Stockwinners Market Radar for October 09, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:36 EDT General Dynamics awarded $482.12M Navy contract modification - General Dynamics was awarded a $482.12M cost-plus-fixed-fee modification to previously awarded contract for lead yard support and development studies and design efforts related to Virginia-class submarines. Work is expected to be completed by October 2022. FY20 shipbuilding and conversion funds in the amount of $53.15M; FY21 shipbuilding and conversion funds in the amount of $28.62M; FY16 shipbuilding and conversion funds in the amount of $9.09M; FY19 shipbuilding and conversion funds in the amount of $6.39M; FY18 shipbuilding and conversion funds in the amount of $4.72M and FY21 research, development, test, and evaluation funds in the amount of $3.17M will be obligated at time of award, of which $3.17M will expire at the end of the current fiscal year. This contract was not competitively procured. The statutory authority for this sole source award is in accordance with Federal Acquisition Regulation 6.302-1 - only one responsible source and no other supplies or services will satisfy agency requirements. The Naval Sea Systems Command is the contracting activity.

16:57 EDT Bluebird Bio provides update on planned business separation - Bluebird bio announced the filing by 2seventy bio of an updated Form 10 Registration Statement with the U.S. SEC. This Form 10 reflects bluebird bio's plans for a tax-free spin-off of its oncology programs and portfolio into 2seventy bio as a publicly traded company. The spin-off is on track to be completed by early November. bluebird bio also announced the appointment of Najoh Tita-Reid and Sarah Glickman to the bluebird bio board of directors. Upon effectiveness of the Form 10, Glickman will also be a member of the board of directors of 2seventy bio and will step down from the bluebird bio board of directors upon completion of the spin-off. Upon separation, bluebird bio plans to distribute 100% of the outstanding shares of 2seventy bio common stock to bluebird's shareholders in a 3:1 ratio. For every three shares of bluebird bio stock, current shareholders will receive one share of 2seventy bio stock. The company anticipates that its cash, cash equivalents and marketable securities balance at separation will be approximately $1.0B, inclusive of proceeds from the recent sale of the company's manufacturing facility in North Carolina and its private placement equity financing. bluebird bio expects to fund 2seventy bio with approximately $480M in cash upon separation, with the balance to be retained by bluebird bio. Together with existing and emerging sources of revenue and other anticipated cash inflows, which includes the potential sale of priority review vouchers that would be issued with anticipated U.S. regulatory approvals of BLAs for bluebird's therapies in beta-thalassemia and cerebral adrenoleukodystrophy, the company expects its cash, cash equivalents and marketable securities balance will be sufficient to fund operations for bluebird bio and 2seventy bio into 2023 under current business plans.

16:32 EDT Autohome announces resignation of Chief Technology Officer Xiao Wang - Autohome announced that Xiao Wang has resigned as Chief Technology Officer of the company due to his other personal commitments, effective immediately. The company's board of directors has appointed Bibo Xiang as the new Chief Technology Officer effective immediately, in charge of the company's overall technology framework and development roadmap. Prior to joining Autohome, Xiang served as senior vice president of VIPKID, and Chief Technology Officer of Koolearn Technology Holding.

16:17 EDT Amerco announces special cash dividend of 50c per share - Amerco declared a special cash dividend on its common stock of 50c per share. The dividend will be payable October 29 to holders of record on October 18.

16:05 EDT Renren signs stipulation of settlement for shareholder derivative litigation - Renren announced that it has entered into a stipulation of settlement as a nominal defendant with respect to the consolidated shareholder derivative lawsuits currently pending in New York State Supreme Court, Commercial Division. The other parties to the stipulation include Oak Pacific Investment and the other named defendants in the action, as well as Heng Ren Silk Road Investments, Oasis Investments II and Jodi Arama who have purported to bring claims derivatively on behalf of Renren. If the stipulation and the settlement and resolution of the action contemplated therein is approved by the court and the settlement becomes effective, then, among other things, the action will be dismissed with prejudice, the release of the released plaintiffs' claims will become effective, and the administrator approved by the court will distribute the settlement fund pursuant to the settlement. In connection with the settlement, the defendants will create a common settlement fund, which amount, before any reductions for settlement fund expenses, will be the greater of $300,000,000 or the sum of $38.6866 per ADS multiplied by the number of issued and outstanding ADSs held by Renren Shareholders as of the record date and $0.859701 per Class A ordinary share multiplied by the total number of issued and outstanding Class A ordinary shares held by Renren Shareholders as of the record date.

15:25 EDT Facebook says aware some people having trouble accessing apps - Facebook tweeted from its official corporate account: "We're aware that some people are having trouble accessing our apps and products. We're working to get things back to normal as quickly as possible and we apologize for any inconvenience." Reference Link

14:58 EDT RedBall Acquisition Corp trading resumes

14:17 EDT Humana says 97% of MA members in contracts rated 4-star or higher for 2022 - Humana announced the Medicare Star Ratings for its Medicare Advantage, or MA, plans, effective January 1, 2022, from the Centers for Medicare and Medicaid Services, or CMS. "With these results, Humana's Star Ratings continue to reflect the company's strong focus on ensuring high quality of care, patient-centered clinical outcomes and reliable customer service for its members. Humana increased the number of contracts that received a 5-star rating on CMS's 5-star rating system from one contract in 2021 to four contracts in 2022, the most in the company's history, including HMO plans in Florida, Louisiana, Tennessee and Kentucky covering approximately 527,000 members... In addition, Humana received a 4.5-star rating for eight MA contracts offered in 33 states and Puerto Rico. In all, Humana has 41 rated contracts to be offered in 2022, 32 of which are rated 4-stars or higher and currently cover 4.8 million members, representing 97% of its existing MA membership in rated contracts as of September 2021. Over 99% of retirees in Humana's Group Medicare Advantage plans remain in 4-star or above contracts for 2022," the company stated.

13:51 EDT Relay Therapeutics trading halted, volatility trading pause

13:03 EDT Baker Hughes reports U.S. rig count up 5 to 533 rigs - Baker Hughes reports that the U.S. rig count is up 5 from last week to 533 with oil rigs up 5 to 433, gas rigs unchanged at 99, and miscellaneous rigs unchanged at 1. The U.S. Rig Count is up 264 rigs from last year's count of 269, with oil rigs up 240 gas rigs up 26 and miscellaneous rigs down 2 to 1. The U.S. Offshore Rig Count is down 2 to 11, down 3 year-over-year. The Canada Rig Count is up 2 from last week to 167, with oil rigs down 2 to 95, gas rigs up 4 to 72. The Canada Rig Count is up 87 rigs from last year's count of 80, with oil rigs up 56, gas rigs up 31.

12:46 EDT Triple-S: Triple-S Advantage HMO Medicare offering receives 4.5 star rating - Triple-S Management Corporation announced that for 2022 its Triple-S Advantage coordinated care contract (HMO H5774) received a quality rating of 4.5 stars out of a maximum possible rating of 5 stars by the Centers for Medicare & Medicaid Services, the regulatory agency for Medicare Advantage plans. In addition, its preferred provider contract increased its quality rating to 4 stars, while Triple-S's Part D plan for both the HMO and PPO contracts received a maximum 5-star rating, Triple-S said in a statement. "This recognition reflects our commitment to providing excellent service to our members and other stakeholders, and the quality of our clinical programs that facilitate continuity of holistic care," said Roberto Garcia-Rodriguez, President and CEO.

12:02 EDT Skillz falls -7.1% - Skillz is down -7.1%, or -62c to $8.22.

12:01 EDT Blue Apron falls -11.4% - Blue Apron is down -11.4%, or -90c to $6.99.

12:00 EDT Macquarie Infrastructure rises 11.7% - Macquarie Infrastructure is up 11.7%, or 39c to $3.70.

11:43 EDT Roche's gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer's - Roche announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of people living with Alzheimer's disease. This designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of AD, in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as other studies. "Learnings from these studies have been incorporated into the optimized design of two ongoing parallel, global, placebo-controlled and randomized Phase III trials, GRADUATE 1 and 2. The pivotal trials are evaluating gantenerumab in more than 2,000 participants for more than two years and are expected to be completed in the second half of 2022," Roche said.

11:29 EDT Nvidia acquires formal verification 'expert' Oski Technology - Jonah Alben of Nvidia stated in a blog post: "We are excited to announce that Oski Technology, a company specializing in formal verification methods, will be joining NVIDIA. Modern processors pack tens of billions of transistors, tiny on/off switches connected by billions of microscopic pathways. A bug in a single transistor can prevent a chip from operating correctly, requiring costly revisions to fix... Formal verification, Oski's specialty, is a powerful alternative that uses mathematical analysis of a design instead of simulations to prove that a particular feature behaves correctly for all possible inputs... In the semiconductor industry, Oski is well known for its leading edge work in formal verification... Oski has since grown to become a well-recognized leader in the field and has been a valued partner to NVIDIA for more than 10 years... As NVIDIA's products have grown in complexity and scope, now spanning markets from gaming and data center computing to networking and autonomous vehicles, the importance of designing perfect first silicon has never been higher. And new autonomous machine applications where safety is the highest goal make verification vital. With this acquisition, we have the opportunity to dramatically increase our investment in and commitment to formal verification strategies to achieve that goal. Powerful verification methods directly enable more rapid innovation, and we are very excited to join forces with the Oski team to deliver even more amazing products for years to come." Reference Link

11:03 EDT Hyundai Motor, Shell enter agreement for hydrogen infrastructure development - Hyundai Motor North America (HYMTF) has joined Equilon Enterprises, also referred to as Shell Hydrogen (RDS.A), to encourage growth of the hydrogen refueling infrastructure in California. The agreement, known as Project Neptune, supports Shell Hydrogen's construction of 48 additional and two upgraded hydrogen refueling stations across the eco-leading Golden State beginning in 2021. In its portion of the agreement, Hyundai has committed to fuel cell vehicle sales growth supporting the expanding hydrogen infrastructure. The company said, "Hydrogen refueling infrastructure growth is critical to rapidly increase consumer adoption of zero-emission fuel cell vehicles. By joining Project Neptune, Hyundai reinforces its commitment to fuel cell technologies and their positive impact on the environment, a key pillar of its long-range strategic vision. The new hydrogen stations will be partially funded by public funds from the California Energy Commission. Two other fuel cell vehicle manufacturers have also joined the consortium with respective agreements for fuel cell vehicle sales to support infrastructure growth."

10:00 EDT Huaneng Power falls -5.3% - Huaneng Power is down -5.3%, or -$1.09 to $19.73.

10:00 EDT Sibanye Stillwater rises 8.5% - Sibanye Stillwater is up 8.5%, or $1.12 to $14.41.

10:00 EDT Renren rises 26.3% - Renren is up 26.3%, or $4.36 to $20.96.

09:52 EDT Renren trading resumes

09:47 EDT Direxion Daily Gold Miners Bear 3X ETF falls -6.1% - Direxion Daily Gold Miners Bear 3X ETF is down -6.1%, or -$1.39 to $21.27.

09:47 EDT Renren trading halted, volatility trading pause

09:47 EDT Macquarie Infrastructure rises 10.2% - Macquarie Infrastructure is up 10.2%, or 34c to $3.65.

09:34 EDT Cloudera completes agreement to become a private company - Cloudera announced the completion of its previously announced agreement to be acquired by affiliates of Clayton, Dubilier & Rice and KKR in an all cash transaction valued at approximately $5.3B. Cloudera common stock has ceased trading and is no longer listed on the New York Stock Exchange. Cloudera delivers a hybrid cloud platform that enables enterprises to access and analyze data across public and private clouds as well as on premises to deliver flexibility, performance, speed and control. Cloudera will continue to be led by CEO Rob Bearden.

09:16 EDT Powerbridge unit to launch cryptocurrency mining in Hong Kong - Powerbridge Technologies is proud to announce that Powercrypto Holdings, a subsidiary of the company, is launching cryptocurrency mining, specifically bitcoin and ethereum, in Hong Kong. These cryptocurrency operations will utilize environmental-friendly, green and sustainable energy. Powercrypto expects to complete the deployment of 2,600 high-performance mining rigs in Hong Kong, encompassing 600 high-performance BTC mining machines with a hashrate of approximately 60 PH/s, and 2,000 high-performance ETH mining machines with a hashrate of approximately 1,000 GH/s.

09:02 EDT Newmark arranges $147.5M sale of industrial distribution project in San Diego - Newmark announces it has arranged the sale of North County Corporate Center, a five-building, 493,898-square-foot, institutional-quality industrial campus in Vista, California.

08:58 EDT Fidelity National's F&G acquires 30% ownership stake in Freedom Equity Group - F&G, part of the FNF family of companies, announced a 30% ownership stake in Freedom Equity Group, a Life IMO and longtime F&G partner. The opportunity brings new distribution capacity for F&G to fuel growth in middle market indexed universal life sales.

08:47 EDT ChemoCentryx jumps 71% to $33.60 after FDA approval of TAVNEOS

08:37 EDT Turning Point Therapeutics presents TRIDENT-1 clinical data for repotrectinib - Turning Point Therapeutics announced the presentation of early clinical data from the NTRK-positive TKI-naive and TKI-pretreated advanced solid tumor cohorts of the ongoing TRIDENT-1 Phase 1/2 study of its lead drug candidate repotrectinib. Mohammad Hirmand chief medical officer said, "Based on these findings... we look forward to discussing next steps toward potential registration of repotrectinib in this patient population at a Type B meeting with the FDA anticipated in the first half of 2022." The safety analysis includes 301 treated patients from the pooled Phase 1 and Phase 2 portions of TRIDENT-1 across all cohorts, and the preliminary efficacy analysis includes 40 evaluable patients from the pooled Phase 1 and Phase 2 portions of TRIDENT-1 in the NTRK-positive advanced solid tumor cohorts. In the NTRK-positive TKI-naive advanced solid tumor population, the confirmed Objective Response Rate, cORR, was 41%. At the time of the data cutoff, three patients with limited time on treatment achieved stable disease with tumor regression of -21%, -23%, and -27% on their first post-baseline scans. Duration of response ranged from 1.9+ to 7.4+ months. In the NTRK-positive TKI-pretreated advanced solid tumor population, the cORR was 48%. As of the cutoff date, three patients had unconfirmed partial responses. Two uPRs have been confirmed since the cutoff date and are included in the cORR. The 48% cORR is an update since the pre-recorded presentation. Duration of response ranged from 0.9+ to 15.1 months. Of the 23 NTRK-positive TKI-pretreated advanced solid tumor patients, 13 had NTRK solvent front mutations. In these 13 patients, the cORR was 62% including one patient who had a complete response. As of the cutoff date, three patients had unconfirmed partial responses. Duration of response ranged from 0.9+ to 13.7 months. Preliminary Safety Analysis: Repotrectinib was generally well tolerated. The most frequently reported treatment-emergent adverse event was low-grade dizziness of which 76% of reported cases were grade 1. Eleven patients reported ataxia in the absence of dizziness. No events of dizziness or ataxia led to treatment discontinuation. Dose modifications due to TEAEs included 27% of patients who had dose reduction and 11% who had drug discontinuation. Turning Point also announced the publication of preclinical data of repotrectinib in the American Association of Cancer Research's peer reviewed journal, Molecular Cancer Therapeutics. Preclinical studies described in the publication titled "Molecular Characteristics of Repotrectinib That Enable Potent Inhibition of TRK Fusion Proteins and Resistant Mutations" show that repotrectinib potently inhibited TRK fusion proteins and resistance mutations. Repotrectinib was the most potent inhibitor of wild-type TRKA/B/C fusions and was more potent than selitrectinib against all tested resistance mutations.

08:36 EDT Prospect Capital announces launch of cash tender offer for notes due 2024 - Prospect Capital Corporation announced that it has commenced a cash tender offer to purchase any and all of the outstanding notes listed below. The Tender Offer will expire at 5:00 p.m., New York City time, on October 15, 2021, or any other date and time to which the Company extends such Tender Offer. The Tender Offer is made pursuant to an Offer to Purchase dated today, which set forth the terms and conditions of the Tender Offer. The consideration to be paid for each $1,000 principal amount of Notes that are validly tendered and not validly withdrawn on or prior to the Expiration Time is $1,077.50, plus accrued and unpaid interest on the Notes, if any, from the applicable last interest payment date up to, but not including, the Settlement Date. The Company will purchase any Notes that have been validly tendered at or prior to the Expiration Time and accepted for purchase, subject to all conditions to the Tender Offer having been either satisfied or waived by the Company, promptly following the Expiration Time. Assuming the Tender Offer is not extended, the Company expects that the Tender Offer will settle and payment will be made on October 20, 2021.

08:33 EDT Big 5 Sporting appoints Lily Chang to board of directors - Big 5 Sporting Goods Corporation announces the appointment of Lily Chang to its Board of Directors, effective October 7, 2021. Ms. Chang is currently the Chief Portfolio Services Officer of Leonard Green & Partners. Additionally, the Company announced today that Sandra Bane has informed the Company that she intends to retire from the Company's Board of Directors, effective as of November 15, 2021.

08:31 EDT TimkenSteel, USW Local 1123 reach tentative agreement on new four-year contract - TimkenSteel and the United Steelworkers Local 1123 have reached a tentative agreement for a new four-year contract. The date of the vote will be set and announced by the union. The tentative agreement provides increases to base wages every year, competitive healthcare and retirement benefits for all members, and a continued focus on employee wellbeing as well as safe and sustainable operations. The current agreement covers approximately 1,180 bargaining employees at the company's Canton, Ohio operations.

08:28 EDT Rogers Corporation acquires Silicone Engineering, sees accretion - Rogers Corporation announced its acquisition of Silicone Engineering, a European manufacturer of silicone material solutions based in Lancashire, UK. Silicone Engineering expands Rogers' existing advanced silicones platform and provides Rogers a European Center of Excellence to service customers requiring silicone solutions for applications in the EV/HEV, industrial, medical and other markets. The transaction closed October 8. Terms were not disclosed. Rogers expects the transaction to be accretive to 2022 earnings per share. Trailing twelve month revenues for Silicone Engineering were approximately GBP 30M, and Silicone Engineering's profitability is comparable to that of the elastomeric material solutions business unit.

08:17 EDT Rise Education receives Nasdaq notice of non-compliance - Rise Education announced that it received a letter dated September 27 from the Listing Qualification Department of The NASDAQ Stock Market indicating that the company is not in compliance with the minimum bid price requirement of $1.00 per share under the Nasdaq Listing Rules. Based on the closing bid price of the company's listed securities for the last 30 consecutive business days from August 13 through September 24, the company no longer meets the minimum bid price requirement set forth in Listing Rule 5550(a)(2). The company intends to monitor the closing bid price of its listed securities and is considering the options available to it to regain compliance with the Listing Rules within the compliance period.

08:06 EDT Fortress Biotech, Cyprium Therapeutics announce clinical data for CUTX-101 - Cyprium Therapeutics, a Fortress Biotech partner company, with support from its licensing partner Sentynl Therapeutics, a wholly owned subsidiary of Cadila Healthcare, announced "positive" results from an efficacy and safety analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101, copper histidinate. In both pre-specified primary and secondary efficacy analyses, treatment with CUTX-101 demonstrated a significantly greater median overall survival compared to untreated historical control patients. These data will be presented as a virtual poster at the 2021 American Academy of Pediatrics National Conference & Exhibition. "There is a significant unmet need for an approved treatment for patients with Menkes disease. These positive data demonstrate the potential of CUTX-101 to be an effective therapy for patients with this devastating disease. We look forward to working with the U.S. Food and Drug Administration to begin our rolling submission of a new drug application for CUTX-101 in the fourth quarter of this year," said Lung Yam, M.D., Ph.D., President and Chief Executive Officer of Cyprium. In two completed open-label, single-arm, single-site studies, 129 patients with Menkes disease were treated with CUTX-101 administered subcutaneously twice daily until 12 months of age, and once daily thereafter, for a total duration of up to three years. Sixty-six patients born after 1999 and with severe loss-of-function ATP7A mutations from these two studies were combined and categorized into an Early Treatment cohort and a Late Treatment cohort. Efficacy of CUTX-101 was assessed by comparing CuHis-ET to untreated HC-ET, and CuHis-LT to untreated HC-LT, using OS as the primary and secondary efficacy endpoints, respectively. The primary efficacy endpoint comparing CuHis-ET to HC-ET and the secondary efficacy endpoint comparing CuHis-LT to HC-LT were both met. Overall, a 79% reduction in risk of death was observed in CuHis-ET patients compared with HC-ET patients and median OS was 177.1 and 16.1 months, respectively with a hazard ratio of = 0.208. A 75% reduction in the risk of death was also observed in CuHis-LT patients compared with HC-LT subjects and median OS was 62.4 and 17.6 months, respectively; HR = 0.253. Clinical benefit was greater for patients who were treated within four weeks of birth with CUTX-101. A newborn screening test for Menkes disease is currently in development. CUTX-101 was shown to be well tolerated. In CuHis-ET and CuHis-LT cohorts, the most common treatment emergent adverse events were pneumonia, seizures, dehydration, failure to thrive, and respiratory distress and no patient discontinued due to an adverse event considered related to treatment.

08:03 EDT FOREWARN partners with Northern Virginia Association of REALTORS - FOREWARN announced that the Northern Virginia Association of REALTORS has contracted to make FOREWARN services available for the 13,000+ REALTOR members it serves throughout Arlington County, Fairfax County, City of Fairfax, City of Falls Church, Town of Vienna, and City of Alexandria to promote proactive real estate agent safety.

07:47 EDT Dundee Precious Metals reports 71.7K oz of gold produced in Q3 - Dundee Precious Metals announced preliminary production results from both of its mines and the smelter for the three and nine months ended September 30, 2021. During the quarter, we continued to deliver strong operating performance at both of our mines, as well as improving smelter performance," said David Rae, President and Chief Executive Officer of Dundee Precious Metals. "We are also encouraged by the progress being made at our Loma Larga project and the government support we are seeing in Ecuador, following closing of the acquisition in the quarter." Ada Tepe continued its track record of strong performance during the third quarter, producing approximately 33,300 gold ounces, which was better than planned as a result of higher-than-expected gold grades. Chelopech also performed well during the third quarter, producing approximately 38,400 ounces of gold and 8.4 million pounds of copper, reflecting mining of lower copper and gold grade zones. Both Chelopech and Ada Tepe are on track to achieve 2021 production guidance. The Tsumeb smelter processed approximately 55,100 tonnes of complex concentrate during the third quarter, in line with recent quarterly performance but below expectation. As a result of a water leak in the offgas system, which has the potential to result in additional unplanned maintenance downtime, Tsumeb is expected to be at or below the low end of the guidance range of 200 to 220 thousand tonnes for 2021. In the third quarter, DPM completed the acquisition of the high-quality, advanced stage Loma Larga gold project in Ecuador. Following closing, the Company has been focused on integration activities, stakeholder engagement and a review of the technical studies and permitting schedule. The Company is also progressing discussions in respect of an investor protection agreement with the government of Ecuador. Key milestones and progress against these milestones will be further communicated alongside quarterly reporting. A drill program focused on geotechnical drilling, condemnation drilling at the planned location of facilities, and extensional exploration drilling is expected to commence in the fourth quarter of 2021.

07:35 EDT Shawcor CFO Gaston Tano to step down - Shawcor announced that Gaston Tano, SVP Finance & CFO, has elected to step down and will depart the Company effective May 31, 2022. Shawcor also announced that Thomas Holloway will join the Company as VP & Chief Accounting Officer, commencing on or about December 1, 2021 and is expected to succeed Tano as the SVP Finance & CFO. In his interim role, Mr. Holloway will immediately assume responsibility for the Company's financial accounting and related reporting activities and will report to Gaston Tano, Shawcor's SVP & CFO. Tano will continue to actively lead Shawcor's finance function. Consistent with the Company's past executive succession practice,Tano will engage in a robust transition process with Holloway to enable a seamless transfer of responsibilities.

07:30 EDT ChemoCentryx trading resumes

07:05 EDT Oshkosh drops 4% to $101.98 after Q4 guidance misses estimates

07:03 EDT ChemoCentryx announces FDA approval of TAVNEOS in ANCA-associated vasculitis - ChemoCentryx announced that the U.S. Food and Drug Administration has approved TAVNEOS, an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, or ANCA vasculitis, specifically granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy. ANCA-associated vasculitis is a systemic autoimmune disease in which over-activation of the complement system further activates neutrophils, leading to inflammation and eventual destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is often fatal if not treated. "Today is a momentous day in the history of ChemoCentryx; the culmination of decades of effort aimed at offering new hope to patients with this and other debilitating and deadly diseases," said Thomas Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We look forward to making TAVNEOS available to clinicians and patients in the next few weeks. We thank the Agency for their collaboration and consideration and we are also immensely grateful to the pioneering scientists, clinicians and patients who believed in the promise of TAVNEOS and who have worked tirelessly to make it a reality, along with my dedicated and talented colleagues at ChemoCentryx." TAVNEOS is the first FDA approved orally-administered inhibitor of the complement C5a receptor. The approval in ANCA-associated vasculitis was supported by the results of the Phase III ADVOCATE trial. Eligible study subjects were randomized to receive either rituximab or cyclophosphamide and either TAVNEOS or study-supplied oral prednisone. The study met its primary endpoints of disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score, or BVAS. The study demonstrated superiority to a prednisone-based standard of care with respect to sustained remission at 52 weeks.

06:55 EDT ChemoCentryx trading halted, news pending

06:34 EDT Air Lease provides Q3 update on aircraft investments, sales, financing - Air Lease (AL) announced an update on aircraft investments, sales, and new significant financing occurring in the third quarter. As of September 30, ALC's fleet was comprised of 370 owned aircraft and 89 managed aircraft, with 320 new aircraft on order from Boeing (BA) and Airbus (EADSY) set to deliver through 2027. Aircraft Investments: Delivered sixteen new aircraft from ALC's order book including one Airbus A320neo, six Airbus A321neos, seven Boeing 737-8s, and two Boeing 737-9s. Aircraft investments in the quarter totaled approximately $800M, with the majority occurring in the second half of the quarter. Sales: No aircraft sales occurred during the quarter. Financing: Issued $1.1B of senior unsecured medium-term notes comprised of $600M of 0.80% senior unsecured medium-term notes due 2024, and $500M of 2.10% senior unsecured medium-term notes due 2028. Upsized senior unsecured revolving credit facility to $6.5B from $6.4B.

06:27 EDT Codiak notified by Sarepta of Research License and Option Agreement termination - In a regulatory filing, Codiak (CDAK) states: "On October 1, 2021, Sarepta Therapeutics (SRPT) notified Codiak BioSciences that it was terminating early the two-year Research License and Option Agreement, effective June 17, 2020, between Sarepta and the company. The notice was given pursuant to Section 11.2 of the Agreement, which provides that Sarepta could terminate the Agreement for any reason or no reason at any time upon 60 days' prior written notice to Codiak. The termination will be effective as of December 3, 2021. As previously disclosed, the Agreement focused on the use of exosomes for non-viral delivery of AAV, gene-editing and RNA therapeutics to address five agreed targets associated with neuromuscular diseases. Pursuant to the Agreement, the company received funding to conduct collaborative research and Sarepta had options to enter into exclusive, worldwide licenses for each of the agreed targets to develop, commercialize and manufacture therapeutic candidates developed using the company's engEx Platform. Under the terms of the Agreement, the company received up-front and non-refundable cash payments totaling $10.0M, consisting of a $7.0M up-front payment and a $3.0M up-front research services prepayment. Under the terms of the Agreement, the company granted to Sarepta a non-exclusive, royalty-free, worldwide license, with a limited right to sublicense, to use certain intellectual property of the company in the conduct of activities for which Sarepta was responsible under the Agreement. The company also granted to Sarepta an option to obtain an exclusive, worldwide, sublicensable license to use certain intellectual property of the company for the development, manufacturing and commercialization of exosome therapeutic candidates directed to one or more of the five agreed targets. As a result of the termination, each of the license and option granted to Sarepta shall terminate in its entirety, according to the terms of the Agreement, and the company shall regain all rights previously granted to Sarepta."

06:06 EDT Facebook rebrands social VR platform to 'Horizon Worlds' - Facebook said in a statement: "When we launched Horizon's invite-only beta last year, we started to build a creator-friendly space in VR with best-in-class social world-building tools. We've spent the past year developing those tools and improving them based on creator feedback. These early creators have grown the social experiences on the Horizon platform, and we've been amazed by their imagination and creativity on display. We're excited to do more to support them, so starting today, we're launching new initiatives to recognize the efforts of Horizon creators and continue to grow the creator and developer community. We're announcing a $10 million Creator Fund to encourage more people to come build with us as we continue rolling out Horizon in beta. And as we grow the social experiences that are part of Horizon, we're rolling out a new name for this experience: Horizon Worlds. Later this year, we'll launch a series of creator competitions to reward people building the very best worlds in Horizon and who are taking advantage of the tools we offer. We'll offer up to $10k in cash prizes for the first-, second- and third-place winners. We'll also continue our Creator Accelerator Program, an application-based initiative designed to give people from diverse backgrounds an advanced crash course in Horizon Worlds creation." Reference Link

06:01 EDT Relay Therapeutics announces interim clinical data for RLY-4008 - Relay Therapeutics announced interim clinical data for RLY-4008, a highly selective irreversible and oral small molecule inhibitor of FGFR2, in a first-in-human trial in patients with FGFR2-altered cholangiocarcinoma and multiple other solid tumors. The data are being presented on October 8 at the virtual AACR-NCI-EORTC Molecular Targets Conference and suggest that RLY-4008 is the first investigational therapy designed to selectively bind to FGFR2 to avoid off-isoform toxicities for the treatment of patients with FGFR2-altered tumors. As will be presented at the conference, study investigators reported robust inhibition of FGFR2 in the first 49 subjects that was not shown to be limited by off-target toxicities, including hyperphosphatemia and diarrhea, in the interim clinical data. The initial toxicity data suggest that certain dose levels administered can achieve greater than85% continuous inhibition of FGFR2. At those levels, acute toxicities that would limit dose intensity have generally not been observed to date. The interim clinical data included results from FGFR2-altered solid tumors, with approximately 80% of all patients treated achieving reductions in tumor size at the cut-off date of September 9, 2021. In pan-FGFRi treatment-naive cholangiocarcinoma patients, RLY-4008 demonstrated tumor shrinkage in all six pan-FGFR treatment-naive FGFR2 fusion positive cholangiocarcinoma patients, with three achieving confirmed partial responses. Three of these six patients remain on study and a fourth patient went on to surgery with curative intent. Relay Therapeutics anticipates selecting a once daily recommended Phase 2 dose and initiating expansion cohorts prior to the end of 2021.

05:21 EDT Humanigen enters deal with Clinigen for managed access program for lenzilumab - Humanigen announced it has entered into an arrangement with Clinigen, a global pharmaceutical services and products company, to implement a managed access program for lenzilumab. LenzMAP will enable access to lenzilumab on a case-by-case basis for hospitalized patients with COVID-19 where the treating physician deems there to be no suitable alternatives and where regulations allow. LenzMAP will be available in the following 16 European countries: Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, France, Greece, Ireland, Lithuania, Luxembourg, Netherlands, Portugal, Spain, Sweden, and Switzerland. To date there have been over 20M cases of COVID-19 reported in these countries. Lenzilumab is an investigational product and is not currently authorized or approved in any country. Under the terms of the agreement, Clinigen will manage key elements of the program including regulatory oversight, logistics and access management.

05:08 EDT 21Vianet announces approval of name change to VNET Group - 21Vianet announced the results of its 2021 extraordinary general meeting which was held on October 8 in Beijing, where it adopted a special resolution to approve the change of the company's name to VNET Group, effective immediately.