Stockwinners Market Radar for September 11, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:09 EDT Cathie Wood's ARK Investment bought 522.2K shares of Robinhood today

20:07 EDT Cathie Wood's ARK Investment bought 184.5K shares of Block today

20:05 EDT Cathie Wood's ARK Investment bought 84.5K shares of Toast today

19:52 EDT Brookdale Senior Living reports August-end occupancy 77.6% - The company states that in August, it has "achieved more than 2,200 move-ins during August, the highest number of move-ins over the past five years. August 2023 weighted average occupancy increased 50 basis points sequentially, from 77.1% in July 2023 to 77.6% in August 2023. Supported by a 120 basis point increase over 2022, August represented 22 consecutive months of year-over-year weighted average occupancy growth. August month end occupancy surpassed 79.0% and achieved new high since the start of the recovery in March 2021."

19:08 EDT Liberty Energy director Babcock sells 58,823 class A shares - In a regulatory filing, Liberty Energy director Ken Babcock disclosed the sale of 58,823 class A common shares of the company on September 6 at a price of $17.928 per share.

18:21 EDT GameStop director buys $266.7K in common stock - In a regulatory filing, GameStop disclosed that its director Alain Attal bought 15K shares of common stock on September 8th in a total transaction size of $266.7K.

17:36 EDT Cactus COO sells $1.07M in common stock - In a regulatory filing, Cactus disclosed that its COO Steven Bender sold 19.4K shares of common stock on September 8th in a total transaction size of $1.07M.

17:25 EDT General Dynamics awarded $226.52M Air Force contract - General Dynamics was awarded a firm-fixed-price, fixed-price incentive, cost-plus-incentive-fee, cost-plus-fixed-fee, and indefinite-delivery/indefinite-quantity contract with a ceiling of $226.52M for Global Aircrew Strategic Network Terminal Increment 2, Block 1. This contract provides for the production of High-Altitude Electromagnetic Pulse and radiation hardened general area alerting, personal area alerting, and ultra-high frequency line of sight communications to aircraft at both fixed sites as well as dispersed locations. Work is expected to be completed by September 10, 2030. This contract was a sole-source acquisition. FY23 Air Force procurement funds in the amount of $10.96M are being obligated at time of award. The Nuclear Networks Division is the contracting activity.

17:13 EDT Biophytis approved by FDA to initiate SARA-31 Phase 3 study in sarcopenia - Biophytis announced that it has received FDA authorization to launch its SARA-31 study in the US, the first ever phase 3 study in sarcopenia. This authorization complements the positive opinion obtained this summer from the Belgian authorities to conduct the SARA-31 phase 3 study. The company still needs to obtain authorizations from ethics committees in the countries before launching this study. The effective start of the study is scheduled for 2024, and will depend on the conclusion of partnership agreements and the company's financial resources.

17:04 EDT Lion Electric CFO Nicolas Brunet switches roles, Richard Coulombe to succeed - Lion Electric announced that Nicolas Brunet has been appointed as president, effective immediately. In his new and expanded role, Brunet will work alongside Marc Bedard, CEO-founder, on the elaboration and execution of all strategic aspects of the business, with a focus on accelerating sales across the United States and Canada, and oversee all commercial operations. Prior to that, Nicolas served as executive VP and CFO since December 2019, playing a critical role in the execution of the company's strategic plan, including through the completion of key financing transactions, the establishment of partnerships with key customers and stakeholders, and the management of the company's corporate development and corporate affairs. Richard Coulombe, who had been serving as Lion's senior VP, strategic initiatives since November 2021, will take over the role of CFO, effective immediately. Coulombe previously oversaw the execution of Lion's key capital projects, namely the establishment of the vehicle manufacturing plant in Joliet, Illinois and the battery factory in Mirabel, Quebec.

17:02 EDT Humacyte to announce top-line data from phase 2/3 V005 trial - Humacyte "will host a virtual webinar to announce top line data results from its Phase 2/3 V005 vascular trauma clinical trial. The V005 trial evaluated the HAV, an off-the-shelf, universally implantable bioengineered human tissue, in vascular trauma repair. The event will also feature Dr. Michael Curi, who will discuss the unmet clinical need in vascular trauma, and the use of the HAV as a potential repair solution for patients and soldiers with limb- and life-threatening injuries. Dr. Curi has utilized the HAV and has participated in the V005 clinical trial. The HAV has received priority designation for the treatment of vascular trauma by the U.S. Department of Defense and Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration."

17:00 EDT Six Flags Chief Legal Officer Aimee Williams-Ramey sells over $284K in shares - Chief Legal Officer of Six Flags Aimee Williams-Ramey disclosed in a regulatory filing that he had sold 11,630 shares of company stock at $24.45 per share on September 8, for a total transaction amount of $284,354.

16:56 EDT 3D Systems submits revised merger proposal to Stratasys - 3D Systems (DDD) announced the delivery of a revised proposal to combine with Stratasys Ltd. (SSYS). Each Stratasys share will convert into $7.00 in cash and ownership of 46% of the aggregate shares of the combined company (representing a 1.6387 exchange ratio based on the last disclosed Stratasys share count). 3D Systems believes this consideration mix is worth more than $27 per share to Stratasys shareholders inclusive of synergies. The revised offer results from discussions between the two companies and addresses feedback provided by Stratasys during an in-person meeting between directors of both companies on August 22, 2023. Stratasys has responded to this proposal by acknowledging that its diligence has confirmed material cost synergies arising from a combination that would translate into hundreds of millions of dollars of shareholder value, but concluded that the current spot price of 3D Systems shares renders the proposal inadequate. In addition, Stratasys has informed 3D Systems that, despite 3D Systems' good faith efforts to reach a negotiated transaction for the benefit of all shareholders, Stratasys' board of directors continues to support the Desktop Metal (DM) merger as its preferred alternative and that the Stratasys board is not interested in any further discussions with or proposals from 3D Systems about a combination. President and CEO Dr. Jeffrey Graves stated, "We listened to shareholder feedback and made a strong effort to reach a friendly transaction but it seems there is no price that would satisfy the Stratasys Board. Shareholders of Stratasys have seen their board turn down offer after offer, watching only the consistent destruction of value in the meantime. The latest game appears to be an attempt to 'run out the clock' on supposed discussions with us, while always moving ahead with the massively value-destructive merger with Desktop Metal. We are confident that shareholders will support our combination and send an unequivocal message to the Stratasys board that they can no longer protect themselves while fiddling away shareholder value."

16:42 EDT CS Disco CEO Kiwi Camara to step down - CS Disco (LAW) "announced that Kiwi Camara, Co-Founder and CEO, has decided to step down from his roles as Chief Executive Officer and a member of the board of directors. Scott Hill has been named as Chief Executive Officer, to serve on an interim basis while the board of directors searches for a permanent successor. Mr. Hill has served as a member of DISCO's board of directors since June 2021 and was previously Chief Financial Officer of Intercontinental Exchange (ICE). Mr. Camara has indicated that he will make himself available to assist Mr. Hill during the transition."

16:35 EDT AssetMark Financial reports platform assets of $102.2B at end of August - AssetMark Financial released its "AssetMark Monthly Knowledge" report. Platform assets of $102.2B at the end of August, up 21.1% year-over-year. Net flows were $555M in the month of August, down 8.3% year-over-year. AssetMark Trust Company client cash was $2.83B, down 36.8% year-over-year. Number of households increased 12.7% year-over-year to 250,307 at the end of August.

16:33 EDT CEO of McKesson Tyler sells $10.7M in shares - The CEO of McKesson Brian Tyler disclosed in a regulatory filing, the sale of 25,246 shares of company stock at $422.58 per share on September 8, for a total transaction amount of $10,668,523.

16:31 EDT MFA Financial names Michael Roper as new CFO - MFA Financial announced today that its Board of Directors has appointed Michael C. Roper as CFO effective at the close of business on September 15, 2023. Mr. Roper succeeds Stephen D. Yarad, who is resigning as MFA's Chief Financial Officer to become chief financial officer of another company. Mr. Roper has held various accounting and financial reporting-related positions since joining MFA in 2014, has been Senior Vice President of MFA since January 2019 and Chief Accounting Officer of MFA since December 2021, and he will continue in these roles.

16:25 EDT Arbutus Biopharma discontinues AB-161 development, AB-343 coronavirus therapy - Arbutus Biopharma announced pipeline updates including its continued focus on its hepatitis B virus, or HBV, assets, imdusiran as a therapy in a functional cure treatment regimen for patients with chronic hepatitis B virus, as well as its oral PD-L1 inhibitor, AB-101. In addition, the company is discontinuing development of its oral RNA destabilizer, AB-161, due to a pre-clinical toxicology finding not related to peripheral neuropathy. There were no safety issues reported in the healthy subjects that received single doses of AB-161 in the Phase 1 clinical trial. The company is also discontinuing its efforts to identify and develop a coronavirus combination therapy that included AB-343 its Mpro candidate, due to an unfavorable PK profile noted in the IND-enabling studies, and a potential nsp12 polymerase inhibitor. These pipeline changes are expected to extend the company's cash runway through Q3 2025. The company remains on track to report preliminary data in the fourth quarter of this year from the Phase 2a clinical trial with imdusiran and Vaccitech's VTP-300 in patients with cHBV. In addition, the company has dosed the first subject in its Phase 1a/1b clinical trial with its oral PD-L1 inhibitor, AB-101, for HBV and expects preliminary data in the first half of 2024.

16:21 EDT OrthoPediatrics receives FDA clearance for PNP Tibia - OrthoPediatrics announced it has received 510(k) clearance from the U.S. Food and Drug Administration FDA for its Pediatric Nailing Platform Tibia surgical system. Part of the Trauma & Deformity Correction suite of products, PNP Tibia represents another pediatric-focused solution for treating patients with fractures and deformities in the lower extremities. It expands the Company's offering to 51 unique surgical systems designed specifically to help treat the needs of pediatric patients and is expected to launch in the third quarter of 2023. The PNP Tibia System features rigid cannulated nails, ranging in diameters from 7mm-12mm, and includes specialized instrumentation to facilitate multiple surgical techniques. Like other OrthoPediatrics products, this system was designed for children's anatomy and growing patients.

16:20 EDT Adeia, Nvidia resolve litigation confidentially - Adeia (ADEA) announced that Nvidia (NVDA) and Adeia have resolved the existing litigation between the companies on confidential terms. "Having resolved these disputes, we are hopeful that this settlement will open the door for future technology collaborations with NVIDIA," said Dana Escobar, chief licensing officer and general manager, semiconductor, at Adeia.

16:19 EDT First Light Acquisition Group, Calidi to complete combination - First Light Acquisition Group (FLAG) announced that it anticipates completing its business combination with Calidi Biotherapeutics on September 12. The common stock and warrants of Calidi have been approved for listing on the New York Stock Exchange American under the ticker symbols (CLDI) and are expected to commence trading on September 13. FLAG shareholders approved the transaction on September 1, following approval by Calidi shareholders. Calidi's existing management team, including CEO and chairman, Allan Camaisa, will lead the combined company. As a result of this business combination, gross proceeds made available to Calidi Biotherapeutics, prior to the payment of transaction expenses and debt repayments, are approximately $28M, which consists of $25M in a private capital raise, cash proceeds of approximately $1M from FLAG's trust account, and approximately $2M in PIPE and non-redemption agreements. Estimated transaction expenses and debt repayments include approximately $13M and, in addition thereto, a $5M working capital adjustment for expenses incurred prior to closing. In addition, Calidi announced a forward purchase agreement with a consortium including Meteora Capital, Great Point Capital and Funicular Funds for up to $10M.

16:16 EDT Tanger Factory names Jessica Norman as EVP and General Counsel - Tanger announced the appointment of Jessica Norman as the company's Executive Vice President, General Counsel and Secretary, effective September 12. In this role, Norman will lead Tanger's legal organization, including its corporate governance and compliance functions. Norman will report to Stephen Yalof, President and CEO, and will sit on the executive leadership team.

16:15 EDT Brookdale Senior Living reports August occupancy - August 2023 Observations: Achieved more than 2,200 move-ins during August, the highest number of move-ins over the past five years. August 2023 weighted average occupancy increased 50 basis points sequentially, from 77.1% in July 2023 to 77.6% in August 2023. Supported by a 120 basis point increase over 2022, August represented 22 consecutive months of year-over-year weighted average occupancy growth. August month end occupancy surpassed 79.0% and achieved new high since the start of the recovery in March 2021.

16:15 EDT Fifth Third raises quarterly dividend to 35c per share from 33c - The dividend is payable on October 16, 2023 to shareholders of record as of September 30, 2023.

16:09 EDT Oracle falls 5% to $120.02 after reporting Q1 results

16:07 EDT Zevia names Kirsten Suarez as Chief Marketing Officer - Zevia "announced the appointment of Kirsten Suarez as its Chief Marketing Officer. Ms. Suarez brings to Zevia over 20 years of experience in marketing and brand-building with leading consumer-packaged goods and quick-service restaurant (QSR) companies including Taco Bell and Procter & Gamble. During her most recent role as CMO at N!CK'S, a Swedish-born, better-for-you growth-stage food company delivering no sugar added products, she led omnichannel marketing, and the brand was named to Bain & Company's List of 2023 Insurgent Brands in recognition of delivering high growth. As Zevia's CMO, she is responsible for leading the development and execution of marketing strategies to drive Zevia's core growth initiatives and build the Zevia brand, and she reports to Amy Taylor, President and CEO of Zevia."

16:07 EDT Desktop Metal announces sale of Production System P-50 - Desktop Metal (DM) "announced the sale of a Production System P-50 and a full fleet of metal binder jet systems to FreeFORM Technologies. FreeFORM's primary investor is Ryerson Holding Corporation (RYI), a leading value-added processor and distributor of industrial metals, with operations in the United States, Canada, Mexico, and China."

16:01 EDT Acelyrin Inc trading halted, news pending

14:07 EDT Novartis issues voluntary recall of one lot of Sandimmune Oral Solution - The FDA said Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune formulations are impacted. Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. The affected lot number and expiration date is: FX001691 (expiration date 12/2025). This lot was distributed nationwide to wholesalers across the US, beginning in April 2023. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

14:03 EDT Moderna announces FDA approval for updated COVID-19 vaccine - Moderna announced the U.S. Food and Drug Administration has approved the supplemental Biologics License Application, or sBLA, for Spikevax for ages 12 years and above. Emergency Use Authorization for the Moderna COVID-19 Vaccine was also received for individuals 6 months through 11 years of age. Moderna's updated COVID-19 vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. With the U.S. FDA's decision, Moderna will begin shipping doses to vaccination sites across the U.S., with updated vaccines expected to be available in the coming days. "COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season. As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season. We appreciate the FDA's timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time," said Stephane Bancel, CEO of Moderna.

13:52 EDT Pfizer, BioNTech announce FDA approval for 2023-2024 COVID-19 vaccine - Pfizer (PFE) and BioNTech SE (BNTX) announced that the U.S. Food and Drug Administration approved the supplemental Biologics License Application for COMIRNATY 2023-2024 Formulation for individuals 12 years and older and granted emergency use authorization for individuals 6 months through 11 years of age for the companies' Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. "This season's vaccine is indicated as a single dose for most individuals 5 years of age and older. Children under the age of 5 may be eligible to receive additional doses of this season's vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine," the companies stated.

13:45 EDT Rosecliff Acquisition Corp I trading halted, volatility trading pause

13:37 EDT Amedisys shareholders vote in favor of UnitedHealth deal - Amedisys (AMED) held a special meeting of its stockholders on September 8, 2023 to vote on the proposals identified in the company's definitive proxy statement on Schedule 14A, filed with the U.S. Securities and Exchange Commission on August 10, 2023, which was first mailed to the Company's stockholders on or about August 10, 2023, a company filing said. The Definitive Proxy Statement was filed in connection with the previously announced Agreement and Plan of Merger, dated June 26, 2023, by and among UnitedHealth Group (UNH), Aurora Holdings Merger Sub, a wholly owned subsidiary of Parent, and Amedisys, pursuant to which Merger Sub will merge with and into the company upon the terms and subject to the conditions set forth in the Merger Agreement, with the company surviving the Merger as a wholly owned subsidiary of Parent. Each of the two proposals voted on was approved by the requisite vote of the company's stockholders. The company's stockholders approved the adoption of the Merger Agreement. The company's stockholders approved, on a non-binding, advisory basis, the compensation that may be paid or become payable to the company's named executive officers in connection with the Merger. Reference Link

13:00 EDT Maximus names John Martinez as general counsel, succeeding David Francis - Maximus announced John Martinez as the company's new General Counsel. Martinez succeeds David Francis, who has been with Maximus since 1998 and will help Martinez transition into the new role before his previously announced retirement at the end of 2023. Martinez joins Maximus after serving as Vice President and General Counsel of GE Aerospace.

12:38 EDT Growth for Good Acquisition Corp trading resumes

12:32 EDT Novelis enters LT agreement to supply aluminum beverage can sheet to Ball Corp. - Novelis (NVL) announced that in early 2023 it signed a new anchor customer contract with aluminum can maker Ball Corporation (BALL) in North America. Under the contract, Novelis will supply aluminum sheet to Ball can making plants in North America. With this contract and other commitments, Novelis has secured all of the beverage can capacity from its new plant in Bay Minette, Ala. The new plant, expected to begin commissioning in 2025, will be the first fully integrated aluminum manufacturing plant built in the U.S. in nearly 40 years and will have an initial capacity of 600,000 tonnes of finished goods primarily for the North American beverage can and automotive markets, the company said in a statement.

12:04 EDT Canadian National, Norfolk Southern announce new domestic intermodal service - Canadian National Railway (CNI) and Norfolk Southern (NSC) announced Monday a new domestic intermodal service. "Launching on October 2, this unique service will provide customers with an integrated, market-competitive, and efficient all-rail service. The service will link CN-served Canadian markets with Norfolk Southern-served Kansas City and Atlanta, the heart of the fast-growing manufacturing and consumer base in the Southeastern U.S. The two carriers will utilize new intermodal steel wheel interchanges in Detroit and Chicago to seamlessly operate like a single-line intermodal product. The new, cost-effective, steel-wheel-connected service option for customers converts truck traffic to long-haul rail. This would help reduce greenhouse gas emissions and customers' overall carbon footprint. Integrated rail interchanges also provide customers with the opportunity to optimize their cargo loaded weights," the companies stated. "CN is pleased to provide customers enhanced market access with the launch of another new Intermodal product. The reliable, cost-effective, and truck-competitive service will help our customers shift more business onto rail," added CN's President and CEO Tracy Robinson.

12:02 EDT Vigil presents VGL101 complete Phase 1 data, Phase 2 IGNITE trial design - Vigil Neuroscience announced the complete data analysis from its VGL101 Phase 1 single and multiple ascending dose - SAD and MAD - healthy volunteer trial in a poster presentation at the 2023 American Neurological Association, or ANA, Annual Meeting. In addition, the company presented a poster highlighting the study design for its ongoing IGNITE Phase 2 clinical trial. "The dataset from the VGL101 Phase 1 healthy volunteer trial is very encouraging and further validates our development strategy for the ongoing IGNITE Phase 2 trial in ALSP. VGL101 continued to demonstrate a favorable safety and tolerability profile and remains the first antibody to show durability of TREM2 engagement in a clinical setting. We are committed to achieving further milestones for VGL101, including the interim data readout from IGNITE in the fourth quarter of 2023. The IGNITE interim analysis will be the first ever clinical data provided from an interventional study in ALSP," said Ivana Magovevi-Liebisch, Ph.D., J.D., President and CEO of Vigil.

12:00 EDT Granite Ridge Resources falls -15.9% - Granite Ridge Resources is down -15.9%, or -$1.19 to $6.31.

12:00 EDT SharkNinja rises 13.2% - SharkNinja is up 13.2%, or $4.62 to $39.64.

12:00 EDT WeWork rises 14.8% - WeWork is up 14.8%, or 39c to $3.04.

11:46 EDT Disney, Charter announce multiyear distribution agreement, end blackout - Disney Company (DIS) and Charter Communications (CHTR) announced a multiyear distribution agreement. As part of the deal, the majority of Disney's networks and stations will be immediately restored to Spectrum's video customers. Among the key deal points: In the coming months, the Disney+ Basic ad-supported offering will be provided to customers who purchase the Spectrum TV Select package, as part of a wholesale arrangement; ESPN+ will be provided to Spectrum TV Select Plus subscribers The ESPN flagship direct-to-consumer service will be made available to Spectrum TV Select subscribers when it launches; Charter will maintain flexibility to offer a range of video packages at varying price points based upon different customer viewing preferences. Charter will also use its distribution capabilities to offer Disney's direct-to-consumer services to all its customers. In a joint statement, Robert Iger, CEO, Disney, and Chris Winfrey, CEO, Charter, said: "Our collective goal has always been to build an innovative model for the future. This deal recognizes both the continued value of linear television and the growing popularity of streaming services while addressing the evolving needs of our consumers. We also want to thank our mutual customers for their patience this past week and are pleased that Spectrum viewers once again have access to Disney's high-quality sports, news and entertainment programming, in time for Monday Night Football."

11:24 EDT Barclays orienting investment bank towards the future, says CEO

11:09 EDT Graf Acquisition IV to adjourn special meeting to approve NKGen combination - Graf Acquisition Corp. IV announced that on September 8, 2023, it adjourned, without conducting any business, the special meeting of its stockholders to be held to approve, among other things, the previously announced business combination with NKGen Biotech, Inc. The Special Meeting will be reconvened at 4:00 p.m., Eastern time, on September 13, 2023. As previously announced, the company has received enough votes to date via proxy to approve each of the proposals to be presented at the Special Meeting; however, it has decided to adjourn the Special Meeting once again to provide additional time to continue its efforts to obtain additional financing, which may be in the form of equity, debt, grants or other equity-linked securities or derivatives, needed to satisfy the $50M minimum cash condition under the agreement and plan of merger entered into in connection with the Business Combination, which condition may be waived by NKGen in its sole discretion.

11:01 EDT Mullen acquires battery pack production assets from Romeo Power for $3.5M - Mullen Automotive announces the purchase of battery pack production assets from Romeo Power for approximately $3.5M. The deal includes equipment, inventory and intellectual property for high volume EV, or electric vehicle, battery pack and module production. "Purchasing the Romeo assets is consistent with our battery pack production path and previous announcements for our high voltage facility in Monrovia. Overall, this purchase further enhances our capabalities for battery pack production right here in California and the U.S.," said David Michery, CEO and chairman of Mullen Automotive.

10:52 EDT S&P raises Carvana credit rating to 'CCC+' with negative outlook - S&P Global Ratings raised its issuer credit rating on the company to "CCC+" from "D." Carvana completed its debt restructuring, swapping its senior unsecured notes for a reduced amount of longer-dated senior secured notes, S&P said in a statement. This reduced Carvana's debt burden and temporarily improved liquidity, the agency added. It says the upgrade reflects the near-term improvement in the company's liquidity position, but adds Carvana's "capital structure remains unsustainable." S&P believes the company's liquidity improvement is only temporary and its liquidity will come under pressure once the payment-in-kind debt converts to cash interest in two years. As such, it has a negative outlook on the company.

10:13 EDT BNY Mellon doesn't see M&A action for now, says CFO

10:12 EDT BNY Mellon CFO: 'No reason to change' FY23 NII guidance of 20% growth - Commence taken from the Barclays Global Financial Services Conference.

10:09 EDT Mirum Pharmaceuticals appoints Eric Bjerkholt as CFO - Mirum Pharmaceuticals (MIRM) announced the appointment of Eric Bjerkholt as CFO. "Eric is an accomplished CFO bringing an outstanding track record in driving financial performance, business development, and operations management," said Chris Peetz, president and CEO at Mirum. "Eric is joining at an important period of growth and global scale for Mirum, and it is a pleasure to have his experience and leadership at Mirum as we continue to execute on numerous initiatives across our rare disease franchises." Bjerkholt comes to Mirum from Chinook Therapeutics (KDNY), where he served as CFO.

10:01 EDT Cineverse partners with Criterion Pictures to expand distribution - Cineverse announced a partnership with Anuvu Operations LLC d/b/a Criterion Pictures to manage and grow its third-party and owned and operated over-the-top channels. In this new deal, a number of popular Cineverse FAST and AVOD channels including The Bob Ross Channel, Fandor, Midnight Pulp, and EntrepreneurTV will be distributed to non-theatrical markets including universities, hospitals, libraries, cruise ships, and more. Each of these channels are either owned, operated or distributed by Cineverse, and all channels are powered by Matchpoint, the company's digital service technology which streamlines delivery. The deal will also include title licensing opportunities to Criterion's land-based North American customer base.

10:00 EDT J.M. Smucker falls -7.1% - J.M. Smucker is down -7.1%, or -$10.07 to $131.51.

10:00 EDT IHS Holding falls -12.6% - IHS Holding is down -12.6%, or -75c to $5.20.

10:00 EDT Carlisle rises 8.4% - Carlisle is up 8.4%, or $21.10 to $272.46.

09:47 EDT Perfect Corp. falls -4.8% - Perfect Corp. is down -4.8%, or -19c to $3.81.

09:47 EDT J.M. Smucker falls -6.6% - J.M. Smucker is down -6.6%, or -$9.28 to $132.30.

09:47 EDT Darling Ingredients rises 7.7% - Darling Ingredients is up 7.7%, or $4.53 to $63.08.

09:34 EDT Arena Investors sends letter to Charge Enterprises seeking changes - Arena Investors said it sent a letter to the board of Charge Enterprise "to reiterate the urgent need for Charge to take decisive action to significantly enhance value for its shareholders." In its letter, Arena outlined steps for Charge to take to "improve its corporate management and operations in order to reverse the current trend of poor performance, including an approximately 78% decline in Charge's stock and a loss of approximately $346M in market capitalization in the past year. The fund says the entire board should be subject to annual elections and "immediately initiate an independent review of Charge's corporate overhead and instill a culture of fiscal responsibility." The letter adds, "As a long-term investor committed to realizing Charge's vast potential, Arena is confident that through stronger leadership, a more well-balanced board, a sound financial basis, and a clear strategy with efficient execution, Charge can drive much needed expansion in electric vehicle charging infrastructure while delivering substantial value to shareholders and benefits for customers, drivers and the environment."

09:25 EDT Alibaba confirms Wu to succeed Zhang as CEO of Cloud Intelligence Group - Alibaba stated in a letter to the Hong Kong Stock Exchange: "As Alibaba Group Holding Limited announced on June 20, 2023, the company has today completed its leadership transition with Mr. Joseph C. Tsai assuming the role of Chairman and Mr. Eddie Yongming Wu assuming the role of Chief Executive Officer and Director of the company. In addition, the company announces that Mr. Wu will succeed Mr. Daniel Yong Zhang as acting Chairman and Chief Executive Officer of the Alibaba Cloud Intelligence Group, with effect from September 10, 2023. The company will continue to execute its previously announced plan to spin off Alibaba Cloud Intelligence Group under a separate management team to be appointed, subject to restructuring of certain assets, liabilities and contracts, implementation of employee equity incentive plans, market conditions, as well as regulatory reviews and approvals in relevant jurisdictions. The board of our company expresses its deepest appreciation to Mr. Zhang for his contributions to Alibaba Group over the past 16 years, including as Chief Executive Officer since 2015 and as Chairman since 2019, as well as his leadership of Alibaba Cloud Intelligence Group since 2022." Reference Link

09:21 EDT Canadian Net REIT announces sale of property in Trois-Rivieres, QC - Canadian Net Real Estate Investment Trust announces the successful sale of a single-tenant property housing a restaurant operating under the Mike's banner in Trois-Rivieres, Quebec. The total consideration received for the Property was $1.3M, translating into a capitalization rate of 5.6%. This is a notable 26% premium above the Property's IFRS value. The net proceeds from this transaction will be directed towards repaying a portion of the Trust's credit facilities. "The disposition of our Mike's property in Trois-Rivieres underscores the increasing disconnect between Canadian Net REIT's unit price and the value of our assets." said Kevin Henley, President and CEO. "This marks our second successful sale this year, achieving prices well above our IFRS values. In addition to being accretive to the Trust, this sale will increase our liquidity, thereby enhancing our capacity to capitalize on future investment prospects."

09:18 EDT Nemaura Medical completes 100 patient study for sugarBEAT 24-hour wear - Nemaura Medical announced it has recently completed a 100-patient study across 4 cohorts of 25 diabetic patients for sugarBEAT(R) and provided interim results. The Company has previously received CE approval in Europe, and SFDA approval for its sugarBEAT glucose sensor for a wear period of 14 hours. The study was conducted in the Middle East on 100 adult patients aged 18 to 75 comprising 20 persons with Type 1 diabetes and 80 persons with Type 2 diabetes, with an approximately equal split between male and female. The Company reports interim data from a first cohort comprising 25 patients, on a single day sensor wear. Over a 12-hour period using a retrospectively applied algorithm, the results indicated an overall mean absolute relative difference of 9.8% with 86% of the paired points within 20/20 of the reference value based on 1,037 paired points and two calibrations. A further calibration indicated an overall MARD of 12.8% over a 24-hour sensor wear period based on 1,379 paired points, and 76% of the paired points within 20/20 of the reference blood serum glucose value. The results indicate that a 24-hour sensor wear period using a single sensor is possible, which is expected to allow users to monitor their glucose fluctuations overnight.

09:15 EDT Scilex generates 'record revenue' in August 2023 - Scilex announces record revenue for the month of August 2023 and is providing certain preliminary unaudited financial results for the month ended August 31, 2023, and year-to-date as of August 31, 2023, based on currently available information. Scilex estimates that: ZTlido gross sales for August 2023 were in the range of $13.0 million to $14.0 million, compared to $10.1 million in August 2022, representing growth in the range of 29% to 39%; and year-to-date August 2023 were in the range of $87.2 million to $91.3 million, compared to $56.3 million for year-to-date August 2022, representing growth in the range of 55% to 62%. ZTlido net sales for August 2023 were in the range of $4.4 million to $4.8 million, compared to $4.0 million in August 2022, representing growth in the range of 10% to 20%; and year-to-date August 2023 were in the range of $26.2 million to $32.0 million, compared to $21.3 million for year-to-date August 2022, representing growth in the range of 23% to 50%. Total product gross sales for August 2023 were in the range of $13.4 million to $14.6 million, compared to $10.1 million in August 2022, representing growth in the range of 33% to 44%; and year-to-date August 2023 were in the range of $89.3 million to $93.7 million, compared to $56.3 million for year-to-date August 2022, representing growth in the range of 59% to 66%. Total product net sales for August 2023 were in the range of $4.5 million to $4.9 million, compared to $4.0 million in August 2022, representing growth in the range of 13% to 23%; and year-to-date August 2023 were in the range of $26.3 million to $32.2 million, compared to $21.3 million for year-to-date August 2022, representing growth in the range of 23% to 51%

09:11 EDT IPG Photonics launches new dual-beam laser - IPG Photonics will highlight new and innovative laser solutions at The Battery Show from September 12-14, 2023 in Novi, Michigan, USA. The IPG booth will include industry-leading fiber laser sources and automated laser systems for EV battery welding applications. "IPG is more than just a laser company," said Trevor Ness, SVP Worldwide Sales and Strategic Business Development. "IPG's lasers and laser systems are designed first and foremost to provide solutions that directly address real-world requirements like battery welding and integrate patented technologies such as real-time laser weld measurement to provide 100% weld quality assurance."

09:08 EDT Valaris announces new contract backlog of approximately $65M - Valaris Limited (VAL) announced new contracts and contract extensions, with associated contract backlog of approximately $65M, awarded subsequent to issuing the Company's most recent fleet status report on August 1. Contract backlog excludes lump sum payments such as mobilization fees and capital reimbursements. One-well contract with BP (BP) offshore Brazil for drillship VALARIS DS-15. The contract is expected to commence in late first quarter or early second quarter 2024 in direct continuation of the rig's current program, with TotalEnergies, and has an estimated duration of 80 days. The estimated contract value is approximately $33M and excludes payments we will receive for mobilization and any additional services. A previously disclosed exercised priced option with TotalEnergies offshore Brazil for drillship VALARIS DS-15 is now expected to be undertaken in direct continuation of the aforementioned BP contract. The option period is expected to commence in late second quarter or early third quarter 2024 and has an estimated duration of 100 days. The operating day rate for the option period is approximately $254,000. The contract backlog for this previously disclosed contract is not included in the $65 million of additional backlog mentioned above. VALARIS DS-15 - Estimated Schedule: Customer Location Contract Start Date Contract End Date(1) Day Rate(2) Total Energies Brazil Jun 21 Feb 24 BP Brazil Mar 24 May 24 $410,000 TotalEnergies Brazil Jun 24 Sep 24 $254,000 Five-well priced option exercised by BP Indonesia for heavy duty modern jackup VALARIS 106. The option period is expected to commence in January 2024, in direct continuation of the existing firm program and has an estimated duration of 365 days. The operating day rate is $85,000 effective from January 6, 2024, increasing to $95,000 from January 6, 2025. As previously disclosed, the rig is expected to be out of service for approximately 90 days for planned maintenance across second quarter and third quarter 2024. (1) Contract duration does not include any unexercised optional extensions. Contract end dates can vary based on how long it takes to complete the wells subject to the contract. (2) Day rates are reported to the nearest thousand and reflect the operating day rates charged to customers, excluding certain types of non-recurring revenues such as lump sum mobilization payments. Day rates are provided unless such disclosures are restricted by confidentiality provisions

09:03 EDT Shuttle Pharmaceuticals expands patent coverage on HDAC inhibitor platform - Shuttle Pharmaceuticals announced the expansion of its patent portfolio following the issuance of a Canadian patent for its Histone Deacetylase inhibitor platform technology titled "Dual Function Molecules for Histone Deacetylase Inhibition and Ataxia Telangiectasia Mutated Activation and Methods of Use Thereof."

09:02 EDT Magellan Midstream declares special cash distribution of 24.74c per unit - The board of directors of Magellan Midstream Partners has declared a special cash distribution expected to equal 24.74c per unit payable on Sept. 25 to unitholders of record at the close of business on Sept. 21.

09:00 EDT Blucora Inc trading resumes

08:52 EDT Longeveron issues letter to stockholders - Longeveron announces that Wa'el Hashad, Chief Executive Officer of Longeveron, has issued a Letter to Stockholders providing a business update. Full text of the letter, which has been posted to the Company's website, is as follows: "When I joined Longeveron as CEO, I was intrigued by the potential of our lead investigational product Lomecel-B in multiple disease states with clear unmet medical needs, and by the scientific foundation laid for this asset by our co-founder, Chief Scientific Officer, and Chairman Dr. Joshua Hare... To execute this program, we have taken steps to strengthen our Board and executive leadership team, and initiated the $30 million Rights Offering we announced on August 14, 2023. I write to you today to highlight the progress we are making and to discuss what these steps mean for our shared future. Lomecel-B is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors... We believe that Lomecel-B(TM) may have multiple potential mechanisms of action that may lead to anti-inflammatory, provascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases.... Our ongoing trials are all progressing and nearing important clinical milestones. As we announced recently, our Phase 2 ELPIS II trial in HLHS has exceeded its 50% enrollment threshold, and we have added an additional study location to further expedite enrollment, and we anticipate completing enrollment in this trial in 2024.... In Alzheimer's disease, our CLEAR MIND Phase 2a trial is on track to report top-line results in October, 2023.... In our Aging-related Frailty program, earlier this year we announced the dosing of the first patient in our Phase 2 clinical trial, evaluating Lomecel-B in this indication in Japan... To execute these compelling programs, over the last several weeks we have taken steps to strengthen Longeveron at both the Board and executive leadership level... On June 27,2023, we filed a registration statement with the SEC to conduct a tradeable subscription rights offering for up to $30.0 million of shares of Class A common stock to stockholders and holders of warrants to purchase common stock as the record date of August 18, 2023. We believe this Rights Offering provides a balanced approach to raising capital necessary to fund clinical development of Lomecel-B while remaining cognizant not to dilute existing shareholders... To conclude, we believe strongly in the potential of Lomecel-B in the therapeutic areas we have under investigation, and in the leadership team we've assembled to advance our development programs toward near-term milestones. Together with our fellow stockholders, we are confident we can bring this potentially lifesaving therapy to patients in need."

08:49 EDT Foremost Lithium completes exploration program in preparation of drill season - Foremost Lithium Resource & Technology has completed an extensive summer exploration program on its "Lithium Lane Properties", near the historic mining center of Snow Lake, Manitoba. "The initial exploration from DGC covering all four properties has gone exceedingly well," said Jason Barnard, President and Chief Executive Officer of Foremost Lithium. "This approach including both geological and prospecting evaluations, combined with onsite rock geochemistry, will enable us to be well-positioned to have high-priority targets this coming drill season. We are focused on advancing our lithium project to the next phase while we work to build long-term shareholder value."

08:48 EDT Avantax to be acquired by Cetera Holdings for $26 per share - Avantax and Cetera Financial Group announced that Avantax and Aretec Group d/b/a Cetera Holdings, the holding company of Cetera, have entered into a definitive agreement whereby Cetera Holdings will acquire all of the issued and outstanding equity of Avantax in an all-cash transaction valuing Avantax at approximately $1.2B, inclusive of Avantax's net debt. Following the closing, Avantax will become a standalone business unit within the Cetera family with 3,078 Avantax financial professionals, representing $83.8 billion in assets under administration and $42.6 billion in assets under management, as of June 30, 2023. Through the transaction, Cetera will retain Avantax's legal entities, core technology, product offerings and existing clearing and custody relationships. Holders of shares of Avantax common stock will receive $26.00 in cash per share, without interest and subject to required withholding taxes. The purchase price represents a premium of approximately 30% to the closing price of shares of Avantax common stock on September 8, 2023, the last full trading day prior to announcement of the transaction. Transaction Details: Avantax's Board of Directors unanimously approved the transaction, and the transaction is expected to close by the end of 2023, subject to stockholder approval, regulatory approvals, and other customary closing conditions. The transaction is not subject to any financing condition. Upon completion of the transaction, Avantax will become a privately held company, and its common stock will no longer be traded on Nasdaq.

08:44 EDT Day One Biopharmaceuticals announces updated FIREFLY-1 data - Day One Biopharmaceuticals announced the recently completed submission of the rolling New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma, pLGG. The Company anticipates the FDA will file the rolling NDA by mid-November 2023. The Company initiated the rolling submission of the NDA in May 2023 based on data from the FIREFLY-1 trial with a data cutoff as of December 22, 2022. An updated Clinical Study Report was submitted to the FDA with an additional six months of safety and efficacy data through June 5, 2023. FIREFLY-1 is an open-label, pivotal Phase 2 trial, which treated a total of 137 patients across two study arms. The primary endpoint of the trial is ORR by Response Assessment for Neuro-Oncology High-Grade Glioma criteria. Secondary endpoints include ORR by Response Assessment in Pediatric Neuro-Oncology Low-Grade Glioma, progression-free survival, duration of response, time to response, clinical benefit rate and safety. Updated FIREFLY-1 Data Demonstrate Consistent and Durable Response: RANO-HGG data, the primary endpoint of the trial: 67% ORR; 93% clinical benefit rate; 17% CR; 49% PR; 26% SD; At the time of data cutoff, the median duration of response based on RANO-HGG criteria was 16.6 months. Among a total of 77 treated patients: The median duration of tovorafenib treatment was 15.8 months, with 66% of patients on treatment at the time of data cutoff. Safety data, based on the 137 patients treated in both Arm 1 and Arm 2 of FIREFLY-1, indicated monotherapy tovorafenib to be generally well-tolerated. The vast majority of adverse events were Grade 1 or Grade 2, with most common side effects reported related to tovorafenib being change in hair color, fatigue, maculopapular rash, dry skin, and dermatitis acneiform. The most commonly reported treatment-related lab abnormalities were CPK elevation, LDH elevation, anemia, hypophosphatemia and AST elevation. The NDA submission also included the evaluation of responses by RAPNO-LGG and RANO-LGG. Those results include: RAPNO-LGG data, a key secondary endpoint of the trial: 51% ORR; 82% CBR ; 37% PR; 14% MR; 30% SD. At the time of data cutoff, the median DOR based on RAPNO-LGG criteria was 13.8 months. RANO-LGG data, an exploratory analysis of the trial: 53% ORR ; 83% CBR; 26% PR; 26% MR; 30% SD. At the time of data cutoff, the median DOR based on RANO-LGG criteria was 14.4 months

08:39 EDT NFT Gaming announces commercial launch with Space Striker AI - The NFT Gaming Company announced that the company has launched its first game, Space Striker AI for Android and iOS. The game is available to download in the Google Play Store and Apple App Store. To download the game, click here: Space Striker AI. "The NFT Gaming Company is extremely pleased to begin commercialization with our first game as we continue to develop an exciting catalogue of casual games that bridge the gap between traditional gaming and Web 3.0," said Vadim Mats, CEO of NFT Gaming Company. "This is the first major milestone for NFTG and the Gaxos vision. Going forward, we anticipate releasing additional games and revenue producing applications in the near future."

08:37 EDT SRM Entertainment announce expanded merchandise agreement with Toonz, Zoonicorn - SRM Entertainment announced the expansion of the multi-year global licensing agreement signed with Los Angeles-based Zoonicorn. SRM Entertainment's patented Sip With Me children's cups which feature Zoonicorn franchise characters will be available online and at retail stores throughout the country. SRM and Zoonicorn are expanding the licensing agreement to additional Zoonicorn branded products which include plush and vinyl backpacks, tumblers and plastic drinkware. The recent SRM Entertainment initial public offering is being utilized to grow and expand SRM's business. "The additional capital gives us the ability to increase manufacturing, add products and sign new licensing agreements. Since August 15th the day of our IPO we have written over $1.3 million in new orders." stated Rich Miller, SRM's CEO.

08:34 EDT Red Violet's FOREWARN partners with Savannah Multi-List Corp. - FOREWARN, LLC, a red violet company, announced that Savannah Multi-List has contracted to make FOREWARN services available for the 2,500+ members they serve throughout the Savannah area and the surrounding Chatham, Bryan and Effingham counties to promote proactive real estate agent safety. "Providing FOREWARN for all our members is the perfect way to recognize REALTOR(R) Safety Month," said Chrissy Campbell, CEO of Savannah Multi-List Corp. "We are thrilled to not only help bring greater awareness to the safety and fraud risks that agents face, but also equip them with a fast and powerful solution to help identify those risks using FOREWARN."

08:32 EDT Neurocrine initiates Phase 1 study of NBI-1117570 - Neurocrine Biosciences announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117570 in healthy adult participants. NBI-1117570 is an investigational, oral, muscarinic M1/M4 selective dual agonist that may have the potential to treat neurological and neuropsychiatric conditions.

08:32 EDT Kingsway Financial forms VMS, acquires Systems Products International - Kingsway Financial Services announced the formation of Vertical Market Solutions and the acquisition of the privately-held vertical market software company Systems Products International. This acquisition is the fourth acquisition completed under the Kingsway Search Xcelerator Program. Operator-in-Residence Drew Richard will be transitioning into the day-to-day operating role as CEO of SPI following the transaction. SPI, based in Miami, Florida, is a preferred partner in the development of software products, created exclusively to serve the management needs of all types of shared-ownership properties. The SPI platform includes a comprehensive set of modules with software solutions that cover the entire vacation ownership enterprise: sales, property management, loan servicing, receivables management, integrations, and mobile applications. Even after taking into consideration the anticipated effects of purchase accounting, Kingsway expects the acquisition to be immediately accretive and provide uplift to its recurring revenue base. The closing purchase price was paid in cash.

08:30 EDT Sonder Holdings appoints Potter as General Counsel - Sonder Holding announced the appointment of Katherine Potter as General Counsel, effective September 11, 2023. After serving as its General Counsel for almost a decade, Potter was most recently Chief Executive Officer at AlerisLife.

08:29 EDT MediWound announces participation at 20th EBA - MediWound announced its successful participation at the recently concluded 20th European Burns Association, EBA, Congress held in Nantes, France on September 6-9, 2023. NexoBrid was featured in 20 scientific oral and poster presentations over the Congress' four days. Leaders in the field of burn care presented and demonstrated their experience and observations of patient outcomes with NexoBrid in a wide range of settings. "We are delighted that NexoBrid was featured so extensively at this year's European Burn Association Congress, one of the top platforms to exchange knowledge and experiences in burn care." stated Ofer Gonen, Chief Executive Officer of MediWound. "As we continue our mission of advancing global burn care, we are honored that the event allowed us to share the latest research findings from the collaborative work of our scientists and prominent burn specialists, showcasing NexoBrid's application in various scenarios, including routine and mass casualties for both adults and pediatric patients."

08:27 EDT Humacyte announces results from FDA sponosored study on HAV - Humacyte announced the presentation of results from a Food and Drug Administration, FDA,-regulated, investigator-sponsored clinical study conducted at the Mayo Clinic. In the study the investigational HAV is being evaluated in patients with chronic limb-threatening ischemia, CLTI, the end stage of peripheral artery disease, PAD. The presentation at the Midwestern Vascular Conference in Minneapolis, MN, entitled Outcomes of Arterial Bypass Using the Human Acellular Vessel In Patients With Chronic Limb Threatening Ischemia, concluded that in the clinical study the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage. This is an important result since approximately 40% of patients requiring lower extremity bypass do not have saphenous vein available, which is the standard of care for treating this challenging disease state. The presentation reported the outcomes of 29 patients, with a mean age of 71 and having no available vein to use as a bypass graft, who underwent HAV implantation. Of these 29 patients, 97% had previously experienced unsuccessful revascularization procedures on the extremity and 21 had tissue loss or gangrene. Based on the state of this disease, this patient group had a 30-50% one-year risk of amputation. Notably, surgery in 22 patients necessitated a tibial artery target, a surgical procedure involving the fusion of two 42 cm long HAVs to achieve the required bypass length. Surgeons reported that the operations to implant the HAV achieved a 100% technical success rate, without any HAV-related major adverse events reported. At a median follow-up of nine months, the secondary patency rate for patients implanted with the HAV was 72%. The limb salvage rate was 86%, corresponding to only a 14% amputation rate.

08:25 EDT Blucora Inc trading halted, news pending

08:23 EDT Aquestive Therapeutics receives FDA acceptance of NDA for Libervant - Aquestive Therapeutics announced acceptance by the U.S. Food and Drug Administration, FDA, of the Company's NDA for Libervant Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024. Aquestive's NDA for approval of Libervant Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in patients between two and five years of age has been accepted by the FDA. Diastat Rectal Gel is the only treatment currently available to this patient population for this indication. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027. "The FDA's acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients," said Daniel Barber, Chief Executive Officer of Aquestive. "When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access."

08:21 EDT Tesla up 6% in pre-market at $263.60 following upgrade at Morgan Stanley

08:21 EDT DermTech appoints Mark Aguillard chief commercial officer - DermTech announced the appointment of Mark Aguillard as chief commercial officer effective September 19. Aguillard will lead DermTech's overall commercial strategy and execution. Commenting on Mr. Aguillard's appointment, Bret Christensen, DermTech's CEO said, "I'd like to welcome Mark to the team. We are confident that his demonstrated success and wide breadth of commercial and payer access experience will serve us well during this transformational period as we focus on generating reimbursed tests to grow revenue. Mark's leadership will be important as we strive to integrate the DermTech Melanoma Test DMT into the melanoma care pathway." Aguillard is a proven commercial leader with over 20 years of experience driving growth through the development and commercialization of multiple, novel molecular diagnostics. Prior to joining the Company, he served as the chief commercial officer of Epic Sciences, where he led the development and launch of a novel liquid biopsy, DefineMBC, designed to personalize treatment for patients with metastatic breast cancer. Prior to joining Epic, Mr. Aguillard served in commercial leadership roles with Myriad Genetics, binx health, OmniSeq and Eli Lilly & Company directing sales, marketing, medical affairs, customer success and market access teams across oncology and women's health. Mr. Aguillard received his Bachelor's in Business Administration with a major in Finance from Texas Tech University.

08:20 EDT Aprea Therapeutics announces preclinical data on its ATRN-1051 candidate - Aprea Therapeutics announced updated preclinical data supporting development of the Company's WEE1 inhibitor candidate, ATRN-1051, for the treatment of ovarian cancer. The preclinical and in vitro data suggest that the selective properties of ATRN-1051 may make it a more efficacious cancer therapy than the other WEE1 inhibitors in development. Importantly, ATRN-1051 is a highly potent and selective inhibitor of WEE1 that does not significantly affect off-target PLK1, PLK2 and PLK3, a family of kinases that promote M phase entry, a critical phase in the cell cycle. Such off-targeting of the PLK family has been a challenge to other WEE1 inhibitors in the class. Evidence generated by Aprea suggests that off-target inhibition of PLK1 substantially limits the ability of WEE1 inhibitors to cause genotoxicity, the proposed mechanism by which WEE1 inhibitors act as cancer therapeutics. The preclinical research of ATRN-1051 in ovarian cancer also shows an increased expression of cyclin E1, or CCNE1. CCNE1 amplification, which is associated with platinum resistance and poor survival, has been shown to be a reliable predictive biomarker of response to WEE1 inhibition. As part of the preclinical studies with ATRN-1051, the Company conducted cell culture and CDX mouse model studies using the CCNE1-normal and CCNE1-amplified ovarian cancer cell lines to show that low doses of ATRN-1051 completely suppress the growth of CCNE1-amplified ovarian cancer cells and tumors

08:18 EDT Enveric files for patent AI based computational methods to ID chemicals - Enveric Biosciences announced the filing of a provisional patent application to support its use of artificial intelligence AI based computational methods for identifying tryptamine derived new chemical entities and modeling interaction with the 5-HT2A receptor. Enveric is currently applying these new computational methods to predict which NCEs from its EVM301 Series offer the potential to minimize or eliminate 5-HT2AR-elicited hallucination, while providing potentially efficacious treatments for critical mental health conditions. The provisional patent application filed is titled, "Computer Implemented Methods and Systems for Identifying Tryptamine Derivative Compounds Capable of Interacting with a 5-HT2A Receptor." This patent application seeks to protect AI-backed methodologies designed to analyze the molecular dynamic -predicted binding modes of NCEs and compare with carefully chosen 'control' drugs to better understand which binding modes correlate with hallucination and which modes correlate with lack of hallucination. The powerful tool has the potential to enable Enveric to predict a compound's hallucinogenic potential, and also represents a general tool in predicting any 5-HT2AR-linked outcomes, such as neuroplasticity and efficacy in the treatment of mental health disorders. "Our research team has developed a unique and industry leading AI-based methodology, which we are now applying to the development of novel neuroplastic compounds, including potentially non-hallucinogenic tryptamine derivatives for our EVM301 Series," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "These novel computational methods offer the potential to identify drug candidates that are optimized to induce neuroplastic changes to address critical mental health disorders while minimizing unwanted side effects and safety concerns. Hallucinations associated with most psychedelic and psychedelic-inspired molecules limit patients access to treatment, given the complicated, costly and time-intensive requirements to monitor patients undergoing therapy. This provisional patent application will help to support our efforts as we work to develop intelligently designed compounds with finely tuned 3D structures that optimize 5-HT2AR binding, which we believe provides the potential to benefit patients and be commercially viable."

08:15 EDT STMicroelectronics announces status of repurchase program - STMicroelectronics announces full details of its common share repurchase program disclosed via a press release dated July 1, 2021. The Program was approved by a shareholder resolution dated May 27, 2021 and by the supervisory board. STMicroelectronics N.V. announces the repurchase on the regulated market of Euronext Paris, in the period between Sep 04, 2023 to Sep 08, 2023, of 244,530 ordinary shares at the weighted average purchase price per share of EUR 42.5572 and for an overall price of EUR 10,406,503.10.

08:14 EDT Lyell Immunopharma to evaluate Cellares' automated manufacturing platform - Cellares and Lyell Immunopharma announced Lyell will evaluate Cellares' automated manufacturing platform, the Cell Shuttle, through Cellares' Technology Adoption Partnership program. As part of the collaboration, the companies have agreed on a proof-of-concept technology transfer process for the manufacture of Lyell's LYL797 CAR T-cell therapy, using the Cell Shuttle.

08:13 EDT SAIC awarded $574M Space Force contract - SAIC announced that it has been awarded a $574M contract with the United States Space Force, or USSF, to support its Ground Based Radar Maintenance and Sustainment Services, or GMASS. Under SAIC's leading system integration services and expertise, GMASS provides an opportunity to augment Space Domain Awareness by leveraging the capabilities inherent in ground-based radars to better meet the needs of warfighters who detect, track and defeat missile threats.

08:11 EDT Enlivex Therapeutics to reduce workforce by 50% - As a result of the Company's reprioritization of its clinical indications and focus on the inflammatory and auto-immune verticals, the Company intends to reduce its workforce by approximately 50%. The workforce reductions and the savings associated with the reclassification of the oncology indications as candidates for external collaborations or out-licensing opportunities in lieu of internal development are expected to result in a substantial extension of the Company's cash runway through the end of 2025. The revised, extended cash runway is expected to support the timeline for the topline data readouts of the two advanced-stage, randomized, controlled Phase II clinical trials in sepsis and osteoarthritis.

08:10 EDT Bird Global appoints H. Joseph Prodan as CFO - Bird Global announced the appointment of H. Joseph Prodan as CFO, effective August 30. Prodan succeeds Michael Washinushi, following his recent appointment to interim CEO. Most recently, Prodan served as CFO of Flexiti, a technology company providing buy now, pay later solutions.

08:09 EDT NovaBay, BioStem enter Amniotic Tissue Allograft commercialization agreement - NovaBay and BioStem Technologies announced an agreement under which NovaBay has been granted the right to commercialize BioStem Technologies' Amniotic Tissue Allograft, which is intended for use as a protective covering during the repair of ocular surfaces. Amniotic Tissue Allograft provides a protective environment or covering for repair of the cornea and conjunctiva, helping ocular surface to return to a healthier state. NovaBay intends to commercialize the prescription-only product as Avenova Allograft to leverage its Avenova eyecare brand and encourage use with other Avenova products. Medically necessary procedures with the Avenova Allograft will be reimbursed through Medicare.

08:08 EDT Enservco acquires Rapdi Hot, appoints Weyel to board of directors - Enservco announced it has acquired all of the assets of oilfield services provider Rapid Hot in an all-stock transaction valued at $1,057,500. "This acquisition substantially strengthens Enservco's position in the Marcellus shale and also strengthens our management team with the addition of Mike Lade, Rapid Hot's president and CFO, who joins Enservco as chief of staff," said Rich Murphy. "We are also pleased to announce the closing of a $1,625,000 convertible debt financing that included participation from lead investors of Rapid Hot, an Enservco board member and Cross River Partners. The financing strengthens our working capital position as we approach our 2023-24 heating season, which is expected to benefit from anticipated cooler winter temperatures." Enservco also announced the addition of Steve Weyel to the Company's Board of Directors. Weyel joins the Board with more than 40 years of experience as a senior executive, board director and chairman of private and public energy companies. He was the founder, CEO and Chairman of EnVen Energy Corporation.

08:07 EDT Arqit Quantum, Exclusive Networks announce US distribution partnership - Arqit Quantum and Exclusive Networks North America announced a distribution agreement for Arqit's unique Symmetric Key Agreement Platform. Joining Exclusive Networks' portfolio of industry-leading vendors, channel partners can offer Arqit's groundbreaking technology that protects against both current and future cyber threats including the risk from quantum computing. David Williams, Arqit Founder, Chairman and CEO said: "We are thrilled to partner with Exclusive Networks North America, making our unique Symmetric Key Agreement Platform available to their industry-leading partners. To counter the growing threats from cyber adversaries in an ever-connected world, organizations need to take urgent action to simplify and strengthen their encryption, safeguarding their data and removing the quantum threat from their risk registers."

08:05 EDT Achieve Life Sciences announces presentation of ORCA-V1 trial results - Achieve Life Sciences announced that Phase 2 ORCA-V1 trial results will be presented at the Society for Research on Nicotine and Tobacco Europe, SRNT-E, Annual Meeting, being held in London September 11-13, 2023. Data from the ORCA-V1 trial, which evaluated cytisinicline as a treatment for e-cigarette cessation, will be presented today, September 11, 2023, by ORCA-V1 Principal Investigator, Dr. Nancy Rigotti. The positive topline results from the ORCA-V1 trial, announced earlier this year, will be presented, as well as additional findings. The primary endpoint analysis demonstrated 2.6 times higher odds, or likelihood, of vaping cessation with 3mg cytisinicline dosed three times daily for a period of 12 weeks compared to placebo in 160 adults in the U.S. who use nicotine vapes daily. The study population had a mean age of 34 years, 72% had been previous smokers, and a majority vaped e-cigarettes with fruit flavoring. Additional analyses showed that vaping abstinence with cytisinicline treatment started by the second week of treatment, with the odds of vaping cessation improving throughout the 12-week treatment period. The odds of vaping cessation for cytisinicline were 1.8 times, 2.2 times, and 2.6 times higher than placebo at Week 3-6, Week 6-9, and Week 9-12, respectively. During the Week 12-16 follow-up period, subjects treated with cytisinicline continued to demonstrate 2.0 times higher odds of vaping cessation compared to placebo.

08:04 EDT Erayak Power Solution initiates plans to expand into Middle East, South Asia - Erayak Power Solution Group announces that it has plans to expand its business operations and distribution within the Middle East and South Asia. The Company is currently in the planning stages to begin construction of a warehouse in the Middle East and is working to build relationships with wholesalers in the region. Erayak's Chairman & CEO, Lingyi Kong, stated, "We are excited about the plans we are devising in an effort to expand our reach to growing and dynamic international markets such as the Middle East and South Asia. Both markets provide us with tremendous growth opportunities and will enable us to diversify our regional concentrations and customer base."

08:03 EDT J.M. Smucker to acquire Hostess Brands for $34.25 per share, or $5.6B - The J. M. Smucker Co. (SJM) announced the signing of a definitive agreement to acquire Hostess Brands (TWNK) for $34.25 per share in a cash and stock transaction, representing a total enterprise value of approximately $5.6B, which includes approximately $900M of net debt. This represents an adjusted EBITDA multiple of approximately 17.2x based on the company's estimate of Hostess Brands full year 2023 results, and an approximate 13.2x multiple when including anticipated run rate synergies of $100M. The acquisition expands the company's offering of beloved brands in growing categories and accelerates its focus on convenient consumer occasions. The transaction is anticipated to close in the third quarter of the company's current fiscal year ending April 30, 2024. The transaction has been unanimously approved by the boards of directors of both The J.M. Smucker Co. and Hostess Brands.

08:01 EDT J.M. Smucker to acquire Hostess Brands for $34.25 per share, or $5.6B

07:47 EDT Jazz Pharmaceuticals: Oxybate improved measures of sleep in study - Jazz Pharmaceuticals announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023. One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy. Oxybate is the active ingredient in Xywav oral solution. This review encompassed key data from five clinical studies that evaluated all high-sodium oxybates, fixed-dose and twice-nightly administrations, in both oxybate-experienced patients and those who had not undergone prior treatment. The review found that oxybate improved measures of sleep architecture and disrupted nighttime sleep in narcolepsy patients, independent of dosing regimen or prior oxybate experience. "These compelling data add to the growing body of literature that looks at the effects of oxybate therapy in terms of sleep quality, sleep architecture and daytime function," said Richard Bogan, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine and Medical University of South Carolina in Charleston, South Carolina. "The review found that there was no significant difference in the improvement of sleep quality between oxybate dosing schedules. This is an important endpoint, as many patients utilize the twice-nightly dosing to individualize treatment of their sleep disorder."

07:36 EDT Quipt Home Medical announces multi-state acquisition - Quipt Home Medical announces that it has acquired a business with operations in Mississippi, Texas and Louisiana reporting unaudited annual revenues of approximately $9 million with anticipated Adjusted EBITDA of $2 million post integration. As a reminder all financial figures stated are in USD. The acquisition adds scale with ten locations across three states, 17,500 active patients, 1,900 unique referring physicians, important insurance contracts, and decades of operating experience in the markets served. The operating footprint aligns closely with regions that have a high prevalence of Chronic Obstructive Pulmonary Disease, a key target patient group. The Company is pleased to share the following updated metrics on a consolidated basis taking into consideration the acquisition disclosed herein: 287,500 current active patients; 34,400 referring physicians; 125 locations across 26 U.S. States. "The completion of this transaction demonstrates our ongoing patience and discipline as it relates to our capital allocation approach. At favorable terms, we were able to significantly expand in three attractive existing states. Given that there are more than 1.5 million COPD patients residing in Mississippi, Texas and Louisiana, we increase our footprint in those three states," said Greg Crawford, Chairman and CEO of Quipt. "Our team of operators will once again utilize our tried-and-true integration approach to efficiently integrate this business onto our existing platform, continuing to build scale across the organization. Moreover, we believe there is an opportunity to leverage our resupply program immediately, creating actionable revenue synergies for us. Additionally, the substantial patient base and excellent referral network we have built up in these three states allow us to take a "land and expand" approach to future growth, which will support our organic growth goals."

07:34 EDT Vision Marine Technologies appoints Couillard to board of directors - Vision Marine Technologies announce the appointment of Dr. Philippe Couillard as an Independent Director to the Board of Directors, effective immediately. Dr. Couillard brings a wealth of knowledge and a diverse range of experiences to his new role, and he will be instrumental in guiding Vision Marine through its next phase of growth and innovation. Dr. Couillard previously served as the Minister of Health for the province of Quebec from 2003 to 2008 and was the 31st Premier of Quebec from 2014 to 2018.

07:32 EDT Nauticus Robotics, MMA Offcshore sign MoU to deploy aquanauts into Asia-Pacific - Nauticus Robotics announced that it has signed a memorandum of understanding, MoU, with MMA Offshore Limited, a global provider of high-specification vessels and a comprehensive suite of marine and subsea services to the offshore energy sector, government and defense, and wider maritime industries. The MOU focuses on developing an integrated service offering to provide more cost-efficient and environmentally friendly maintenance of subsea infrastructures in the Asia-Pacific region and provides a pathway to integrate Nauticus' services into MMA Offshore's offerings. "This MOU is just one in a series of strategic moves we are making to disrupt autonomous subsea robotics and solidify our place as the industry leader in the field," said Nicolaus Radford, founder and CEO of Nauticus. "Aligning with an established industry player, such as MMA Offshore, in multiple offshore markets provides a significant opportunity for Nauticus to continue expanding its reach and international customer base."

07:31 EDT Qualcomm announces agreement with Apple for chip supply - Qualcomm Technologies (QCOM) announced that it has entered into an agreement with Apple (AAPL) to supply Snapdragon 5G Modem-RF Systems for smartphone launches in 2024, 2025 and 2026. This agreement reinforces Qualcomm's track record of sustained leadership across 5G technologies and products.

07:21 EDT Farmland Partners : No significant recent storm damage, strong lease renewals - Farmland Partners provided business updates on several topics, including recent storms in California and the Southeast, the status of lease renewals, and updated disposition expectations for 2023. While there was substantial rain on the Company's farms in the areas affected by Hurricane Idalia and Tropical Storm Hilary, there was no significant damage that would impair productivity. Many farmers, businesses, and residents in both areas were not so fortunate, and we wish them a speedy recovery. Leases to renew in 2023: Approximately 14% of total revenue. Renewals already completed: Approximately 50% by acres. Rental rates: Average increases more than 15%. Lease renewals signed in the fall of 2023 generally commence in Q4 and, accordingly, contribute to revenue to a greater extent in 2024 and beyond than in 2023. When reporting earnings for the quarter ended June 30, 2023, the Company estimated that it would sell up to $135M of assets in 2023. As of the date of this release, the total identified transactions have increased to approximately $190M

07:15 EDT InflaRx announces results from its SAD Phase I study with INF904 - InflaRx N.V. announced its topline results from the single ascending dose, SAD, part of its randomized, double-blind, placebo-controlled Phase I trial of the orally administered, low molecular weight C5aR inhibitor INF904. In the SAD part of the study, INF904 demonstrated an excellent safety and tolerability profile as well as a very favorable pharmacokinetic, PK, and pharmacodynamic, PD, profile, confirming INF904's best-in-class potential. The SAD part of the Phase I first-in-human trial enrolled 62 healthy volunteers within six different dosing groups from 3 mg to 240 mg who were randomly assigned to receive INF904 or a placebo. Different drug concentrations were tested for the 60 mg dosing group. The main objectives were to assess safety and tolerability of single ascending doses under fasting conditions. Secondary endpoints included several PK parameters, and the effect of INF904 on C5a-induced neutrophil activation in blood samples from treated volunteers ex vivo also was explored. The results show that INF904 was well tolerated in treated patients and resulted in no safety signals of concern in single doses ranging from 3 mg to 240 mg. The overall percentage of adverse events was lower in the INF904 treated patients compared to the placebo group, and no serious or severe AEs were observed at any dosing level. No related AEs were reported in conjunction with INF904 dosing. Analysis of INF904 PK in subject plasma samples revealed sustained exposure to INF904 with six hours to maximum concentration. INF904 plasma levels were dose proportional for systemic exposure and nearly dose proportional for maximum concentration over the dose range used in the study. With the 30 mg dose, INF904 reached a Cmax of 289 ng/ml with an AUClast of 5197 h.ng/ml, which are approximately 3-fold and 10-fold, respectively, higher than the published Phase I data from the only marketed comparator. Single doses of 30 mg or higher of INF904 achieved greater than or equal to90% blocking of C5a induced up-regulation of the activation marker CD11b on neutrophils in plasma samples from subjects ex vivo at 24 hours post dosing. The MAD part of the Phase 1 trial is ongoing, and the Company expects to present results from the approximately 24 healthy volunteers at the beginning of 2024.

07:13 EDT Kaixin Auto announces non-binding acquisition term sheet with WM Motor - Kaixin Auto announced that the Company has signed a non-binding acquisition term sheet with WM Motor Holdings Limited, planning to issue a certain number of new shares to acquire 100% of equity of WM Motor held by its current shareholders. WM Motor owns and operates two Industry 4.0 intelligent manufacturing factories in Wenzhou and Huanggang, respectively. Mingjun Lin, chairman and CEO of Kaixin, said: "WM Motor's fashion technology product positioning and branding has a good match with Kaixin's strategic development goals. Through the intended acquisition, WM Motor will gain access to more capital support to enhance the development of its smart mobility business!"

07:11 EDT Eledon Pharmaceuticals appoints Robinson to board of directors - Eledon Pharmaceuticals (ELDN) announced the appointment of James Robinson to its Board of Directors effective October 1, 2023. Robinson is a seasoned biopharmaceutical executive with over 30 years of experience in the industry, most recently serving as Chief Executive Officer and Director of Urovant Sciences until its merger with Sumitomo Pharma America (DNPUF) on July 1, 2023.

07:10 EDT EVgo receives first shipment of 350kW fast chargers from Delta Electronics - EVgo announced that it received the first-ever shipment of 350kW fast chargers from Delta Electronics that are manufactured according to Build America, Buy America Act, or BABA, standards. Delivered from Delta Electronics' recently opened factory in Plano, Texas, this first shipment marks a milestone in developing the robust domestic supply chain needed to support the rapid growth in EV adoption across the U.S. and unlock funding through the National Electric Vehicle Infrastructure, or NEVI, Formula Program. Delta has delivered 10 chargers to date, and EVgo expects to receive additional 350kW BABA-compliant chargers from Delta Electronics later this year.

07:10 EDT RTX updates 2025 free cash flow commitment to reflect estimated GTF impact - RTX is providing an update on the impact to the Pratt & Whitney GTF fleet arising from the previously disclosed rare condition in powder metal used to manufacture certain engine parts. "As a result of recent updates to this matter, RTX will recognize a third quarter charge which will impact reported sales and earnings for the year," the company stated. RTX reaffirms 2020 to 2025 RTX sales growth and margin expansion commitments and updates 2025 free cash flow commitment to reflect estimated impact of Pratt & Whitney powder metal matter. Expects cash impact of approximately $1.5B during 2025, resulting in estimated RTX 2025 free cash flow of approximately $7.5B. Reaffirms $33 - $35B capital return commitment to shareowners from the merger through 2025. "We are focused on addressing the challenges arising from the powder metal manufacturing issue," said RTX Chairman and CEO Greg Hayes. "We will never compromise on the safe operation of our fleet, which is why the Pratt & Whitney team has worked diligently to develop its fleet management plan. At the same time, we recognize this is an extremely difficult situation for our customers, and we are proactively taking steps to support and mitigate the operational impact to them." RTX Executive Vice President & Chief Financial Officer, Neil Mitchill, stated "The financial charges related to the powder metal manufacturing issue, that will be recognized this quarter, reflect the impact of this matter and how we expect to support our customers. That said, the financial position of RTX remains strong, and we remain well positioned to execute on our strategic priorities."

07:08 EDT Marker announces complete response in lymphoma patient treated with MT-601 - Marker Therapeutics announces the preliminary results of the first participant treated with MT-601, its multi-tumor associated antigen-specific T cell product targeting 6 TAAs, in the Phase 1 multicenter APOLLO clinical trial. The APOLLO trial is investigating the safety and efficacy of MT-601 for the treatment of patients with lymphoma who have either failed or are ineligible to receive anti-CD19 CAR T cell therapy. This first APOLLO study participant had diffuse large B cell lymphoma and was enrolled into the Phase 1 dose escalation stage of the trial after failing 4 prior lines of therapy, including anti-CD19 CAR T cell therapy. After relapse following anti-CD19 CAR T cell therapy, the participant was treated with 2 doses of MT-601 at the 200 million cell dose level without prior lymphodepletion. MT-601 treatment was well tolerated with no reports of higher than Grade 1 treatment-related adverse events. The tolerability at this initial dose level is consistent with the favorable clinical safety profile and tolerability previously reported for other multiTAA-specific T cell products. Eight weeks after the 2nd infusion of MT-601, the participant demonstrated complete metabolic response based on PET-CT scans. Marker previously reported non-clinical proof-of-concept data that showed that MT-601 has the potential to eliminate lymphoma cells that are resistant to anti-CD19 CAR T cells, highlighting the therapeutic potential of MT-601 in vitro.

07:07 EDT Paragon 28 gets IDE from FDA for Its SMART Total Talus combo with the APEX 3D - Paragon 28 announced they have received an Investigational Device Exemption, IDE, approval from the FDA to commence a feasibility study for configurations of the SMART Total Talus System used in conjunction with the Paragon 28 APEX 3D Total Ankle Replacement System. The study is expected to begin in early 2024. This milestone is an important achievement in the advancement of Paragon 28's SMART 28SM strategy, which targets to provide meaningful options to their surgeon customers and significantly improve patient outcomes. The IDE of the SMART Total Talus adds to the company's existing Patient Specific Total Talus offering by expanding use of the technology as an option for prospective total ankle replacement candidates.

07:07 EDT Madrigal Pharmaceuticals appoints Bill Sibold as CEO - Madrigal Pharmaceuticals (MDGL) announced that Bill Sibold has succeeded Paul Friedman, M.D., as Chief Executive Officer, CEO, and joined Madrigal's Board of Directors. Dr. Friedman, who has served as Madrigal's CEO since 2016, will continue to serve on the Board of Directors. From 2017 until joining Madrigal, Sibold served as Executive Vice President, Specialty Care of Sanofi (SNY) and President, Sanofi North America.

07:06 EDT Veru reports clinical data from discontinued ARTEST study - Veru announced clinical data from the discontinued Phase 3 ARTEST clinical trial of enobosarm monotherapy for the 3rd line or greater in the metastatic setting of AR+ER+HER2- breast cancer. Enrollment was discontinued in order to prioritize and focus the clinical development of enobosarm therapy earlier in the treatment sequence, the 2nd line metastatic setting, for AR+ER+HER2- metastatic breast cancer in the Phase 3 ENABLAR-2 study. Data reported from the discontinued trial, which is based on an analysis of available data, may not be predictive of the results of larger, later-stage controlled clinical trials. Highlights of clinical data from discontinued Phase 3 ARTEST clinical study: At the time enrollment was stopped, there were 34 evaluable patients randomized to either 9mg enobosarm monotherapy or a standard of care active control in the Phase 3 open label, randomized clinical trial for the treatment of AR+ER+HER2- metastatic breast cancer with sufficient AR expression in their breast cancer tissue who had previously received at least a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor. Active control treatment group received an average of 2.6 and enobosarm 9mg monotherapy an average of 2.9 prior lines of treatment. On average, enobosarm or the active control was given in the 4th line treatment for AR+ER+HER2- metastatic breast cancer. Safety: Enobosarm monotherapy was generally well tolerated without masculinizing adverse events or increases in hematocrit.

07:05 EDT Innovative Eyewear announces new patent for spring hinges for smartglasses - Innovative Eyewear is excited to announce a patent filing on a key product innovation, flexible spring hinges for smart eyewear. The new patent application, entitled Spring-loaded Hinges for Smartglasses (# 18/463,465) covers a proprietary component developed by the company to enhance comfort in smart eyewear. The addition of flexible hinges, planned for most upcoming frames produced by the company, will enhance both the comfort and the range of fit for the frames, enabling each style to be worn by a wider array of users. Finally, we believe these new hinges will also increase the durability of the frames by reducing stress points on the temples caused by extended wear.

07:04 EDT EyePoint announces interim masked safety data for EYP-1901 - EyePoint Pharmaceuticals announced positive interim masked safety data for its lead product candidate EYP-1901 from the Company's ongoing Phase 2 PAVIA trial evaluating EYP-1901 as a potential nine-month treatment for moderately-severe to severe non-proliferative diabetic retinopathy and DAVIO 2 trial as a potential six-month sustained delivery maintenance treatment for wet age-related macular degeneration. All treatment arms in the PAVIA trial have reached at least 3-months post-dosing follow-up as of September 1, 2023. Approximately 170 patients have received EYP-1901 with a minimum of three months of follow-up post injection from the ongoing Phase 2 PAVIA and DAVIO 2 clinical trials and the completed DAVIO 1 trial with no reported drug-related ocular severe adverse events and no reported drug-related systemic SAEs. In the PAVIA clinical trial, there have been no reported drug-related ocular SAEs and no reported drug-related systemic SAEs. There were two ocular SAEs deemed unrelated to EYP-1901 by investigators: Hemorrhagic posterior vitreous detachment in a study eye eight weeks after dosing; Macular edema leading to vision loss in the non-study fellow eye

07:02 EDT BioLineRx announces FDA approval of APHEXDA/filgrastim combination - BioLineRx announced that the U.S. FDA has approved APHEXDA in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA is administered by injection, for subcutaneous use.

07:01 EDT Next Hydrogen Solutions, Casale sign MoU to develop green ammonia systems - Next Hydrogen Solutions and Casale, have signed a non-exclusive memorandum of understanding to develop green ammonia and methanol systems that integrate Next Hydrogen's electrolysis technology and products. Under this agreement, the companies will bring together their collective experience and capabilities to accelerate and scale-up green ammonia and methanol plants connected to renewable energy sources. "We are delighted to work closely with Casale, a world leader in the fertilizer marketplace" says Raveel Afzaal, President and CEO of Next Hydrogen. "Collaboration with such an innovative leader in green ammonia provides an opportunity to accelerate adoption of our green hydrogen products."

06:57 EDT MagnaChip launches 1200V, 650V IGBTs - Magnachip announced the launch of its 1200V and 650V Insulated Gate Bipolar Transistors, or IGBTs, designed for the positive temperature coefficient, or PTC, heaters of electric vehicles, or EVs.

06:42 EDT Crescent Point Energy sees FY24 capital expenditures C$1.05B-C$1.15B - Sees FY24 annual production of 145,000-151,000 boe/d. Crescent Point expects to generate significant excess cash flow of over C$1B at $80/bbl WTI under its preliminary 2024 budget. "Throughout 2023, our strong results and outperformance have demonstrated the benefits of our improved asset base alongside our ongoing operational execution", said Craig Bryksa, president and CEO of Crescent Point. "This inflection we are seeing in our business is a direct result of our strategy, which is focused on maintaining a resilient portfolio of high-return short- and long-cycle assets. Our disciplined approach is expected to generate sustainable returns and significant excess cash flow for shareholders."

06:32 EDT SpringWorks Therapeutics names Dr. Tai-An Lin as Chief Scientific Officer - SpringWorks Therapeutics announced the appointment of Tai-An Lin, Ph.D., as its Chief Scientific Officer. Dr. Lin brings more than 25 years of biotechnology and global pharmaceutical experience in advancing drug discovery programs from target identification through early clinical trials across the therapeutic areas of oncology, immuno-oncology, and immunology. Dr. Lin joins SpringWorks from Black Diamond Therapeutics, where he was Senior Vice President, Translational Science and Discovery Biology.

06:31 EDT Sandoz announces exclusive deal to commercialize biosimilar ustekinumab - Sandoz, a Novartis division, announced that it has entered into a development and commercialization agreement with Samsung Bioepis. The agreement provides Sandoz with the exclusive rights to commercialize the biosimilar SB17 ustekinumab in the US, Canada, EEA, Switzerland, and UK. Other specific terms of the agreement are confidential. The reference medicine Stelara is a monoclonal antibody medication to interleukin-12/23 for the treatment of autoimmune disorders including Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. "This deal represents another major step to reinforce our high-value biosimilar pipeline, in line with our plans to become a standalone global leader," says Sandoz CEO Richard Saynor. "It will further strengthen our immunology patient offering and means we now have five potential high-value upcoming biosimilar launches over the next few years."

06:28 EDT GSK momelotinib submission for myelofibrosis accepted for review by Japan's MHLW - GSK plc announced that the Ministry of Health, Labour and Welfare, or MHLW, Japan, has accepted for review a new drug application for momelotinib, a potential new medicine with a differentiated mechanism of action that may address the significant medical needs of myelofibrosis patients, especially those with anaemia. The NDA is based on data from the pivotal phase III trials SIMPLIFY-1 and MOMENTUM. Momelotinib is not currently approved in any market, the company noted.

06:25 EDT Vermilion Energy restarts Wandoo facility production, provides update - Vermilion Energy provided an update on our Australia and Ireland operations and European gas hedge program. The company reported that it now expects Q3 production to come in at the upper end of our quarterly guidance range of 80,000 to 83,000 boe/d due to positive developments in Australia and Ireland. In Australia, the company successfully completed the remaining inspection and repair work on our Wandoo facility and restarted production in early September without incident. Initial production rates are strong and Australia is forecasted to produce approximately 4,000 bbl/d in Q4 2023. The Wandoo asset has been in our portfolio since 2004 and has generated a significant amount of free cash flow over this time frame. In 2022, Wandoo crude sold at a $14 premium to Brent, which drives very strong netbacks. Under current strip pricing we are forecasting over $100 million of FCF from Australia in 2024. In Ireland, the company completed the planned major turnaround at Corrib approximately five days ahead of schedule in August. Corrib is forecasted to produce approximately 10,000 boe/d of premium-priced European gas net to Vermilion in Q4. European gas prices remain strong due to continued supply concerns as winter approaches. The 2024 and 2025 forward prices of $22 and $21 per mmbtu, respectively, generate robust free cash flow. As a result, we continue to add more European gas hedges over this period, and currently have 51% of our 2H 2023 European gas hedged at an average floor price of $32 per mmbtu, 31% of our 2024 European gas production hedged at an average floor price of $33 per mmbtu and 14% of our 2025 European gas production hedged at an average floor price of $21 per mmbtu. Hedging at these price levels enables us to lock in future fund flows from operations and provides greater certainty on achieving our near-term debt targets while enhancing our future return of capital to shareholders. Our Q4 production forecast of 86,000 to 89,000 boe/d and full year guidance range of 82,000 to 86,000 boe/d remains unchanged.

06:11 EDT Ideaya Biosciences initiates monotherapy expansion in IDE161 trial - Ideaya Biosciences announces initiation of a Phase 1 monotherapy expansion in the first-in-human clinical trial evaluating IDE161. The Phase 1 first-in-human clinical trial is evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 in patients having tumors with homologous recombination deficiency, or HRD. Early clinical data from the dose escalation cohorts showed dose-dependent pharmacodynamic modulation of poly-ADP ribose proteins in peripheral blood, demonstrating IDE161 target engagement. These clinical data also demonstrated IDE161 exposure levels in humans which correlate to preclinical exposures that were efficacious, achieving tumor regressions in xenograft models. The Phase 1 expansion is based on preliminary tumor shrinkage observed in multiple HRD solid tumor patients, including an BRCA1/2 endometrial cancer subject with a first imaging assessment of a partial response in the target lesion, a complete response in the non-target lesion and an 87% reduction in the CA-125 tumor marker. The company is also continuing to evaluate the optimal move forward dose for Phase 2 expansion. The expansion portion of the Phase 1 trial will include patients having HRD-associated breast cancer and ovarian cancer, as well as a basket of other selected solid tumors. The breast cancer focus is on estrogen receptor positive, human epidermal growth factor receptor 2 negative, HRD+ tumors, which represent approximately 10% to 14% of breast cancer patients. The ovarian cancer focus represents approximately 50% of ovarian cancer where HRD is observed. Ideaya is targeting clinical program updates for IDE161 in the second half of 2023.

06:09 EDT ImmunityBio announces $470M equity and debt financing - ImmunityBio announced that it has executed financing transactions resulting in approximately $200M of proceeds to the company through a financing including an exchange into equity of current debt and a new convertible debt instrument from Nant Capital, LLC, an entity affiliated with Dr. Patrick Soon-Shiong, the company's Founder, Executive Chairman and Global Chief Scientific and Medical Officer. With this new financing from Dr. Soon-Shiong, including the extension of the maturity date of current debt, ImmunityBio believes that it is well-positioned to fund its ongoing business operations and pre-commercialization efforts as it continues to drive toward a potential regulatory approval of N-803 plus BCG for BCG-unresponsive non-muscle invasive bladder cancer. The new $200M convertible note with Nant Capital has a three-year term and is convertible into shares of ImmunityBio common stock at a conversion price of a 50% premium over the closing market price immediately preceding the date of the note. In addition, the financing transactions restructure the company's existing debt obligations with the Nant entities, including an extension of the nearest term debt maturities by one year to December 2024. Further, ImmunityBio executed a stock purchase agreement pursuant to which all of the outstanding fixed-rate promissory notes held by Nant Capital and certain other Nant entities, representing approximately $270M in aggregate principal amount and accrued and unpaid interest as of September 8, 2023, were exchanged for ImmunityBio common stock, based on the closing stock price on September 8, 2023.

06:02 EDT Sinovac Biotech completes Anti-COVID-19 Antibody SA55 Injection study - Sinovac Biotech announced that the company has completed the phase I clinical trial for its broad-spectrum neutralizing antibody product, the Anti-COVID-19 Antibody SA55 Injection in Beijing and has entered the phase II clinical trial in Shanghai after successfully enrolling its first participant recently. Sinovac's SA55 Injection, which is intended for the treatment of COVID-19 infections, was approved for clinical trial in China on May 24. The phase I clinical trial has confirmed its preliminary safety profile in 40 healthy adults aged 18 to 65 in China. Preliminary results are anticipated by the year's end. Their studies underscore the SA55's efficacy in neutralizing the omicron variant and its sublineages, including BA.5, BF.7, BQ.1.1, XBB.1.5, BA.2.86 and the currently dominant strain, EG.5. Xie noted that SA55 is reportedly the only clinical antibody that SARS-CoV-2 hasn't escaped.

05:27 EDT Firehouse Subs to open more than 100 restaurants across UAE, Oman - Firehouse Subs, a subsidiary of Restaurant Brands, announced new plans to develop and open more than 100 Firehouse Subs restaurants across UAE and Oman in the next decade as part of an exclusive agreement. Firehouse Subs was founded in Jacksonville, Florida in 1994 by two brothers and former firefighters.

05:17 EDT Elbit Systems awarded $109M contract by BAE Systems Hagglunds - Elbit Systems (ESLT) announced that it was awarded a contract worth $109M to supply BAE Systems Hagglunds (BAESY) the Iron Fist Active Protection System , or APS, for its CV90 platform, for a European customer. The contract will be carried out over three years.

05:09 EDT Accenture announces investment in, collaboration with Open Cosmos - Accenture announced an investment and collaboration with Open Cosmos, a space technology company that focuses on the design, manufacturing and integration of satellites. Open Cosmos builds and operates space missions, providing access to satellite data and insights on a global scale via a data services platform. The two companies will help clients track and analyze data found in space in order to help solve business challenges found on Earth, particularly related to sustainability. Accenture Ventures led the investment as part of its broader Project Spotlight initiative.