Stockwinners Market Radar for September 17, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:09 EDT Astellas Pharma, Pfizer: XTANDI improved OS in Phase 3 ARCHES study - Astellas Pharma (ALPMY) and Pfizer (PFE) announced ahead of the European Society for Medical Oncology Congress 2021 that XTANDI improved overall survival in the ARCHES study in men with metastatic hormone-sensitive prostate cancer. The Phase 3, randomized, double-blind, placebo-controlled trial compared XTANDI plus androgen deprivation therapy versus placebo plus ADT in men with mHSPC and OS was a key secondary endpoint. In the study, XTANDI plus ADT reduced the risk of death by 34% compared to placebo plus ADT. Median OS, which represents the time from randomization to death due to any cause, was not reached in either treatment group. The safety profile in both study arms was consistent with findings from the primary analysis.

17:48 EDT NTSB to conduct safety investigation of fatal Tesla Model 3 crash in Florida - The NTSB said that, in coordination with City of Coral Gables Police Department, it is sending three investigators to conduct a safety investigation of the fatal Sept. 13, 2021, vehicle crash involving a Tesla Model 3 that departed the roadway and collided with a tree in Coral Gables, Florida. Reference Link

17:17 EDT Rolls-Royce awarded $194M Army contract - Rolls-Royce was awarded a $194M firm-fixed-price contract for the acquisition of Namer Armored Personnel Carrier Power Packs Less Transmissions. Bids were solicited via the internet with one received. Work will be performed in Novi, Michigan, with an estimated completion date of December 31. FY20 Foreign Military Sales funds in the amount of $194M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.

17:12 EDT Quidel awarded $710.57M Defense Logistics Agency contract - Quidel has been awarded a maximum $710.57M indefinite-delivery/indefinite-quantity contract for over-the-counter antigen test kits. This was a competitive acquisition with three responses received. This is a one-year contract with no option periods. Location of performance is all 50 states, with a September 14, 2022, ordering period end date. Primary customer is the Department of Health and Human Services. Type of appropriation is FY21 through FY22 defense working capital funds. The contracting activity is the Defense Logistics Agency Troop Support.

17:08 EDT Oscar Health CEO acquires 57,300 class A shares - In a regulatory filing, Oscar Health CEO Mario Schlosser disclosed the purchase of 57,300 class A common shares of the company on September 16 at a price of $17.5308 per share.

16:40 EDT FDA panel also recommends Pfizer booster for people with job exposure risk - According to CNBC's Meg Tirrell, an FDA panel voted 18 "yes" to zero "no" to include healthcare workers or others at high risk for occupation exposure to be included in the Pfizer booster EUA. Reference Link

16:25 EDT FDA panel votes in favor of recommending Pfizer booster for people aged 65+ - An FDA advisory committee panel voted 18 "yes" to 0 "yes" on whether the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least six months after completion of the primary series for use in individuals 65 year or older and those at high risk of severe COVID-19.

16:22 EDT Vertex announces LOI with pCPA over TRIKAFTA public reimbursement - Vertex Pharmaceuticals Incorporated announced that it has signed a Letter of Intent with the pan-Canadian Pharmaceutical Alliance, which represents an agreement in principle regarding the public reimbursement of PrTRIKAFTA for eligible patients with cystic fibrosis. This is an extension of the LOI with the pCPA including PrKALYDECO and PrORKAMBI. "This is a significant milestone for patients with CF in Canada," said Duncan McKechnie, Senior Vice President, North America Commercial Operations, Vertex Pharmaceuticals. "We would like to thank the pCPA and the participating jurisdictions for their collaborative approach. We share the urgency of the CF community to bring this process to a successful conclusion, and we will continue our work with all the provinces and territories so that eligible people with CF have the opportunity to receive TRIKAFTA, KALYDECO and ORKAMBI."

16:01 EDT Incyte says Health Canada grants conditional approval of Pemazyre - Incyte announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre, a selective fibroblast growth factor receptor inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement. "For appropriate patients with cholangiocarcinoma, the approval of Pemazyre in Canada offers patients hope with a new potential treatment option after their cancer has returned, following the failure of first-line treatment," said Durhane Wong-Rieger, Ph.D., President and CEO, Canadian Organization for Rare Disorders. "Cholangiocarcinoma is a rare cancer of the bile duct with limited treatment options. As a result, patients face a poor prognosis," said Dr. Vincent Tam, MD, Medical Oncologist, Tom Baker Cancer Centre. "With the approval of Pemazyre, we now have a targeted treatment option for those patients with progressive disease after first-line chemotherapy."

15:33 EDT FDA panel votes against recommending booster dose of Pfizer COVID vaccine - An FDA advisory committee panel voted 16 "no" to 2 "yes" on whether the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least six months after completion of the primary series for use in individuals 16 years of age and older.

15:23 EDT Copart CEO sells 170,000 common shares - In a regulatory filing, Copart CEO A. Jayson Adair disclosed the sale of 170,000 common shares of the company on September 15 at a price of $147.20 per share.

13:45 EDT Idacorp raises common stock dividend 5.6% to 75c per share - Idacorp announced that its board of directors approved a 5.6% increase in the regular quarterly cash dividend on its common stock to 75c per share. "Idacorp's board of directors has approved a dividend increase every year over the last decade, resulting in a cumulative average dividend growth rate of approximately 8.6%. These changes represent an overall increase of 150% in IDACORP's quarterly dividend over that period. Our financial and operational performance have allowed us to increase the dividend to shareholders, all while Idaho Power customers continue to benefit from some of the lowest energy prices in the nation. At this time, management expects to recommend to the board of directors future annual increases in the dividend of 5% or more, with the intent of remaining within our target payout ratio of between 60 and 70% of sustainable Idacorp earnings," said Lisa Grow, President and CEO.

13:06 EDT Baker Hughes reports U.S. rig count up 9 to 512 rigs - Baker Hughes reports that the U.S. rig count is up 9 from last week to 512 with oil rigs up 10 to 411, gas rigs down 1 to 100, and miscellaneous rigs unchanged at 1. The U.S. Rig Count is up 257 rigs from last year's count of 255, with oil rigs up 232 gas rigs up 27 and miscellaneous rigs down 2 to 1. The U.S. Offshore Rig Count is unchanged at 6, down 8 year-over-year. The Canada Rig Count is up 11 from last week to 154, with oil rigs up 8 to 95, gas rigs up 3 to 59. The Canada Rig Count is up 90 rigs from last year's count of 64, with oil rigs up 65, gas rigs up 25.

12:55 EDT W.R. Grace shareholders approve Standard Industries deal - W.R. Grace announced that, at a Special Meeting of Shareholders, the company's shareholders approved a proposal to adopt the merger agreement between Grace and an affiliate of Standard Industries Holdings Inc., under which Standard Industries Holdings will acquire all of the outstanding shares of Grace common stock for $70.00 per share in cash. Approximately 99.6% of the votes cast at the meeting, representing approximately 69.5% of shares of the company's common stock issued and outstanding as of the close of business on August 9, 2021, the record date for the Special Meeting, voted to adopt the Merger Agreement. The final vote results, as certified by an independent Inspector of Election, will be filed on a Form 8-K with the U.S. Securities and Exchange Commission. The completion of the transaction is expected to occur on Wednesday, September 22, 2021, subject to the satisfaction or waiver of the remaining customary closing conditions set forth in the Merger Agreement. Following the closing of this transaction, Grace will become a privately held company that will operate as a standalone company within the portfolio of Standard Industries, and Grace's common stock will no longer be listed on the New York Stock Exchange.

12:10 EDT AstraZeneca says Enhertu showed clinically meaningful, durable response in trial - AstraZeneca (AZN) announced that detailed results from the Phase II DESTINY-Gastric02 trial showed that Enhertu, the AstraZeneca and Daiichi Sankyo (DSNKY) HER2-directed antibody drug conjugate, provided a clinically meaningful and durable tumor response in patients with HER2-positive metastatic and/or unresectable gastric or gastroesophageal junction adenocarcinoma previously treated with a trastuzumab-containing regimen. Results were presented during a late-breaking mini-oral presentation at the European Society for Medical Oncology, or ESMO, Congress 2021. In the primary analysis of DESTINY-Gastric02, the first trial of Enhertu specifically in Western patients with HER2-positive metastatic gastric cancer or GEJ adenocarcinoma, Enhertu demonstrated a confirmed overall response rate, or ORR, of 38% as assessed by independent central review. Three complete responses and 27 partial responses were observed in patients treated with Enhertu. These results were consistent with those from the registrational DESTINY-Gastric01 Phase II trial previously published in The New England Journal of Medicine, the company stated.

12:00 EDT Dutch Bros falls -10.2% - Dutch Bros is down -10.2%, or -$4.90 to $43.10.

12:00 EDT Offerpad Solutions falls -22.9% - Offerpad Solutions is down -22.9%, or -$4.57 to $15.40.

12:00 EDT Spire Global rises 10.3% - Spire Global is up 10.3%, or $1.17 to $12.58.

11:37 EDT FDA warning on potential for false positives with Abbott Alinity COVID test - The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers of a potential for false positive results with Abbott Molecular's Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096. The false positive results may be related to current mixing parameters of the PCR reaction mixture that may result in potential overflow that could carry over into neighboring wells in the assay reagent tray. Overflow into the wells of true negative samples that are positioned near positive samples in the assay tray could produce false positive results. "The FDA is working with Abbott Molecular Inc. to resolve these issues. The FDA will continue to keep clinical laboratory staff, health care providers, and the public informed of significant new information," the FDA stated in a letter to clinical laboratory staff and health care providers posted to its website. Reference Link

11:17 EDT Chembio Diagnostics touts testing capabilities in tweet, cites Biden COVID plan - Chembio Diagnostics' official Twitter account tweeted: Biden has announced a new plan for COVID-19 Employers with 100+ workers will now require vaccines or weekly testing Chembio provides tests for Symptomatic & Asymptomatic serial testing, as well as multiplex COVID/Flu testing" In morning trading, Chembio Diagnostics shares are up 24c, or 9%, to $2.92 following the company's tweet. Reference Link

10:46 EDT Farmers & Merchants raises quarterly dividend 5.9% to 18c per share - The Board of Directors of Farmers & Merchants Bancorp announced that it has approved a 5.9% increase in the Company's quarterly cash dividend. The new cash dividend has been raised to 18c per share from the previous dividend of 17c and represents the 27th consecutive annual increase in the Company's regular dividend payment since 1994. The third quarter dividend is payable on October 20, 2021, to shareholders of record as of September 28, 2021.

10:00 EDT BlackSky falls -7.2% - BlackSky is down -7.2%, or -92c to $11.88.

10:00 EDT Offerpad Solutions falls -21.3% - Offerpad Solutions is down -21.3%, or -$4.26 to $15.71.

10:00 EDT Gannett rises 7.1% - Gannett is up 7.1%, or 46c to $6.96.

09:57 EDT Thermo Fisher sees FY25 revenue $48.8B-$50.8B - Sees FY25 adjusted operating margin greater than 26%, adjusted operating income $12.9B-$13.7B, adjusted ROIC 17%.

09:47 EDT U.S. Steel falls -4.9% - U.S. Steel is down -4.9%, or -$1.24 to $24.15.

09:47 EDT Offerpad Solutions falls -19.9% - Offerpad Solutions is down -19.9%, or -$3.97 to $16.00.

09:47 EDT On Holding rises 7.9% - On Holding is up 7.9%, or $2.95 to $40.44.

09:11 EDT Baidu-backed DeepWay unveils smart new energy heavy-duty truck - DeepWay, a Baidu-backed company, unveiled Xingtu, a smart new energy heavy-duty truck with a computing power of more than 500 TOPS and ultra-long-distance sensing capabilities of more than 1 kilometer. This announcement marks Baidu's entry into the multi-trillion global freight market. Powered by Baidu's globally recognized AI technology stack and the Baidu Apollo autonomous driving platform, Xingtu is a prime example of the next generation vehicles we will see in the smart driving era. The first generation of Xingtu is designed to enable L3 self-driving on high-speed freight routes and achieve L4 capabilities on these same routes between 2024 and 2026.

09:07 EDT Lincoln National enters $9.4B reinsurance agreement, sees accretion - Lincoln Financial announced it has entered into an agreement with Security Life of Denver Insurance Company, a subsidiary of Resolution Life, to reinsure approximately $9.4B of in-force executive benefit and universal life reserves. The transaction will generate approximately $1.2B of capital. The proceeds will predominantly be used to fund incremental share repurchases of approximately $900M that will be completed by the end of the first quarter of 2022. The remaining proceeds will be used for general corporate uses, primarily paying down debt. The transaction is expected to be approximately 5% accretive to Lincoln Financial's adjusted operating earnings per share and expand ROE in 2022. Under the terms of the reinsurance agreement, Lincoln Financial will retain account administration and recordkeeping of the policies. The transaction will have no impact on Lincoln Financial's relationship with, or commitments to, its distribution partners and policyholders. Additionally, Lincoln Financial remains focused on the continued growth of its Life Insurance business, including the sales of individual life insurance and executive benefits products. The agreement is dated September 17, with an effective date of October 1. Closing of the transaction is subject to usual and customary closing conditions, but there are no regulatory approvals required to close the deal. The transaction is structured as a coinsurance treaty for the general account reserves and as a modified coinsurance treaty for the separate account reserves, with counterparty protections including a comfort trust and investment guidelines to meet Lincoln Financial's risk management objectives.

09:05 EDT Zynga to launch ReVamp game on Snapchat - Zynga (ZNGA) announced that ReVamp, an upcoming multiplayer social deception game, will launch soon in select markets exclusively for Snapchat (SNAP). The vampire-themed game will be the first social deception title on Snapchat, giving Snapchatters their first chance to sink their teeth into this popular genre. ReVamp is a real-time multiplayer imposter game where players aim to reveal who the vampire player is among their group of friends while they renovate the rooms of an old mansion. In the game, human players must complete renovation tasks, such as demolition and building, to improve their chances of survival while identifying and defeating the vampire during the voting phase. Vampire players must avoid suspicion while picking off human players by completing a list of fake tasks throughout the mansion.

09:03 EDT Helbiz Media enters deal with Fox Networks to broadcast Serie B championship - Helbiz (HLBZ) announced an agreement between Helbiz Media, the company's new streaming entertainment service and exclusive distributor of the Serie BKT media rights worldwide, and Fox Networks (FOX) to broadcast the Italian Serie B championship across the USA and the Caribbean. This partnership marks Helbiz Media's arrival in North America and is the first time the entire Serie B championship will be available to view in this region. Helbiz Media will provide Fox with exclusive audiovisual rights to broadcast the top Serie B matches and game highlights live on the Fox Sports family of networks. Fox will broadcast three Serie B games per week in HD with English language commentary, and Helbiz Live will feature commentary in Italian for all Italians living in America. The partnership is confirmed for the next three seasons including 2021-2022, 2022-2023 and 2023-2024.

09:01 EDT United Airlines to begin flights between Washington, D.C. and Lagos, Nigeria - United Airlines announced that new service between Washington, D.C. and Lagos, Nigeria will begin November 29, subject to government approval. The airline will operate three weekly flights connecting the U.S. capital to Nigeria's largest city, which is also the top Western African destination for U.S-based travelers. Tickets will be available for sale on united.com and the United app this weekend.

08:58 EDT Evercel issues shareholder letter prior to Annual Meeting - Evercel issued a letter to shareholders, providing an update on the Company's business as it approaches its Annual Meeting. The letter read in part, "It has been an active period at Evercel and we are very excited about our holdings, positioning and path forward. We are writing to provide some business highlights ahead of the Company's Annual Meeting, which will be held on October 7, 2021 at 10:00am ET. Put plainly, we have assembled a great asset base, which we believe is valuable now and will be more so in the future. Since 2012, we have grown $18 million of cash into approximately $80 million worth of assets, after fees. Importantly, we believe there is significant incremental, embedded value in these assets that is yet to be recognized by the market, as demonstrated by the mismatch between the value of Evercel's assets and Evercel's current market capitalization. We are disappointed that to date the Company's stock price has not appreciated consistent with the increase in value of Evercel's underlying investments. The Board will be taking important steps to increase communication with shareholders, as described below. Additionally, we are confident that our application to be listed on the OTCQX market and our recent additions to the Board will help us better harness that value...If you haven't already, you soon will be receiving a proxy statement from the Company regarding the Annual Meeting. In the proxy, we provide background information on our two highly qualified nominees for election to the Board, Patrick McGeehin and Richard Perkins. We believe Mr. McGeehin and Mr. Perkins warrant your support as both have been instrumental on the Board in helping define the Company's path forward, and we are confident that, if reelected, Mr. Perkins and Mr. McGeehin will strengthen leadership's efforts to help Evercel's share price better reflect the Company's true value. As noted above, Mr. McGeehin, who recently joined the Board, has valuable accounting and consulting experience, and he also has been a shareholder in Evercel for over a decade with a meaningful number of shares. Mr. Perkins brings with him decades of management and investing experience that we believe will be additive to Evercel's efforts to drive value creation. You can find additional information about their qualifications in the proxy statement. A proxy card for you to vote your shares in support is also included with the proxy...Finally, we also wanted to let you know that as we approach October 7th, you may be contacted by our proxy firm, Okapi Partners. We encourage you to speak with them, as they can answer any questions you may have and provide accurate information about the nominees, management and the existing Board so you can confidently vote your shares...We believe the past year has been a very productive one for your company, Evercel, and one that has positioned us well for the future. We trust that you are excited about our prospects as we are, and we hope to have your support at the Annual Meeting. We plan to build on the success and continue seeking out compelling opportunities to increase the value and share price of your company."

08:39 EDT Save Foods establishes presence in Turkey - Save Foods announces it has engaged a local commercial post-harvest expert in Turkey, who is well connected in the local produce market, particularly within the citrus sector, to introduce the Company to local post-harvest operators with ties to the EU produce market.

08:35 EDT MaxCyte set to join Russell 2000 Index - MaxCyte announced that it is set to join the Russell 3000 and Russell 2000 indices, effective after the U.S. market opens on September 20, 2021, according to a preliminary list of quarterly IPO additions posted earlier this month by FTSE Russell.

08:34 EDT Corcept announces results from Phase 2 trial of relacorilant plus nab-paclitaxel - Corcept Therapeutics announced that results from its 178-patient, randomized, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer were featured in a proffered paper oral presentation at the European Society for Medical Oncology, or ESMO, Congress 2021. William Guyer, PharmD, Corcept's Chief Development Officer said, "The results presented at ESMO today clearly demonstrate the benefit experienced by the women who received relacorilant - delayed disease progression without increased side effect burden. We and our investigators are excited to begin a pivotal Phase 3 trial in the first quarter of next year to confirm these results." Women who entered the trial were randomized 1:1:1 to receive either nab-paclitaxel plus 150 mg of relacorilant given the day before, the day of, and the day after each weekly nab-paclitaxel infusion, nab-paclitaxel plus 100 mg relacorilant given daily, or nab-paclitaxel alone. While women in both relacorilant treatment arms experienced an improvement in progression free survival relative to the Comparator arm, the improvement in the Intermittent arm was statistically significant. Safety and tolerability of relacorilant plus nab-paclitaxel was comparable to nab-paclitaxel monotherapy. Women who received the higher dose of relacorilant intermittently exhibited a statistically significant improvement in median progression free survival, or PFS, compared to those who received nab-paclitaxel alone. The women in the Intermittent arm also experienced a statistically significant improvement in the duration of response relative to those in the Comparator arm. While the overall survival, or OS, data was only 63% mature at the time of the database cut-off, the women in the Intermittent arm exhibited a median OS of 12.9 months versus 10.4 months in the Comparator arm.

08:21 EDT Better Choice Company repurchases $1.3M of common stock - Better Choice Company announced that it has repurchased approximately $1.3 million of the Company's common stock at an average price of $3.67 per share in the open market with cash on hand. The Company's Board of Directors had previously authorized a stock repurchase program under which the Company can repurchase up to $2.0 million of the currently outstanding shares of the Company's common stock, until December 31, 2021.

08:18 EDT Via Renewables CEO buys 11K shares of common stock - In a regulatory filing, Via Renewables disclosed that its CEO Keith Maxwell bought 11K shares of common stock on September 14th in transaction size of $110K.

08:12 EDT Kymera Therapeutics discloses Chief Scientific Officer departing - In a regulatory filing, Kymera Therapeutics disclosed that Richard Chesworth, its Chief Scientific Officer, will be departing the company effective as of October 22. "Dr. Chesworth's departure was not related to any disagreements with the company on any matter relating to its scientific or other operations, policies, practices or any issues regarding financial disclosures, accounting or legal matters. The company has commenced a search for a new chief scientific officer," Kymera stated.

08:10 EDT Brickell Biotech to host KOL webinar on DYRK1A - Brickell Biotech announced that it is scheduled to host a key opinion leader webinar on DYRK1A, which is believed to play a key role in autoimmune and inflammatory diseases, on Friday, September 24, 2021 at 10:00 a.m. EDT. The webinar will feature a presentation by KOL Bernard Khor, M.D., Ph.D., Benaroya Research Institute at Virginia Mason, who will discuss the latest findings on the novel target DYRK1A, its role in autoimmune and inflammatory diseases, and the broad therapeutic potential of restoring immune homeostasis by inhibiting DYRK1A. Dr. Khor will be available to answer questions following the formal presentation. Brickell's management team will also provide a brief update on the Company's investigational DYRK1A inhibitor platform. This includes BBI-02, which is a Phase 1-ready, potential first-in-class oral DYRK1A inhibitor with promising preclinical validation and broad potential to treat autoimmune diseases including atopic dermatitis, rheumatoid arthritis, and other debilitating inflammatory conditions.

08:08 EDT Intuit enters 23-year partnership with LA Clippers for Intuit Dome - The LA Clippers and Intuit announced that they have entered a 23-year strategic partnership. Intuit is the exclusive naming rights partner of the Intuit Dome, the future home of the Clippers, which is scheduled to open in Inglewood, California for the 2024-2025 NBA season. The Clippers, Intuit and community leaders will break ground this morning.

08:06 EDT Westport restates Q2 financial statements due to accounting error - Westport Fuel Systems announced that it has filed amended and restated unaudited condensed consolidated interim financial statements for the three and six months ended June 30, 2021 and related amended and restated management's discussion and analysis. The Amended Statements were required to correct an accounting error which was identified during an internal review of one of the Company's subsidiaries' statutory financial records. All figures are expressed in millions of United States dollars. The Company recently became aware of and corrected a non-routine intercompany inventory sale of $5.7 million in the second quarter of 2021 which was not eliminated from reported consolidated revenue and cost of revenue. There was no impact on gross margin, net income, or the Company's statement of cash flows. The Company's consolidated revenue for the three and six months ended June 30, 2021 was restated to $79.0 million and $155.5 million, respectively. The Company's consolidated cost of revenue for the three and six months ended June 30, 2021 was restated to $63.3 million and $126.7 million, respectively.

08:05 EDT HarborOne Bancorp announces share repurchase program - HarborOne Bancorp announced that its board of directors has adopted a share repurchase program. Under the share repurchase program, which has received regulatory approval, the company may repurchase up to 2,668,159 shares of the company's common stock, or approximately 5% of the company's issued and outstanding shares following completion of the share repurchase program announced on April 16. The April 16, share repurchase program was completed on September 8. Any repurchased shares will be held by the company as authorized but unissued shares. The repurchase program may be suspended or terminated at any time without prior notice, and it will expire on September 17, 2022.

08:04 EDT InMode announces two-for-one split of ordinary shares - InMode announced a two-for-one share split of the company's ordinary shares, with a record date of September 27. The share split will take effect on September 30, and the company's ordinary shares will begin trading on a post-split basis on the Nasdaq Global Select Market on October 1. The share split was approved by the company's board of directors on September 14.

08:03 EDT Aerovate Therapeutics announces addition to Russell 2000 Index - Aerovate Therapeutics announced it has been added to the Russell 2000 Index, effective after the market's close today, following the recent Russell US Indexes annual reconstitution.

08:03 EDT Eagle Bulk Shipping takes delivery of M/V Antwerp Eagle - Eagle Bulk Shipping announced that it has taken delivery of its previously announced vessel acquisition, the M/V Antwerp Eagle. The ship, which was acquired this past May, is a 2015-built, high specification scrubber-fitted SDARI-64 Ultramax vessel built at Jiangsu Hantong Ship Heavy Industry. Proforma for the one pending vessel acquisition, the Company's fleet totals 53 ships with an average age of 8.8 years.

08:02 EDT CoreCivic does not expect USMS Contract for Tennessee facility to be renewed - CoreCivic has a direct contract with the U.S. Marshals Service, or USMS, at the 600-bed West Tennessee Detention Facility in Mason, Tennessee that is scheduled to expire on September 30, 2021. The Company recently was provided with a definitive inmate population ramp down plan from the USMS indicating that all inmates will be transferred out of the facility by September 30, 2021. As a result, the Company does not expect the USMS to exercise its renewal option under the existing contract. The Company has been actively marketing the facility to other government agencies, and in August 2021, the Company submitted a formal response to a government agency's request for proposal to utilize the West Tennessee Detention Facility. However, the Company can provide no assurances that it will be successful in entering into a new contract with the government agency. The revenue generated from the USMS at the West Tennessee Detention Facility for the year ended December 31, 2020, and six months ended June 30, 2021, was $18.4M and $10.2M, respectively. For the year ended December 31, 2020, the facility incurred a $1.4M net operating loss, and for the six months ended June 30, 2021, the facility generated net operating income of $0.8M.

07:47 EDT AstraZeneca presents results from COAST Phase 2 trial of monalizumab - Innate Pharma SA IPHA) announced that AstraZeneca (AZN) presented results from the randomized COAST Phase 2 trial during the European Society for Medical Oncology Congress 2021 on September 17, 2021. In particular, the results of the interim analysis showed monalizumab in combination with durvalumab improved progression-free survival and objective response rate compared to durvalumab alone in patients with unresectable, Stage III non-small cell lung cancer who had not progressed after concurrent chemoradiation therapy. Monalizumab, Innate's lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells. Based on these results, AstraZeneca informed Innate that it plans to start a registrational study with monalizumab in combination with durvalumab in patients with unresectable, Stage III non-small cell lung cancer.

07:39 EDT Turning Point Brands receives MDO from FDA in response to PMTA - Turning Point Brands was informed by the FDA that the agency has issued a Marketing Denial Order, or MDO, in response to a Premarket Tobacco Product Application, or PMTA, covering certain of the company's vapor products. The company said, "The Company stands behind the high quality of its PMTA, which we believe established that the products' continued marketing would be "appropriate for the protection of public health," the standard established by the Family Smoking Prevention and Tobacco Control Act of 2009. These products are crucial to improving public health by helping adult smokers migrate to less harmful products. TPB will continue to engage with the FDA and other stakeholders as we consider options moving forward, including a formal appeal of the decision and potential legal relief. The PMTA denied by this MDO included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use. The data demonstrated that TPB products do not appeal to never users, youth, or former users and that a significant majority of users of TPB products had completely ceased use of combustible cigarettes. The scientific literature on lower-risk nicotine delivery systems shows that these products can significantly improve public health by providing alternatives that are much less harmful than combustible cigarettes. The Company continues to monitor regulatory developments and intends to take appropriate measures to manage and mitigate any risk exposure that may result from these and any future MDOs."

07:36 EDT Novartis says real-world study of alpelisib demonstrates clinical benefit - Novartis announced findings from a real-world study evaluating the safety and efficacy of alpelisib for people living with PIK3CA-Related Overgrowth Spectrum, or PROS, who received treatment daily for at least 24 weeks. Results from EPIK-P1 showed alpelisib effectively reduced volume of clinically significant PROS-related lesions and improved signs and symptoms in pediatric and adult patients. Results were presented at the European Society of Medical Oncology, or ESMO, Virtual Congress 2021. In EPIK-P1, alpelisib reduced target lesion volume and improved PROS-related symptoms and manifestations. The primary endpoint analysis conducted at week 24 in patients with complete cases showed 38% of patients achieving a response to treatment which was defined as 20% or greater reduction in the sum of PROS target lesion volume. Nearly three in four patients, or 74%, showed some reduction in target lesion volume, with a mean reduction of 13.7%, and no patients experienced disease progression at time of primary analysis. Additionally, at week 24, investigators reported patient improvements from baseline in pain, fatigue, vascular malformation, limb asymmetry, and disseminated intravascular coagulation across the full study population.

07:34 EDT Climb Channel Solution to distribute MSP solutions by N-able - Climb Channel Solutions (WSTG) announced a new agreement with N-able (NABL), a global provider of software that empowers managed services providers to help small and medium enterprises navigate the digital evolution. This partnership with N-able strengthens Climb's leadership in service management solutions by offering simple and sophisticated monitoring, security, and business solutions.

07:31 EDT Navidea appoints Alexander Cappello as chair of the board - Navidea Biopharmaceuticals announced that on September 14, 2021, at a meeting of the Board of Directors of the company that followed the company's 2021 Annual Meeting of Stockholders, S. Kathryn Rouan, Ph.D. retired as Chair of the Board and as a director, and Claudine Bruck, Ph.D. retired as a director, both effective immediately. Following the retirement of Dr. Rouan as Chair, the Board appointed Alexander L. Cappello and John K. Scott, Jr., who were both existing members of the Board, as Chair of the Board and Vice Chair of the Board, respectively.

07:18 EDT Galapagos announces positive CHMP opinion for Jyseleca - Galapagos announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Jyseleca, a once-daily, oral, JAK1 preferential inhibitor for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Following this positive opinion, a final decision from the European Commission is expected later this year. The CHMP positive opinion is based on data from the pivotal Phase 2b/3 SELECTION program, which evaluated filgotinib as an induction and maintenance therapy in adult patients with moderately to severely active UC who have failed conventional therapy or biologics. SELECTION comprised two placebo-controlled induction studies, one in biologic-naive patients and the other in biologic-experienced patients, followed by a 47-week maintenance study for those who responded to filgotinib after 10 weeks. Responders to placebo continued on blinded placebo during the maintenance phase. The CHMP positive opinion will now be reviewed by the European Commission and a decision is expected before year end 2021. This positive opinion follows the previous approval of filgotinib for the treatment of patients with moderate to severe active rheumatoid arthritis. The use of filgotinib for UC is investigational and is not approved anywhere globally.

07:17 EDT Roche announces positive CHMP opinion for Gavreto in NSCLC with RET fusions - Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has recommended the approval of Gavreto as a monotherapy for the treatment of adult patients with rearranged during transfection, or RET, fusion-positive advanced non-small cell lung cancer, or NSCLC, not previously treated with a RET inhibitor. "This positive CHMP opinion for Gavreto represents another important step towards our goal of providing effective therapeutics that target genomic drivers of disease for as many cancer patients as possible," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development.

07:10 EDT Red White & Bloom Brands appoints Ryan Costello to board of directors - Red White & Bloom Brands is pleased to announce the appointment of Mr. Ryan Costello to its Board of Directors to become effective upon completion of any regulatory and/ or other requirements, as applicable. Costello is a former U.S. Congressman, and now public policy consultant.

07:09 EDT CN reaffirms commitment to enhancing competition - The company said, "Despite the recently terminated transaction, CN's bid for Kansas City Southern reaffirmed CN as the premier North American railroad and secured CN an incremental US$700 million in break-up fees. CN will continue to engage with market participants, railroads and shippers to ensure that all regulatory rules are enforced fairly, and customers do not suffer anti-competitive effects arising from a combination between Canadian Pacific and KCS."

07:07 EDT CN announces value creation plan targeting C$700M of additional operating income - CN announced the details of its strategic and financial value creation plan, "Full Speed Ahead - Redefining Railroading," which will allow CN to continue delivering high-quality service to customers while generating profitable growth and enhanced returns to shareholders. The plan announced today builds upon CN's January 2021 strategic plan to lead on safety, customer value, operational excellence, sustainability and social inclusion, while also delivering industry-leading shareholder returns. CN has outlined a plan that is both ambitious and achievable. The Company's focus will be on redefining railroading, driving profitable growth and making structural improvements for the next generation. CN has conducted an extensive review of all revenue and cost levers and has targeted C$700 million of operating income improvements to drive future growth. To achieve these improvements in 2022, CN intends to use a balanced approach that includes a strategic review of non-rail businesses and an optimization of labor productivity. For 2022 CN expects to grow operating income and earnings per share by approximately 20% and improve its operating ratio to 57%. Additionally, CN is reviewing its capital structure and financial leverage with a view to increasing total shareholder distributions. CN is committed to operational excellence and delivering value for its shareholders by: Resuming share repurchases: CN will recommence share repurchases under the plan previously approved by CN's Board of Directors in January 2021 and expects to complete the remaining C$1.1 billion of share repurchases by the end of January 2022. Increasing shareholder returns: CN is reviewing capital structure and financial leverage with a view to increase total shareholder distributions, including share repurchases in the range of C$5 billion for 2022. Reducing capital expenditures: CN expects to reduce capex to 17% of revenue in 2022 as a result of the current good condition of its network and the Company's continued absolute commitment to safety and customer service. CN expects to maintain capex at 17% of revenue for 2023-24 unless there are significant market shifts. Producing compelling financial returns: CN is committed to driving top-quartile Total Shareholder Return: leading the industry in organic revenue growth driven by CN's intermodal business and showing continuous improvement on its operating margin. Lowering its operating ratio: CN is targeting an operating ratio of 57% for 2022 by: Prioritizing rail operations, including car velocity, train speed and train length, and committing to pursuing strategic alternatives for adjacent non-rail businesses that are not best-in-class; and Rationalizing its cost structure by streamlining management, especially support functions, to improve labor productivity by accelerating speed and quality of decision making. CN believes an operating ratio of 57% is optimal for a world in which customers and regulators are putting a greater emphasis than ever on expanding customer choice, service and reliability.

07:06 EDT Clene presents Phase 2 REPAIR-PD clinical trial data - Clene along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine announced a poster presentation titled "Homeostatic Improvement of Brain Bioenergetic Metabolism in Parkinson's Disease: Results From A Phase 2 REPAIR-PD Clinical Trial With CNM-Au8" at the International Parkinson and Movement Disorder Society Virtual Congress 2021 which takes place September 17 - 22, 2021. Clene's Phase 2 REPAIR program achieved a statistically significant increase in its primary endpoint, the mean change in brain NAD+/NADH ratio. NAD is an essential molecule responsible for cellular energy production. While the NAD+/NADH ratio declines normally during aging by approximately 0.5% per decade, reduced NAD+/NADH ratios have been reported in multiple neurodegenerative diseases, and the decline in the ratio is implicated in Parkinson's disease. In the REPAIR-PD study, the trend in NAD+/NADH ratio improvement was driven by both increased NAD+ and decreased NADH. End of treatment results were compared to baseline. Exploratory endpoints revealed that taking CNM-Au8 resulted in the normalization of several critical markers of brain energy production capacity including beta-ATP levels and phosphorylation potential. There were no serious adverse events and treatment-emergent adverse events were mild and transient. Rob Etherington, Clene's Chief Executive Officer, added, "In addition to achieving its primary endpoint, the RESCUE-PD study reinforced our lead candidate CNM-Au8's central nervous system target engagement, as well as its ability to significantly rebalance brain metabolites, both of which have implications across most neurodegenerative diseases."

07:04 EDT Ucommune International announces key contract with Besunyen - Ucommune International announced that Besunyen Holdings Company, an investment company engaged in the manufacture and sale of therapeutic tea products, signed an agreement for space at the company's landmark asset-light project in the Beijing Asia Finance Center. As part of the Agreement, Besunyen will occupy 3,047.6 square meters at the Project for a total of 327 workstations from July 1, 2021, to December 31, 2023. In addition, the company will also furnish its one-stop customized U Design services to Besunyen under the Agreement to provide the company with a tailored interior design, enhance its brand image, accelerate its corporate transformation, and more.

07:03 EDT VBL Therapeutics announces independent DSMC provides clearance for OVAL phase 3 - VBL Therapeutics announced that the independent Data Safety Monitoring Committee, or DSMC, of the ongoing OVAL Phase 3 registration-enabling study of VB-111 in ovarian cancer has conducted its fifth pre-planned review and has provided clearance to proceed with further clinical research as planned with no changes to the protocol. The OVAL trial is planned to enroll approximately 400 adult patients globally and more than 320 patients have already been recruited. The trial has two primary endpoints: progression free survival, PFS, and overall survival, OS. Successfully meeting either primary endpoint has the potential to support a biologics license application, or BLA. Meeting the PFS endpoint, with a readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the U.S. Food and Drug Administration, compared to original projections based on the readout of the OS primary endpoint that remains anticipated in 2023.

07:02 EDT Bitfarms engages LHA for investor relations, advisory services - Bitfarms announces it has retained LHA Investor Relations, a leading IR and strategic advisory firm. LHA will focus on expanding market awareness for Bitfarms and conveying the Company's integrated business model and global growth strategies to the institutional and retail investment communities. LHA plans to build greater investor community awareness through enhanced communications, drive investor and sell-side analyst targeting, organize non-deal roadshows, and provide capital markets advisory services. LHA has been engaged at a rate of $20,000 per month for an initial term of six months. The engagement may be cancelled after ninety days upon thirty days' notice. LHA and its directors, officers and employees are arm's length to Bitfarms and do not have any interest, directly or indirectly, in Bitfarms or its securities, or any right or intent to acquire such an interest. The agreement with LHA is subject to TSX Venture Exchange approval.

06:58 EDT Tuesday Morning CEO buys 227K shares of common stock, CIO buys 100K shares - In a regulatory filing yesterday evening, Tuesday Morning disclosed that its CEO Fred Hand bought 227K shares of common stock and CIO William Baumann bought 100K shares of common stock on September 15th and 14th in transaction sizes of $375K and $171K respectively. Shares of Tuesday Morning are up 3.2% in early pre-market trading at $2.29.

06:36 EDT Zhongchao launches MDT training platform - Zhongchao announced the launch of its multidisciplinary treatment, or MDT, clinical thinking training platform for hematology. The Hematology MDT Platform provides clinicians with a channel to learn multidisciplinary thinking skills online. MDT is a medical service model in which multidisciplinary specialists discuss cases of a certain disease or a systemic disease and then develop a treatment plan for the patient taking into considerations of opinions from all disciplines.

06:10 EDT AMC CEO: Ticket buyers to be able to pay in Bitcoin, litecoin, ethereum - AMC CEO Adam Aron said Wednesday that the movie theatre operator expects to accept ether, litecoin, and bitcoin cash as payment, in addition to bitcoin, by the end of the year. The executive said via Twitter: "Cryptocurrency enthusiasts: you likely know @AMCTheatres has announced we will accept Bitcoin for online ticket and concession payments by year-end 2021. I can confirm today that when we do so, we also expect that we similarly will accept Ethereum, Litecoin and Bitcoin Cash." Reference Link

06:01 EDT Amazon.com says over 1M people applied for jobs at Career Day 2021 - Amazon announced that over 1M people applied for a job at Amazon as part of Career Day 2021. The virtual event attracted job seekers from more than 170 countries around the world. In the span of 24 hours, more than 2,000 Amazon recruiters offered 30,000 individual career coaching sessions with participants. The recruiters provided job seekers with professional advice to start, transition, or grow their careers-whether they wanted to work at Amazon or elsewhere.

05:14 EDT Dada Nexus announces launch of open digital logistics platform - Dada Group announced the launch of its open digital logistics platform, Dada Smart Delivery SaaS System. Based on Dada Now's self-developed Smart Logistics System and Big Data Platform, it provides integrated delivery solutions, including operation platform, merchant application and rider application. More than 100 merchants, that operate proprietary delivery teams or need delivery services, have adopted this system to match their omni-channel orders, manage delivery capacity and dispatch orders.