Stockwinners Market Radar for December 13, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:44 EST Cathie Wood's ARK Investment bought 261K shares of Robinhood on Monday

20:42 EST Cathie Wood's ARK Investment bought 50.9K shares of Coinbase on Monday

20:31 EST JetBlue announces five-year contract ratification for crewmembers - The company states: "JetBlue with its inflight crewmembers, represented by the Transport Workers Union, announced the ratification of a five-year contract."

19:57 EST AstraZeneca, Samsung Biologics expand partnership to include COVID therapy - Samsung Biologics announced that it "continues its strategic biopharmaceutical manufacturing collaboration with AstraZeneca. The partnership is based on an expanded deal this year in May 2021 which followed the signing of a long-term strategic agreement made in September 2020. Under the agreement, valued at approximately $380M up from the initial $331 million for the production of drug substance and drug product, Samsung Biologics manufactures AstraZeneca's COVID-19 long-acting antibody combination, AZD7442, and will start to manufacture a cancer immunotherapy product from next year. AZD7442 is a combination of two LAABs being developed for the prevention and treatment of COVID-19. AZD7442 is the first LAAB to receive an EUA from the FDA for COVID-19 prevention and it has received authorizations from the US, France, Italy, and Bahrain. AZD7442 has the potential to complement national vaccination programs by providing additional protection for those considered at increased risk of an inadequate response to a COVID-19 vaccine, including people who are immunocompromised, patients on dialysis, oncology patients, those taking medications after an organ transplant or those who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis."

19:20 EST Mesoblast notified by Novartis about terminating agreement - Mesoblast Limited (MESO) was notified today by Novartis (NVS) that it has chosen to terminate the agreement with Mesoblast prior to closing. Mesoblast said it remains highly focused on executing on our short term objective to bring remestemcel-L to market for patients with acute respiratory distress syndrome due to COVID-19. The observed mortality reduction with remestemcel-L in patients aged under 65 in the completed COVID ARDS trial, despite having missed the primary endpoint, is considered by Mesoblast to be a sufficiently strong signal to support pursuing an emergency use authorization, the most direct path to market. Mesoblast is preparing to initiate a pivotal Phase 3 trial that may support a COVID ARDS EUA. COVID-19 is likely to remain a serious global problem and to provide a major commercial opportunity for Mesoblast, with a steady state of intensive care unit ARDS patients irrespective of vaccines and anti-viral treatments. Variants including Omicron present a growing threat due to increased infectivity and immune evasion from vaccines and monoclonal antibodies, increasing the urgent need for therapeutics to prevent the likely high mortality of those progressing to ICU and ARDS.

19:13 EST CECO Environmental director buys $183K in common stock - In a regulatory filing, CECO Environmental disclosed that its director Richard Wallman bought 30K shares of common stock for about $183K on December 9th, boosting his stake by about 84%.

18:54 EST YouTube says it is in talks with Disney over YouTube TV content - Alphabet's (GOOGL) YouTube said in a blog post that it is in negotiations with Disney (DIS) to continue distributing their content on YouTube TV so users can continue watching everything from ESPN to The Bachelor to Good Morning America. "Our deal expires on Friday, December 17, and we haven't been able to reach an equitable agreement yet, so we wanted to give you an early heads up so that you can understand your choices," YouTube said. "Disney is an important partner for us and we're in active conversations with them and working hard to keep their content on YouTube TV. Our ask to Disney, as with all our partners, is to treat YouTube TV like any other TV provider - by offering us the same rates that services of a similar size pay, across Disney's channels for as long as we carry them."

18:43 EST CI Financial reports preliminary AUM $149.4B at November 30 - CI Financial reported preliminary assets under management as at November 30 of $149.4B and wealth management assets of $188.7B, for total assets of $338.1B.

18:41 EST Sierra Oncology's ferritin data predicts Myelofibrosis transfusion independence - Sierra Oncology "announced data from new retrospective analyses of the Phase 3 SIMPLIFY studies demonstrate baseline ferritin differentially predicts Week 24 Transfusion Independence Response for momelotinib and ruxolitinib in patients with myelofibrosis. The data were presented at the 63rd American Society of Hematology Annual Meeting being held virtually and in Atlanta, GA December 11-14, 2021. Key results for SIMPLIFY-1 include: Ruxolitinib was associated with a significantly greater increase in ferritin levels over time compared with momelotinib, irrespective of baseline ferritin, highlighting the differential treatment impact on serum ferritin between the two agents. Baseline hemoglobin, an indicator of anemic status, differentially predicted Week 24 TI-R in patients randomized to momelotinib or ruxolitinib. Baseline ferritin also differentially predicted Week 24 TI-R in patients randomized to momelotinib or ruxolitinib. In patients with baseline Hgb less than12 g/dL, baseline ferritin levels provided additional, differential predictive value for Week 24 TI-R. No correlation was observed between baseline ferritin and Week 24 splenic or symptom response rates."

18:23 EST Beyond Air CEO buys $341K in common stock - In a regulatory filing, Beyond Air disclosed that its CEO Steven Lisi bought 40K shares of common stock for $341K on December 10th, boosting his stake by about 4%.

18:04 EST Johnson Controls general counsel sells $2.5M in common stock - In a regulatory filing, Johnson Controls disclosed that its General Counsel John Donofrio sold 31.8K shares of common stock for about $2.5M on December 13th, reducing his stake by about 47%.

18:01 EST Global Water Resources to acquire Farmers Water Co - Global Water Resources announces it has "signed a Letter of Intent to acquire Farmers Water Co., a subsidiary of Farmers Investment Co., located in Pima County, Arizona. The acquisition, if completed, would add approximately 3,300 active water service connections in Sahuarita and surrounding unincorporated Pima County to the Global Water family of companies. The primarily residential connections are in close proximity to the service area of Global Water's recently acquired Las Quintas Serenas, Francesca, Mirabell, and Red Rock water companies. The next steps in the acquisition process include the completion of due diligence, execution of definitive agreements, and other customary conditions and approvals."

17:56 EST 'Call of Duty: Vanguard' debuted as best-selling U.S. game in November, says NPD - NPD analyst Mat Piscatella said that Activision Blizzard's (ATVI) "Call of Duty: Vanguard" debuted as November's best-selling game in the U.S., instantly becoming the 2nd best-selling game of 2021 to date. This is the 14th consecutive year a "Call of Duty" game has ranked as the best-selling game of its release month. Electronic Arts' (EA) "Battlefield 2042" launched as the #2 best-selling game of November, ranking as the 6th best-selling game year to date. "Battlefield 2042" was the 2nd best-selling game of November on both PlayStation (SONY) and Xbox (MSFT) platforms. Xbox Game Studios' "Forza Horizon 5" set a new "Forza" franchise launch month sales record while ranking as the 4th best selling game of November 2021. "Forza Horizon 5" was the #3 best-selling game on Xbox platforms in the month. Sega's (SGAMY) "Shin Megani Tensei V" achieved the highest launch month dollar sales of any "Shin Megami Tensei" title in history. "Shin Megami Tensei V" ranked as the 16th best-selling game of November 2021 while also ranking 6th on Nintendo (NTDOY) platforms. Other top sellers in the U.S. in November include Nintnedo's "Pokemon Brilliant Diamond/Shining Pearl," EA's "Madden NFL 22," Nintendo's "Mario Party Superstars," Square Enix's (SQNXF) "Marvel's Guardians of the Galaxy," Ubisoft's (UBSFY) "Far Cry 6," and Take-Two's (TTWO) "NBA 2K22." Reference Link

17:46 EST MGM Resorts to sell Mirage Hotel & Casino for $1.075B in cash - MGM Resorts International announced it has reached an agreement to sell the operations of The Mirage Hotel & Casino to Hard Rock International for $1.075 billion in cash, subject to customary working capital adjustments. Under the terms of the agreement, MGM Resorts will retain The Mirage name and brand, licensing it to Hard Rock royalty-free for a maximum period of three years while it finalizes its plans to rebrand the property. The transaction is expected to close in the second half of 2022, subject to regulatory approvals and other customary closing conditions.

17:26 EST MagnaChip, Wise Road Capital to terminate previously announced merger pact - Magnachip Semiconductor and South Dearborn Limited, a company incorporated in the Cayman Islands, and Michigan Merger Sub, Inc., a Delaware corporation, which are investment vehicles established by Wise Road Capital LTD and certain of its limited partners, announced that they received permission from the Committee on Foreign Investment in the United States to withdraw their joint CFIUS filing in relation to their proposed transaction and will be terminating their previously announced definitive merger agreement. This course of action resulted from the inability of the parties, despite months of effort, to obtain CFIUS's approval for the Merger. In connection with the termination of the merger agreement, South Dearborn will pay the Company a termination fee of $70.2M, of which $51M will be paid promptly and $19.2M will be deferred up to March 31, 2022. In connection with the termination of the merger agreement, the parties will be releasing each other from all obligations with respect to the proposed merger transaction as well as from any claims arising out of or relating to the merger agreement. The company also intends to have Magnachip Semiconductor, Ltd., the Korean operating subsidiary of the company, withdraw its application concerning the Merger that had been submitted to the Korean Ministry of Trade, Industry and Energy under Article 11-2 of the Act on Prevention of Divulgence and Protection of Industrial Technology.

17:20 EST Raytheon Technologies awarded $145.29M Navy contract modification - Raytheon Technologies was awarded a $145.29M cost-plus-incentive-fee modification to a previously awarded contract. This modification exercises options to procure material and support equipment for depot maintenance facilities as well as supplies, services, and planning for depot activations in support of F-35 aircraft sustainment efforts for the Air Force, Marine Corps, Navy, and non-U.S. Department of Defense, or DOD, participants. Work is expected to be completed in September 2024. FY21 aircraft procurement funds in the amount of $59.53M, FY21 aircraft procurement funds in the amount of $59.53M and non-U.S. DOD participant funds in the amount of $26.23M will be obligated at time of award, none of which will expire at the end of the current fiscal year. The Naval Air Systems Command is the contracting activity.

17:17 EST TeraWulf completes business combination with IKONICS - TeraWulf (WULF) "announced that it has completed its previously announced business combination with IKONICS Corporation (IKNX) . The combined company is now named "TeraWulf Inc." and its common stock is expected to commence trading on the Nasdaq Stock Market LLC on December 14, 2021 under the ticker symbol "WULF." TeraWulf previously announced that it raised approximately $200 million in debt and equity financing from a group of leading institutional and individual investors. The additional capital raised is expected to enable TeraWulf to achieve 6 exahash per second, or 200 megawatts, of mining capacity by the second half of 2022. In addition, TeraWulf expects to have 800 megawatts of mining capacity deployed by 2025, enabling over 23 exahash per second of expected hashrate."

17:09 EST Callaway Golf announces new $50M share repurchase program - This new repurchase authorization replaces the pre-pandemic repurchase program, which has been terminated by the Board of Directors.

17:05 EST Energy Transfer CFO buys $500K in common stock, CEO, buys $600K - In regulatory filings, Energy Transfer disclosed that its CFO Bradford Whitehurst bought 67.1K shares of common stock for $500K and co-CEO Thomas Long bought 80.5K shares or common stock for $600K on December 10th.

17:03 EST CooTek receives noncompliance letter from NYSE - CooTek announced that it has received a letter from the NYSE dated December 6, notifying CooTek that it is below compliance standards due to the trading price of CooTek's American depositary shares, or ADSs. Pursuant to NYSE rule 802.01C, a company will be considered to be below compliance standards if the average closing price of a security as reported on the consolidated tape is less than $1.00 over a consecutive 30 trading-day period. Once notified, the company must bring its share price and average share price back above $1.00 by six months following receipt of the notification. The company can regain compliance at any time during the six-month cure period if on the last trading day of any calendar month during the cure period the company has a closing share price of at least $1.00 and an average closing share price of at least $1.00 over the 30 trading-day period ending on the last trading day of that month. In the event that at the expiration of the six-month cure period, both a $1.00 closing share price on the last trading day of the cure period and a $1.00 average closing share price over the 30 trading-day period ending on the last trading day of the cure period are not attained, the NYSE will commence suspension and delisting procedures. To address this issue, CooTek intends to monitor the market conditions of its listed securities and is still considering its options.

17:02 EST Sigilon announces strategic reprioritization, workforce reduction - Sigilon Therapeutics announced a strategic reprioritization to enable the company to focus on MPS-1 and diabetes. "There have been key learnings in our Phase 1/2 trial of SIG-001 for Hemophilia A. While we continue to investigate the findings from our SIG-001 study to help inform our development of the platform, following a review of our programs, we have made the strategic decision to refocus our pipeline. We will be prioritizing MPS-1-a rare lysosomal disease-with our product candidate that is designed to produce the same enzyme as the native human structure, and Type 1 diabetes, alongside our partner, Eli Lilly, with a program that utilizes iPSC-derived islets," said Rogerio Vivaldi, President and CEO of Sigilon. "As part of our plan to refocus our pipeline, we will also make workforce reductions, which are expected to extend our cash runway... The company will reduce its full-time workforce by approximately 38%. The positions eliminated are primarily related to research, manufacturing, and general and administrative services. The significant reduction in expenses associated with the strategic reprioritization is expected to extend the company's cash runway into 2024."

17:00 EST American Financial Group declares $2.00 per share special dividend - American Financial Group announced that it has declared a special, one-time cash dividend of $2.00 per share of American Financial Group Common Stock. The dividend is payable on December 30 to holders of record on December 24. The aggregate amount of the payment to be made in connection with this special dividend will be approximately $170M. This special dividend is in addition to the company's regular quarterly cash dividend of 56c per share most recently paid on October 25. With this special dividend, the company has declared $26.00 per share in special dividends in 2021.

16:35 EST Lakeland Bancorp, 1st Constitution Bancorp announce regulatory non-objection - Lakeland Bancorp, Inc. (LBAI), the parent company of Lakeland Bank, and 1st Constitution Bancorp (FCCY), the parent company of 1st Constitution Bank, announced that on December 10, 2021, the Federal Reserve Bank of New York issued a non-objection to Lakeland's request to waive the application requirement in connection with the proposed merger of 1st Constitution with and into Lakeland. The companies have now received all regulatory approvals and non-objections in connection with the proposed merger. The closing of the proposed merger remains subject to certain customary closing conditions. The merger is expected to close on January 6, 2022.

16:32 EST Fate Therapeutics reports 'positive' interim Phase 1 data from FT596 program - Fate Therapeutics showcased positive interim Phase 1 data from the company's FT596 program for patients with relapsed / refractory B-cell lymphoma at the 63rd American Society of Hematology Annual Meeting and Exposition. FT596 is the Company's off-the-shelf, multi-antigen targeted, iPSC-derived natural killer cell product candidate derived from a clonal master induced pluripotent stem cell line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity, non-cleavable CD16 Fc receptor that has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion that augments NK cell activity. "The interim dose-escalation clinical data from our FT596 program in relapsed / refractory B-cell lymphoma demonstrate that off-the-shelf, iPSC-derived CAR NK cells can bring substantial therapeutic benefit to heavily pre-treated patients in urgent need of therapy, with high response rates and meaningful duration of responses," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are particularly pleased with the therapeutic profile that has emerged with FT596 in combination with rituximab, where over half of the patients treated with a single dose of FT596 at higher dose levels achieved a complete response with a favorable safety profile that is clearly differentiated from CAR T-cell therapy. We look forward to assessing a two-dose treatment schedule for FT596 to further define its potential best-in-class therapeutic profile and ability to reach more patients, including those earlier in care." The ongoing Phase 1 study in relapsed / refractory BCL is assessing a single dose of FT596 as monotherapy and in combination with a single dose of rituximab following three days of conditioning chemotherapy. Certain patients are eligible for re-treatment with a second, single-dose cycle.

16:31 EST Leidos awarded $82M contract by U.S. Air Force - Leidos announced it has been awarded a prime contract by the U.S. Air Force to support the service's counter-small unmanned aerial system efforts. This single-award, indefinite delivery, indefinite quantity contract has a total estimated value of $82M. It includes a one-year period, as well as four one-year options. Work will be performed at various CONUS locations.

16:29 EST Saia expands George operations, opens new terminal north of Atlanta - Saia announced that Saia LTL Freight's newest terminal, in Calhoun, Georgia, is open for business as the company seeks to not only add capacity to its existing network of facilities, but move closer to its customers located just northwest of the Atlanta metro area. "This new terminal will add much needed capacity for us in this region, near Atlanta, which is a major freight hub," said Vice President of Operations, East Jared Mull. "Remarkably, Atlanta is only one of five cities in the country that is served by three major interstates. Interstate 75, which runs along the edge of Calhoun, is a vital link to both it and Chattanooga, Tennessee. In fact, over 80% of both commercial and consumer markets are accessible from Atlanta within just a couple of days." For the last several years, Saia has been quickly expanding its footprint in the Northeast, but also opening new facilities in its legacy coverage area. As the company's network expands, an added benefit comes from being able to pinpoint new pockets of labor, like Calhoun, that offer the opportunity to recruit and hire much-needed drivers and dockworkers.

16:23 EST Riley Exploration sees FY22 CapEx $85M-$95M

16:20 EST Oric Pharmaceuticals presents preclinical CD73 data at ASH - Oric Pharmaceuticals presented preclinical data with Oric's small molecule inhibitor of CD73 in multiple myeloma at the American Society of Hematology, or ASH, in collaboration with Kenneth Anderson's research laboratory at Dana-Farber Cancer Institute. Multiple myeloma patient samples have demonstrated that the tumor environment is adenosine rich, and studies have shown that high CD73 and adenosine levels are associated with poor prognosis and therapeutic resistance. The ASH presentation focused on the role of adenosine signaling in immunosuppression in patients with relapsed or refractory multiple myeloma and the ability of Oric's small molecule inhibitor of CD73 to restore antitumor immune activity. Key highlights from a series of experiments utilizing bone marrow aspirates from patients with multiple myeloma include: CD73 inhibition addressed adenosine mediated immunosuppression, which stimulated T-cell proliferation, T-cell activation, and activation of plasmacytoid dendritic cells in ex vivo assays derived from patients with multiple myeloma. Oric's small molecule inhibitor of CD73 overcame immunosuppression and triggered significant lysis and cell death of multiple myeloma cells by autologous T-cells from the bone marrow microenvironment. Oric's CD73 inhibitor demonstrated single agent activity, comparing favorably to standard of care therapies, in bone marrow-derived mononuclear cell assays from relapsed or refractory myeloma patients. The company plans to pursue a single agent clinical development plan for ORIC-533 in multiple myeloma and initiate a Phase 1 trial in the fourth quarter of 2021.

16:16 EST Williams names John Porter as new CFO effective January 1 - Williams announced that John Porter has been appointed Senior Vice President and CFO, overseeing all financial aspects of the company, effective Jan. 1, 2022. Porter will replace John Chandler, who announced his planned retirement from Williams earlier this year. Chandler will serve as a strategic advisor until his retirement date in March 2022.

16:15 EST Nike acquires RTFKT, terms not disclosed - Nike announced the acquisition of RTFKT, a brand that "leverages cutting edge innovation to deliver next generation collectibles that merge culture and gaming." "This acquisition is another step that accelerates Nike's digital transformation and allows us to serve athletes and creators at the intersection of sport, creativity, gaming and culture," said John Donahoe, President and CEO of NIKE, Inc. "We're acquiring a very talented team of creators with an authentic and connected brand. Our plan is to invest in the RTFKT brand, serve and grow their innovative and creative community and extend Nike's digital footprint and capabilities." Terms of the deal were not disclosed.

16:13 EST Vaccitech acquires Avidea Tech, consideration to shareholders is $40M - Vaccitech announced that it has acquired US-based Avidea Technologies. The consideration to Avidea's existing shareholders is $40M, comprised of approximately $12.5M cash and $27.5M in Vaccitech American Depository Shares in addition to potential future payments that are conditioned upon the achievement of certain development milestones The acquisition of Avidea strengthens Vaccitech's position as a leader in immunotherapies and vaccines. Product candidates: Avidea's existing product candidates are based on its SNAPvaxTM platform. As reported in several recent high-profile publications, Nature Biotechnology and Nature Immunology, the SNAPvaxTM platform uses self-assembly to co-deliver multiple antigens and immunomodulators in nanoparticles of precise, programmable size and composition, thereby enabling immunotherapy product candidates with tighter control over immune responses. The SNAPvaxTM platform can be configured either to induce high magnitude cytotoxic T cells for treating cancer and chronic infections or to induce regulatory T cells for treating autoimmunity and allergies. Within oncology, Avidea's platform will expand Vaccitech's pool of target antigens and can be used to augment Vaccitech's heterologous prime-boost vaccines, thereby increasing the probability of therapeutic success in this highly competitive area. The ability to induce antigen-specific regulatory CD4+ T cells with SNAPvaxTM also broadens the range of therapeutic areas that Vaccitech can pursue to include allergies and autoimmune diseases, each with significant market potential.

16:12 EST Avanos to acquire OrthogenRx, Inc. for $160M - Avanos Medical announced it has entered into a definitive agreement to acquire OrthogenRx, Inc., an emerging leader in viscosupplementation therapies for the treatment of knee osteoarthritis pain, for a total consideration of $160M. The purchase price consists of $130M in cash at closing plus an additional $30M in contingent cash consideration, payable upon the achievement of growth milestones related to the company's commercial hyaluronic acid therapy products, GenVisc 850 and TriVisc. The transaction is expected to close in Q1 2022, subject to customary closing conditions including clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Avanos will finance the acquisition through a combination of funds from its existing credit facility and available cash. The company estimates that the new business will contribute approximately $65M in 2022 revenue and will be immediately accretive to gross and operating margins.

16:11 EST Adaptive Biotechnologies announces new clonoSEQ Assay data at ASH - Adaptive Biotechnologies announced new data highlighting the clinical utility of Adaptive's next-generation sequencing, or NGS-based clonoSEQ Assay to assess minimal residual disease, or MRD, in patients with multiple myeloma, or MM, and chronic lymphocytic leukemia, or CLL. The data are being presented at the American Society of Hematology, or ASH. MRD refers to the cancer cells that can remain in a patient's body after treatment. MRD may not cause symptoms, but the presence of even a small number of cells may ultimately predict clinical relapse. These residual cells can be present at very low levels and require highly sensitive tests like clonoSEQ to identify them. Data generated from an analysis of the MASTER trial showed that regularly evaluating the MRD status of patients with newly diagnosed MM, or NDMM, allowed confident and successful treatment discontinuation. This data was presented in an oral presentation. The study evaluated 123 patients who were treated with the combination of daratumumab, carfilzomib, lenalidomide and dexamethasone over 30 months. MRD was assessed utilizing clonoSEQ in 118 patients. Of those, 84 patients achieved two consecutive MRD-negative results less than10-5, which facilitated subsequent treatment discontinuation and entry into the MRD surveillance (MRD-SURE) phase of the study. MRD follow-up for MRD-SURE patients occurred at six months after treatment cessation and then on an annual basis. At 12 months post treatment cessation, the risk of MRD resurgence was 4% for patients with standard or high-risk cytogenetic abnormalities, or HRCA. In Phase 2 results from a poster presentation, undetectable MRD, or uMRD, was assessed from the peripheral blood and bone marrow of 39 patients with relapsed or refractory CLL to determine the duration of a regimen including zanubrutinib, obinutuzumab and venetoclax. Overall, 33 patients stopped therapy based on predefined uMRD criteria. Of those, 94% remained MRD-negative after a median of 15 months without treatment. clonoSEQ was used to demonstrate that a greater than400-fold decrease in MRD from PB after four months was highly predictive of achieving uMRD in the BM in less than8 months. These data support further investigation of the use of kinetics of early response with clonoSEQ to discontinue therapy.

16:08 EST EQT Corporation announces $1B share repurchase plan, reinstates dividend - EQT Corporation announced that its Board of Directors approved a $1B share repurchase program and has determined to reinstate its regular dividend starting in the first quarter 2022. The company also announced an updated long-term leverage target of 1.0x - 1.5x. To achieve this target leverage, the company has committed to reducing absolute debt by at least $1.5B by the end of 2023, which at current pricing is expected to result in leverage of 1.0x or less. The company expects the execution of this plan to result in investment grade financial metrics during 2022, setting the stage for potential credit ratings upgrades and providing maximum future financial flexibility.

16:06 EST Rocket Lab to acquire SolAero Holdings for $80M in cash - Rocket Lab USA "announced it has signed a definitive agreement to acquire SolAero Holdings, a premier supplier of space solar power products and precision aerospace structures for the global aerospace market, for $80M in cash. The acquisition is expected to close in the first quarter of 2022. Founded in 1998 and headquartered in Albuquerque, New Mexico, SolAero's solar cells, solar panels, and composite structural products have supported more than 1,000 successful space missions with 100% reliability and mission success to date."

16:06 EST Independence Realty Trust stockholders approve STAR merger - Independence Realty Trust announced that at its special meeting of stockholders held today, its stockholders approved the issuance of shares of IRT common stock to the stockholders of Steadfast Apartment REIT, Inc. in connection with IRT's previously announced merger transaction with STAR. The share issuance proposal is described in detail in IRT's and STAR's definitive joint proxy statement/prospectus, which was filed with the Securities and Exchange Commission on September 29, 2021. IRT and STAR held separate special stockholders meetings today in conjunction with the proposed transaction. During STAR's special meeting of stockholders, STAR stockholders voted to approve the Merger. Subject to the satisfaction or waiver of the remaining conditions to the closing of the Merger, the Merger is expected to close on or before Thursday, December 16, 2021. Upon the consummation of the Merger, each share of STAR common stock will be automatically converted into the right to receive 0.905 shares of newly issued IRT common stock, and cash in lieu of fractional shares.

16:02 EST Paragon 28's patient specific titanium talus spacer approved by FDA - Paragon 28 announced that it has received a supplemental approval order from the U.S. Food and Drug Administration for the Patient Specific Talus Spacer. The supplemental approval order allows the Patient Specific Talus Spacer to be additively manufactured in titanium alloy with a titanium nitride coating. The Patient Specific Talus Spacer was first approved on February 17, 2021, by the FDA under a Humanitarian Device Exemption for treatment of avascular necrosis of the ankle joint. Originally approved in cobalt chromium metal alloy, the implant is now available in titanium with a titanium nitride coating. The surgeon selects which material is best suited for his/her patient. The Patient Specific Talus Spacer was first approved on February 17, 2021, by the FDA under a Humanitarian Device Exemption for treatment of avascular necrosis of the ankle joint. Originally approved in cobalt chromium metal alloy, the implant is now available in titanium with a titanium nitride coating. The surgeon selects which material is best suited for his/her patient. Albert DaCosta, President and CEO of Paragon 28, commented, "P28 now has expanded material options available for the first and only FDA approved patient specific total talus replacement implant. P28 will continue to invest in patient specific solutions to help surgeons address unique and complex clinical challenges. We thank the FDA for a tremendous partnership during this process."

15:18 EST WD-40 raises quarterly dividend to 78c per share - Reflecting an increase of more than 8% compared to the previous quarter's dividend. The quarterly dividend is payable January 31, 2022 to stockholders of record at the close of business on January 14, 2022.

14:51 EST Syndax reports additional 'positive' data from Phase 1 AUGMENT-101 trial - Syndax Pharmaceuitcals announced updated positive data from the Phase 1 dose escalation portion of the AUGMENT-101 trial of SNDX-5613 in patients with mutant nucleophosmin or mixed lineage leukemia rearranged relapsed/refractory acute leukemias. SNDX-5613 is the company's highly selective oral menin inhibitor. As of an October 18, 2021 data cutoff date, a total of 59 patients with a median of four prior therapies, including 42% who received a prior stem cell transplant and 59% who received prior venetoclax, were dosed in the Phase 1 portion of the trial. Across evaluable patients with mNPM1 or MLLr acute leukemia who received at least one dose of SNDX-5613, the overall response rate was 55%, with a CR/CRh rate of 24% and nine patients proceeding to stem cell transplant. The ORR in evaluable patients harboring an NPM1 mutation was 38%, with a CR/CRh rate of 23%. The ORR in evaluable patients harboring an MLL-rearrangement was 61%, with a CR/CRh rate of 24%. The overall MRD negative rate was 31%. Among those patients who achieved CR/CRh, 92% were MRD negative, including 100% of NPM1 patients and 89% of MLLr patients. Median time to response for patients achieving a CR/CRh was two months. Median duration of response was not reached, inclusive of patients who received stem cell transplant, and 6/12 patients who achieved CR/CRh had a duration of response greater than six months. SNDX-5613 was well-tolerated, with no discontinuations due to treatment-related adverse events observed in heavily pretreated patients. The only dose limiting toxicity observed was Grade 3 QT prolongation, which occurred in 7% of patients treated at the four doses that met the study's pre-defined recommended Phase 2 dose criteria. Differentiation syndrome was reported in 14% of patients with all cases being Grade 1 or 2 and readily managed with standard therapies. As data from the Phase 1 portion of the trial have continued to mature, the results have demonstrated consistent and compelling anti-leukemic activity with favorable tolerability in patients with both R/R MLLr and NPM1 acute leukemias. The following table summarizes select efficacy and safety data that has been presented by the company throughout 2021.

14:48 EST Gilead's Kite says Yescarta study shows 78% complete response rate - Kite, a Gilead company, announced primary results from ZUMA-12, a global, multicenter, single-arm, open-label Phase 2 study evaluating Yescarta as part of first-line treatment in patients with high-risk large B-cell lymphoma. This is the first study to evaluate CAR T-cell therapy as part of first-line therapy in high-risk LBCL. The study is based on the desire to utilize potential curative treatment as quickly as possible and the hypothesis that earlier use of CAR T-cell therapy when T cells are healthier may produce better outcomes. The data were presented in an oral session during the 63rd American Society of Hematology Annual Meeting & Exposition. After a single infusion of Yescarta, 89% of evaluable patients achieved a response, including 78% of patients with a complete response at a median follow-up of 15.9 months. CR rate was consistent among key subgroups. Among evaluable patients, median time to response was one month. At time of data cut-off, 73% of evaluable patients had ongoing responses. Medians for duration of response, event-free survival, and progression-free survival were not yet reached, with 12-month estimates of 81%, 73%, and 75%, respectively, and an estimated 12-month OS rate of 91%. Yescarta was successfully manufactured for all 42 enrolled patients with a median turnaround time of 18 days between leukapheresis and delivery to the trial site for treated patients. Levels of CCR7+CD45RA+ T cells found in pre-infused product were more than double what was measured in the heavily pre-treated third line ZUMA-1 patient population. Levels of CCR7+CD45RA+ T cells in pre-infused product have been associated with a favorable pharmacokinetic profile. CAR T-cell expansion also appeared greater in ZUMA-12 compared with ZUMA-1.

14:01 EST Uber Eats makes food delivery to International Space Station - Uber Technologies, Inc. announced their first-ever food delivery to outer space. Expanding the global company's footprint beyond earth's surface and into the thermosphere, Uber Eats became the first delivery platform to send food to the International Space Station. Uber Eats teamed up with Japanese entrepreneur and delivery superfan, Yusaku Maezawa, to hand deliver beloved ready-to-eat canned Japanese dishes to the astronauts at the International Space Station as part of his 12-day orbit. This delivery was made on December 11 at 9:40am EST having traveled 248 miles and 8 hours and 34 minutes since Maezawa's departure from Earth. "One small handoff for Yusaku Maezawa, one giant delivery for Uber Eats!" said Uber CEO, Dara Khosrowshahi. "We're over the moon to have helped make our first successful delivery to space. Our goal is to help people go anywhere and get anything, so we're proud to serve the astronauts at the International Space Station. Yusaku Maezawa gets a thumbs up on this delivery, even though it took a bit longer than the usual 30 minutes to arrive."

13:01 EST Veeva to acquire Veracity Logic; financial terms not disclosed - Veeva Systems announced it has acquired Veracity Logic, a provider of cloud software for randomization and trial supply management. "We are pleased to have the Veracity Logic team join Veeva and look forward to bringing RTSM excellence to our customers," said Jim Reilly, vice president, Vault R&D and Quality at Veeva Systems. "This expands Veeva's clinical offering with flexible and user-friendly RTSM capabilities." Veeva RTSM will be led by founder Steve Zimmerman as general manager, current President David Goldston as vice president of sales, and Natalie Townsend as vice president of strategy.

12:54 EST Meta Financial sells rights to Meta name and domains for $60M - Meta Financial disclosed in a regulatory filing that it discussions with respect to and executed a purchase agreement on December 7 with Beige Key, a Delaware limited liability company. Pursuant to the agreement, the company has assigned to assignee for $60M in cash all of the company's worldwide right, title, and interest in and to: company names and trade names including Meta and other Meta-formative names, including MetaBank and Meta Financial Group, trademark registrations and common law rights for Meta and and Meta-formative domain names and social media accounts. Subject to the terms and conditions set forth in the agreement, within one year following the date of the agreement, Meta Financial has agreed to phase out and cease all use of the Meta Marks and names, and change its corporate names to names that do not include "Meta." Pursuant to the agreement, the company will receive $50M upon execution and delivery of the agreement and $10M will be paid to and held in escrow by a third-party bank escrow agent, to be released to the company within three business days of Meta Financial's certification to the escrow agent that the phase out period has been completed. The company plans to use a portion of the proceeds for the cost of implementing a new corporate mark and name. The company is "working through its plan and intends to give an estimate of rebranding costs when it announces results for first quarter of its 2022 fiscal year, which is expected to occur in late January 2022."

12:11 EST Ubisoft announces departure of Chief Studios Operating Officer Haas - Ubisoft announced the departure of Virginie Haas, who served as its Chief Studios Operating Officer for the past 16 months following three years as an independent director on its board. She is leaving Ubisoft to pursue other activities. "The company is well on its way to appointing her successor. In the interim, the senior team she was in charge of will ensure the continuity and seamless execution of the current projects," Ubisoft said in a statement.

12:05 EST MAA announces promotions, including Brad Hill to CIO - MAA announced several promotions among its leadership team. Brad Hill has been promoted to Executive Vice-President, Chief Investment Officer. Rob DelPriore has been promoted to Executive Vice-President, Chief Administrative Officer & General Counsel. Joe Fracchia has been promoted to Executive Vice-President, Chief Technology & Innovation Officer. Tim Argo has been promoted to Executive Vice-President, Chief Strategy & Analysis Officer. In connection with Argo's promotion, Andrew Schaeffer has been promoted to Senior Vice-President, Treasurer and Director of Capital Markets. Eric Bolton, MAA CEO, said, "We have an active program focused on leadership development at MAA. It is an exciting time for our company as performance trends are strong, external growth is accelerating and new technologies offer expanding opportunities to drive even higher value for those we serve. The promotions announced today support our ongoing commitment to strengthen and grow our executive leadership team and capitalize on the opportunities in front of us."

12:01 EST AMC Entertainment falls -16.0% - AMC Entertainment is down -16.0%, or -$4.38 to $23.06.

12:01 EST Expro rises 10.1% - Expro is up 10.1%, or $1.37 to $14.91.

12:00 EST Dingdong rises 17.0% - Dingdong is up 17.0%, or $2.24 to $15.42.

11:35 EST Biote to be listed on Nasdaq through combination with Haymaker Acquisition III - BioTE Holdings, which identifies itself as "a high-growth, differentiated medical practice-building business within the hormone optimization space," and Haymaker Acquisition Corp. III (HYAC), a special purpose acquisition company, announced earlier today that they have entered into a definitive business combination agreement. Upon closing, the combined company's Class A common stock is expected to be traded on the Nasdaq Stock Market under the symbol "BTMD." The combined company is projected to have approximately $195M in cash on its balance sheet after closing, after the payment of transaction expenses and distributions to Biote members, derived from $317.5M of cash held in Haymaker's trust account transferred to the company, assuming zero redemptions from trust, the proceeds of the Truist debt financing, and expected balance sheet cash as of closing. As part of the transaction, Biote's current management and existing equity holders will roll the majority of their equity into the combined company. Assuming no public stockholders of Haymaker exercise their redemption rights, ownership of the combined company immediately following the closing is expected to be comprised of current Biote equity holders with 48% and Haymaker stockholders, including its sponsor, with 52%, excluding the impact of deferred equity held by Biote members and Haymaker Sponsor III LLC. Biote intends to use the proceeds of the transaction to expand commercial operations and accelerate growth in the U.S. The transaction, which has been approved by the members and board of managers of Biote and the board of directors of Haymaker, is subject to approval by Haymaker's stockholders and other customary closing conditions. The proposed business combination is expected to be completed in the first half of 2022. "Biote has a huge opportunity to enable physicians to help this highly underserved patient population take greater control of their health. Biote is committed to educating and empowering providers to effectively treat patients and help them understand the critical role that hormones play in healthy aging. We welcome Haymaker as partners and look forward to the role our status as a public company will play in increasing access to, and awareness of, our leading hormone therapy practice-building business," said Terry Weber, CEO of Biote.

11:03 EST Turquoise Hill 'committed' to working with Mongolia to advance Oyu Tolgoi - Turquoise Hill Resources Ltd. (TRQ) noted recent media coverage regarding ongoing negotiations between the Government of Mongolia, Rio Tinto (RIO) and the company. The company and Rio Tinto have made a joint offer to the Government of Mongolia which aims to reset the relationship and allow all parties to move forward together. The offer includes, among other elements, a proposal to forgive and write-off the entirety of the approximately $2.3B carry account loan owing by the Mongolian-owned shareholder to the company and cancellation of the UDP agreement on a go-forward basis. The offer follows on months of discussions between Turquoise Hill, Rio Tinto and the Government of Mongolia to understand the Government's issues and priorities, deliver greater economic value to Mongolia and build a stronger partnership for a prosperous future for all. Turquoise Hill remains committed to working with the Government of Mongolia to advance the Oyu Tolgoi project for the benefit of all stakeholders, including securing approval for the commencement of the undercut as quickly as is practical following the entering into of a definitive agreement among the parties. Negotiations continue and remain subject to required approvals, with all parties focused on being in a position to finalize an agreement. A further market update will be provided as and when appropriate.

10:52 EST Sigmatron International trading resumes

10:46 EST Rafael Pharmaceuticals announces published data on CPI-613 - Rafael Pharmaceuticals announced a publication on its Phase 2 clinical trial of CPI-613 for the treatment of relapsed or refractory Burkitt lymphoma/leukemia or high-grade B-cell lymphoma at the American Society of Hematology, ASH, Annual Meeting and Exposition. Highlights from the published study, "Complete Remission with Devimistat in Refractory Burkitt Lymphoma," include a patient with four prior therapies, who had a near complete metabolic remission after four cycles of devimistat, and complete remission after cycle seven. As of July 2021, he was in cycle eleven. Typically, such patients have no viable treatment options. The ongoing study is currently recruiting at MD Anderson Cancer Center, City of Hope, Memorial Sloan Kettering Cancer Center and Massachusetts General Hospital. Rafael plans to open four additional sites at key institutions across the United States in Q1 2022.

10:42 EST Sigmatron International trading halted, volatility trading pause

10:39 EST Fate Therapeutics announces data from Phase 1 study of FT516 - Fate Therapeutics presented positive clinical data from the dose-escalation stage of its ongoing Phase 1 study of FT516 for patients with relapsed / refractory B-cell lymphoma at the 63rd American Society of Hematology Annual Meeting and Exposition. FT516 is the Company's universal, off-the-shelf natural killer cell product candidate derived from a clonal master induced pluripotent stem cell line engineered with a novel high-affinity, non-cleavable CD16 Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity, a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. In addition, the Company today announced that the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to FT516 for the treatment of relapsed / refractory diffuse large B-cell lymphoma. "We continue to be highly encouraged by the differentiated therapeutic profile of FT516 as an off-the-shelf NK cell therapy administered in the outpatient setting, and its potential to deliver deep and durable responses for patients with advanced B-cell lymphomas, including those that have received prior autologous CAR T-cell therapy," said Wayne Chu, M.D., Senior Vice President of Clinical Development of Fate Therapeutics. "The RMAT designation for the treatment of relapsed / refractory DLBCL reflects the positive clinical data we have observed with FT516 in the dose-escalation stage of our Phase 1 study, and it is an important milestone for the Company that recognizes the unique potential of off-the-shelf, iPSC-derived, NK cell cancer immunotherapy. We look forward to working closely with the FDA to accelerate the development of FT516 in this area of significant unmet medical need with the goal of expanding the reach of transformative cell therapies."

10:38 EST Pfizer 'confident' regulators will clear deal for Arena Pharmaceuticals - Pfizer (PFE) executives said on a call with investors, according to Bloomberg, that they are "confident" that regulators will clear the company's agreement to acquire Arena Pharmaceuticals (ARNA).

10:32 EST Corvus Pharmaceuticals announces new preclinical data on CPI-818 - Corvus Pharmaceuticals announced new preclinical data demonstrating the potential of CPI-818, the company's ITK inhibitor, for the prevention and therapy of acute graft versus host disease, aGVHD, in patients receiving allogeneic hematopoietic cell transplantation. The data will be presented today in a poster at the 63rd American Society of Hematology, ASH, Annual Meeting & Exposition. CPI-818 is an investigational, orally bioavailable, covalent inhibitor of ITK designed to have low nanomolar affinity. In vitro studies have shown that it potently inhibited T cell receptor signal transduction. Preclinical Data Presented at ASH: The study evaluated CPI-818 in two mouse models of aGVHD. Recipient mice were pre-conditioned by having their bone marrow ablated with high dose radiation, and then received an allogeneic bone marrow transplantation.The results of the study demonstrated that mice receiving CPI-818 had: Statistically significant improvement in GVHD score and survival compared to the placebo group; Increased concentrations of anti-inflammatory cytokines; Increased numbers of T suppressor cells in their spleens. Collectively, the data demonstrated that ITK inhibition with CPI-818 has potential as a targeted approach to prevent or treat aGVHD through the suppression of T cell activation and proliferation, reducing concentrations of pro-inflammatory cytokines and increasing the concentration of anti-inflammatory cytokines. Corvus is studying CPI-818 in a Phase 1/1b clinical trial that was designed to select the optimal dose of CPI-818 and evaluate its safety, pharmacokinetics, target occupancy, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies. Corvus' partner in China, Angel Pharmaceuticals, plans to initiate a Phase 1/1b clinical trial of CPI-818 for the treatment of refractory T cell lymphomas in early 2022, with the potential to expand into autoimmune diseases over time. Angel Pharmaceuticals will be responsible for all expenses related to executing the trial in China.

10:28 EST Norwegian Cruise Line completes multi-year investment in EGCS - Norwegian Cruise Line announced the successful completion of its nearly $200M, multi-year investment in exhaust gas cleaning systems, EGCS, on certain ships across its fleet with the successful commissioning of EGCS onboard Norwegian Breakaway and Norwegian Getaway. The new systems are aimed at improving the ships' environmental footprint by significantly reducing emissions, including sulfur oxides and particulate matter, and improving air quality. "We are pleased to announce that our ambitious multi-year investment to install exhaust gas cleaning systems on our ships has concluded with the successful completion of EGCS retrofits on the Norwegian Breakaway and Norwegian Getaway," said Frank Del Rio, president and chief executive officer of Norwegian Cruise Line Holdings Ltd. "We took the opportunity during the COVID-19 pandemic related voyage suspension to accelerate installations on existing ships and complete this project nearly two years ahead of schedule. Approximately 70% of our operational capacity, or 13 ships, are now equipped with this innovative environmental technology and all but one ship is equipped with a hybrid system which can operate in closed or open loop. The EGCS project is just one of many examples of our ongoing commitment to protect and preserve the environment through our global sustainability program, Sail & Sustain, and we will continue to invest in this critical mission." The Company has completed EGCS installations on 13 Norwegian Cruise Line ships which represent approximately 70% of operational capacity. Ships equipped with this technology can reduce SOx emissions by up to 98%. 92% of systems installed on the Company's ships can operate in open or closed loop, which is known as a hybrid system. The Company expects its normalized fuel consumption mix will now be approximately 50% heavy fuel oil and 50% MGO in 2022.

10:25 EST Global Consumer Acquisition Corporation trading resumes

10:04 EST Akoya Biosciences announces collaboration with PathAI - Akoya Biosciences, The Spatial Biology Company, and PathAI announced a collaboration to advance the discovery and validation of novel predictive biomarkers for immunotherapies. The partners will leverage their capabilities in spatial biology and deep data mining using Phenoptics, Akoya's throughput spatial phenotyping platform, and PathAI's artificial intelligence tools and algorithms to enhance their shared biopharmaceutical partners' ability to identify patients most likely to respond to drugs in clinical trials. Akoya will work with PathAI to create an interface between the Advanced Biopharma Solutions service offerings and PathAI's analytical capabilities to provide a powerful and complete solution for biopharma partners. This partnership and ABS' recent CLIA certification represent significant milestones in advancing Akoya's ability to serve the growing demand for spatial biomarkers in clinical trials. "This collaboration takes Akoya's ABS offering to the next level by providing biopharma partners with a comprehensive offering that integrates the most advanced technologies and know how in the field of spatial biomarkers and digital pathology," said Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "The combination of our Phenoptics platform and PathAI's AI-powered technology has the potential to transform biomarker use in clinical trials and ultimately impact cancer care."

10:02 EST Celularity presents preclinical data on CYNK-101, CAR19-CYNK programs - Celularity presented preclinical data on the development of its placental-derived allogeneic genetically modified NK cell therapy program, CYNK-101, and its placental-derived allogeneic CAR-NK cell therapy program, CAR19-CYNK, respectively. The Company reported its findings in two poster presentations at the 63rd American Society of Hematology Meeting and Exposition taking place in Atlanta and virtually December 11-14, 2021. Poster no. 2773: "Human Placental CD34+-Derived Natural Killer Cells with High Affinity and Cleavage Resistant CD16 in Combination with Daratumumab for Immunotherapy Against CD38 Expressing Hematological Malignancies" Highlights: CYNK-101 is a cryopreserved, off the shelf, allogeneic NK cell product candidate, overexpressing a high IgG binding affinity, proteinase cleavage resistant, CD16 variant. The results show the synergistic effect of combining CYNK-101 with daratumumab to drive antibody dependent cellular cytotoxicity activity against CD38+ hematological malignancies in vitro and in vivo. In these studies, CYNK-101 was not susceptible to daratumumab-directed fratricide and did not display on-target, off-tumor cytotoxicity, suggesting CYNK-101 may be a unique NK cell platform that preserves innate immune function in the presence of daratumumab. Poster no. 2779: "Development of CD19 CAR Engineered Human Placental CD34+-Derived Natural Killer Cells As an Allogeneic Cancer Immunotherapy" Highlights: The results demonstrate the feasibility and functionality of expressing a Chimeric Antigen Receptor directed to CD19 on placental CD34+ derived, cryopreserved, off-the-shelf, allogeneic CYNK cells. The introduction of CAR in the product candidate CAR19-CYNK did not impact performance of CYNK cell manufacture and endowed additional tumor cell killing against resistant lymphoma cell lines in a CD19-dependent manner, when tested both in vitro and in vivo.

10:00 EST Renren falls -7.2% - Renren is down -7.2%, or -90c to $11.62.

10:00 EST Southwestern Energy falls -9.5% - Southwestern Energy is down -9.5%, or -53c to $4.97.

10:00 EST Turquoise Hill rises 13.5% - Turquoise Hill is up 13.5%, or $1.97 to $16.57.

09:58 EST Principal Solar, IPLTech Electric extend licensing agreement - Principal Solar announced that it has extended its Memorandum of Understanding, MOU, with India-based heavy electric vehicle maker IPLTech Electric Pvt.. Per the amended terms of the Agreement, IPLT has modified its original licensing deal with a revised payment schedule that now extends into 2022. "The extension of our Agreement is proof positive that IPLT and Principal remain committed as ever to the future success of our business relationship," said K. Bryce "Rick" Toussaint, CPA, MBA, Chairman and CEO of PSWW. "Not only does our collaboration with IPLTech have the potential to bring significant value to Principal's stakeholders, it also aligns perfectly with our corporate mission of supporting the near-term commercialization of green and transitional emissions reduction technologies." Per the terms of the Agreement, upon completion of the development of a pure electric truck prototype, Principal and IPLTech will enter into a Licensing Agreement in which Principal will receive a license to deploy IPLT's proprietary technologies in U.S. truck platforms. The Agreement also provides an opportunity for the Company to co-invest in IPLTech alongside private equity funds. In exchange, the Company will receive a combination of exclusive and non-exclusive rights to commercialize IPLT's proprietary technologies for North American markets. Per the terms of the Agreement, in exchange for the License, the Company will contract with IPLT to develop a working prototype in India. Principal will assist IPLT in acquiring the approvals necessary for the prototype to operate on U.S. roads.

09:54 EST Enlivex receives regulatory authorization to expand Allocetra trial into Greece - Enlivex Therapeutics announced that, following a review of the Company's preclinical and clinical data, study design, and manufacturing process, Greece's National Organization of Medicines has authorized the expansion of the Company's Phase IIb trial evaluating Allocetra in severe and critical COVID-19 patients with acute respiratory distress syndrome, ARDS, to sites in the country. The placebo-controlled trial, which is currently enrolling patients at clinical trial sites in Israel and was recently cleared to expand into Spain, is expected to recruit up to 152 severe or critical COVID-19 patients. It is designed to assess the safety and efficacy of Allocetra when administered in addition to standard-of-care treatment. The trial's two primary endpoints are ventilation-free survival and recovery for each of the two sub-populations of patients in the study, and could potentially be sufficient for obtaining emergency or conditional marketing authorization for either patient sub-population, though no guidance as to the potential for such emergency or conditional marketing authorization has been provided by the Israeli Ministry of Health or European regulators. Enlivex currently expects that top-line data from the trial will be available in late 2022 or Q1 of 2023.

09:52 EST Magnite announces $50M share repurchase program - Magnite announced that its Board of Directors has approved a share repurchase program, under which the company is authorized to purchase up to $50M of its common stock over the twelve month period commencing December 10, 2021. "Our Board of Directors and executive team are confident in the growth prospects of the company and our ability to execute on our strategic objectives and deliver continued strong performance," said Michael Barrett, Chief Executive Officer of Magnite. "We believe that the share repurchase program represents an attractive use of our capital to buy our common shares at a discount to their intrinsic value. Our strong balance sheet and cash flow generation allow us to return value to shareholders through share repurchases, while still affording us the ability to pursue disciplined investments in our future growth and to reduce our debt leverage ratio."

09:47 EST Direxion Daily Russia Bull 3X Shares falls -6.6% - Direxion Daily Russia Bull 3X Shares is down -6.6%, or -$1.79 to $25.22.

09:47 EST Southwestern Energy falls -7.5% - Southwestern Energy is down -7.5%, or -41c to $5.09.

09:47 EST Clear Channel Outdoor rises 11.5% - Clear Channel Outdoor is up 11.5%, or 35c to $3.40.

09:46 EST Bio-Path presents data from ongoing phase 2 study of Prexigebersen - Bio-Path Holdings announces a poster highlighting the safety and preliminary efficacy data of its Phase 2 study of prexigebersen, BP1001, was presented at the 2021 American Society of Hematology Annual Meeting, taking place from December 11-14, 2021. The poster, titled, "Safety and Efficacy of Lower Intensity Induction Therapy with Intravenous Prexigebersen in Patients with High-Risk and Relapsed/Refractory Acute Myeloid Leukemia,". The poster described the safety and preliminary efficacy of Bio-Path's lead drug candidate, prexigebersen, from a Phase 2 study in combination with decitabine or decitabine plus venetoclax as a potential treatment for patients diagnosed with AML. "Our study's novel clinical trial protocol was designed to adjust for the inclusion of newly approved therapies that we believed would be enhanced from combination with our DNAbilize technology," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "This robust design provided for early evaluation of various combinations of prexigebersen to optimize the best potential outcomes for patients and allows for the most expeditious pathway to market. We are delighted to have these safety and preliminary efficacy data presented among an audience dedicated to bringing new cancer treatments to patients." The Phase 2 clinical trial is a multi-center, open label study with three patient cohorts: Untreated AML patients treated with prexigebersen in combination with decitabine plus venetoclax; Refractory/relapsed AML patients treated with prexigebersen in combination with decitabine plus venetoclax; and Refractory/relapsed AML patients, resistant or intolerant to venetoclax, treated with prexigebersen in combination with decitabine. The primary objective of the study is to assess whether prexigebersen in combination with decitabine plus venetoclax provides higher response rates than decitabine plus venetoclax in AML patients and whether prexigebersen in combination with decitabine provides higher response rates than decitabine alone in AML patients. The study was amended to obtain safety run-in data for patients treated with prexigebersen + decitabine first before proceeding to safety run-in for patients treated with prexigebersen + decitabine + venetoclax. In the Poster we report the safety run-in and efficacy data of AML patients treated with prexigebersen + decitabine or prexigebersen + decitabine + venetoclax.

09:44 EST Mereo BioPharma announces data from study of alvelestat - Mereo BioPharma announced the presentation of data from the initial seven patients in an investigator-sponsored study of alvelestat in patients with BOS following hematopoietic stem cell transplantation, HCT. These data were presented at the 63rd American Society of Hematology Annual Meeting in Atlanta, GA. The Phase 1b/2 study of alvelestat, an oral neutrophil elastase inhibitor, is being conducted under a Clinical Trial Agreement between Mereo and the National Cancer Institute, part of the National Institutes of Health, led by the Principal Investigator Dr. Steven Pavletic, Immune Deficiency Cellular Therapy Program, Center for Cancer Research, NCI. Patients received escalating doses of alvelestat over an 8-week period, from 60 mg twice daily to a maximum of 240 mg twice daily, which was tolerated in all patients. Treatment with alvelestat was associated with improvement in biomarkers of mechanistic efficacy, with ex vivo zymosan stimulated elastase activity showing progressive decrease over the dose escalation period, with some subjects demonstrating 100% suppression. The first evidence of elevated elastase activity in BOS and chronic Graft vs. Host Disease was demonstrated by the elevation of desmosine/isodesmosine at baseline mean 0.464 ng/ml, with 6 of 7 subjects above the Upper Limit of Normal. Desmosine/isodesmosine levels progressively declined during the dose escalation period to 0.380 ng/ml by week 8, representing a mean within subject 16.2% change from baseline. There was also reduction in the collagen synthesis biomarkers PRO-C3 and PRO-C6 following alvelestat treatment which is encouraging for its potential to impact progressive lung fibrosis in BOS. There was consistency of improvement across biomarkers of elastase activity, desmosine/isodesmosine and collagen synthesis in 6 of the 7 treated patients, all of whom had improved or stable lung disease. Six patients had stable disease while 4 had improved symptoms at end of study.

09:42 EST Aaon announces acquisition of BasX for upfront payment of $100M - AAON announced it completed the acquisition of BasX, dba BasX Solutions on December 10, 2021. The Company previously announced on November 18, 2021 that it had entered into a membership interest purchase agreement to acquire 100% of the equity interests of BasX. The transaction was funded through a combination of cash, borrowings under its revolving credit facility and equity. The terms required an upfront payment of $100M, of which almost all was funded via cash-on-hand. Additional payments, all of which would be in the form of equity, valued at up to an additional $80M, are subject to earn-out milestones that extend through 2023. Finally, as a condition to closing, AAON signed a real estate purchase agreement with BasX Properties, LLC, an affiliate of BasX, to acquire the real property and improvements utilized by BasX for an additional $22 million, with such real estate transaction subject to customary closing conditions and adjustments. The Company expects this real estate transaction to close by the end of the first quarter of 2022.

09:40 EST Neuronetics granted 510k approval for NeuroStar TMS Therapy System - The FDA has granted FDA 510k approval to Neuronetics for the NeuroStar TMS Therapy System, according to a notice posted on the FDA's website. Reference Link

09:31 EST First Wave CEO issues letter to shareholders in connection with annual meeting - First Wave BioPharma announced that James Sapirstein, Chairman, President and CEO First Wave BioPharma, has issued a Letter to Shareholders in connection with the company's 2021 Annual Meeting of Stockholders, to be held on December 17, 2021. The letter provides an update on recent events and an outlook for the Company's clinical programs in 2022. "First Wave BioPharma is a company transformed, and I write to you today as excited about our future as I have been since becoming Chief Executive Officer in 2019. Two major events provided book ends for what has been an extraordinary year for our company. In January, as AzurRx BioPharma, we signed an exclusive worldwide licensing agreement with First Wave Bio, Inc. for their patented and proprietary formulations of niclosamide for the treatment of COVID-19-related GI infections and immune checkpoint inhibitor-associated colitis. Eight months later, in September 2021, we completed the acquisition of First Wave Bio, which included patented and proprietary formulations of niclosamide for additional indications in inflammatory bowel diseases including ulcerative proctitis, ulcerative colitis and Crohn's disease. Subsequently, we rebranded our company to better align with our new IBD assets and opportunities, including changing our corporate name to 'First Wave BioPharma' and began trading our common stock on Nasdaq under a new ticker symbol (FWBI). Over the course of 2021, we moved from being a Company with a single asset, adrulipase, with two clinical programs, to one with two assets and five new programs in our clinical-stage pipeline, including three niclosamide programs targeting multi-billion-dollar commercial markets for IBDs. Highlighting this potential, our Phase 2 clinical trial investigating our lead niclosamide-based drug candidate, FW-COV, in COVID-19-related GI infections, is rapidly advancing with enrollment continuing to increase, and we recently launched our FW-UP clinical program with our first clinical trial in IBD, a Phase 2a study evaluating the safety and efficacy of niclosamide in ulcerative proctitis and ulcerative proctosigmoiditis, the most prevalent forms of ulcerative colitis. Supporting this growth, we have strengthened our clinical operations, regulatory, quality assurance and manufacturing teams, added new members to our Board of Directors and Scientific Advisory Board, and strengthened our capital position. In 2021, we completed financial transactions that raised approximately $48 million to date and restructured the payment terms for the merger consideration to First Wave Bio, thereby freeing capital to fund our ongoing clinical trials. As the year comes to an end, we are looking ahead to 2022 with excitement. Our priorities for the coming year are set, and we are well positioned to achieve several critical milestones. I am pleased to share with you more details on what has been accomplished and what we soon plan to achieve," the letter reads.

09:22 EST Advent Technologies in MOU with BASF for supply chain for fuel cell membranes - Advent Technologies recently signed a Memorandum of Understanding. The agreement aims to develop and increase the manufacturing scale of advanced fuel cell membranes designed for long-term operations under extreme conditions. BASF intends to improve the long-term stability of its Celtec membrane and to increase production capacity with advanced technical capabilities to enable further improved and competitive Advent fuel cell systems and membrane electrode assembly . Under the agreement the two companies will explore the implementation of high-volume manufacturing for the Celtec membranes, utilize Advent's fuel cell stack and system testing facilities to assess and qualify the new Celtec membrane for the SereneU , M-ZERO, and Honey Badger Advent product families. Furthermore, BASF supports the realization of large-scale Important Projects of Common European Interests White Dragon and Green HiPo , through materials for power generation, hydrogen generation, and power storage. The goal of the two projects as submitted by Advent and the White Dragon consortium of companies is to replace Greece's largest coal-fired power plants with renewable solar energy parks, which will be supported by CO2-free hydrogen production , and fuel cell heat and power production . In addition, BASF will also evaluate the producibility of the ion pair membrane developed in collaboration by Advent and the US Department of Energy. Advent Technologies' Chairman and CEO Dr. Vasilis Gregoriou commented, "The MEA is the heart of the fuel cell, determining the overall system performance. Our high temperature polymer electrolyte membrane-based MEA is a critical component used in fuel cells and other electrochemistry applications such as CO2-free hydrogen production, and energy storage. The agreement with BASF advances our vision to accelerate electrification through advanced materials, components, and next-generation fuel cell technology and to support industries in decarbonizing at a faster rate."

09:19 EST Genius Brands appoints Zrinka Dekic as Chief Financial Officer - Genius Brands (GNUS) International announces the appointment of Zrinka Dekic as Chief Financial Officer and Head of Strategy and Mergers and Acquisitions. Dekic brings nearly 20 years of entertainment industry and financial markets experience, including corporate strategy, investment banking, investment management and corporate finance at The Walt Disney Company (DIS).

09:15 EST Legend shares new data on CARTITUDE clinical development program - Legend Biotech announced new and updated results from the CARTITUDE clinical development program studying ciltacabtagene autoleucel, cilta-cel, in the treatment of multiple myeloma, which were presented at the 63rd American Society of Hematology Cilta-cel is an investigational B-cell maturation antigen -directed chimeric antigen receptor T cell therapy being studied as a one-time treatment for multiple myeloma. The median time to first response was one month the median time to best response was 2.6 months ; and the median time to complete response or better was 2.9 months .1 The longer-term data showed no new safety signals and there were no new events of cilta-cel-related neurotoxicity or movement and neurocognitive treatment emergent adverse events reported since the median ~1 year follow-up. Implementation of MNT mitigation measures has decreased the incidence rate to 0.5 percent in the CARTITUDE clinical development program. In the 18-month follow-up data previously presented at ASCO 2021, the most common hematologic adverse events observed were neutropenia ; anemia ; thrombocytopenia ; leukopenia and lymphopenia (53 percent).2 At 18 months, cytokine release syndrome of any grade was observed in 95 percent of patients with a median duration of four days and median time to onset of seven days. Of the 92 patients with CRS, 95 percent experienced Grade 1/2 events and CRS resolved in 91 patients within 14 days of onset. Neurotoxicity of any grade was observed in 21 percent of patients, with Grade 3 or higher neurotoxicity observed in 10 percent of patients. "Patients with heavily pre-treated multiple myeloma often have exhausted available treatment options and face poor prognoses. The updated results from the CARTITUDE-1 trial continue to suggest that cilta-cel may provide this patient population with lasting deep and durable responses," said Thomas Martin, M.D., director of clinical research, clinical professor of medicine, Adult Leukemia and Bone Marrow Transplantation Program, interim Division Chief, co-director, Myeloma Program and co-leader, Hematopoietic Malignancies Program, at UCSF Helen Diller Family Comprehensive Cancer Center, and principal study investigator. "As a one-time infusion that shows potential to improve long-term survival and offer patients a break in ongoing treatments, cilta-cel may offer hope to patients, caregivers and physicians."

09:11 EST Annexon announces data from trial of ANX009, preclinical data on wAIHA - Annexon announced safety and dose-response data from its Phase 1 clinical trial of ANX009, the company's subcutaneously administered product candidate that is designed to block the activity of C1q and the entire classical complement pathway. In addition, Annexon reported preclinical data supporting the role of the complement pathway in warm autoimmune hemolytic anemia, wAIHA. The data were presented during two poster sessions at the 63rd American Society of Hematology, ASH, Annual Meeting & Exposition. Poster Title: Safety, Tolerability, and Clinical Pharmacology of ANX009, an Inhibitory Antibody Fab Fragment Against C1q, Administered Subcutaneously to Healthy Volunteers. Data Summary: ANX009 is an antigen-binding fragment that disrupts autoantibody complement activation through the inhibition of C1q. Data reported in the poster are from a single and multiple ascending dose Phase 1 trial of ANX009 in 48 healthy volunteers. Findings demonstrated that ANX009 was well-tolerated across all doses with no drug-related safety, dose-limiting toxicities, serious adverse events, or adverse events leading to discontinuations. Further, a dose-response was observed across dose cohorts with notable reductions in C1q in serum. Poster Title: Evidence of Classical Complement Pathway Involvement in a Subset of Patients with Warm Autoimmune Hemolytic Anemia. Data Summary: Autoimmune hemolytic anemia is a constellation of diseases caused by autoantibodies targeting red blood cells with or without complement activation, with the two main types being cold agglutinin disease and wAIHA. Annexon conducted a series of in vitro studies using patient blood samples. The company believes multiple factors may affect complement deposition in this assay and is assessing how these and other in vitro assay results may be translated to demonstrate classical complement pathway involvement in AIHA patients in vivo in an ongoing Phase 0 non-interventional trial. Annexon is also currently evaluating ANX005 in a Phase 2 clinical trial for the treatment of wAIHA patients with evidence of classical complement activity.

09:09 EST Sally Beauty announces partnership with DoorDash - Sally Beauty (SBH) announced a partnership with DoorDash (DASH) to offer products from more than 1,100 stores across the U.S. Sally Beauty will offer free 2-hour delivery on all SallyBeauty.com orders for the entire month of December, the company said in a statement. "We expect the holiday season will be busier than ever as things continue to open up. In-person celebrations and gifting are expected to increase versus the previous year. This is an extremely busy time for consumers, so we thought this was a great way to make the celebratory season less stressful," said John Goss, Senior Vice President and President of Sally Beauty. "We are listening to our consumers and responding with speed to ensure their shopping needs are met when it matters most."

09:08 EST Tantech Holdings receives order for 12 driverless street sweepers - Tantech Holdings announced that its subsidiary, Lishui Smart New Energy Automobile Co., Ltd., received a milestone order for twelve of its SC-120A driverless and autonomous street sweepers. The customer is a real estate development and property management company, managing industrial parks and other properties in China, Tantech said in a statement. This represents the first order since the recent completion of the final phase of factory testing and standard factory quality control reviews. The company separately announced the successful development of its third generation of driverless and autonomous sweeper with enhanced features, including expanded route and memory capabilities, additional sensors and improved further improved navigation and positioning accuracy.

09:07 EST Alpine 4 Holdings, Inc. acquires RCA Commercial Electronics - Alpine 4 Holdings announced that it has acquired RCA Commercial Electronics of Indianapolis, Indiana, and its operating entity DTI Services. Terms of the deal were not disclosed.

09:06 EST Redbox signs distribution agreement with LG Electronics - Redbox announced it has signed a distribution agreement with LG Electronics to include its branded Free Ad Supported Television, or FAST, channels as part of LG Channels, which is available on 2016-2021 LG Smart TVs including their LG OLED Smart TVs. Redbox Free Movies is live now on LG Channels.

09:05 EST CTI BioPharma presents data from pacritinib program at ASH - CTI BioPharma Corp. announced five scientific poster presentations on the pacritinib clinical program at the 63rd American Society of Hematology Annual Meeting & Exposition, being held as a hybrid meeting in Atlanta, Georgia, December 11-14, 2021. Pacritinib, a JAK 2/interleukin-1 receptor-associated kinase 1 inhibitor that does not inhibit JAK1, is in development for use in patients with myelofibrosis who have thrombocytopenia. Pacritinib was studied in thrombocytopenic patients in the randomized phase 3 PERSIST-2 trial, which showed pacritinib was superior to best available therapy, including ruxolitinib, based on spleen volume reduction and modified total symptom score esponse. While many patients in the BAT arm received ruxolitinib, an analysis of the comparison between pacritinib and ruxolitinib has not been previously performed. This retrospective head-to-head analysis of pacritinib versus ruxolitinib in "first-line" patients treated in PERSIST-2 showed that patients with moderate or severe thrombocytopenia were able to maintain full dose intensity with pacritinib. Pacritinib fully dosed at 400 mg/day resulted in numerically higher rates of SVR and mTSS response, and a similar safety profile compared with lower doses of ruxolitinib in "first-line" patients with cytopenic myelofibrosis, suggesting that pacritinib may address the unmet medical need of patients with cytopenic myelofibrosis who cannot tolerate full doses of JAK1/2 inhibitors, such as ruxolitinib.

09:03 EST Akerna addresses prohibited use of 'Cashless ATMs' in cannabis industry - Akerna issued information in response to investor inquiries relating to news about so-called "Cashless ATM" usage in the cannabis industry. "Akerna and its family of brands have always sought to strictly adhere to all state and federal legislative guidelines and compliance regulations around banking and payments in the cannabis industry. Akerna does not offer a Cashless ATM product and has never collected revenue relating to Cashless ATM transactions. Akerna fully vets all integration partners, including payment providers."

09:00 EST Information Analysis closes acquisition of Gray Matters - Information Analysis Incorporated announced it has closed the previously announced acquisition of Gray Matters. The consideration at closing consisted of $7.5M cash; deferred consideration of $1.5M ; and $1.5M in IAI stock. The terms also include up to $4.0M in additional consideration for achieving certain performance metrics in 2022. "As noted in our announcement of the definitive agreement to acquire Gray Matters, we have been hard at work repositioning our company to be a leading provider of high-value software solutions," said IAI Chairman and CEO Jamie Benoit. "Closing of this acquisition is a significant piece of the puzzle. Gray Matters' platform provides the company with valuable intellectual property and a beachhead from which to begin executing on our ambitious plans. Gray Matters' technology was purpose-built to solve a difficult global problem to help the mission of a complex government agency and we're confident our new capabilities will scale in the wider government and commercial marketplace. We start with several million dollars of booked 2022 revenue and a small but solid contract base with very desirable government customers and ample cash on our balance sheet."

08:59 EST Global Consumer Acquisition Corporation trading halted, news pending

08:57 EST Universe Pharmaceuticals announces strategic alliance with Kitanihon - Universe Pharmaceuticals announced that on December 1, 2021 the Company entered into a strategic cooperation agreement and associated ancillary agreements with Kitanihon Pharmaceutical, a Japanese company engaged in the research, development, manufacturing, and distribution of Kampo pharmaceutical and medical products. Pursuant to the Agreements, the Company and KP agree to exchange equity interests in each other's company and, as previously disclosed, jointly build a new manufacturing facility in Ji'an, Jiangxi Province, in accordance with the market access requirements from the Japan's Pharmaceutical and Medical Devices Agency. The Company will appoint a director to KP's board of directors to directly participate in the management of KP. The Chief Executive Officer of KP, Nishimura Ichiri, will be named as Foreign Expert of the Company. The Facility, once built, will principally serve as a production facility for Kampo medicine and high-end TCM products. Products manufactured in the Facility will be sold in Japan, Southeast Asia, and countries in China's Belt and Road initiative.

08:57 EST Donnelley Financial Solutions acquires Guardum - Donnelley Financial Solutions announced it has acquired Guardum, a data security and privacy software provider that helps companies locate, secure, and control data. The acquisition strengthens DFIN's software solutions portfolio by making data security a competitive differentiator, enhancing regulatory compliance, safeguarding privacy, and improving data accuracy, the company said in a statement.

08:54 EST Volcon enters dealership agreement with Nash Powersports - Volcon announced a dealership agreement with Nash Powersports, one of the nation's off-road dealerships, to bring its line of electric powersports vehicles to the West Coast. In six weeks, with a goal of closing 25 dealers by the end of 2021, Volcon has already added 32 influential dealers to its roster to bring its lineup to market in the US in 2022.

08:53 EST Aditx in arrangement to buy point-of-care diagnostic technology firm - Aditxt announced it had signed a non-binding letter of intent to acquire a company focused on developing Point-of-Care diagnostics for early detection of diseases including cancers and SARS-CoV-2 through a range of non-invasive and affordable point of care and at-home/in-office portfolio to include at-home/in-office COVID-19 rapid antigen test kits complimenting the AditxtScore for COVID-19, and other proprietary tests targeting Celiac, H. Pylori, and cancers including ovarian and prostate. Offering multiple growth opportunities focusing on the early detection of diseases. Access to global scale manufacturing, and clinical capabilities to support AditxtScore's commercialization efforts. Experienced senior management team; the current team has deep sectoral knowledge and is expected to join to support AditxtScore's next growth phase. "The potential acquisition is complementary to AditxtScore technologically and commercially, and is one of the main components to executing our growth plans in 2022," said Amro Albanna, Co-Founder and CEO of Aditxt. "We believe that Point-of-Care rapid testing combined with our current capabilities is key to driving the transformation from reactive care to precision-driven, proactive care delivery." The LOI is non-binding, and the closing of the transaction contemplated thereby is subject to the satisfaction of numerous conditions, including satisfactory due diligence, the negotiation, and execution of binding definitive agreements. The parties have agreed to an exclusivity period until January 31 to reach the definitive agreement. In connection with the Letter of Intent, the Company entered into a secured credit agreement with the target company, pursuant to which the Company made a secured loan to the target company in the amount of $500,000, and agreed to make additional secured loans, as requested by the target company, and approved by the Company, in an amount not to exceed $4.5M.

08:51 EST Sonoco Products, Asiana Cargo sign global master lease agreement - Sonoco ThermoSafe, a unit of Sonoco, and Asiana Airlines, a South Korean airline headquartered in Seoul, announce a global partnership agreement for leasing the new Pegasus ULD temperature-controlled bulk shipping container. The agreement enables pharmaceutical freight forwarders access to Pegasus ULD containers directly from Asiana Airlines. Sonoco ThermoSafe's Pegasus ULD is the world's first FAA and EASA-approved passive bulk temperature-controlled ULD container for pharmaceutical use. Bourji Mourad, who heads Logistics & Partner Management for Sonoco ThermoSafe's Bulk Rental group, said, "Partnering with Asiana Cargo and the inclusion of Pegasus ULD to their "Cool+" specialised cold chain service is very much welcomed. The next steps will be systems training, particularly 'ThermoSafe Connect', our online tool for container ordering, and other admin functions." Mourad further confirmed, "Incheon in South Korea is a new addition to Sonoco ThermoSafe's global network, where Unilode manages the ground handling operations, including storage, servicing, preconditioning to the right temperature, as well as container repair, which is beneficial to all stakeholders."

08:43 EST Dorel Industries enter agreement to sell remaining China manufacturing facility - Dorel Industries announced that it has entered into a definitive agreement to sell its remaining juvenile products manufacturing facility in Huangshi, China to Ningbo Xihe Children Products Co for gross proceeds of approximately $4M. This sale follows the March 2021 disposition by Dorel of its Zhongshan based manufacturing facility and is part of the overall strategic direction of Dorel Juvenile that includes the co-development of innovative new products with a diverse supplier base. "To re-iterate what we stated earlier this year, our strategic direction for Juvenile is to bring a broader product line to market with greater speed and to decrease complexity and improve cash flow. Our strategic direction is also expected to reduce volatility in the direct costs of manufacturing due to variations in the Chinese currency and commodity prices. Now that we will no longer own facilities in China, we can better focus on co-development opportunities while simplifying the organization and freeing-up resources to concentrate on product innovation and branding across our various markets," commented Dorel President & CEO, Martin Schwartz. The sale, which is subject to approval by regulatory authorities in the People's Republic of China, is expected to close within the next two months.

08:40 EST CareDx partnersh with NAPRTCS in launching pediatric kidney transplant study - CareDx announced a partnership with the North American Pediatric Renal Trials and Collaborative Studies, NAPRTCS, organization to use their patient registry to evaluate the long-term impact of using AlloSure Kidney, a donor-derived cell-free DNA, dd-cfDNA, service, for routine organ transplant surveillance in pediatric kidney patients. AlloSure had the first publication in pediatric patients titled, "Donor-Derived Cell-Free DNA for Detection of Allograft Rejection in Pediatric Kidney Transplants" in the Pediatric Transplantation journal in November 2020.1 The partnership with NAPRTCS will further validate the utility of AlloSure surveillance over long-term patient management. Data will be collected from participating centers by NAPRTCS for five years or until the study concludes the utility of dd-cfDNA, whichever is sooner. The objectives of the study are to characterize the use of dd-cfDNA testing and measure longitudinal outcomes following transplantation. "Pediatric transplant patients need innovative solutions to monitor their care, and I am proud of our commitment to leading with a scientific focus on studies that can continue to bring new insights to this most important patient population. AlloSure had the first publication specifically on dd-cfDNA utility for pediatric patients, and we continue to lead innovation in this space by partnering with NAPRTCS," said Reg Seeto, CEO and President of CareDx.

08:39 EST Clene Nanomedicine's receives $1M grant award from Maryland DHCD - Clene announced a $1M grant award from the Maryland Department of Housing and Community Development, DHCD, to further support the redevelopment of the Clene manufacturing facility in Elkton, MD. The legacy site is being redeveloped for pharmaceutical product development to increase Clene's manufacturing capacity and support anticipated product commercialization for amyotrophic lateral sclerosis with Clene's lead asset, CNM-Au8. "Clene is committed to supporting the infrastructure growth of the Maryland community, and we are grateful for this recognition by the State of Maryland and the assistance of the Town of Elkton," said Mark Mortenson, Founder & Chief Scientific Officer of Clene Nanomedicine. "Maryland's community of innovators and state-of-the-art facilities will enable the accelerated development of Clene's neuroprotective therapeutic. We look forward to expanding our partnership with the State and the Town of Elkton."

08:37 EST Code Chain New Continent announces withdrawal of proposed public offering - Code Chain New Continent Limited said it has determined that given the market conditions it is not in the best interest of the company and its shareholders to raise equity capital at this time and intends to withdraw its previously announced underwritten public offering of common stock and warrants.

08:35 EST GlaxoSmithKline announces new data from DREAMM-9 phase I trial - GlaxoSmithKline announced new data from the DREAMM-9 phase I trial and two GSK collaborative studies investigating the potential use of Blenrep, a first-in-class anti-B-cell maturation antigen therapy, in combination with standard of care therapies in earlier lines of multiple myeloma treatment. These data were presented at the 63rd American Society of Hematology, or ASH, Annual Meeting and Exposition. Preliminary results from this phase I trial evaluating a quadruplet combination treatment regimen of belantamab mafodotin with standard of care in transplant-ineligible patients with newly diagnosed multiple myeloma demonstrated lower rates of corneal events in the cohorts with extended dose schedules and lower doses, while maintaining a high ORR. Dosing across the five cohorts in DREAMM-9 trial varies. Cohort 1 is 1.9 mg/kg Q3/4W; Cohort 2 is 1.4 mg/kg Q6/8W; Cohort 3 is 1.9 mg/kg Q6/8W; Cohort 4 is 1.0 mg/kg Q3/4W and Cohort 5 is 1.4 mg/kg Q3/4W. An ORR of 100% was observed in Cohorts 1, 3 and 5 and an ORR of 83% was observed in Cohorts 2 and 4. At least 50% of patients in each cohort achieved a very good partial response or better, with the highest rates observed in Cohorts 1 and 5 of 100% in each. In Cohort 1, 7 out of 9 patients achieved minimal residual disease-negative status at the first test after a VGPR. There were no new adverse events associated with belantamab mafodotin in DREAMM-9. The majority of patients experienced treatment-related AEs, which were generally managed with dose modifications. The most common AEs leading to dose modifications were thrombocytopenia, neutropenia and corneal AEs. All patients experiencing corneal AEs remained on treatment. Hesham Abdullah, Global Head of Oncology Development, GSK, said: "We remain committed to addressing unmet needs by evaluating belantamab mafodotin in earlier lines of treatment in combination with standard of care therapies, as well as assessing different dosing regimens to optimise efficacy and safety in these settings. These promising data at ASH, while early-stage, underscore the importance of exploring the potential of belantamab mafodotin as part of combination regimens to improve outcomes for patients with multiple myeloma."

08:34 EST AltEnergy Acquisition announces separate trading of common stock, warrants - AltEnergy Acquisition Corp. announced that, commencing December 13, 2021, the holders of the company's units may elect to separately trade the shares of Class A common stock and warrants included in the Units. The Common Stock and Warrants resulting from the unit separation will trade on The Nasdaq Global Market under the symbols "AEAE" and "AEAEW", respectively. Units that are not separated will continue to trade on the Nasdaq under the symbol "AEAEU".

08:29 EST Galecto announces preliminary results for GB1211 - Galecto announced that it has successfully completed Part 1 of its Phase 1b/2a GULLIVER-2 trial, assessing the safety, tolerability and pharmacokinetics of the oral galectin-3 inhibitor GB1211 in patients with moderate hepatic impairment as compared to healthy volunteers. GB1211 was observed to be well-tolerated, there were no drug-related serious adverse events, and exposure was only moderately increased in the Child-Pugh class B patients. Galecto has also initiated Part 2 of the trial, which is a randomized, double-blind placebo-controlled trial designed to assess the effect of 12-week dosing of GB1211 on a wide series of biological markers of hepatic function and structure in participants with moderate hepatic impairment. The Phase 1b/2a GULLIVER-2 trial is the first in Galecto's clinical program for GB1211 in liver cirrhosis. Liver cirrhosis represents a significant unmet medical need for which there is no currently approved disease modifying therapy. "Completing Part 1 of the GULLIVER-2 trial and initiating upon Part 2 is an important step forward in our development of GB1211 for liver cirrhosis," said Dr. Hans Schambye, CEO of Galecto. "We are very encouraged by the initial safety findings and favorable interim exposure data seen in Part 1 of the trial. We look forward to completing Part 2 of the trial in 2022, where we hope to demonstrate biomarker and clinical activity of GB1211. We remain on track to report top line data from the full trial in the second half of 2022."

08:28 EST X4 Pharmaceuticals presents new clinical data for Mavorixafor at ASH meeting - X4 Pharmaceuticals highlighted key takeaways from three clinical and scientific posters presented over the weekend at the American Society of Hematology, ASH, Annual Meeting, taking place both virtually and in person in Atlanta, GA from December 11-14, 2021. Poster: "Oral Administration of Mavorixafor, a CXCR4 Antagonist, Increases Peripheral White Blood Cell Counts Across Different Disease States" Key Poster Takeaways: Ongoing studies across a wide variety of diseases, show that oral administration of mavorixafor increases blood neutrophils, lymphocytes, and monocytes; Mavorixafor efficacy has been observed with short-term and long-term treatment both alone and in combination with other therapies; These results suggest that mavorixafor, through its mechanism of CXCR4 antagonism, has the potential to reduce the prevalence and/or severity of a broader array of immunodeficiencies than previously recognized, regardless of the presence or absence of CXCR4 mutations. Poster #1121: "Mavorixafor, an Oral CXCR4 Antagonist, for Treatment of Patients with WHIM Syndrome: Results from the Long-Term Extension of the Open-Label Phase 2 Study" Key Poster Takeaways: Mavorixafor continues to show durable increases in neutrophils, lymphocytes, and monocytes, sustained improvements in infections and warts; Infection rates decreased with increased doses of mavorixafor; Decreases in mean annualized infection rates correlate well with time above threshold for absolute neutrophil count; Data continue to support the potential of mavorixafor to be a safe, effective, and long-term oral therapy targeting the underlying cause of WHIM syndrome. Phase 3 top-line clinical results from the 52-week trial are expected in the fourth quarter of 2022. Poster #2063: "Comprehensive In Vitro Characterization of CXCR4WHIM Variants to Decipher Genotype-Phenotype Correlations in WHIM Syndrome" Key Poster Takeaways: In this study, detailed functional analyses of 14 published CXCR4WHIM mutations were performed; Data suggest that CXCR4 internalization and AKT activation may be used as key assays for the prediction of CXCR4 variant pathogenicity in vitro and potentially as in vitro WHIM-related disease biomarkers. All tested CXCR4 variant cell lines were sensitive to mavorixafor at clinically relevant concentrations.

08:23 EST Enphase Energy launches Enphase Installer Network in Mexico - Enphase Energy announced the launch of the Enphase Installer Network, EIN, in Mexico. The EIN is "a network of trusted installers that deliver exceptional homeowner experiences using Enphase products and is designed to help installers grow their business with a range of innovative digital tools and exclusive benefits," the company said. EIN members can take advantage of access to a digital platform that delivers sales leads and self-service tools, as well as metrics and analytics that can be leveraged to improve business efficiency and profits. "We are pleased with the launch of our EIN in Mexico as the country is important to our international growth strategy," said Dave Ranhoff, chief commercial officer at Enphase Energy. "The EIN is part of an ongoing initiative at Enphase to provide an outstanding experience for installers and homeowners. Our goal is to improve the bottom line for Enphase product installers and give them another reason to continue being enthusiastic evangelists of our products."

08:19 EST Iterum Therapeutics appoints Puttagunta as Chief Medical Officer - Iterum Therapeutics (ITRM) announced the appointment of Sailaja Puttagunta, M.D., to the newly created position of Chief Medical Officer, where she will oversee global clinical development and regulatory initiatives for Iterum. Most recently Dr. Puttagunta served as Chief Medical Officer at BiomX (PHGE).

08:16 EST Kymera Therapeutics presents preclinical data on STAT3 degraders - Kymera Therapeutics announced the company presented new preclinical data for its STAT3 degraders, including its first-in-class KT-333 STAT3 degrader, at the virtual 63rd American Society of Hematology, ASH, Annual Meeting taking place from December 11 - 14, 2021 in Atlanta, GA and virtually. Kymera's first presentation, "A First-in-Class STAT3 Degrader KT-333 in Development for Treatment of Hematologic Cancers" showcased how its clinical compound KT-333 induced growth arrest and cell death in multiple models of anaplastic large cell lymphoma. This resulted in eradication of ALK+ ALCL tumor xenografts with weekly or every other week dosing associated with greater than 90% STAT3 knockdown in tumors and modulation of STAT3-dependent signaling. "KT-333 is a potent and selective STAT3 degrader targeting a high priority, previously undruggable transcription factor that has the potential to address a range of hematologic and solid cancers based on a growing body of preclinical studies described to date," said Nello Mainolfi, PhD, Co-Founder, President and CEO, Kymera Therapeutics. "We are excited about the development opportunities as a monotherapy in STAT3-dependent T and NK cell hematologic malignancies and in combination with immune checkpoint inhibitors in solid tumors as we are about to initiate our Phase 1 trial in liquid and solid tumors." The second presentation, "Selective STAT3 Degraders Dissect Peripheral T-Cell Lymphomas Vulnerabilities Empowering Personalized Regimens". In primary patient-derived tumor xenograft models of anaplastic large cell lymphoma , selective STAT3 degraders were shown to potently degrade STAT3 and modify STAT3-dependent signaling, leading to tumor growth inhibition and cell death in an ALK- ALCL model characterized by STAT3 activation via STAT3 and Jak1 mutations. STAT3 degraders were also shown to synergize with other targeted agents, such as venetoclax, in various peripheral T-cell lymphoma PDTX models.

08:12 EST Cerence, Micware partner to develop, launch two-wheeler mobility applications - Cerence announced announced that it will partner with Micware to develop applications and voice-powered assistants for Japanese two-wheeler makers. The collaboration between the two companies will enable two-wheeler riders to use voice commands through a helmet communication system connected to the vehicle's digital speedometer or the rider's smartphone. By collaborating with Micware, Cerence can quickly launch proprietary voice assistants for two-wheeler makers. "The explosive growth of the two-wheeler market presents an exciting opportunity to leverage our experience in the automotive market for an entirely new mobility experience," said Charles Kuai, SVP & GM, Mobility Solutions, Cerence. "We are excited to collaborate with Micware to deliver a wide range of intelligent voice experiences to riders around the world in partnership with Japanese two-wheeler makers."

08:11 EST Keros Therapeutics announces licensing agreement with Hansoh on KER-050 - Keros Therapeutics announced it has entered into a licensing agreement with Hansoh Healthtech Company Limited, a subsidiary of Hansoh Pharmaceutical Group Company Limited, a leading R&D driven biopharmaceutical company in China. Under the terms of the agreement, Hansoh will obtain an exclusive license from Keros to develop, manufacture and commercialize KER-050 within the territories of mainland China, Hong Kong, and Macau. Under the terms of the agreement, Hansoh is responsible for the development, regulatory approval and commercialization of KER-050 in mainland China, Hong Kong, and Macau. Keros will receive a $20M upfront payment and will also be eligible to receive up to $170.5M in development and commercial milestones, plus tiered royalties on net product sales ranging from the low double digit to high teens.

08:10 EST Aquestive receives written response from FDA on pre-IND meeting submission - Aquestive Therapeutics reported that it has received a written response from FDA to its pre-investigational new drug, pre-IND, meeting submission confirming that the development of AQST-109 for the treatment of anaphylaxis under the 505(b)(2) pathway is acceptable. The FDA's written response to Aquestive indicates that, pending review, Aquestive has performed sufficient clinical and nonclinical activity to support the opening of an Investigational New Drug , IND, application for AQST-109. In addition, the FDA provided comments on both Aquestive's toxicology plan and clinical development plan. The FDA confirmed its agreement that (i) the 505(b)2 pathway is appropriate for the development of AQST-109 and (ii) AQST-109 has the potential to meet the regulatory criteria for Fast Track designation. Aquestive plans to file its IND for AQST-109 early in the first quarter 2022. In addition, Health Canada has provided clearance for Aquestive's crossover study, known as the EPIPHAST study, of AQST-109. Patient recruitment has begun and the Company expects the first dosing to occur before the end of the year. This study will be used to determine the final product configuration that will be used to manufacture registration batches and conduct pivotal studies planned for the second half of 2022.

08:08 EST Sirius XM announces retirement of Jim Cady as chief innovation officer - The company announced that Jim Cady, its Chief Innovation Officer, who has been serving as Interim Head of Product Development, will retire following eight years. Jim will work with Joseph Inzerillo until the end of February 2022 to ensure a seamless transition.

08:07 EST Sirius XM names Joseph Inzerillo as chief product and technology officer - Sirius XM Holdings announced that Joseph Inzerillo is joining the company as Chief Product & Technology Officer effective January 10, 2022. In this expanded role, Inzerillo will set and lead the implementation of SiriusXM's product roadmap, satellite infrastructure enhancements, and technology vision and strategy to drive innovation and growth across all SiriusXM platforms. Inzerillo will report directly to CEO, Jennifer Witz, and will lead a team of 1,500-plus engineers, product leaders and technology professionals as they enhance SiriusXM's capabilities, create an even better customer experience, and drive scale. Going forward, Inzerillo will also oversee SiriusXM's Information Technology and Broadcast Infrastructure, along with the teams that design, build, and operate these platforms.

08:06 EST Deere announces new Chicago office, plans to add 150 IT jobs - Deere & Company announced the expansion of its U.S. footprint with the opening of a new Chicago office where it plans to add 150 Information Technology jobs over the next two years, with the goal of hiring a total of 300 positions to support IT and additional roles within the company. Initially, the facility will target IT capabilities in eCommerce, cloud, data and analytics, and a variety of innovation related technical skills, the company said in a statement.

08:05 EST United Airlines announces equity stake in ZeroAvia - United became the largest airline to invest in zero-emission, hydrogen-electric engines for regional aircraft, the latest move toward achieving its goal to be 100% green by reducing its GHG emissions 100% by 2050, without relying on traditional carbon offsets, the company said in a statement. Through a new equity stake in ZeroAvia, a company focused on hydrogen-electric aviation solutions, United expects to buy up to 100 of the company's new zero-emission, 100% hydrogen-electric engines, it said.

08:04 EST Oracle's Cloud Infrastructure selected by Wipro - Oracle (ORCL) announced that Wipro Limited (WIT) has chosen Oracle Cloud Infrastructure to power its next-generation Cargo Reservations, Operations, Accounting and Management Information System Application suite. This will allow Wipro to offer CROAMIS as part of Wipro FullStride Cloud Services, to customers worldwide, aiding faster modernization of the air cargo industry amidst growing demand for rapid cargo transportation services, the company said in a statement.

08:01 EST Exicure to reduce workforce by 50%, end development of cavrotolimod - After a review of the Audit Committee's findings from the investigation and in combination with a previously initiated strategic review of the company's business plans and objectives and its existing cash resources, Exicure's board has implemented the following approved plan: A staggered workforce reduction of approximately 50%, expected to be completed by January 2022; Discontinuation of further enrollment and the ethical wind down of the company's ongoing Phase 1b/2 cavrotolimod clinical trial in patients with solid tumors; Indefinite suspension of further development of the company's XCUR-FXN program for the treatment of Friedreich's ataxia; Restructuring and realignment of the company's executive team as follows: Brian Bock, the company's former Chief Financial Officer, has been appointed as President and Chief Executive Officer, replacing David Giljohann, and was appointed as a member of the board. Dr. David Giljohann, the company's former Chief Executive Officer, has resigned from the board and will serve as Chief Technology Officer through January 31, 2022. Matthias Schroff, the company's former Chief Operating Officer, has assumed the new role of Chief Scientific Officer; Sarah Longoria, the company's former Vice President of Human Resources has been appointed as Chief Human Resources Officer and Chief Compliance Officer; and Douglas Feltner, the company's Chief Medical Officer, has agreed to assist in the wind down of the cavrotolimod and XCUR-FXN programs and will depart the company on January 31, 2022. Exicure expects to realize approximately $6M in employee related cost savings in 2022, plus additional costs relating to the elimination of the cavrotolimod and XCUR-FXN programs. The Company estimates that it will incur total expenses relating to the restructuring of approximately $1.2M, consisting of severance and termination-related costs and expects to record a significant portion of these charges in Q4.

07:59 EST TG Therapeutics presents data at American Society of Hematology meeting - TG Therapeutics announced four data presentations, including three oral presentations and one poster presentation. Presentation highlights: Oral Presentation Title: The Combination of Umbralisib Plus Ublituximab Is Active in Patients with Relapsed or Refractory Marginal Zone Lymphoma: Results from the Phase 2 Global Unity-NHL Trial. A total of 72 relapsed/refractory marginal zone lymphoma patients were enrolled in the ublituximab plus umbralisib cohort of the UNITY-NHL; Patients had a median of 2 prior lines of therapy; Overall Response Rate, ORR, by independent review committee was 70%, with 21% complete response rate; Median duration of response was not reached at a median follow up of 20 months; Grade 3/4 AEs of clinical interest included diarrhea, neutropenia, ALT/AST increased and non-infectious colitis. Oral Presentation Title: Efficacy and Safety of Umbralisib, Ublituximab, and U2 Plus Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma, DLBCL. A total of 226 patients were treated within the DLBCL cohort of the UNITY-NHL trial. IRC assessed response rates: 43% ORR and 17% CR for U2 plus bendamustine triple combination; 32% ORR and 11% CR for U2 double combination; 13% ORR and 3% CR for umbralisib monotherapy. Both U2 and U2 + bendamustine demonstrated a manageable safety profile. Grade 3/4 AEs of special interest occurring in the U2 group included ALT/AST increase, non-infectious colitis, diarrhea, neutropenia and pneumonitis. Oral Presentation Title: A Phase 2 Study Evaluating the Addition of Ublituximab and Umbralisib (U2) to Ibrutinib in Patients with Chronic Lymphocytic Leukemia: A Minimal Residual Disease-Driven, Time-Limited Approach-Limited Approach. This study utilized an "add-on" approach, where the combination of umbralisib and ublituximab was added to therapy in patients who were on ibrutinib for greater than 6 months. 28 patients with chronic lymphocytic leukemia were enrolled, with 27 evaluable for efficacy. Patients were on ibrutinib for a median of 21 months prior to study entry. 77% of evaluable patients achieved uMRD, with a median time to first uMRD of 7.4 months Grade 3/4 AEs included diarrhea, hypertension, ALT/AST increased and COVID-19. Poster Presentation Title: The Selective Bruton Tyrosine Kinase Inhibitor TG-1701 As Monotherapy and in Combination with Ublituximab and Umbralisib in Patients with B-Cell Malignancies. A total of 135 patients with R/R CLL or B-cell lymphoma were included in this presentation. Efficacy Overall Response Rate and Complete Response Outcomes: 100% ORR observed in the CLL 300 mg QD TG-1701 monotherapy expansion cohort at a median follow up of 13.8 months; 95% ORR observed in the CLL 200 mg QD TG-1701 monotherapy expansion cohort at a median follow up of 20 months; 86% ORR, including 19% CR rate, observed in the 1701+U2 dose escalation cohort at a median follow up of 20.2 months; 83% ORR, including 6% CR rate, observed in the 1701+U2 dose expansion cohort at a median follow up of 2.7 months. Grade 3/4 AEs occurring in patients treated with 200 mg QD of TG-1701 and 300 mg QD of TG-1701, respectively, included neutropenia, ALT increased, AST increased and anemia. Grade 3/4 AEs occurring in patients treated with the triple combination in the U2 plus TG-1701 expansion cohort and U2 plus TG-1701 escalation cohort , respectively, included neutropenia, ALT increase, AST increased.

07:51 EST Equifax announces OnboardConnect to streamline business transactions - Equifax introduced a new solution designed to help business-to-business transactions occur faster, with a higher degree of certainty and at a lower cost. The new OnboardConnect solution combines differentiated data sources and analytics that 'Only Equifax' can provide to enable near real-time business verification, fraud checks, tax identification number checks, anti-money laundering and credit risk checks, the company said in a statement.

07:50 EST Agios Pharmaceuticals announces data on mitapivat - Agios Pharmaceuticals announced new data from investigator-led studies of mitapivat, an investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated pyruvate kinase enzymes, in adults with sickle cell disease. The data were featured in two presentations at the American Society of Hematology, ASH, Annual Meeting and Exposition. The data demonstrate the potential of mitapivat to provide clinically meaningful outcomes for patients, including improvements in anemia, hemolysis and red blood cell sickling. Consistent with previously reported proof-of-concept data, mitapivat reduced 2,3-diphosphoglycerate and increased adenosine triphosphate, and through this mechanism, may reduce hemoglobin S polymerization and red blood cell sickling. The safety profile observed in both studies was also generally consistent with previously published clinical data, including Phase 3 data in adults with pyruvate kinase deficiency. Safety and Efficacy of Mitapivat : The Phase 2 ESTIMATE study being conducted by UMC Utrecht is designed to assess safety and efficacy of mitapivat in patients with sickle cell disease. The primary endpoints of the study are safety and point of sickling, and key secondary endpoints include changes in hemoglobin levels and clinical complication rates. Key findings from six patients who completed the eight-week dose-finding period, all reaching 100 mg twice daily dosing, include: No serious adverse events occurred; observed changes in 2,3-DPG and ATP levels were consistent with proposed mechanism of action; Mitapivat increased hemoglobin and decreased hemolysis and sickling parameters; Five out of six patients achieved hemoglobin response; Early improvements in albumin-to-creatinine ratio were observed. Phase q study on mitapivat: The Phase 1 study is being conducted in collaboration with the NIH. The primary endpoint of the study is safety and tolerability. Secondary endpoints include changes in hemoglobin, markers of hemolysis, 2,3-DPG and ATP levels and hemoglobin S polymerization. Key findings from the 16 evaluable patients who completed the core period of the study include: No AEs led to drug discontinuation; No VOCs occurred during dose-escalation; Treatment with mitapivat demonstrated improvement in anemia and decreases in markers of hemolysis; Nine out of 16 patients achieved a hemoglobin response

07:43 EST Intellia announces first patient dosed in Phase 1/2 trial of NTLA-2002 - Intellia Therapeutics announced that the first patient has been dosed with NTLA-2002, the company's in vivo CRISPR/Cas9 genome editing candidate being developed as a single-dose therapy to prevent attacks in people living with hereditary angioedema, HAE. NTLA-2002 is a systemically administered therapy designed to inactivate the target gene kallikrein B1, KLKB1, to reduce plasma kallikrein activity and thus prevent HAE attacks. "HAE is a genetic disorder that can cause painful and life-threatening inflammatory attacks, and currently available chronic therapies have a high treatment burden," said Intellia President and Chief Executive Officer John Leonard, M.D. "With the progress of our first-in-human clinical study evaluating NTLA-2002 for people living with HAE, we look forward to beginning clinical testing as we aim to develop a single-dose treatment for these patients."

07:41 EST Alcanna announces postponement of special meeting on plan of arrangement - Alcanna (LQSIF) announced that pursuant to the terms of the Arrangement Agreement and the interim order of the Court of the Queen's Bench of Alberta dated November 9, 2021, Alcanna and Sundial Growers (SNDL) have agreed to postpone the special meeting of Alcanna shareholders to consider, and if deemed advisable, to pass the special resolution to approve the proposed plan of arrangement with Sundial originally scheduled to be held at 10:00 a.m. on December 14, 2021 to 10:00 a.m. on January 7, 2022. The board of directors of Alcanna, having received a unanimous recommendation from a special committee comprised solely of independent directors of Alcanna, and after careful consideration of various factors, in consultation with its financial and legal advisors has determined that the Arrangement is in the best interests of Alcanna and is fair to Alcanna Shareholders, and unanimously recommends Alcanna Shareholders vote "FOR" the Arrangement Resolution.

07:38 EST Stealth Biotherapeutics provides update on rare disease programs - Stealth BioTherapeutics reported an update on its clinical-stage rare disease programs. The company said: "Early data from a study of elamipretide and an exon-skipping phosphorodiamidate morpholino oligomer (PMO), a therapeutic class that has already garnered regulatory approval and commercialization, in the X-linked muscular dystrophy mouse model, demonstrated that elamipretide in combination with the PMO significantly increased dystrophin expression in muscle to almost twice the levels observed following stand-alone treatment with the PMO. This may be due to improved mitochondrial bioenergetics augmenting the retainment/efficacy of the PMO. Additional studies are ongoing, and the Company hopes to present the data from these studies at a scientific conference next year. The Company is scheduled to meet with DCN to discuss its development plan for DMD later this month. During a constructive Type A meeting to discuss next steps in the Barth syndrome development program, DCN signaled alignment with various design elements of a proposed new clinical trial. At DCN's recommendation, the Company will submit a Request for Advice on the protocol synopsis and expects written feedback from the Division within 45 days. DCN also expressed its willingness to consider other means of generating data supportive of potential approval under alternate pathways, which may require additional animal studies. The Company expects additional interactions with the Division early next year to explore the feasibility of DCN's suggestion. The Company remains on track to initiate NuPOWER, its Phase 3 clinical trial enrolling patients with pathogenic nuclear DNA mutations leading to mitochondrial myopathy with site initiation currently underway. This trial is enriched for the subgroup of patients who responded to elamipretide therapy in prior clinical trials."

07:37 EST Soluna Holdings announces November site level financials - Soluna Holdings announced the release of its November site level financials, business update and outlook. Michael Toporek, CEO of MTI, stated, "Our team delivered another solid month of strong performance. We expect financial results to accelerate over the next several months as we remain on track to deliver over 1EH/s by the end of Q1 next year. That should drive a yearly revenue run-rate exceeding $61 million and cash contribution margin over $40 million. It is extremely gratifying to see our team executing at this level." Key Summary Highlights for November 202: Strong financial results continuing to scale and will accelerate over the next several months; Current yearly cash contribution margin run-rate at $23.3M; Currently at 623 PH/s, expect to hit 722 PH/s in +/- 30 days due to supply chain issues; Targeted 912 PH/s by end of Q1 2022 and expect to exceed that with over 1 EH/s; Expect to have Sophie scaled up to 25 MW and fully energized by December 31st; and Continue to carefully ramp and test infrastructure

07:35 EST Navidea announces 3rd-party asset valuation of Tc99m tilmanocept for RA - Navidea Biopharmaceuticals announced the results of a third-party asset valuation of its Rheumatoid Arthritis diagnostic product candidate. The Company engaged the independent third-party valuation firm, LifeSci Partners , to perform a U.S.-focused market research valuation of its advanced pipeline product Tc99m tilmanocept for prediction of treatment efficacy of anti-TNFalpha therapy in RA. A summary of the valuation report and the assumptions on which it is based is available on the Company's website, www.navidea.com. The Company is advancing its program evaluating Tc99m tilmanocept imaging, a radiopharmaceutical that selectively targets the CD206 receptor expressed on activated macrophages, for indications in RA. A previously completed Phase 2B study demonstrated results in support of the hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA. The planned Phase 3 trial will evaluate the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in RA patients switching to an anti-TNFalpha therapy.

07:34 EST Bristol-Myers raises dividend 10.2% to 54c per share, adds $15B to buyback plan - Bristol Myers Squibb announced that its board of directors approved an increase in the quarterly dividend and authorized an additional multi-year share repurchase program. The board of directors has declared a quarterly dividend of 54c per share on the common stock of the company. The dividend is payable on February 1, 2022 to stockholders of record at the close of business on January 7, 2022. This amount represents a 10.2% increase in the quarterly dividend over last year's quarterly rate of 49c per share. The board of directors also authorized the repurchase of an additional $15B of the company's common stock. With this increase, the company's total outstanding share repurchase authorization is approximately $15.2B. This multi-year authorization enables management to execute repurchases at its discretion, the company said. "The company's financial position is strong, and we remain committed to a consistent, balanced capital allocation strategy. With significant free cash flow of $45 billion to $50 billion expected between 2021 and 2023, investment in business development continues to be a key priority for the company in driving innovation and sustained growth as we return capital to shareholders through the dividend increase and expanded share repurchase authorization. We remain committed to maintaining a strong investment grade credit rating and reducing our debt," said Giovanni Caforio, board chair and CEO of Bristol Myers Squibb.

07:33 EST Nucor acquires majority ownership of California Steel Industries for $400M - Nucor Corporation (NUE) announced that it has reached agreements to acquire a majority ownership position in California Steel Industries, Inc. by purchasing a 50% equity interest from a subsidiary of Vale S.A. (VALE) and a 1% equity ownership stake from JFE Steel Corporation. The company will be a joint venture between Nucor and JFE, pending regulatory approvals. Nucor will pay a cash purchase price to Vale of $400M for the 50% enterprise value, adjusted for net debt and working capital at closing, which approximates less than 6.0x historical average EBITDA. "Acquiring a majority ownership stake in California Steel Industries expands our geographic reach in sheet steel and gives us a strong presence on the West Coast," said Leon Topalian, President & Chief Executive Officer of Nucor Corporation. "This acquisition will grow our portfolio of value-added sheet products, provide opportunities for increased internal shipments and enable us to provide our downstream businesses in the region such as Verco and Hannibal Industries with sheet steel products. We look forward to continuing to grow with our partners at JFE."

07:31 EST RingCentral announces $100M share repurchase authorization - RingCentral announced that its board of directors has authorized a share repurchase program under which RingCentral may repurchase up to $100M of its outstanding Class A common stock.

07:26 EST Vivid Seats announces acquisition of Betcha Sports - Vivid Seats announced it has completed the acquisition of Betcha Sports. The upfront purchase price is $25M in Vivid Seats equity, subject to customary purchase price adjustments, with additional payments of up to $40M of earnouts that, if earned, will be payable in a mix of cash and equity. The acquisition of Betcha will allow Vivid Seats to extend its marketplace technology into the online gaming sector. "The acquisition of Betcha further strengthens our position as a leading marketplace, accelerating our journey into naturally adjacent areas with engaging features that deliver unique experiences for our customers," said Stan Chia, Chief Executive Officer of Vivid Seats. "We have been incredibly impressed with their continued growth and are excited to welcome the Betcha team to Vivid Seats, as we combine their new way to play with our desire for fans everywhere to experience it live. We believe this acquisition can significantly increase our TAM, while allowing for customer acquisition synergies with our high interest fan base. I look forward to leveraging our collective expertise and passion to drive enhanced fan engagement through discovery, loyalty, and content to deliver outstanding customer experiences."

07:21 EST Novo Nordisk to invest more than DKK 17B in Kalundborg plant expansion - Novo Nordisk announced plans to invest more than 17B Danish kroner in construction of three new manufacturing facilities as well as expansion of one existing facility at its production site in Kalundborg, Denmark. "The investment will establish additional capacity across the entire global value chain from manufacturing of active pharmaceutical ingredients to assembly and packaging, with the vast majority being invested in API capacity. These expansions will provide capacity for the production of Novo Nordisk's current and future oral and injectable products. The new facilities will be automated and include state-of-the-art production technologies," the company said. The investment projects are expected to be finalised in 2027 and will create around 400 new jobs. More than 2,500 external staff will be engaged in the building phase.

07:17 EST Trevena announces advancement of TRV045 into clinical development - Trevena announced it is advancing TRV045 into clinical development, following receipt of a notification from the U.S. Food and Drug Administration, FDA, that the study may proceed. TRV045 is the Company's novel S1P1 receptor modulator being developed as a potential treatment for diabetic neuropathic pain. In addition, through a collaboration with the National Institutes of Health, the Company is also exploring TRV045 as a potential treatment for epilepsy. The Company will initiate a three-part Phase 1 single ascending dose, food effect, and multiple ascending dose trial. The primary objective of the study is to evaluate the safety and tolerability of TRV045 in healthy adult subjects. The study will also assess the pharmacokinetics of TRV045 and determine whether TRV045 is associated with changes in lymphocyte counts, hemodynamic function, and QTcF interval.

07:16 EST Gritstone added to the Nasdaq Biotechnology Index - Gritstone bio (GRTS) announced that the company has been added to the NASDAQ Biotech Index (NBI), effective prior to market open on Monday, December 20, 2021.

07:15 EST LiveWire to go public through merger with AEA-Bridges Impact Corp.

07:13 EST Henry Schein expands access to point-of-care testing, PPE and supplies - Henry Schein announced that it has signed a cooperative contract with OMNIA Partners, one of the nation's largest purchasing organizations for public and private sector procurement, that will expand access to point-of-care diagnostic testing, personal protective equipment and medical products and supplies in academic and public health settings. Products and supplies will be available through the Henry Schein Medical University Health business. In connection with the contract, Henry Schein Medical has entered into a master agreement with the University of California for the distribution of medical supplies to the University of California and all eligible public agencies registered with OMNIA Partners. The Master Agreement will better serve Henry Schein Medical customers involved in university health, K-12 education, local and state government health care, and first-aid services by helping to increase savings and support, and provide easier access to COVID-19 testing and services. Through the Master Agreement, Henry Schein Medical will also offer the following types of supplies to help fulfill the needs of student health centers, physical therapy, occupational therapy, sports medicine, athletic training, lab, and pharmacy customers: medical, laboratory, equipment and treatment room, pharmaceutical, vaccine, flu, education, and training and simulation products.

07:10 EST 4D pharma announces results from trial of MRx-4DP0004 for asthma - 4D pharma announces positive topline results from Part A of phase I/II clinical trial of MRx-4DP0004, an orally-delivered single strain Live Biotherapeutic being developed for the treatment of asthma. The Phase I/II trial is a multi-center, double-blind, placebo-controlled study in patients with partly controlled asthma taking long-term medication. The primary endpoint of Part A was to evaluate the safety and tolerability of MRX-4DP0004 with secondary endpoints evaluating clinical activity. Part A met the primary endpoint and the safety profile of MRx-4DP0004 was comparable to placebo. No serious adverse events related to treatment were reported. In addition to the achieving the primary endpoint, MRx-4DP0004 generated promising signals of clinical activity, which supports progression into Part B of the study. Part B is expected to enroll up to 90 patients, informed by the clinical signals identified in Part A. "The results from Part A of 4D pharma's Phase I/II study of MRx-4DP0004 as a treatment for asthma are an important step forward in our development of a new safe oral therapeutic for asthma patients," said Dr. Alex Stevenson, Chief Scientific Officer of 4D pharma. "Not only do the results support the excellent safety profile shown to date across our clinical pipeline of Live Biotherapeutics for a variety of indications, but also demonstrate our ability to identify and develop single strain LBPs with potent systemic activity using our MicroRx platform. MRx-4DP0004 has shown encouraging activity in key secondary endpoints of clinical activity, and this data will help to guide the selection of patients for future development of the product." "For a study of this size in a relatively mild and heterogeneous population the signals are encouraging and if the effects on ACQ and SABA are maintained in larger numbers of participants and confirmed in later studies then could be clinically meaningful," said Prof. Chris Brightling, NIHR Senior Investigator and Clinical Professor in Respiratory Medicine at the University of Leicester. "Asthma is a heterogeneous disease of numerous clinical phenotypes. Current therapeutic options are not effective in all severe patients and thus there remains a significant unmet need for new treatment options. I look forward to the results of the Part B expansion phase, which will help to further identify an optimal target patient population for future development of MRx-4DP0004."

07:09 EST Cullinan to provide clinical update for CLN-081 - Cullinan Oncology will provide a clinical update on CLN-081 during a webinar on Thursday, December 16, 2021, at 8:00 a.m. ET. During the webinar, Cullinan's team will review updated safety and efficacy data from an ongoing Phase 1/2a trial evaluating CLN-081 in non-small cell lung cancer patients harboring Epidermal Growth Factor Receptor exon 20 insertion mutations whose disease has progressed on or after prior therapy.

07:08 EST Aterian, Recurrent announce online media, e-commerce partnership - Aterian announced that it plans to partner with Recurrent Ventures for strategic marketing efforts. As part of the collaboration, Recurrent and Aterian intend to combine Recurrent's digital media brands and publishing business with Aterian's data and E-Commerce platform to promote products through affiliate marketing and editorial coverage as well as launching new co-branded products and brands. Aterian's Chief Executive Officer, Yaniv Sarig, commented, "Recurrent's combination of iconic brands, world class editorial capabilities and performance marketing expertise make them a perfect strategic partner for Aterian. We believe that the power of publishers and their authentic connection with their audiences will pair well with our E-commerce platform to create a strong opportunity to drive growth for both companies. We look forward to working closely with the Recurrent team to drive more sales to Aterian's existing brands through Recurrent's portfolio of online editorial publications reaching over 60 million monthly unique visitors. We are particularly excited also about the potential prospect of launching co-branded products designed through our data driven methodology and promoted through Recurrent's channels."

07:07 EST SVB Financial acquires technology equity research firm MoffettNathanson - SVB Financial Group announced its continued expansion into technology investment banking with the acquisition of MoffettNathanson LLC, a New York-based independent sell-side research firm. The acquisition enables SVB's investment banking business, SVB Leerink, to expand its research coverage to include companies in both the healthcare and technology industries, the company said in a statement.

07:05 EST SCVX and Bright Machines mutually agree to terminate business combination pact - SCVX a special purpose acquisition company, and Bright Machines, Inc., a Delaware corporation announced that both companies have mutually agreed to terminate their previously announced business combination agreement, effective immediately. In light of the low likelihood that the business combination agreement could be completed prior to the January 15 "outsidetate" set forth in the merger agreement and current market conditions, SCVX and Bright Machines believe that terminating the business combination agreement is the best path forward for the parties and their respective stockholders. SCVX is considering alternative transactions, including extending its current dissolution deadline of January 28, 2022 and pursuing another business combination.

07:03 EST Nuvation Bio announces FDA clearance of IND application for NUV-422 - Nuvation Bio announced that the U.S. FDA has cleared its investigational new drug application to evaluate NUV-422, a cyclin-dependent kinase 2/4/6 inhibitor, for the treatment of prostate cancer. The FDA accepted the company's first IND application for NUV-422 in October 2020 for the treatment of patients with high-grade gliomas, including glioblastoma multiforme, and a second IND for the treatment of advanced breast cancer in December 2021. The Company began a monotherapy Phase 1/2 study in December 2020 in high grade gliomas and later amended the protocol in the second quarter of 2021 to include HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer. The Company is continuing to enroll patients in the monotherapy Phase 1 dose escalation portion of the study. "FDA clearance of our third IND application for NUV-422 is another important achievement for our lead investigational CDK 2/4/6 inhibitor program as we develop our deep pipeline of innovative new cancer therapeutics across a variety of tumor types," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We look forward to sharing data from the Phase 1 monotherapy dose escalation portion in the second half of 2022." With the clearance of this IND in prostate cancer, Nuvation Bio will be initiating a Phase 1b/2 study in patients with mCRPC who have received prior treatment with abiraterone acetate. This study will begin with a Phase 1b dose escalation portion designed to evaluate safety and tolerability of NUV-422 plus enzalutamide combination and to determine a recommended Phase 2 combination dose of NUV-422. The Phase 2 portion will be an open-label, single-arm study designed to evaluate efficacy and further explore safety of NUV-422 in combination with enzalutamide in previously treated mCRPC patients who can have measurable or nonmeasurable disease.

07:01 EST Renren provides update on court order denying proposed settlement - Renren announces that a hearing was held before the New York State Supreme Court, Commercial Division in the consolidated shareholder derivative lawsuits captioned In re Renren, Inc. Derivative Litigation, Index No. 653594/2018 on December 9, 2021 to consider the motion of the Plaintiffs to approve the Stipulation of Settlement settling the Action. At the hearing, the Court announced that it intended to deny the motion to approve the Stipulation. Subsequently, on December 10, 2021, the Court issued a written order formally denying the motion to approve the Stipulation and set a subsequent hearing on the motion of the Stipulation for January 30, 2022.

06:54 EST Arena Pharmaceuticals jumps 95% to $97.50 after Pfizer takeover deal

06:51 EST Jackson Financial announces $125M share repurchase - Jackson Financial (JXN), as part of its previously disclosed $300M share repurchase program, has signed agreements to repurchase Class A common stock from Prudential plc (PUK) and Athene Co-Invest Reinsurance Affiliate 1A for a total purchase price of approximately $125M. Jackson is repurchasing a total of 2,242,516 shares of its Class A common stock from Prudential, consistent with Prudential's previously disclosed intent to sell a portion of its ownership of Jackson shares. Jackson is also repurchasing a total of 1,134,767 shares of its Class A common stock from Athene. The transactions are being funded with cash on hand. Today's repurchases from Prudential and Athene bring Jackson's total share repurchases to approximately $185M under the share repurchase program.

06:49 EST Ryan Specialty Group signs definitive agreement to acquire Keystone Risk - Ryan Specialty Group has signed a definitive agreement to acquire certain assets of Keystone Risk Partners. Commenting on this acquisition, Patrick Ryan, Founder, Chairman and CEO of Ryan Specialty, said, "Keystone brings new talent to Ryan Specialty allowing us to expand our offerings to our retail broker and agent trading partners facilitating access to alternative risk capital. We are very excited to welcome the team of Keystone into the Ryan Specialty family and look forward to developing our alternative risk strategy together." Terms of the transaction were not disclosed. The acquisition is expected to close later this month, subject to the completion of certain closing conditions.

06:48 EST Pfizer to acquire Arena for $100 per share in all-cash transaction - Pfize (PFE) and Arena Pharmaceuticals (ARNA) announced that the companies have entered into a definitive agreement under which Pfizer will acquire Arena, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Under the terms of the agreement, Pfizer will acquire all the outstanding shares of Arena for $100 per share in an all-cash transaction for a total equity value of approximately $6.7B. The boards of directors of both companies have unanimously approved the transaction. "The proposed acquisition of Arena complements our capabilities and expertise in Inflammation and Immunology, a Pfizer innovation engine developing potential therapies for patients with debilitating immuno-inflammatory diseases with a need for more effective treatment options," said Mike Gladstone, Global President & General Manager, Pfizer Inflammation and Immunology. "Utilizing Pfizer's leading research and global development capabilities, we plan to accelerate the clinical development of etrasimod for patients with immuno-inflammatory diseases." Arena has built a development program for etrasimod, including two Phase 3 studies in ulcerative colitis, UC, a Phase 2/3 program in Crohn's Disease, a planned Phase 3 program in atopic dermatitis, and ongoing Phase 2 studies in eosinophilic esophagitis and alopecia areata. In addition, Arena's pipeline includes two development-stage cardiovascular assets, temanogrel and APD418. Temanogrel is currently in Phase 2 for the treatment of microvascular obstruction and Raynaud's phenomenon secondary to systemic sclerosis. APD418 is currently in Phase 2 for acute heart failure. Pfizer expects to finance the transaction with existing cash on hand.

06:42 EST BitNile holdings completes name, stock symbol change from Ault Global - BitNile announced that it has completed the company's previously announced corporate name change from "Ault Global Holdings, Inc." (DPW) to "BitNile Holdings, Inc." In conjunction with the corporate name change, the Company will begin trading on the NYSE American under the new ticker symbol, NILE, effective at the open of market trading today, December 13, 2021. This change follows the Company's announced plan to split into two public companies by pursuing a spin-off of Ault Alliance to its stockholders. Following the spin-off of Ault Alliance, the Company will be a pure-play provider of Bitcoin (BTC) mining and data center operations, pursuing DeFi-related initiatives. The Company believes that both BitNile and Ault Alliance will, as separate public companies, be better positioned to deliver long-term growth and maximize stockholder value. The Company's Founder and Executive Chairman, Milton Ault, III said, "Our name change to BitNile coupled with our investments in Bitcoin mining equipment, our Michigan data center and DeFi initiatives, including Earnity, demonstrate our focus for the future of the Company. We have announced purchase commitments to grow active miners to 20,600 by the end of 2022 as we seek to become one of the top 10 publicly traded Bitcoin mining companies."

06:36 EST BlackSky newest satellites complete commissioning, generating revenue - BlackSky's newest satellites began revenue generating commercial operations within 18 hours. "This successful Rocket Lab launch marks our final BlackSky mission for 2021," said Nick Merski, BlackSky chief operations officer. "With each successive launch BlackSky continues to commission our satellites at unprecedented speed and deliver revenue-generating intelligence products to customers within a day of launch. Adding two more satellites increases our constellation's revisit rates dramatically and we're bringing the value of that benefit to our customers instantly," he said. BlackSky achieved a 12 small satellite constellation following the "A Data with Destiny" mission.

06:34 EST Symbotic to become public company through merger with SVF Investment Corp. - Symbotic and SVF Investment Corp. 3 (SVFC), a special purpose acquisition company sponsored by an affiliate of SoftBank (SFTBY) Investment Advisers, announced a definitive merger agreement expected to make Symbotic a public company listed on Nasdaq. Upon completion of the merger, which is expected in the first half of 2022, the combined company will operate under the "Symbotic Inc." name and will trade on Nasdaq under the ticker symbol "SYM." Symbotic is a product movement technology platform. The Company rebuilt the traditional warehouse, powered by a fleet of autonomous robots with A.I.-enabled software, to create a physical structure that can power a customer's supply chain technology platform. The company operates systems that service over 1,400 stores in 16 states and 8 Canadian provinces. The transaction values Symbotic at a pro forma enterprise value of $4.8B, representing 4.8x Symbotic's forecast 2023 calendar year end estimated revenues, and a pro forma equity value of approximately $5.5B. The transaction is expected to deliver up to $725M of primary gross proceeds, consisting of $320M of cash in trust from SVFC, assuming no public shareholders of SVFC exercise their redemption rights, a $205M common equity PIPE at a $10.00 per share entry price, including a $150M PIPE participation from Walmart (WMT), and a $200M forward purchase of common equity at $10.00 per share by an affiliate of SoftBank Vision Fund 2. The minimum cash of the transaction is fully covered by the $405M of committed equity capital that Symbotic and SVFC have raised. Symbotic also expects to receive an additional $174M in cash from Walmart by the end of December. At closing, assuming no public shareholders of SVFC exercise their redemption rights, existing Symbotic equity holders are expected to own 88% of the combined business, with Symbotic Chairman and Chief Executive Officer Rick Cohen retaining 76% ownership, Walmart retaining 9% and other holders retaining 3%. New investors will own 12%, with SPAC public shareholders owning 6%, the SVFC sponsor and its affiliates owning 5% and other PIPE investors owning 1%. Symbotic's CEO and CFO will be subject to a one-year lock-up period post-closing.

06:07 EST Eli Lilly, Foghorn Therapeutics enter collaboration for novel oncology targets - Loxo Oncology at Lilly, a research and development group of Eli Lilly (LLY) and Foghorn Therapeutics (FHTX), announced a strategic collaboration to create novel oncology medicines by applying Foghorn's proprietary Gene Traffic Control platform. The collaboration includes a co-development and co-commercialization agreement for Foghorn's selective BRM oncology program and an additional undisclosed oncology target. In addition, the collaboration includes three additional discovery programs using Foghorn's proprietary Gene Traffic Control platform. Under the terms of the agreement, Foghorn will receive upfront consideration of $300M in cash for the collaboration agreement and an equity investment by Lilly of $80M in Foghorn common shares at a price of $20 per share. For the BRM-selective program and the additional undisclosed target program, Foghorn will lead discovery and early research activities, while Lilly will lead development and commercialization activities with participation from Foghorn in operational activities and cost sharing. Foghorn and Lilly will share 50/50 in the U.S. economics, and Foghorn is eligible to receive royalties on ex-U.S. sales starting in the low double-digit range and escalating into the twenties based on revenue levels. For the additional discovery programs, Foghorn will lead discovery and early research activities. Foghorn may receive up to a total of $1.3B in potential development and commercialization milestones. Additionally, Foghorn will have an option to participate in a percentage of the U.S. economics and is eligible to receive tiered royalties from the mid-single digit to low-double digit range on sales outside the U.S. that may be exercised after the successful completion of the dose-finding toxicity studies. The terms of the transaction have cleared the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. This transaction will be reflected in Lilly's reported results and financial guidance according to GAAP. There will be no change to Lilly's 2021 non-GAAP earnings per share guidance as a result of this transaction.

06:06 EST Credit Suisse appoints Francesco De Ferrari as CEO of wealth management - Credit Suisse announces the appointment of Francesco De Ferrari as CEO of the Wealth Management division. He will join the Executive Board of Credit Suisse Group, effective January 1, 2022, reporting to Group CEOThomas Gottstein. Francesco De Ferrari has also been appointed as ad interim CEO of Europe, Middle East and Africa region. Christian Meissner, CEO of the Investment Bank division, has been appointed as CEO of the Americas region. In addition, Helman Sitohang and Andre Helfenstein have been appointed as CEOs of the APAC and Switzerland regions, respectively. Further, Mark Hannam has been named as Head of Internal Audit. Finally, Credit Suisse announces a new Board of Directors model structure to enhance the effectiveness and governance of the subsidiary Boards. The new appointments are in line with the Group's new strategy and organizational structure, as announced in November 2021, which is designed to move Credit Suisse to a matrix organization to allow for the best possible implementation of the strategy of strengthening, simplifying and investing for growth. From January 1, 2022, the Group will be organized into four business divisions - Wealth Management, Investment Bank, Swiss Bank and Asset Management - and four geographic regions - EMEA, Americas, Switzerland and APAC.

05:34 EST Cloopen to acquire Zhuge for a mix of cash, shares - Cloopen announced that it has entered into a definitive agreement to acquire the entire equity interests of Zhuge, a user-centric intelligent data solution provider, for a mix of cash and shares consideration. The shares issued will account for less than 1% of the company's outstanding share capital on a fully-diluted basis. The shares will be issued under a private placement pursuant to an exemption or exclusion from the registration requirements under the Securities Act of 1933, as amended. The transaction is expected to be completed in December, subject to customary closing conditions. There is no assurance that the transaction will be completed within the anticipated timeframe, or at all.

05:28 EST Genentech announces results from HAVEN-6 interim analysis at ASH - Genentech, a member of Roche, announced results from an interim analysis of the Phase III HAVEN 6 study, which show Hemlibra demonstrated a favorable safety profile and effective bleed control in people with moderate or mild hemophilia A without factor VIII inhibitors. The data were presented at the 63rd American Society of Hematology, or ASH. Considering this population may not use preventative treatments, these patients may experience worsened clinical burden, with less than 30% of people with moderate or mild hemophilia A living a bleed-free life. HAVEN 6 is a Phase III study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of Hemlibra in people with moderate or mild hemophilia A without factor VIII inhibitors. This interim analysis included data from 71 participants, 20 of whom had mild hemophilia A without factor VIII inhibitors and 51 of whom had moderate hemophilia A without factor VIII inhibitors. Thirty-seven participants were on factor VIII prophylaxis at baseline. This interim analysis was conducted after 50 participants with moderate hemophilia A completed at least 24 weeks in the study or withdrew. Data cutoff was on April 16. These data show Hemlibra demonstrated a favorable safety profile and effective bleed control in the HAVEN 6 study, with 80.3% of participants experiencing no bleeding episodes that required treatment and 90.1% experiencing no joint bleeds that required treatment. Annualized bleeding rates, or ABR, remained low, consistent with previously reported observations from the HAVEN 1-4 studies. In addition, of the 50 participants aged 12 years or older who responded to the EmiPref questionnaire, 48 preferred Hemlibra to their previous treatment, one preferred their old treatment, and one expressed no preference. The most common adverse events, or AEs, occurring in 10% or more people in the HAVEN 6 study were headache and local injection site reactions, or ISRs. Eleven people reported a Hemlibra-related AE, with ISRs being the most common. There were no deaths, or cases of thrombotic microangiopathy, or TMA, or serious thrombotic events, or TEs, in the study as of the data cutoff, reinforcing Hemlibra's favorable safety profile. A separate analysis of TE and TMA events in people taking Hemlibra, including real-world data, will also be presented as a poster at ASH. These results showed that the evaluation of reported events without concomitant activated prothrombin complex concentrate remains similar to previous analyses as exposure increases, and the benefit/risk profile of Hemlibra remains unchanged. These data further confirm the favorable safety profile of Hemlibra, consistent with results from previous HAVEN and STASEY studies.

05:16 EST Jazz Pharmaceuticals, PharmaMar initiate LAGOON trial - PharmaMar and partner Jazz Pharmaceuticals announced the initiation of a confirmatory Phase 3 clinical trial, LAGOON, evaluating Zepzelca for the treatment of patients with relapsed small cell lung cancer, or SCLC. The trial will measure overall survival, or OS, as the primary endpoint and progression-free survival, or PFS, as a secondary endpoint of lurbinectedin monotherapy or lurbinectedin in combination with irinotecan compared with investigator's choice of topotecan or irinotecan, in patients with SCLC whose disease has progressed following prior platinum-containing chemotherapy with or without anti-PD-1 or anti-PD-L1 agents. LAGOON is a Phase 3, randomized, multicenter, open-label clinical trial with three arms: one arm to receive lurbinectedin 3.2 mg/m2 as monotherapy, the second arm to receive lurbinectedin 2.0 mg/m2 in combination with irinotecan 75 mg/m2, and the third arm to receive topotecan or irinotecan based on the investigators' choice. The trial will be conducted in patients with SCLC, whose disease has progressed following prior platinum-containing chemotherapy with or without anti-PD-1 or anti-PD-L1 agents. LAGOON is expected to enroll 705 patients from more than 100 sites mainly in North America and Europe.

05:08 EST IFF business unit receives European Commission approval for Enviva Pro - Danisco Animal Nutrition, a business unit of IFF, announced the final authorization from the European Commission to expand the use of Enviva Pro, a multi-strain probiotic, to the European turkey production market. This development is the next step in Danisco Animal Nutrition's continuing commitment to support the food solution needs of the poultry industry.