rise to TTR amyloidosis, or ATTR. In a Phase 2 clinical trial in patients with symptomatic ATTR-CM, AG10 was generally well tolerated, demonstrated greater than 90 percent average TTR stabilization at Day 28, and increased serum TTR concentrations, a prognostic indicator of survival in a retrospective study of ATTR-CM patients, in a dose-dependent manner. AG10 was designed to mimic a naturally-occurring variant of the TTR gene that is considered a rescue mutation because co-inheritance has been shown to prevent or ameliorate ATTR in individuals also inheriting a pathogenic, or disease-causing, mutation in the TTR gene. To our knowledge, AG10 is the only TTR stabilizer in development that has been observed to mimic the stabilizing structure of this rescue mutation. The Phase 3 ATTRibute-CM study of AG10 in patients with ATTR-CM is underway. Part A of the study will assess the change from baseline in 6-minute walk distance at 12 months. Part B of the study will evaluate reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations at 30 months. In addition, Eidos plans to initiate a Phase 3 study of AG10 in ATTR polyneuropathy by the end of 2019.
AVEO AZN

Hot Stocks

07:05 EDT Aveo Pharmaceuticals initiates Fotivda with Imfinzi clinical trial - Aveo Pharmaceuticals (AVEO) announced that it has initiated enrollment in an open-label, multi-center Phase 1b/2 clinical trial evaluating Fotivda, the company's once-daily and selective vascular endothelial growth factor receptor tyrosine kinase inhibitor, or VEGFR-TKI, in combination with Imfinzi, AstraZeneca's (AZN) human monoclonal antibody directed against programmed death-ligand 1, or PD-L1, in patients with hepatocellular carcinoma, or HCC, who have not received prior systemic therapy. The study is expected to enroll approximately 50 patients. The Phase 1b portion will evaluate the safety, tolerability, dose limiting toxicity, maximum tolerated dose and preliminary anti-tumor activity starting with 1 mg of tivozanib for 21 days followed by 7 days rest together with 1500 mg of durvalumab every 28 days. Assuming satisfactory completion of the Phase 1b portion of the study, a Phase 2 expansion cohort will enroll at the dose schedule designated in Phase 1b. The primary outcome measure is incidence of treatment emergent adverse events. Secondary outcome measures include objective response rate per RECIST 1.1, progression free survival, duration of response, and overall survival. The trial is being conducted as part of a clinical collaboration between AVEO and AstraZeneca. AVEO is serving as the study sponsor, with study costs shared equally by both parties and clinical drug supplied by each respective company.
OBE

Hot Stocks

07:03 EDT Obsidian Energy provides Phase 2 Cardium program update - The 13 well Willesden Green Cardium development program planned for the second half of the year is progressing as planned, with six wells rig released. Four of those wells have been completed and are expected to be on stream by mid-October. The company has seven additional wells planned in the fourth quarter. All locations are expected to be onstream before the end of the year. The company is on target to deliver its $120M capital program, with $75M of the total spending planned for the second half of the year. Recent oil price volatility allowed the company to build on its fourth quarter hedge position, adding 2,663 barrels per day with an average strike price of $79.62 per barrel, on a Canadian dollar basis.
UXIN

Hot Stocks

07:03 EDT Uxin to divest 2C intra-regional business to Golden Pacer - Uxin announced it entered into definitive agreements with Golden Pacer to divest its loan facilitation related business. Previously on July 12, 2019, the Company announced that it had entered into a binding term sheet with Golden Pacer relating to the divestiture. Pursuant to the definitive agreements, the Company will divest its entire 2C intra-regional business to Golden Pacer, and cease to provide guarantee services in connection with its 2C cross-regional business going forward, and thus divest the corresponding assets and liabilities. In return, the Company will receive an aggregate of $100M cash from Golden Pacer and certain preferred shares of Golden Pacer representing approximately 18.4% of the share capital of Golden Pacer on a fully diluted basis. The Company will have the right to appoint one director on Golden Pacer's board of directors. The transactions contemplated under the definitive agreements are subject to certain closing conditions, and are currently expected to close by the end of 2019. The Company's board of directors, acting upon the unanimous recommendation of its Audit Committee consisting of independent and disinterested directors, approved the definitive agreements and the transactions contemplated thereunder. The Audit Committee reviewed and considered the terms of the definitive agreements and the transactions with the assistance of its financial and legal advisors.
WUBA

Hot Stocks

07:01 EDT 58.com to acquire certain number of shares of Golden Pacer - 58.com announced that it has entered into definitive agreements to acquire a certain number of shares of Golden Pacer, a leading financial technology platform in China, by converting its profit participation right with respect to the financial services and other finance related business disposed by the company in 2017 to equity stake in Golden Pacer. Golden Pacer is the ultimate holding company of the Disposed Business. In parallel, Golden Pacer entered into definitive agreements with Uxin Limited, a leading national online used car dealer in China, pursuant to which Golden Pacer will acquire the loan facilitation related business from Uxin and Uxin will receive a certain number of shares of Golden Pacer as part of the consideration. As a result, upon the completion of these transactions, the company will hold approximately 32.6% of the share capital of Golden Pacer on a fully diluted basis. The transactions contemplated under the definitive agreements are subject to certain closing conditions, and are currently expected to close by the end of 2019.
SRE

Hot Stocks

07:00 EDT Sempra Energy to sell stake in Luz del Sur In Peru - Sempra Energy announced that it has entered into an agreement to sell its equity interests in its Peruvian businesses, including its 83.6% stake in Luz del Sur, to China Yangtze Power International. Sempra Energy's interests will be sold for $3.59 billion in cash, subject to closing adjustments for working capital and net indebtedness. "We could not be more pleased about today's announcement," said Jeffrey W. Martin, chairman and CEO of Sempra Energy. "It directly supports our mission of building North America's premier energy infrastructure company. Proceeds from this transaction will be used to strengthen our balance sheet and meet the growing capital needs of our core utilities in California and Texas." The sale will also include Sempra Energy's interest in Tecsur S.A., which provides electric construction and infrastructure services to Luz del Sur and third parties, and Inland Energy S.A.C., Luz del Sur's generation business. The sale is expected to be completed in the first quarter of 2020, subject to customary closing conditions, including approval by the Peruvian anti-trust authority and the Bermuda Monetary Authority.
MSG

Hot Stocks

06:58 EDT MSG Networks announces preliminary results of modified Dutch auction tender - MSG Networks announced the preliminary results of its modified Dutch auction tender offer, which expired at 12:00 midnight, New York City time, on September 27. Based on the preliminary count by Equiniti Trust Company, the depositary for the tender offer, a total of 14,980,092 shares of MSG Networks' Class A common stock, par value 1c per share, were properly tendered and not properly withdrawn at or below the purchase price of $16.70 per Class A Share, including 7,515,909 Class A Shares that were tendered by notice of guaranteed delivery. In accordance with the terms and conditions of the tender offer and based on the preliminary count by the Depositary, MSG Networks expects to accept for purchase, at a price of $16.70 per Class A Share, approximately 14,980,092 Class A Shares properly tendered at or below the purchase price and not properly withdrawn before the expiration date, for an aggregate cost of approximately $250,167,536, excluding fees and expenses relating to the tender offer. Included in the 14,980,092 Class A Shares MSG Networks expects to accept for purchase in the tender offer are approximately 10,032 Class A Shares that MSG Networks has elected to purchase pursuant to its right to purchase up to an additional 2% of its outstanding Class A Shares. As MSG Networks expects to accept for purchase all the Class A Shares that were properly tendered and not properly withdrawn at a price at or below $16.70, MSG Networks expects there to be no proration factor. The Class A Shares expected to be purchased represent approximately 24.3% of the Class A Shares issued and outstanding as of September 26, 2019. The company will pay for the Class A Share repurchases with a combination of available cash and borrowings under its existing revolving credit facility.
MNK

Hot Stocks

06:57 EDT Mallinckrodt finalizes settlement to resolve Ohio opioid cases - Mallinckrodt, along with its wholly owned subsidiaries, announced that it has executed a definitive settlement agreement and release with Cuyahoga and Summit Counties in Ohio in connection with lawsuits pending in multidistrict opioid litigation, or MDL, in the U.S. District Court for the Northern District of Ohio. The settlement fully resolves the Track 1 cases against all named Mallinckrodt entities that are currently scheduled to go to trial in October in the MDL. The Track 1 cases assert various claims related to the opioid business operated by SpecGx. Under the agreement, Mallinckrodt will pay $24M in cash and provide $6M in generic products, including addiction treatment products. It also will provide a $500,000 payment in two years in recognition of the counties' time and expenses. Further, in the event of a comprehensive resolution of government-related opioid claims, Mallinckrodt has agreed that the two plaintiff counties will receive the value they would have received under such a resolution, less the payments described above. All named Mallinckrodt entities will be dismissed with prejudice from the lawsuit. The value of the settlement should not be extrapolated to any other opioid-related cases or claims.
IDXG

Hot Stocks

06:56 EDT Interpace Diagnostics announces new contracts with Blue Cross Blue Shield - Interpace Diagnostics announced that it has contracted with 3 independent Blue Cross Blue Shield plans totaling nearly 5M covered lives across Alabama, Arkansas, and Arizona. These members of the BCBS Association are the largest payers in their respective states and each affiliate's customers now have access to both the ThyGeNEXT and ThyraMIR tests for assessing indeterminate thyroid biopsies on an in-network basis.
GCO

Hot Stocks

06:53 EDT Genesco announces new $100M stock repurchase authorization - Genesco announced that its board has authorized it to repurchase up to $100M of the company's common stock. The company exhausted its previous $100M authorization from May, pursuant to which the company repurchased roughly 2.5M shares at a total cost of approximately $100M. During Q3 of FY20, 0.9M of those shares were repurchased at a total cost of approximately $31M. Earlier this year, the company exhausted its $125M repurchase authorization from December 2018, pursuant to which the company repurchased roughly 2.8M shares at a total cost of approximately $125M. Between these two authorizations, the company has repurchased 5.3M shares at a total cost of approximately $225M.
TW STT

Hot Stocks

06:50 EDT Charles River, Tradeweb expand multi-asset trading collaboration - Charles River Development, a State Street (STT) company, and Tradeweb Markets (TW) announced an expansion of their collaboration to provide mutual clients with direct access to fixed income inventory and streamlined workflows from the Charles River Investment Management Solution. The collaboration enables institutional and retail investment firms to seamlessly source cross product liquidity available on Tradeweb from the Charles River Inventory Hub and Order and Execution Management System for global fixed income securities.
MRK

Hot Stocks

06:47 EDT Merck: Phase 3 RECARBRIO RESTORE-IMI 2 trial met primary endpoint - Merck announced that the pivotal Phase 3 RECARBRIO RESTORE-IMI 2 trial met its primary endpoint. The global, multicenter, randomized, non-inferiority trial investigated the efficacy and safety of Merck's antibacterial product RECARBRIO for use in adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Results from the trial showed RECARBRIO met both the primary and key secondary endpoints of statistical non-inferiority compared to piperacillin/tazobactam in Day 28 all-cause mortality and clinical response at early follow up, respectively, in the modified intent-to-treat population. Rates of adverse events observed in the trial were similar in both groups. Merck plans to present the full data from the trial at a scientific congress in 2020.
COG NEP

Hot Stocks

06:38 EDT Cabot Oil & Gas to divest 20% interest in Mead Pipeline for $256M - Cabot Oil & Gas (COG) announced that it has reached an agreement to sell its 20% ownership interest in Meade Pipeline to a subsidiary of NextEra Energy Partners (NEP) for $256M, or over 13 times expected 2019 EBITDAX. Meade owns approximately 39% of the Central Penn Line, the greenfield pipeline segment of the Atlantic Sunrise project. This transaction is expected to close during Q4, subject to customary closing conditions and adjustments. Proceeds from this transaction, in addition to the company's ongoing operating free cash flow, will allow Cabot to continue to enhance shareholder value by returning capital to shareholders through a combination of a growing dividend and a share repurchase program.
DLR

Hot Stocks

06:37 EDT Digital Realty to acquire additional land in Tokyo - Digital Realty announced it has signed an agreement to acquire an additional plot of land in Tokyo. MC Digital Realty expects to close on the acquisition in Q1 of 2020. The new site is strategically located in Greater Tokyo's Inzai data center cluster, in close proximity to the five-acre parcel MC Digital Realty acquired earlier this year, likewise located in the Inzai data center cluster and expected to support the development of a 38-megawatt facility.
AZZ

Hot Stocks

06:34 EDT AZZ Inc. acquires all assets of Preferred Industries, sees accretion - AZZ Inc. announced that it has acquired all the assets of Preferred Industries, a privately held powder coating company in the Dallas-Fort Worth area. Preferred provides powder and e-coating services to the automotive, HVAC, marine, transportation, medical, industrial and plastics industries. Terms of the transaction were not disclosed. AZZ expects the acquisition will be accretive to earnings within the first year of operation. Through the acquisition, AZZ gains the powder and e-coating operations as well as employees of Preferred, which operates a 155,000 square foot facility in Terrell and an 89,600 square foot facility in Rowlett, Texas. Going forward, AZZ intends to operate the facilities as AZZ Surface Technologies - Terrell and AZZ Surface Technologies - Rowlett. AZZ will integrate them with six existing powder coating and plating operations the company operates in the area.
CALM

Hot Stocks

06:33 EDT Cal-Maine Foods CEO: Q1 results reflect 'very challenging market conditions' - Dolph Baker, chairman and CEO of Cal-Maine Foods, stated, "Our financial and operating results for the first quarter reflect the very challenging market conditions that prevailed throughout the summer. While our sales volumes were up 1.7 percent over the first quarter last year, the extreme drop in market prices adversely affected our results. The Southeast large market average price for conventional eggs dropped 40.7 percent for the first quarter of fiscal 2020 compared to the first quarter of fiscal 2019. At the same time, our average sales price was down 30.0 percent for the first quarter compared to the same period last year. The significant drop in market prices reflects the oversupply of eggs that began to affect the market starting in early calendar 2018. This trend has continued as the most recent USDA Chickens and Eggs Report showed 331.4 million laying hens as of September 1, 2019, which was approximately 800,000 more hens than a year ago. Our specialty egg business will continue to be a primary focus of our growth strategy in fiscal 2020. For the first quarter, specialty eggs, excluding co-pack sales, accounted for 22.2 percent of our sales volumes, compared with 23.8 percent a year ago. Specialty egg volumes were affected by the significant price differential between conventional and specialty eggs. However, specialty egg revenue was 44.9 percent of total shell egg revenue, compared with 34.2 percent for the first quarter of fiscal 2019, reflecting less volatility in the average selling price for specialty eggs. Specialty egg prices were only down 1.4 percent as compared to the first quarter of fiscal 2019. We remain committed to offering a favorable product mix that meets the changing demands of our customers. As a result of California Proposition 12 and other industry changes, we are preparing for the expected higher demand for cage-free eggs. Throughout the first quarter, we have made considerable progress with our expansion plans designed to increase our cage-free capacity. As previously announced, we have capital projects underway in Florida, Texas and Utah, which at completion, will provide significant additional processing, pullet and cage-free capacity." Baker continued, "In spite of challenging conditions, we have remained focused on efficient and responsible management across our operations. For the first quarter, our farm production costs per dozen were up 2.3 percent over the first quarter last year. A majority of the increase was due to flock rotation adjustments, as we sold flocks early in response to market conditions, and higher labor costs. Our feed costs per dozen have remained relatively flat since the first quarter of fiscal 2019. Based on the USDA's current yield and harvest estimates for the calendar 2019 corn and soybean crops, we expect to have an adequate supply of both grains in fiscal 2020. However, ongoing uncertainties and geopolitical issues surrounding trade agreements and international tariffs could create more price volatility in the coming year. As we move forward in fiscal 2020, we will focus on the aspects of our business we can control, regardless of market prices and challenging conditions. We are well positioned to execute our growth strategy and make the right investments to support our operations and continue to serve our valued customers."
NEP

Hot Stocks

06:32 EDT NextEra Energy Partners to acquire Meade Pipeline in deal valued at $1.37B
KFY

Hot Stocks

06:26 EDT Korn/Ferry to acquire three companies from TwentyEighty, terms not disclosed - Korn Ferry announced that it has entered into a definitive agreement to acquire three companies from TwentyEighty in the leadership development area: Miller Heiman Group, AchieveForum, and Strategy Execution. The transaction, which is subject to customary closing conditions, is expected to close by November 1. Terms of the deal were not disclosed. The acquisition is expected to be accretive to adjusted earnings in the first year of Korn Ferry's ownership.
RHHBY ONCE

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06:21 EDT Roche again extends Spark Therapeutics tender offer to October 30 - Roche (RHHBY) and Spark Therapeutics (ONCE) announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of common stock of Spark for $114.50 per Share, net to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law and upon the terms and subject to the conditions set forth in the Offer to Purchase dated March 7, 2019. Pursuant to the Agreement and Plan of Merger, dated as of February 22, 2019, by and among Roche Holdings, Inc., 022019 Merger Subsidiary, Inc., and Spark, the Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on Tuesday, October 1, 2019, has been extended until 5:00 p.m., New York City time, on Wednesday, October 30, 2019, unless it is extended further under the circumstances set forth in the Merger Agreement. All terms and conditions of the Offer shall remain unchanged during the extended period. The Offer was extended to provide additional time for the U.S. FTC and the UK Competition and Markets Authority to complete their previously disclosed reviews of Roche's pending acquisition of Spark. The parties remain committed to the transaction and are working cooperatively and expeditiously with the FTC and the CMA. Citibank, N.A., the depository for the Offer, has advised Roche that, as of 5:00 p.m., New York City time, on September 27, 2019, approximately 8,251,571 Shares of Spark had been validly tendered and received, and not validly withdrawn, pursuant to the Offer, representing approximately 21.4% of Spark's outstanding Shares.
GMO

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06:03 EDT General Moly provides update on liquidity matters - On September 26, 2019, the company entered into a 90-day deferral and forbearance agreement with the primary holder of the 2014 Senior Convertible Notes, along with certain of the company's members of management and directors who participated in the 2014 debt offering. As a result, the company will defer approximately $162,000 of interest payments due at the end of the third quarter 2019. The company continues to explore opportunities with such note holders to exchange the notes for assets and/or extensions to the December 26, 2019 maturity date. Additionally, on September 27, 2019, the company entered into a Consent Agreement with POS-M to accelerate the repayment of the balance of $1 million the Company advanced to EMLLC to fund the initial settlement payment to the Kobeh Valley ranching family to settle protests to the Mt. Hope water applications, as announced in the Company's May 14, 2019 news release. Prior to the Consent Agreement, the company had been repaid $293,000 from the sale of EMLLC non-critical assets, leaving a balance of $707,000. The remaining balance will now be paid over three monthly installments beginning in October 2019, with the third installment subject to receipt of $400,000 in additional sales of EMLLC non-critical assets.
CAAS

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06:03 EDT China Automotive enters new supply contract with SAIC Maxus - China Automotive announced it has entered into a new supply contract with SAIC Maxus, an SUV and commercial vehicle subsidiary of SAIC Motor. SAIC is one of the largest auto makers in China. Pursuant to the agreement, CAAS will become a Type A supplier to SAIC's Maxus' SV63 model starting in 2019. The mass production of CAAS' steering systems for the SV63 model has started.
GMO

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06:02 EDT General Moly receives final permit for Mt. Hope molybdenum project in Nevada - General Moly announced that it has received the final federal permit in the form of a Record of Decision from the Bureau of Land Management for the Mt. Hope Project on September 27, 2019. The Mt. Hope Project has now received all permits from the State of Nevada and the federal government to allow construction and operation of the proposed molybdenum mine. Receipt of the ROD marks completion of the National Environmental Policy Act process and approval of the Supplemental Environmental Impact Statement by the Bureau of Land Management and the U.S. Department of Interior for the Mt. Hope Project. General Moly owns an 80% interest in the world-class Mt. Hope molybdenum project in Nevada through the Eureka Moly LLC joint venture. POS-Minerals Corporation, a wholly owned subsidiary of POSCO, the Korean steel company, owns the remaining 20% interest. Engineering remains approximately 65% complete at the Mt. Hope moly project. Some preconstruction site work also was previously completed. A development decision to proceed with construction of the Mt. Hope Project requires approval from POS-M and the company's Board of Directors, following receipt of project financing.
YRD

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06:02 EDT Yirendai announces name change to 'Yiren Digital Ltd' - Yiren Digital, previously named as Yirendai Ltd., announced that in an extraordinary general meeting of the shareholders of the company held in 10/F, Tower B, Gemdale Plaza, 91 Jianguo Road, Chaoyang District, Beijing, the People's Republic of China on September 30, the shareholders approved the proposed change of the company's name from "Yirendai Ltd." to "Yiren Digital Ltd."
LDOS

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06:01 EDT Leidos awarded $110M Army contract - Leidos was awarded a $110M hybrid contract to retrofit, procure, integrate, produce, test, refresh hardware/software and upgrade capabilities to the current U.S. Army common driver trainer simulator systems. Bids were solicited via the internet with five received. Work locations and funding will be determined with each order, with an estimated completion date of September 30, 2026. U.S. Army Contracting Command is the contracting activity.
ARDS

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05:53 EDT Aridis Pharmaceuticals executes license agreement with Serum Institute of India - Aridis Pharmaceuticals announced that it has consummated a licensing agreement with Serum AMR, an affiliate of Serum International BV, or SIBV, and the Serum Institute of India, Ltd. The agreement grants Serum AMR a license to multiple programs from Aridis for certain limited territories and access the Company's MabIgX platform technology for asset identification and selection. As part of the agreement, Aridis will receive the remaining upfront cash payment of $10M, which is in addition to the $5M that was initially received when the companies signed an option agreement on July 30. Moving forward, Aridis is eligible for future milestone payments for achieving product development and commercial objectives, along with royalties on net sales.
ACHV

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05:43 EDT Achieve Life Sciences announces completion of MTD study - Achieve Life Sciences announced completion of their maximum tolerated dose, or MTD, study. The results indicate a lack of dose-limiting toxicity as defined by protocol criteria even at the highest 30 mg single, oral dose of cytisinicline evaluated in the study. This study, initiated in March, is required by the FDA as part of a New Drug Application, or NDA, for marketing approval in the United States. It was designed to determine dose-limiting adverse events, or AEs, and to define the maximum tolerated dose for a single, oral dose of cytisinicline. An independent Data Safety Monitoring Committee, or DSMC, composed of the Study Investigator and two independent physicians evaluated all safety outcomes before each dose escalation. Stopping criteria for further dose escalation was defined as the occurrence of severe or serious AEs or any other safety information considered as a concern. The starting dose was 6 mg, which increased in 3 mg increments up to 21 mg. When the MTD was not reached at 21 mg, the study was amended to evaluate doses up to 30 mg. At this dose, the stopping criteria of serious or severe AEs were still not met, but the DSMC recommended stopping the study. The results will be reviewed with the FDA to determine if further escalation beyond 30 mg will be required.
XFOR

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05:40 EDT X4 Pharmaceuticals reports data from Phase 2A trial of mavorixafor - X4 Pharmaceuticals announced "positive results" from the Phase 2a portion of its open-label Phase 1/2 clinical trial of mavorixafor in combination with axitinib in patients with advanced clear cell renal cell carcinoma, or ccRCC. Data were presented at the European Society for Medical Oncology 2019 Congress today in Barcelona. Combination therapy with mavorixafor and approved tyrosine kinase inhibitor, or TKI, axitinib was generally well tolerated with a manageable safety profile and demonstrated clinical improvement with encouraging median progression free survival, or mPFS, in a heavily pretreated advanced ccRCC patient population. Of the 65 patients in the trial, 49 patients received mavorixafor + axitinib as a third- to ninth-line therapy, having received between two and eight prior therapies with a TKI, immuno-oncology, or IO, agent, or other systemic therapy. Fifty-seven of the 65 patients in the trial had an intermediate or poor prognosis. Overall mPFS across clinically evaluable patients receiving mavorixafor + axitinib was 7.4 months. Predefined subpopulations examined patients with immediate prior TKI and IO treatment. Patients treated in the subgroup with immediate prior TKI therapy demonstrated an objective response rate, or ORR, of 18% and an increased mPFS of 7.4 months. This is a greater than 50% improvement from the 4.8-month historical mPFS with axitinib alone.1 Patients treated with mavorixafor + axitinib in the subgroup with immediate prior IO therapy had an ORR of 61% and an increased mPFS of 11.6 months. In addition, eight of the 65 patients remain on the combination therapy today, with durations of treatment of 17 months or longer. Results suggest mavorixafor may enhance clinical response to axitinib and other TKIs that target tumor angiogenesis, as well as immunotherapy agents. "In recent years a growing number of vascular endothelial growth factor TKI-based therapies, have improved outcomes for patients with ccRCC. Despite these advances, most patients eventually develop resistance to therapy, and new treatment options are necessary to meet this unmet medical need," commented David McDermott, M.D., Beth Israel Deaconess Medical Center, Harvard Medical School and lead investigator of the study. "In this trial of mavorixafor, a novel CXCR4 pathway inhibitor, and axitinib in patients with metastatic ccRCC who had failed prior therapy, the combination was well tolerated and the anti-tumor activity was encouraging. We look forward to confirming the efficacy of mavorixafor in a randomized trial."
CVS SNY

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05:38 EDT CVS suspends sales of Zantac and other ranitidine products - CVS Health (CVS) announced Saturday that it has suspended the sale of all Zantac brand and CVS brand ranitidine products until further notice. "This action is being taken out of an abundance of caution due to a recent Product Alert from the U.S. Food and Drug Administration that ranitidine products may contain a low level of nitrosodimethylamine, which is a probable human carcinogen," the company said in a statement. Zantac is sold by (SNY) and ranitidine is an H2 blocker that is taken to provide heartburn relief. CVS Pharmacy will continue to sell other over-the-counter H2 blockers, including Pepcid, Tagamet and its respective generic equivalents, famotidine and cimetidine. Reference Link
ASLN

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05:25 EDT Aslan Pharmaceuticals, Bukwang Pharmaceutical establish JV - Aslan Pharmaceuticals and Bukwang Pharmaceutical announced that they have established a new joint venture to develop preclinical aryl hydrocarbon receptor, or AhR, antagonists from ASLAN's early stage pipeline. The independent company, JAGUAHR Therapeutics, will focus on developing new immuno-oncology therapeutics for global markets targeting the AhR pathway and will be based in Singapore. Under the terms of the agreement, ASLAN will transfer the global rights to all of the assets related to AhR technology, originally discovered and developed by ASLAN and its collaborator Dr Mark Graham, into JAGUAHR. Bukwang will invest $5M in JAGUAHR in two tranches to fund the development of the assets, identify a lead development compound and file an Investigational New Drug application.
DOVA

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05:24 EDT Dova Pharmaceuticals to be acquired by Swedish Orphan Biovitrum for $27.50/share - Dova Pharmaceuticals announced it has entered into an agreement and plan of merger with Swedish Orphan Biovitrum, or Sobi. Under the terms of the agreement, an indirect subsidiary of Sobi will commence a tender offer for all outstanding shares of Dova, whereby Dova stockholders will be offered an upfront payment for $27.50 per share in cash, along with one non-tradeable Contingent Value Right, or CVR, that entitles them to an additional $1.50 per share in cash upon regulatory approval of DOPTELET for the treatment of chemotherapy-induced thrombocytopenia, or CIT, representing a total potential consideration of $29.00 per share, or a total potential consideration of up to $915M on a fully diluted basis. The upfront consideration of $27.50 per share represents a premium of 36% to Dova's closing price on September 27 and a premium of 59% to the 30-day volume weighted average price. The transaction was unanimously approved by the boards of both companies and is expected to close in Q4. Dova will file a recommendation to shareholders recommending they tender their shares to Sobi, subject to the terms of the definitive merger agreement. Certain of the company's major stockholders, including Paul Manning, representing a majority of the outstanding shares have entered into a Tender and Support Agreement committing them to tender their shares into the tender offer. The transaction is subject to customary closing conditions, including the tender of more than 50% of all shares of Dova outstanding at the expiration of the offer and termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
OXY...

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05:20 EDT Occidental Petroleum provides update on divestiture, deleveraging initiatives - Occidental Petroleum provided an update on its divestiture and deleveraging initiatives following the recent close of its acquisition of Anadarko Petroleum on August 8. Occidental's progress includes: Sale of Anadarko's Mozambique LNG Stake to Total: Occidental has completed the sale of Anadarko's Mozambique LNG stake to Total S.A. (TOT), for $3.9B. As previously announced, Occidental entered into a binding agreement to sell Anadarko's African assets to Total for $8.8B. Following the completion of the Mozambique transaction, Occidental and Total continue to work towards closing the remaining Africa transactions in Algeria, Ghana and South Africa pursuant to the definitive agreement signed in August. Sale of the Plains Stake: Occidental completed the sale of its holdings in Plains All American Pipeline, L.P. (PAA) and Plains GP Holdings, L.P. (PAGP) for $650M. Ecopetrol Joint Venture: In conjunction with Occidental's Q2 earnings, Occidental announced a strategic partnership with Ecopetrol (EC) to develop Midland Basin acreage for $750M in cash plus $750M in carried capital. The transaction is expected to close before year end. Occidental remains on track to deliver $10B-$15Bof planned asset sales and remains confident in its deleveraging strategy. Occidental will continue to take actions to drive value for all of the company's stakeholders.
GSUM

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05:16 EDT Gridsum co-CFO Michael Peng Zhang resigns, co-CFO Ravi Sarathy named CFO - Gridsum Holding announced that Ravi Sarathy, previously co-CFO of the company, has been appointed as the CFO of the company, effective September 30. Concurrently with this appointment, Michael Peng Zhang, previously co-CFO of the company, has resigned from his position and will continue to serve the company as Vice President in charge of corporate development.