Stockwinners Market Radar for November 27, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:07 EST Cathie Wood's ARK Investment bought 143K shares of Robinhood

20:06 EST Cathie Wood's ARK Investment bought 1.89M shares of Recursion Pharmaceuticals

19:50 EST Caleminder Inc trading halted, news pending

19:35 EST Perrigo exec buys $172.1K in common stock - In a regulatory filing, Perrigo disclosed that its EVP Robert Willis bought 5,550 shares of common stock on November 24th in a total transaction size of $172.1K.

18:05 EST SpringWorks Therapeutics announces FDA approval of OGSIVEO - SpringWorks Therapeutics announced that the U.S. FDA has approved OGSIVEO, an oral gamma secretase inhibitor, for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. The FDA previously granted breakthrough therapy, fast track and orphan drug designations to nirogacestat for the treatment of desmoid tumors.

17:48 EST Troika Media receives delinquency notification letter from Nasdaq - Troika Media Group announced that it received a delinquency notification letter from Nasdaq on November 17, 2023 stating that the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) because it had not timely filed its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023. Nasdaq has informed the Company that the Company must submit a plan of compliance within sixty days addressing how it intends to regain compliance with Nasdaq's listing rules or otherwise file the Form 10-Q before the expiration of such sixty (60) day period. The Company will continue to work diligently to complete and file its Form 10-Q as soon as practicable and, if applicable, will work diligently to submit the Plan promptly and take the necessary steps to regain compliance as soon as practicable.

17:35 EST Seadrill announces $250M share repurchase program - Seadrill announces it has "initiated $250 million shareholder return program and completed share repurchases totaling $213 million as of November 24, 2023." The company also "increased share repurchase authorization by an additional $250 million, taking aggregate authorization to $500 million."

17:30 EST Northrop Grumman awarded $265M Navy contract modification - Northrop Grumman was awarded a modification to increase the maximum ceiling by $265M of a previously awarded firm-fixed-price and cost-plus-fixed-fee basic ordering agreement. The total cumulative ceiling of the agreement is $514.3M. The additional ceiling provides for sustaining engineering and logistics support services for the Ground/Air Task Oriented Radar, or G/ATOR, program, including engineering changes, contractor logistics support, depot lifecycle support, software support activity support, diminishing manufacturing sources and material shortages support, technical refresh, studies and analyses, services for the retrofit of six fielded Gallium Arsenide G/ATOR Low Rate Initial Production systems with Gallium Nitride technology, operational spares buys, software development for current and future radar systems, and the 5G America's Mid-band Initiative Spectrum accommodation. Work locations will be determined by individual task orders and is expected to be complete by Sept. 28, 2025. No funds will be obligated at the time of award. Funds will be obligated on individual task orders as they are issued. Marine Corps Systems Command is the contracting activity.

17:28 EST Elbit Systems awarded $500M Navy contract - Elbit Systems was awarded a $500M firm-fixed-price, indefinite-delivery/indefinite-quantity contract for the procurement of Squad Binocular Night Vision Goggle systems; spare and repair parts; contractor logistics support; and test article refurbishment. Work is expected to be completed in November 2028. FY22 procurement funds in the amount of $944,730 will expire at the end of the current fiscal year; FY23 procurement funds in the amount of $46.66M that will not expire until FY25 and FY24 procurement funds in the amount of $79.29M that will not expire until fiscal year 2026, for a total amount of $126.89M, will be obligated on the first delivery order immediately following contract award. This contract was competitively procured via SAM.gov, with three offers received. Marine Corps System Command is the contracting activity.

17:22 EST Clearway Energy to replace Veritiv in S&P 600 at open on 11/30 - Clayton, Dubilier & Rice is to acquire Veritiv (VRTV) in a deal expected to be completed soon, pending final closing conditions.

17:19 EST W.P. Carey to replace Worthington in S&P 400 at open on 11/30

17:18 EST Carlyle to replace ICU Medical in S&P 400 at open on 11/30

17:05 EST SunPower receives Nasdaq notice of deficiency - SunPower received on November 22, 2023, a notice from The Nasdaq Stock Market LLC indicating that, as a result of not having timely filed the Form 10-Q with the SEC, the company is not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of all required periodic financial reports with the SEC. The Notice has no immediate effect on the listing or trading of the company's common stock on the Nasdaq.

17:02 EST SSR Mining announces automatic share purchase plan - SSR Mining announced that, in connection with its previously announced normal course issuer bid to purchase for cancellation up to 10.2M common shares of the company, the company has entered into an automatic share purchase plan with a designated broker. The ASPP is intended to facilitate repurchases of Common Shares under the NCIB when the company would ordinarily not be permitted to purchase such shares due to regulatory restrictions and customary self-imposed blackout periods. Pursuant to the ASPP, purchases of Common Shares will be made by the designated broker based on pre-established purchasing parameters, without further instructions by the company, in compliance with the rules of the Toronto Stock Exchange. The ASPP is also intended to meet the requirements of a Rule 10b5-1 trading plan under the U.S. Securities Exchange Act of 1934, and transactions under the ASPP, and under the NCIB generally, will be conducted in accordance with Rule 10b-18 under the U.S. Securities Exchange Act of 1934. The ASPP has been pre-cleared by the TSX, is expected to be implemented on November 28, 2023 and will end no later than June 19, 2024. Outside of the ASPP, Common Shares may be purchased under the NCIB based on management's discretion, in compliance with TSX rules and applicable securities laws. The NCIB allows for SSR Mining to purchase Common Shares over the twelve-month period that began June 20, 2023 and ends June 19, 2024.

16:49 EST H&R Block CFO sells $2.21M in common stock - In a regulatory filing, H&R Block disclosed that its CFO Tony Bowen sold 46.9K shares of common stock on November 27th in a total transaction size of $2.21M.

16:43 EST Sempra Energy names Diana Day chief legal counsel, Karen Sedgwick CFO - Sempra announced updates to its officer team. The following management updates are effective January 1, 2024, unless otherwise noted, and these individuals will report directly to Martin. Diana Day, who currently serves as deputy general counsel, has been appointed chief legal counsel of Sempra with responsibility for the company's legal affairs and governance. Trevor Mihalik, who currently serves as the company's executive vice president and chief financial officer, has been appointed executive vice president and group president of Sempra. Karen Sedgwick, who currently serves as the company's chief administrative officer and chief human resources officer, has been appointed executive vice president and chief financial officer of Sempra, where she will lead several corporate functions, including accounting, tax, finance and investor relations.

16:38 EST Acelyrin says 'disappointed' by developments in Izokibep clinical program - Acelyrin provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis, PsA trial. In September 2023, ACELYRIN disclosed top-line results from Part B of its Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe Hidradenitis Suppurativa . Given certain confounding factors observed in the trial, including responder discontinuations without adverse events and a marked increase in placebo rates arising in the latter half of the study, the Company implemented quality control measures above and beyond standard protocol for the ongoing open-label extension of the HS trial, the ongoing Phase 3 trial in HS, and the ongoing PsA trial. These trials are being conducted by the same Contract Research Organization CRO . The CRO does not conduct any trials on behalf of ACELYRIN beyond the izokibep clinical program. "We are disappointed by these developments, especially for the patients who need better treatment options for psoriatic arthritis and hidradenitis suppurativa," said Shao-Lee Lin, MD, PhD, founder and CEO of ACELYRIN. The Company reported cash of $788.4Mat September 30, which represents a multi-year runway to fund operations through key value-driving milestones across its portfolio of clinical programs. As a result of these developments, the Company will not attend Piper Sandler's 35th Annual Healthcare Conference on Tuesday, November 28 or the 6th Annual Evercore ISI HealthCONx Conference on Thursday, November 30, 2023, as previously disclosed.

16:34 EST ACM Research CEO sells $1.59M in common stock - In a regulatory filing, ACM Research disclosed that its CEO David Wang sold 90K shares of common stock on November 22nd in a total transaction size of $1.59M.

16:23 EST Oshkosh to produce Medium Equipment Trailer for U.S. Army in $342M contract - Oshkosh Defense announced that the U.S. Army Contracting Command - Detroit Arsenal awarded a production contract for the Medium Equipment Trailer, or MET. Oshkosh will partner with Broshuis, B.V to execute the $342 million contract. The five-year Indefinite Delivery/Indefinite Quantity (IDIQ) contract includes the option for two additional years and calls for Oshkosh to produce an estimated 557 trailers.

16:21 EST Inari Medical announces first patient enrolled in PEERLESS II study - Inari Medical announced the first patient enrollment in the PEERLESS II study. This prospective, global, multi-center randomized controlled trial, or RCT, compares the outcomes of intermediate-risk acute pulmonary embolism, or PE, patients treated with the FlowTriever System against those treated with traditional anticoagulation therapy alone.

16:19 EST Tenable Holdings announces $100M stock repurchase pact - Tenable Holdings announced that its Board of Directors has approved the repurchase of up to an aggregate of $100 M of its common Stock.

16:17 EST AnaptysBio announces exclusive license agreement with Centessa Pharmaceuticals - AnaptysBio announced an exclusive license agreement for Centessa Pharmaceuticals' blood dendritic cell antigen 2, or BDCA2, modulator antibody portfolio, including lead asset CBS004 and related family of backup antibodies, for the treatment of autoimmune and inflammatory diseases. Anaptys anticipates filing an IND application for CBS004, which will be renamed ANB101, in H2 2024.

16:16 EST Universal Display signs OLED material supply, license pacts with BOE Technology - Universal Display Corporation announced the signing of long-term OLED material supply and license agreements with BOE Technology Group Co., an IoT innovation company providing intelligent interface products and services for information interaction and human health. These agreements extend the strong partnership between the two companies. Universal Display Corporation will continue to supply its proprietary UniversalPHOLED phosphorescent OLED materials and technology to BOE Technology for use in its OLED displays through its wholly-owned subsidiary UDC Ireland Limited. Further details and financial terms of the agreements have not been disclosed. "We are pleased to enter into these long-term agreements that extend our robust partnership with BOE," said Steven V. Abramson, President and Chief Executive Officer of Universal Display Corporation. "BOE is a leading IoT innovation company providing intelligent interface products and services for information interaction and human health that is fueling the proliferation of OLEDs across the global consumer electronics landscape with its innovative and cutting-edge technology. As our comprehensive portfolio of highly-efficient, cost-effective and proprietary OLED technologies and phosphorescent emissive material solutions continues to grow, we look forward to broadening our long-term collaboration with BOE."

16:15 EST Bitfarms to purchase 35,888 Bitmain T21 miners at $2,660 per unit - Bitfarms has placed a firm purchase order for 35,888 Bitmain T21 miners at a price of $2,660 per unit with deliveries scheduled from March 2024 to May 2024. With its recently announced financing, Bitfarms will have sufficient liquidity to complete the purchase obligations for this order. Concurrently, Bitfarms has secured a purchase option for an additional 28,000 Bitmain T21 miners. Management will discuss the 2024 transformative fleet upgrade plan on a conference call to be held on November 28.

16:08 EST Cetera Holdings announces close of Avantax acquisition - Avantax and Cetera Holdings, the holding company of Cetera Financial Group, announced the successful completion of Cetera's acquisition of Avantax. Avantax's Board of Directors unanimously approved the transaction, and holders of approximately 81% of the outstanding shares of Avantax common stock entitled to vote thereon approved the transaction. Avantax is now a privately held company, and its common stock will no longer be traded on Nasdaq. Holders of shares of Avantax common stock are entitled to receive $26.00 in cash per share, without interest and subject to required withholding taxes.

16:06 EST ZIM Integrated takes measures in response to threats in Arabian, Red Seas - ZIM Integrated Shipping Services reaffirmed its continued commitment to serve the East Mediterranean and Israeli ports. Operations to and from these ports will be maintained with the highest regard for safety protocols which are essential to safeguarding the interests of all stakeholders. In light of the threat to safe transit of global trade in the Arabian and Red Seas, ZIM is taking temporary proactive measures to ensure the safety of its crews, vessels, and customers' cargo by re-routing some of its vessels. As a result of these measures, longer transit times in the relevant ZIM services are anticipated, though every effort is being made to minimize disruptions. ZIM is closely monitoring the situation to address potential risks and ensure the ongoing safety and efficiency of its operations. ZIM will maintain the highest level of service to its customers.

16:00 EST Aldeyra trading halted, news pending

13:07 EST European Commission sends Amazon statement of objections over iRobot deal - The European Commission has informed Amazon (AMZN) of its preliminary view that its proposed acquisition of iRobot (IRBT) may restrict competition in the market for robot vacuum cleaners, or "RVCs." The Commission stated: "Amazon provides an online marketplace, which allows retailers to advertise and sell products (including RVCs) to customers. Amazon is active as a retailer of various products (including RVCs) on its online marketplace. iRobot manufactures RVCs and sells them also through Amazon's online marketplace. On 6 July 2023, the Commission opened an in-depth investigation to assess if Amazon's acquisition of iRobot may (i) restrict competition in the market for the manufacturing and supply of RVCs; and (ii) allow Amazon to strengthen its position in the market for online marketplace services to third-party sellers (and related advertising services) and/or other data-related markets. As a result of this in-depth investigation, the Commission is concerned that Amazon may restrict competition in the European Economic Area ('EEA')-wide and/or national markets for RVCs, by hampering rival RVC suppliers' ability to effectively compete... The Commission has conducted a wide-ranging investigation to understand the market and the potential impact of the deal. This investigation has included, among others, analysing internal documents provided by the parties and gathering views from market participants such as suppliers of RVCs and other smart home devices, as well as from providers of online sales channels. The Commission closely cooperated with other competition authorities during both the initial investigation and the in-depth investigation and will continue such cooperation during the remainder of the in-depth investigation... The proposed transaction was notified to the Commission on 1 June 2023. The Commission opened an in-depth investigation on 6 July 2023 and now has until 14 February 2024 to take a final decision." Reference Link

13:05 EST iRobot trading resumes

12:52 EST Banco Macro sees Q4 ROE in 'high-teens' or 'close to 20%' - Says for FY24 ROE, "let's assume" a scenario between 10%-15% in real terms. Says Q4 ROE view depends on the evolution of bond prices. Guidance taken from Q3 earnings conference call.

12:45 EST Crown Castle says board 'confident' in executive leadership

12:00 EST Clipper Realty falls -7.4% - Clipper Realty is down -7.4%, or -36c to $4.56.

12:00 EST Huya falls -7.9% - Huya is down -7.9%, or -30c to $3.54.

12:00 EST Annovis Bio rises 16.5% - Annovis Bio is up 16.5%, or $1.07 to $7.57.

10:00 EST Lithium Americas falls -5.1% - Lithium Americas is down -5.1%, or -36c to $6.72.

10:00 EST Flotek falls -11.0% - Flotek is down -11.0%, or -44c to $3.56.

10:00 EST Irsa Inversiones y Representaciones SA rises 13.9% - Irsa Inversiones y Representaciones SA is up 13.9%, or $1.12 to $9.24.

09:58 EST Acadia Pharmaceuticals initiates ACP-204 study - Acadia Pharmaceuticals announced the initiation of a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis.

09:49 EST Aspira Women's Health receives final crosswalk pricing determination from CMS - Aspira Women's Health announced that during the 2024 Clinical Laboratory Fee Schedule rate setting process, the Centers for Medicare & Medicaid Services has approved the crosswalk of the fee to be paid to the company for OvaWatch to the fee paid historically for Ova1. Aspira will be reimbursed at a rate of $897 for all OvaWatch and Ova1 tests processed for Medicare patients meeting applicable coverage requirements beginning on January 1, 2024. "Nothing is more important than reliable clinical data when a patient is facing a possible ovarian cancer diagnosis. With CMS's approval of OvaWatch's price on the 2024 laboratory fee schedule, we are closer than ever to ensuring that our ground-breaking technology is available to all women with an adnexal mass," said Nicole Sandford, President and CEO of Aspira.

09:47 EST a.k.a. Brands falls -7.5% - a.k.a. Brands is down -7.5%, or -74c to $9.11.

09:47 EST Banco Macro rises 8.8% - Banco Macro is up 8.8%, or $2.29 to $28.21.

09:47 EST Irsa Inversiones y Representaciones SA rises 16.1% - Irsa Inversiones y Representaciones SA is up 16.1%, or $1.31 to $9.43.

09:40 EST Northann Corp trading halted, volatility trading pause

09:16 EST Accelerate Diagnostics announces collaboration with Bruker - Accelerate Diagnostics (AXDX) announced the signing of a collaboration and quality agreement with Bruker Corporation (BRKR), the provider of the market-leading MALDI Biotyper system for microbial identification. This agreement enables both companies to validate the use of Accelerate Diagnostics' Arc system, an innovative, automated positive blood culture sample preparation platform, with Bruker's MALDI Biotyper sirius instruments and Sepsityper software for subsequent registration in both the US and EMEA markets.

09:13 EST Fat Brands announces new locations for Great American Cookies, Marble Slab - FAT Brands announces two new development deals set to open 10 new co-branded Great American Cookies and Marble Slab Creamery locations across Texas. The Great American Cookies and Marble Slab Creamery locations will open their doors over the next five years. "Both Great American Cookies and Marble Slab Creamery have become a go-to destination for sweets in Texas," said Taylor Wiederhorn, Chief Development Officer of FAT Brands. "At FAT Brands, we continue to see strong growth potential for the brands as a co-branded concept, offering a one-stop-shop for all things Cookie Cakes, homemade ice cream and more. As Texas grows, so will we."

09:11 EST Safe Bulkers announces sale of 2015-built Kamsarmax dry-bulk vessel - Safe Bulkers announced that it has entered into an agreement for the sale of MV Pedhoulas Cherry, a 2015 Chinese-built, Kamsarmax class, dry-bulk vessel at a gross sale price of $26.6 million and an estimated forward delivery in January to February 2024. Dr. Loukas Barmparis, President of the Company, commented: "As we take delivery of Phase 3 newbuilds we decided to proceed with a selective sale of MV Pedhoulas Cherry at a price we consider attractive. Company's remaining orderbook includes seven more Phase 3 newbuilds, two of which are methanol dual fuel, with delivery dates three in 2024, two in 2025, one in 2026, and one in 2027, targeting one of the most environmentally efficient dry bulk fleets in the market."

09:09 EST AIM ImmunoTech announces issuance of two key U.S. patents - AIM ImmunoTech announced that the U.S. Patent and Trademark Office, USPTO, has issued U.S. patent No. 11,813,279 and 11,813,281 for Ampligen titled "Compositions for cancer therapy and methods," and "Methods for improving exercise tolerance in myalgic encephalomyelitis patients," respectively. AIM Chief Executive Officer Thomas Equels stated: "Our ongoing effort to expand and solidify AIM's global intellectual property estate is a foundational component of our development strategy for Ampligen. AIM's expectation for Ampligen - both as a therapeutic for people suffering from dire diseases and as a valuable asset for our stockholders - is the driving force behind our multiple clinical studies in oncology, ME/CFS and Post-COVID conditions. These two new U.S. patents will serve to further strengthen the potential financial future of our company by extending certain sole rights to Ampligen and for these uses to 2039."

09:08 EST Blue Star Foods provides shareholder update - Blue Star Foods provides a Shareholder Update, from its Chairman and Chief Executive Officer John Keeler. "I write to you today with gratitude, pride and excitement. Gratitude and pride for the dedication and support of our employees, partners and shareholders in our accomplishments to date, and great excitement for the value I see for us in the path ahead. Our Quarterly Report 10Q was filed with the U.S. Securities and Exchange on November 20, 2023. While our year-to-date 2023 revenues of $5.1 million were not as high as expected, our quarterly losses have been declining throughout the year. Additionally, we paid off convertible debt, which had caused derivative accounting warrants liability on our balance sheet, as that reduced debt goes back to increasing our equity. Importantly, those warrants liabilities reserves are not related in any way to the cash operations of the Company. The previously taken steps of reducing our corporate and operating expenses and streamlining our business has improve our financial condition. Of note, we have significantly reduced our cash burn, substantially reduced the debt net of discounts to $0.9 million and currently maintain $4.1 million in cash, inventory and A/R. We could buy our current market capitalization with board consent. We currently have 14.4 million shares outstanding. Now turning to our business, we continue to make progress with our RAS segment, highlighted by our option to purchase land in South Carolina for our expansion. Our recently reported quarterly revenue was lower than expected due to us delaying our salmon harvest for two months... Overall, management is focused on returning to revenue growth and profitability. We continue to explore strategic opportunities for growth that are both acquisitive and organic, as we recognize we need to be of larger size in order to build shareholder value."

09:07 EST LPL Financial welcomes Momentum Wealth - LPL Financial announced that financial advisors Rob Elstad, Steven "Coert" Van Voorhees and Bill Blankenship have joined LPL Financial's broker-dealer, RIA and custodial platforms. The team reported having served approximately $150 million in advisory, brokerage and retirement plan assets, and joins LPL from Ameriprise. Formerly known as Van Voorhees, Elstad & Associates, the team is rebranding to Momentum Wealth with the move to LPL.

09:06 EST Affirm up after Adobe says orders using BNPL rising - Black Friday online buying hit a record $9.8B in the U.S. according to Adobe Analytics as sales were up by 7.5% compared to last year's numbers, reported TechCrunch. Buy now, pay later, or BNPL, options as a complement to other kinds of credit continued to grow in popularity and Adobe said that orders using BNPL were up by 72% on last year across the week going into Black Friday, according to TechCrunch's report. In Monday morning trading, shares of BNPL solution provider Affirm are up $1.09, or 4%, to $27.32 in pre-market trading. Reference Link

09:04 EST Scilex announces completion of commercial manufacturing of Gloperba - Scilex Holding announced that it has completed commercial manufacturing of Gloperba, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. and is expecting to launch Gloperba in the U.S. in the first quarter of 2024. Gloperba is a highly complementary commercial asset that allows the Company to provide physicians with another tool in their non-opioid pain management armamentarium to treat gout earlier in the patient journey as the Company continues to work towards re-defining the role of opioids as a last resort rescue medication.

08:52 EST LKQ Corp. announces executive leadership succession plan - LKQ Corporation announced that Dominick Zarcone, the Company's current President and Chief Executive Officer, has informed the Company's Board of Directors of his intention to retire from his role effective June 30, 2024. The Board has unanimously selected Justin Jude, the Company's current Senior Vice President and President of its Wholesale - North America segment, to succeed Zarcone as LKQ's next President and CEO. In the interim, the Board has appointed Mr. Jude to serve as LKQ's Executive Vice President and Chief Operating Officer from January 1, 2024 until he officially succeeds Mr. Zarcone as President and CEO on July 1, 2024. It is anticipated that Messrs. Zarcone and Jude will be included on the slate of nominees for election as members of the LKQ Board of Directors at the Company's Annual Meeting of Stockholders in May 2024.

08:46 EST TC Biopharm announces FDA clearance of Phase 1B IND for TCB-008 in AML - TC BioPharm announced that the FDA provides clearance on the company's investigational new drug application for a Phase 1B study in relapse/refractory Acute Myeloid Leukemia. The Phase 1B study, dubbed ACHIEVE2, will be a 9 patient, dose escalating study measuring for safety and dose optimization. The Open-label, multi-center study conducted in 2 parts will evaluate safety, persistence/expansion, and preliminary efficacy of single and multiple IV doses of TCB008 in patients with AML or MDS/AML. Patients may be reinfused with TCB008 up to 3 times following initial infusion as deemed appropriate by the investigator or designee should protocol specified criteria be met. Additionally, the company will be continuing the UK ACHIEVE trial in AML, expecting to submit amendments to the protocol before year-end to align the dosing and other criteria with the ACHIEVE2 trial of TCBP's lead product. "The acceptance of the TCB-008 IND is a significant milestone for TC BioPharm and reflects execution of our strategic plan which we announced to shareholders in April. TC BioPharm will continue to work towards its primary goal of establishing a better method of treatment for the millions of people around the world suffering blood and bone marrow cancer as we establish TCB008 the standard of care for these patients, with higher quality of life and extended remission of these devastating diseases," said Bryan Kobel, CEO of TC BioPharm.

08:41 EST GRI Bio announces FDA clearance of IND for GRI-0621 - GRI Bio announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug, IND, application for GRI-0621 for the treatment of IPF. The Company plans to evaluate GRI-0621 in a randomized, double-blind, multi-center Phase 2a biomarker study, on track to commence before year end. "Clearance of our IND application for GRI-0621 represents a significant milestone for the Company and for our innovative pipeline of NKT cell modulators. Our team has worked tirelessly to meet our planned milestones and I am proud of the continued progress made. We look forward to initiating patient enrollment before year end and potential future data releases in 2024," commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

08:39 EST Evoke Pharma announces FDA Orange Book listing of new GIMOTI patent - Evoke Pharma announced that its recently issued U.S. patent related to GIMOTI, No. 11,813,231 is now listed in the U.S. Food and Drug Administration, FDA, publication, "Approved Drug Products with Therapeutic Equivalence Evaluations", commonly known as the "Orange Book". The patent titled "Nasal Formulations of Metoclopramide" covers a collection of nasal solutions of metoclopramide and its characteristics when formulated. This new patent is now listed in the FDA's Orange Book and carries a patent term to 2029. The listing of the patent in the Orange Book adds additional patent protection for GIMOTI beyond the prior three listed patents. "Due to our relentless efforts to continuously realize the significant commercial potential of GIMOTI and the need for an improved treatment solution for diabetic gastroparesis, our IP portfolio now boasts an impressive set of patents and four FDA Orange Book listings," commented Matt D'Onofrio, President and Chief Operating Officer of Evoke Pharma. "We are proud to have achieved this milestone as we aim to redefine the standard for gastroparesis treatment by providing GIMOTI, a direct route to deliver medication leading to less hospitalizations than oral metoclopramide."

08:37 EST Imax, Pathe Cinemas expand strategic partnership agreement - PATHE CINEMAS, an exhibitor in Continental Europe, and IMAX Corporation announced a significant expansion to their historical partnership with five new state-of-the-art IMAX with Laser systems in Europe, including four in France. The new agreement also spans distribution, with IMAX and PATHE LIVE, PATHE's subsidiary dedicated to production and distribution of event cinema, set to release three upcoming PATHE LIVE films across the IMAX network.

08:37 EST Encompass Health names Spirit Airlines CEO Ted Christie to board - Encompass Health Corporation (EHC) announced the appointment of Edward M. Christie III to its board of directors. This appointment will expand the Encompass Health board to 12 director seats as part of its ongoing succession planning. Christie currently serves as President and CEO of Spirit Airlines (SAVE).

08:36 EST Unisys buys group annuity contracts from F&G Annuities totaling $250M - Unisys (UIS) announced it has closed agreements with F&G Annuities & Life, Inc. (FG) to purchase group annuity contracts totaling approximately $250M through which Unisys will transfer projected benefit obligations valued at a similar amount related to certain retirees under one of the company's U.S. pension plans to F&G. As part of the transfer, F&G's insurance subsidiaries, Fidelity & Guaranty Life Insurance Company and Fidelity & Guaranty Life Insurance Company of New York, will assume responsibility for pension benefits for approximately 3,900 retirees and beneficiaries with monthly benefits lower than certain thresholds. There will be no changes to the gross amount, timing, or form of the monthly pension payments. Unisys anticipates this action will result in a one-time, non-cash, pre-tax settlement charge of approximately $244M. Since the purchase will be made by the pension trust, there will be no impact on the company's cash position.

08:35 EST Spyre Therapeutics names Cameron Turtle as CEO - The company announced the appointment of Cameron Turtle, DPhil as CEO and member of the Board of Directors. Prior to his appointment as CEO, Dr. Turtle was the COO of Spyre and previously served as the Chief Strategy Officer of BridgeBio Pharma, Inc. and Chief Business Officer of Eidos Therapeutics, Inc. "The Spyre team is dedicated to materially improving upon today's standard of care for the treatment of IBD," said Dr. Turtle. "I am delighted to lead this team of knowledgeable and passionate industry experts as we seek to deliver infrequently administered, subcutaneous antibody combinations targeting the best validated therapeutic pathways for this disease. We look forward to initiating clinical studies of our lead programs against alpha4beta7 and TL1A next year, followed shortly thereafter by our IL-23 program. These programs are expected to be the basis of combination therapy studies to follow."

08:34 EST Aeglea BioTherapeutics announces name change to Spyre Therapeutics - Aeglea BioTherapeutics announced its name change to Spyre Therapeutics, Inc. Effective as of market open on November 28, 2023, Spyre will trade on Nasdaq under the ticker symbol "SYRE". The name change follows the acquisition of privately held Spyre Therapeutics, Inc. by the company in June of 2023. Named to reflect the company's ambition to achieve new heights in efficacy and convenience of Inflammatory Bowel Disease therapies, Spyre aims to create a next-generation of IBD products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision patient selection approaches to enhance efficacy for patients.

08:32 EST Brera Holdings' Tchumene promoted to Mocambola - Brera Holdings announces that its Mozambican Club Brera Tchumene has been promoted to the Mocambola, the First Division of football in Mozambique. Brera Tchumene reached this milestone in just its first season of professional football in Mozambique, on Saturday, November 25th, following the win in the second leg match of the play-off final. Brera Tchumene won the South Zone of Mozambique versus Desportivo da Matola, with the score of 1-0 decided by Julio Carrelo's goal. Previously, the first leg match was played Saturday, November 18th, and ended up with a 3-1 win for Brera with scores by Adinane, Anacleto and Romao.

08:32 EST HeartCore Enterprises' subsidiary launches Psyche60s VR experience - HeartCore Enterprises announced that its subsidiary, Sigmaways, launched the Psyche60s virtual reality experience, as part of its broader augmented reality, and mixed reality initiatives. Sigmaways Immersive Studio aims to capitalize on the surging interest in the immersive virtual reality realm, riding the momentum generated by recent launches in Apple Vision Pro, Meta-Quest Pro, and Quest 3. Armed with cutting-edge technologies including Unity, Unreal Engine, Adobe Generative AI, Nivida computing, and ChatGPT, the Psyche60s project crafts a distinctive virtual reality entertainment experience that incorporates a unique educational aspect. "I am pleased to announce the successful launch of our immersive Psyche60s virtual reality experience as part of our digital transformation strategy," said Ankit Sahu, Creative Head at Sigmaways Immersive Studios. "With the support of our parent company, HeartCore Enterprises, and our strategic positioning as early pioneers in the content development field, we are leveraging the latest, cutting-edge tools such as AI, augmented reality, and mixed reality to deliver unparalleled solutions for our clients and customers. We look forward to continue integrating advanced technologies and potentially forming strategic partnerships with esteemed, public institutions in the education sector to transform the way people learn, experience entertainment, and engage with digital content."

08:30 EST BIMI International Medical receives Nasdaq notification of non-compliance - BIMI International Medical announced that on November 21, 2023, the Company received a notification letter from The Nasdaq Stock Market LLC stating that, because the Company has not yet filed its Quarterly Report on Form 10-Q for the period ended September 30, 2023, the Company is no longer in compliance with Nasdaq Listing Rule 5250(c)(1). Nasdaq Listing Rule 5250(c)(1) requires listed companies to timely file all required periodic financial reports with the Securities and Exchange Commission. The Nasdaq letter has no immediate effect on the listing of the Company's shares. The Nasdaq letter also stated that previously Nasdaq had granted the Company an exception until December 8, 2023, to file its delinquent Form 10-Q for the period ended June 30, 2023. As a result, any additional Nasdaq exception to allow the Company to regain compliance with all delinquent filings, will be limited to a maximum of 180 calendar days from the due date of the Initial Delinquent Filing, or February 20, 2024. As a result of this additional delinquency, the Company must submit an update to its original plan to regain compliance with respect to the filing requirement. The update should be as definitive as possible, including plans to file the Form 10-Q for the period ended September 30, 2023, and indicate the progress the Company has made towards implementing the plan submitted in connection with the Initial Delinquent Filing.

08:26 EST Stratasys partners with Siemens Healthineers on CT phantoms research project - Stratasys (SSYS) announced it has partnered with Siemens (SIEGY) Healthineers to carry out a landmark research project designed to develop new solutions for the advancement of medical imaging phantoms for computed tomography, or CT, imaging. A tool in medical imaging and an almost universal resource in hospitals worldwide, CT phantoms are specialized devices used to evaluate and ensure the performance of CT scanners. Designed to simulate certain characteristics of the human body, phantoms enable the assessment of various core metrics, including radiation dose and image quality, aiding calibration and safeguarding consistent scanner performance. The joint development leverages Stratasys' PolyJet technology in combination with its unique RadioMatrix technology, and Siemens Healthineers' advanced algorithm aimed at translating scanned patient images into specific material characteristics with radiopacity of human anatomy. The solution will allow for tailored phantom manufacturing and the creation of ultra-realistic human anatomy characteristics with complete radiographic accuracy of patient-specific pathology not previously possible.

08:21 EST Gracell announces FDA clearance of IND application for Phase 1/2 trial - Gracell Biotechnologies announced that the U.S. Food and Drug Administration, FDA, has cleared Gracell's Investigational New Drug, IND, application, allowing the Company to initiate a Phase 1/2 clinical trial of FasTCAR-T GC012F in the United States for the treatment of refractory systemic lupus erythematosus, rSLE. "We are excited to expand the clinical development of our lead FasTCAR asset, GC012F, for treatment of rSLE in the United States," said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell. "This progress marks the second U.S. IND clearance for GC012F, a notable milestone. As a next-generation CAR-T therapy, GC012F combines the innovative CD19/BCMA dual-targeting approach and our breakthrough FasTCAR next-day manufacturing technology, both of which could potentially provide meaningful benefits to SLE patients. Additionally, what sets GC012F apart is its consistently favorable safety profile demonstrated by the absence of neurotoxicity in 60 patients treated across three IIT studies. We look forward to developing GC012F as a transformative therapy for SLE patients, who are in urgent need of highly effective and safe treatment options."

08:18 EST INmune receives EMA authorization in France, Spain for Phase II trial of XPro - INmune Bio announced it has received European Medicines Agency's, EMA, Authorized Decision from the Agence Nationale de Securite du Medicament et des Produits de Sante, ANSM, in France and the Agencia Espanola de Medicamentos y Productos Sanitarios, AEMPS, in Spain to initiate a Phase II trial in Early Alzheimer's Disease, AD, with XPro. This authorization follows the acceptance of the Company's Clinical Trial Application under EU Clinical Trials Regulation and prior EMA's Authorized Decision in Poland on Nov 15, 2023. The Spanish and French arms are part of the Company's international clinical development strategy for XPro in patients with early AD. The trial is currently enrolling patients in Australia, Canada, and the United Kingdom. "The French and Spanish clinical sites will significantly broaden the trial in Europe. We are grateful for the collaboration from the ANSM and the AEMPS and look forward to continuing our progress toward completing enrollment of the Phase II trial. We believe clinical sites in these two countries will be significant contributors to the Phase II program and will be part of the global Phase III clinical trial," said RJ Tesi M.D., CEO of INmune Bio.

08:16 EST Roivant Sciences, Priovant announce results from Phase 2 study of brepocitinib - Roivant and Priovant announced the Phase 2 study evaluating oral brepocitinib in adult patients with moderate to severe active lupus did not meet its primary endpoint of Systemic Lupus Erythematosus Responder Index change of 4 at Week 52. Priovant plans to disclose the study data at a future date. "We saw some of the highest SRI-4 responder rates ever observed in a lupus study in the active arm of this trial, along with a favorable safety and tolerability profile. Unfortunately, we also saw the highest placebo response rate observed in any significant SLE study, and as such it was not possible to truly assess the impact of the drug, or to establish sufficient differentiation from other therapies in lupus patients. While we do not plan to progress the program in SLE, these results continue to support our view that oral brepocitinib is a highly active agent with a good safety profile, and we remain enthusiastic about brepocitinib's ability to produce meaningful clinical benefit in non-infectious uveitis and dermatomyositis in Priovant's ongoing trials, as well as in many other potential indications" said Matt Gline, CEO of Roivant. "Roivant and Priovant would like to extend our gratitude to the patients who participated in this trial, their caregivers, and the trial investigators that enabled this study and these insights."

08:14 EST Rapt Therapeutics announces publication of Phase 1a/1n trial of zelnecirnon - RAPT Therapeutics announced that results from its previously disclosed Phase 1a/1b clinical trial of zelnecirnon were published in Allergy. The Phase 1a portion of the trial was a standard single and multiple dose-escalation study in 72 healthy volunteers. The Phase 1b portion of the trial was a randomized, double-blind, placebo-controlled study examining zelnecirnon as monotherapy in 31 patients with moderate-to-severe atopic dermatitis. The findings showed that once-daily zelnecirnon treatment was generally well tolerated, with no serious adverse events reported, and all reported treatment-emergent adverse events were mild-to-moderate in nature across both patients with atopic dermatitis and healthy volunteers. In the Phase 1b trial, after four weeks of treatment, patients with moderate-to-severe AD who received zelnecirnon showed a 36.3% change from baseline in the Eczema Area and Severity Index score, a standard measure of disease severity, compared to 17.0% in the placebo group. Notably, in the two-week period following the end of treatment, the zelnecirnon group showed continued deepening of the response and a statistically significant difference compared to placebo with a 53.2% change from baseline in EASI at the six-week time point compared to 9.6% in the placebo group. Key Findings from the Phase 1b Study in Patients with Atopic Dermatitis: In the Phase 1b study, 21 patients with moderate-to-severe atopic dermatitis were treated with 400 mg of zelnecirnon, administered orally once a day for four weeks, while 10 patients received placebo. The zelnecirnon group showed clear improvement in key efficacy measures compared to placebo at the end of the four-week treatment period, including percent change from baseline in the Eczema Area and Severity Index score, validated Investigator Global Assessment and pruritis Numerical Rating Scale: Patients treated with zelnecirnon achieved a 36.3% change from baseline in EASI score compared with 17.0% in patients in the placebo group; 42.9% of patients treated with zelnecirnon achieved a 50% change from baseline in EASI score compared with 10.0% in the placebo group; 4.8% of patients treated with zelnecirnon achieved a vIGA score of 0/1 and at least a two-point improvement over baseline compared with 0.0% in the placebo group; and 45.0% of patients treated with zelnecirnon achieved at least a four-point reduction in the pruritus NRS score, compared with 22.2% in the placebo group; Patients were also evaluated for exploratory endpoints at six weeks. At six weeks, the patients treated with zelnecirnon showed further deepening of the response in EASI score and vIGA: Patients treated with zelnecirnon achieved a 53.2% change from baseline in EASI score compared with 9.6% in patients in the placebo group; 61.9% of patients treated with zelnecirnon achieved EASI-50 compared with 20.0% in the placebo group; and 14.3% of patients treated with zelnecirnon achieved a vIGA score of 0/1 and at least a two-point improvement over baseline compared with 0.0% in the placebo group

08:10 EST Kratos Defense supports successful US Navy, MDA intercept test - Kratos Defense & Security Solutions announced that its Defense & Rocket Systems business supported the successful intercept test of two Short-Range Ballistic Missile targets, known as Aegis Readiness Assessment Vehicle by two Standard Missile 3 Block IA interceptors during the test event Vigilant Wyvern, also known as Flight Test Aegis Weapon System-48. The successful test demonstrated the capability of a ballistic missile defense-configured Aegis ship to detect, track, engage and execute intercepts of two SRBM targets while concurrently demonstrating an Anti-Air Warfare engagement of two subsonic anti-ship cruise missile drone targets. This live-fire, raid scenario represented one of the largest Integrated Air and Missile Defense events ever conducted in the U.S. Indo-Pacific Command Area of Responsibility and demonstrated for the first time a concurrent Ballistic Missile Defense and Anti-Air Warfare raid. The successful intercepts by the Arleigh Burke-class destroyer USS CARL M. LEVIN were the highlight of the Vigilant Wyvern/FTM-48 event and the culmination of a four-week campaign during which Kratos Rocket Systems business, along with its government and industry partners, integrated and launched the two SRBM targets from the Pacific Missile Range Facility in Hawaii. "Our team works side-by-side with our government customers to deliver transformative and affordable target systems and vehicles from mission inception through successful launch operations. FTM-48, which was one of our largest recent mission campaigns, is just the latest example of this successful partnership," said Dave Carter, President of Kratos Rocket Systems Division. "Kratos' affordable systems allow our customers to cost effectively effect multi system raid scenarios like Vigilant Wyvern, and we are grateful to be able to continue supporting the U.S. DoD and its allies in this very important mission area."

08:09 EST Auddia announces commercial free podcasting enabled by new AI technology - Auddia announced that it is deploying its new commercial-free podcasting technology into the faidr mobile application on January 15, 2024. "This first-of-its-kind feature has been in the works for some time, and we're very excited to bring it to faidr users in January of next year," said Auddia's CEO Michael Lawless. "It's important that we can extend our commercial-free offerings into more content categories, and podcasts are a perfect fit alongside our existing ad-free AM/FM offering." The Company will launch the feature in the faidr app on January 15, with approximately 50,000 episodes of commercial-free podcasts available, representing the top 200 most popular shows.

08:08 EST Aclarion announces commercial milestone with completion of 1,000 nociscan exams - Aclarion announced that it has completed 1,000 commercial Nociscan exams. "The milestone by itself is significant, but the pace of our commercial adoption is the most exciting aspect of achieving 1,000 commercial scans," stated Brent Ness, CEO of Aclarion. "For context, 36% of these 1,000 studies were done in the past 12 months, demonstrating the adoption our strategy has produced along our journey to standard of care. As imaging sites continue to be added and KOLs continue to gain access to Nociscan, we anticipate hitting the 2,000 scan milestone in an even more accelerated fashion."

08:06 EST Fathom receives $4.50 per share non-binding acquisition proposal from CORE - Fathom Digital Manufacturing announced that it has received a non-binding proposal from CORE Industrial Partners on behalf of itself and its affiliated investment vehicles to acquire all of the Company's outstanding shares of Class A Common Stock and Class B Common Stock that they do not already own for $4.50 cash per share. The non-binding proposal states that as of November 22 the CORE Funds collectively owned shares of Class A Common Stock and Class B Common Stock representing approximately 63% of the Company's outstanding voting power. The board of directors of the Company previously formed a special committee of independent directors to evaluate and consider any potential or actual transaction proposal from the CORE Funds and any other alternative proposals or other strategic alternatives that may be available to the Company. The Special Committee is comprised of Messrs. Adam DeWitt, David Fisher and Peter Leemputte. The Company understands that the Special Committee is reviewing the proposal from the CORE Funds, has not made any decisions with respect to its response to the proposal and has not set a definitive timetable for the completion of its evaluation of the proposal. There can be no assurance that any definitive agreement will result from the proposal submitted by the CORE Funds or that any transaction will be consummated. The Company and the Special Committee do not intend to comment further about this proposal unless and until they deem that further disclosure is appropriate.

08:06 EST iHeartMedia to receive $100M of proceeds related to equity interest in BMI - iHeartMedia announced that in connection with the previously announced acquisition of Broadcast Music, or BMI, to a shareholder group led by New Mountain Capital, it expects to receive approximately $100M of proceeds related to its equity interest in BMI, subject to approval of the transaction by BMI shareholders and customary regulatory approvals. The company plans to use the proceeds for general corporate purposes, which may include the repayment of debt. The transaction is expected to close by the end of Q1 2024.

08:05 EST Spectral AI appoints Spangenberg to board of directors - Spectral AI announced the appointment of Erich Spangenberg to the Board of Directors. Spangenberg will serve as Chairman of the Company's Executive Committee as well as the Nominating and Corporate Governance Committee. Spangenberg was Spectral AI's initial outside investor in 2011 and is currently the Company's largest shareholder.

08:04 EST Asset Entities announces stock repurchase program - Asset Entities announced that the Company's Board of Directors has approved a stock repurchase program to purchase up to an aggregate of 1,250,000 shares of its outstanding Class B Common Stock. Acquisitions pursuant to this stock repurchase program may be made through a combination of open market repurchases in compliance with Rule 10b-18 promulgated under the Securities Exchange Act of 1934, as amended, privately negotiated transactions, and/or other transactions at the Company's discretion. The stock repurchase program will expire on November 21, 2024, unless otherwise modified by the Board of Directors. "This stock buyback program reflects our firm commitment to maximizing shareholder value," said Asset Entities Chief Executive Officer Arshia Sarkhani. "We believe our business is strong and dynamic as we move forward with the objective of growing our business in the coming quarters."

08:03 EST L3Harris Technologies to sell CAS business for $800M - L3Harris Technologies announced the signing of a definitive agreement under which an affiliate of TJC L.P. will acquire L3Harris' Commercial Aviation Solutions, or CAS, business for $800M. The acquisition includes a $700M cash purchase price and $100M earnout based on the achievement of certain 2023 and 2024 financial performance targets, which together represent an approximate 15x LTM 9/30 EBITDA purchase multiple. The transaction is expected to close in the first half of 2024 and is subject to customary closing conditions and regulatory approvals. The CAS transaction includes the sale of L3Harris' surveillance joint venture and is subject to a right of first refusal; if exercised, an affiliate of TJC L.P. will acquire the rest of CAS. L3Harris' CAS business employs approximately 1,450 people and offers pilot training, flight data analytics, avionics, and advanced air mobility products and services, among other capabilities.

08:03 EST iCAD to present new studies on ProFound Breast Health Suite - iCAD will present new studies validating its artificial intelligence powered ProFound Breast Health Suite for uncovering hidden heart or vascular disease and predicting a woman's risk for developing breast cancer in the next one- or two-years. Researchers will present their findings at the Radiological Society of North America's annual meeting in Chicago, Nov. 27 - 30, 2023. "The ProFound Breast Health Suite significantly increases cancer detection rates with up to 2x enhanced clinical performance compared to other AI platforms, and reduces the rate of false positive results while accurately evaluating a woman's breast density and cancer risk," said Dana Brown, president and CEO of iCAD, Inc. "Our growing body of important research illustrates the potential our newest solution, ProFound Heart Health, holds for the assessment of calcium deposits in the breast arteries as a proxy for hidden cardiovascular disease, the leading cause of death for women worldwide. We believe iCAD's ProFound AI has the power to positively transform healthcare for clinicians and patients alike."

08:02 EST Earlyworks enters into MOU with Pocket RD for business expansions - Earlyworks announced that it has signed a Memorandum of Understanding, MOU, with Pocket RD to form a business alliance with an aim to leverage the strengths of both companies and expand Earlyworks' market footprint. Pursuant to the MOU, Earlyworks and PocketRD agree to work together to perform the following tasks: Improve performance and options for PocketRD's technology. Build a low-cost, high-quality blockchain system using the GLS-System Development Kit. New business development and provision of systems and products that leverage the strengths of both companies. Pursuant to the MOU, Earlyworks agrees to provide GLS, offer design or design support for each product, and conduct technical verification, system development and operation. PocketRD agrees to provide its technology, review specifications, develop new business, and plan and sell systems and products. Atsuya Momikura, the CEO of PocketRD, commented, "We are promoting business development through both avatar solutions and phygital marketing solutions utilizing blockchain technology. The technologies related to 3D expression and the market formation related to the Web are constantly evolving, and we believe that bold and prompt decision-making is an important factor in seizing the market. In this situation, we are glad to enter into the Alliance with Earlyworks, an attractive partner that shares a similar point of view. We hope to create a market by leveraging the strengths of both companies in the field of phygital marketing."

07:43 EST Elliott: Crown Castle 'suffers from a profound lack of oversight'

07:38 EST Elliott sends letter to board of Crown Castle, calls for 'significant' changes - Elliott Investment Management L.P., which manages funds that collectively have an investment of approximately $2B in Crown Castle Inc., released a letter and presentation detailing its perspectives on the company's history of underperformance and calling for significant changes. Elliott's 2023 "Restoring the Castle" campaign follows its 2020 "Reclaiming the Crown" campaign, which called for enhanced governance and fiber-strategy improvements at Crown Castle. In its letter today, Elliott noted that the Company "disregarded our data-driven analysis, and our recommended changes were neither made nor taken seriously." As a result, Crown Castle has continued to underperform its peers over all time periods in the last 15 years; has underperformed the S&P 500 index over one-, three- and five-year periods; and has seen its stock price recently hit a six-year low. In its letter, Elliott wrote, "Crown Castle suffers from a profound lack of oversight by the Board, which has contributed to its irresponsible stewardship and flawed financial policy. The Company's strategy, led by CEO Jay Brown since 2016, has been a failure, as demonstrated by the breathtaking magnitude of its underperformance." Elliott added that "During the tenure of the current executive team, Crown Castle has underperformed its direct peers by an average of 85% in total return, which translates into nearly $26B of unfulfilled shareholder value." Elliott outlined the following steps it believes are necessary to set the company on the right course, including new executive and board leadership, a strategic and operating review of the fiber business, and an optimized incentive plan. its letter, Elliott wrote that while it prefers to pursue a constructive engagement with the company, as it attempted in 2020, Elliott is prepared and intends to make its case directly to shareholders with a majority slate of alternative directors at the company's annual meeting of shareholders in May 2024.

07:36 EST Complete Solaria announces Will Anderson to remain interim CEO - Complete Solaria announced that Taner Ozcelik will not join the Company as its new CEO and that Founder Will Anderson will remain interim CEO. T.J. Rodgers, Complete Solaria's Executive Chairman, announced during the Company's November 14 earnings call that Taner Ozcelik had agreed to join the Company on Monday, November 20 as the new CEO, with founder Will Anderson reporting to him. Rodgers said, "The purpose of this press release is to inform investors that, after extended discussions with me over the Thanksgiving week, Taner has decided not to join CSLR, a personal decision on his part that I have agreed to respect."

07:35 EST Annovis Bio announces full enrollment in Phase II/III Alzheimer's disease trial - Annovis Bio announced that Alzheimer's, AD, phase II/III study of its lead compound buntanetap has exceeded full enrollment. "We are very pleased to share the news of the successful completion of enrollment for our phase II/III study of buntanetap in Alzheimer's Disease," said Annovis' founder, president and CEO, Maria Maccecchini, Ph.D. "The number of enrolled patients exceeded our initial projections, revealing the Alzheimer's community's strong endorsement of our mission to develop a treatment targeting multiple neurotoxic proteins. This not only proves their support but also underscores their willingness to contribute to advancing this important cause."

07:33 EST Abeona announces FDA accepts, grants priority review for pz-cel BLA - Abeona Therapeutics announced that the U.S. Food and Drug Administration, FDA, has accepted and granted Priority Review for the Biologics License Application, BLA for pz-cel, Abeona's investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa. Under the Prescription Drug User Fee Act, PDUFA, the FDA has set a target action date of May 25, 2024. The FDA also advised that it does not currently plan to convene an Advisory Committee meeting to discuss the pz-cel application. "The FDA's acceptance of our BLA for priority review underscores the high unmet need in RDEB and the potential for pz-cel to provide meaningful benefit to these patients," said Vish Seshadri, Chief Executive Officer of Abeona. "We thank the FDA for their commitment and look forward to working with them through the BLA review, with the goal of bringing this therapy to patients as soon as possible."

07:31 EST Ituran announces distribution of cash dividend of 24c per share - Ituran Location and Control Ltd. announced that the Board of Directors approved the distribution of a cash dividend in the amount of 24c per share, totaling approximately $5M. The dividend will be paid to shareholders of record as of December 20, 2023. The company will pay the dividend out on January 4, 2024 net of taxes at the rate of 25%.

07:21 EST Sernova receives ODD, RPDD for Hemophilia A program from FDA - Sernova announced the U.S. Food and Drug Administration has granted both Orphan Drug Designation, ODD, and Rare Pediatric Disease Designation, RPDD, for the company's Hemophilia A program. "We are pleased with the FDA's decision to grant these designations for our novel treatment for Hemophilia A, which uses the Cell Pouch in combination with cells corrected for the production of Factor VIII," commented Cynthia Pussinen, Chief Executive Officer of Sernova. "Hemophilia A is a serious, life limiting condition and we are committed to advancing development of the program, with a hope to positively impact patients around the world who are waiting for improved treatments."

07:12 EST nLight announces $34.5M contract for DE M-SHORAD laser weapon system - nLIGHT announced a $34.5M contract award that will be executed over approximately 18 months to provide a High Energy Laser or HEL in support of the U.S. Army's Rapid Capabilities Critical Technologies Office, RCCTO, Directed Energy Maneuver-Short Range Air Defense or DE M-SHORAD prototyping effort. nLIGHT is serving as a subcontractor to KORD Technologies as prime contractor in support of this effort. DE M-SHORAD is a component of the U.S. Army's broader modernization strategy for air and missile defense and focuses on integrating a 50kW-class laser weapon system onto a Stryker combat vehicle to provide defensive capabilities against unmanned aircraft systems; rockets, artillery, and mortar; and rotary- and fixed-wing aircraft. Compared to conventional heavy kinetic weapons, directed energy laser weapons can offer deeper magazines with lower cost-per-shot in a smaller footprint.

07:09 EST RTI Surgical receives FDA IDE approval for clinical investigation of Cortiva - RTI Surgical announced that the U.S. Food and Drug Administration has granted Investigational Device Exemption approval for a clinical study designed to confirm the safety and effectiveness of Cortiva Allograft Dermis in implant-based breast reconstruction. Processed using the proprietary Tutoplast Tissue Sterilization Process, Cortiva Allograft Dermis implants are currently regulated as Section 361 human cell and tissue products and restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue.

07:08 EST Canadian Solar's eSTORAGE selected by CIP for battery storage solutions - Canadian Solar Inc. announced that e-STORAGE, which is part of the company's majority-owned subsidiary CSI Solar Co., Ltd., has been selected as the preferred supplier for Engineering, Procurement, and Construction and Operations and Maintenance by Copenhagen Infrastructure Partners to deliver its Summerfield battery storage project in South Australia.

07:07 EST Genelux receives FDA Fast Track designation for Olvi-Vec - Genelux announced that the United States Food and Drug Administration, FDA, has granted Fast Track designation for the development program of Olvi-Vec for the treatment of patients with platinum resistant/refractory ovarian cancer. "The Fast Track designation granted for Olvi-Vec underscores its potential to address unmet medical needs in ovarian cancer, a significant recognition as we continue to enroll our Phase 3 OnPrime study," said Thomas Zindrick, President, Chairman and CEO of Genelux. "We eagerly anticipate ongoing engagement with the FDA as we progress in the development of this promising treatment." Genelux is currently conducting OnPrime/GOG-3076, a Phase 3 multi-center, randomized, open-label registrational trial evaluating the efficacy and safety of Olvi-Vec in combination with platinum-based chemotherapy in patients with platinum-resistant/refractory ovarian cancer.

07:06 EST Xenon Pharmaceuticals announces results from Phase 2 X-NOVA trial on XEN1101 - Xenon Pharmaceuticals reported topline results from the randomized, double-blind, placebo-controlled, Phase 2 proof-of-concept X-NOVA clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 10 mg and 20 mg of XEN1101 in 168 patients with moderate to severe major depressive disorder, or MDD. Summary of Efficacy Data: The primary endpoint of the study was a change in the Montgomery-Asberg Depression Rating Scale, or MADRS, at week 6. The mean reduction was 13.90 in the placebo group, 15.61 in the XEN1101 10 mg group and 16.94 in the XEN1101 20 mg group. A clear dose response and a clinically meaningful, but not statistically significant, 3.04 difference between placebo and the XEN1101 20 mg group was observed. Statistical significance was achieved on the pre-specified endpoint of the Hamilton Depression Rating Scale, or HAM-D17, at week 6 with a mean reduction of 10.18 in the placebo group and 13.26 in the XEN1101 20 mg group. Statistical significance was achieved on the key secondary endpoint of a change in the Snaith-Hamilton Pleasure Scale, or SHAPS, measuring anhedonia at week 6 with a reduction of 5.30 in the placebo group and 7.77 in the XEN1101 20 mg group. Statistical significance was achieved in MADRS at week 1 with a mean reduction of 4.88 in the placebo group and 7.54 in the XEN1101 20 mg group demonstrating early onset of efficacy. Statistical significance was achieved in reporting of at least minimally improved symptoms of depression as assessed by physicians using the Clinical Global Impression of Improvement in the XEN1101 20 mg group compared to placebo. Summary of Safety and Tolerability Data: XEN1101 was well tolerated with similar rates of adverse events reported across all treatment arms. The most commonly reported treatment-emergent adverse events in the XEN1101 20 mg group included dizziness, somnolence, headache and disturbance in attention, as compared to the placebo group which reported dizziness, somnolence, headache and disturbance in attention. Rates of discontinuation were similar across all treatment arms and rates of discontinuation due to TEAEs were low with three patients in the XEN1101 20 mg group, as compared to two patients in the placebo group. No serious adverse events were reported in the two XEN1101 treatment groups and there were two patients in the placebo group who experienced a treatment-emergent SAE. XEN1101 was not associated with clinically meaningful weight gain or sexual dysfunction

07:06 EST APi Group Chubb - APi Group (APG) provided an update on the strategic initiatives relating to the Chubb (CB)business announced one year ago at the Company's Investor Day meeting in New York City. Russ Becker, APi's President and Chief Executive Officer, stated, "The leaders in our international business continue to deliver organic growth and margin expansion while executing on our Chubb value capture plan. I'm pleased that we are now in a position to increase the Chubb value capture target by 25% to $125M. We expect that we will continue our 1:1, or better, cost-benefit ratio and spend up to $125 million in total to capture these savings. We expect to conclude these value capture efforts by year-end 2025. The team has also driven a substantial reduction in our loss-making branches in the international business through operational improvements-supported by footprint optimization-and a continued focus on addressing low-value contracts through increased pricing and pruning. It is gratifying to know that the evolution in our international business is inclusive of our culture as well, with over 7,500 leaders participating in our online introductory "I am a Leader" development program. As I look across our global operation, I am confident in our leaders' ability to continue to deliver double-digit core inspection organic growth and continued margin expansion across the business as we drive towards our 2025 target of 13% Adjusted EBITDA margin. As we look to 2024 and beyond, we have great confidence in the business, our ability to deliver consistent organic growth globally, while simultaneously increasing our discipline on project selection and pruning low margin revenue opportunities. Our backlog is strong and our balance sheet is in an advantageous position. We expect to end 2023 below our targeted 2.5x debt to Adjusted EBITDA ratio, which gives us many strategic options for capital deployment in the coming years. We expect to continue to evolve APi into an even lower capex, asset light business focused on high-margin, statutorily mandated services. I look forward to updating you early in the new year on our continued progress, our year end 2023 results, and our 2024 guidance."

07:05 EST Aris Mining increases gold mineral reserves by 75% to 1.3 moz - Aris Mining announced updated mineral reserve estimates for its Segovia Operations in Colombia effective September 30, 2023. This updated mineral reserve estimate follows the updated mineral resource estimate announced on November 2, 2023. Aris Mining is also increasing the capacity of the Maria Dama processing plant within the Segovia Operations from 2,000 to 3,000 tonnes per day. As it has an existing unutilized ball mill on site, the costs for the plant expansion are estimated at $11M and completion is expected by early 2025. Neil Woodyer, CEO of Aris Mining, commented "We are pleased to announce a 75% increase to the high-grade mineral reserves at the Segovia Operations to 1.3 million ounces of gold at 11.63 grams per tonne. Based on our current operating profile, the updated estimate extends the reserve-only mine life to nearly seven years. Like other operations with extensive vein systems within a large mining title, we expect to continue to extend mine life through ongoing exploration programs. Based on the increased mineral resource and reserve estimates, we are implementing a small-scope project to increase the processing capacity by 50% to 3,000 tpd at the Maria Dama plant by utilizing a previously purchased ball mill that is already on-site. This creates the potential to gradually increase annual gold production from 200,000 to 300,000 ounces, as we fill the extra capacity by increasing our mining rates. A portion of this extra capacity will be allocated to our artisanal and small-scale mining partners, offering processing solutions to them, while mitigating the environmental impacts of informal mining in Segovia."

07:04 EST KKR acquires Potter Global Technologies, terms undisclosed - KKR announced that investment funds managed by KKR have acquired Potter Global Technologies from Gryphon Investors. KKR plans to support the company. Financial terms were not disclosed. Headquartered in St. Louis, Missouri, Potter is a global provider of fire safety and emergency communication equipment used by thousands of customers across diverse end markets including education, multi-family, industrial, and healthcare.

07:04 EST AbbVie granted breakthrough therapy designation for epcoritamab-bysp - AbbVie announced updates from the U.S. Food and Drug Administration and European Medicines Agency for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory follicular lymphoma. The FDA has granted Breakthrough Therapy Designation to epcoritamab-bysp for the treatment of adult patients with R/R FL after two or more therapies. Additionally, the EMA has validated a Type II application for epcoritamab for the same indication. If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union. "The FDA granted BTD and validated European application are an important step in our commitment to improving the lives of patients with relapsed/refractory follicular lymphoma, a complex blood cancer with limited treatment options," said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. "Together with Genmab, we are continuing to investigate epcoritamab as a potential core therapy for multiple B-cell malignancies, including diffuse large B-cell lymphoma and now follicular lymphoma."

06:53 EST Suncor announces restart of production at Terra Nova - Suncor Energy announced that the Terra Nova Floating, Production, Storage and Offloading vessel has safely restarted following the completion of the Terra Nova Asset Life Extension project. Production is expected to ramp up over the coming months. Terra Nova is an oil field located offshore Newfoundland and Labrador approximately 350 kilometres southeast of St. John's. The Terra Nova Partners are Suncor - 48%, Cenovus - 34%, and Murphy Oil Corporation - 18%. "Focusing on safety and operational integrity, we have brought this key offshore project online, providing additional cash flow for our shareholders as well as many benefits to the Newfoundland and Labrador and Canadian economies," said Rich Kruger, Suncor President and Chief Executive Officer. "We appreciate the collaboration and support from the provincial and federal governments regarding this project."

06:44 EST Pagaya CFO resigning to pursue other opportunities - In a regulatory filing on Friday, Pagaya Technologies disclosed that on November 20 the company appointed Evangelos Perros as its Interim Chief Financial Officer. Perros is replacing Michael Kurlander. Kurlander, who has served as Pagaya's Chief Financial Officer since June 2021, is resigning to pursue other opportunities and "his decision to resign was not related to any disagreement with the Company on any matter relating to its operations, policies or practices," the filing stated.

06:34 EST Ault Inc. issues letter to stockholders on Q3 - Ault Alliance issued a letter from its Executive Chairman to its valued stockholders. "Ault Alliance proudly announces its financial results for the third quarter 2023 and a strategic shift in capital raising plans. The Company recently announced a strategic corporate alignment, whereby it intends to focus on the strengths of its three core subsidiaries, Circle 8 Crane Services LLC, Sentinum, Inc., and Ault Venture Group... In line with our strategic focus, we have listed key properties owned by Ault Global Real Estate Equities, Inc. for sale, with the goal of streamlining our holdings and reducing debt. This move aligns with our commitment to concentrate on our core businesses and optimize capital allocation... Key third quarter 2023 financial highlights included: Total assets of $378 million as of September 30, 2023; A book value of $7.23 per share; Total stockholders' equity exceeding $119 million; Revenue growth of 38% from the prior period, reaching $120 million for the nine months ended September 30, 2023; Revenue from Sentinum's Bitcoin mining operations for the nine months ended September 30, 2023 were $23 million, up $12 million, or 104%, from $11 million in the prior fiscal period; and Revenue from Circle 8, acquired in December 2022, were $39 million for the nine months ended September 30, 2023... Our Bitcoin operations and our data center, at which we mine Bitcoin and offer colocation and hosting services for the emerging artificial intelligence ecosystems and other industries, were significant in increasing our revenues for this reporting period. The Sentinum team is making tremendous progress on developing our Montana site and the team is excited for it to come online. Once the Montana site becomes operational, which is expected to occur in the first quarter 2024, it will significantly change the Sentinum financial model... Ault Alliance is actively exploring options to address the undervaluation of our common stock. Our strategies, including potential share buybacks, tender offers or special dividends funded by Bitcoin operations, are focused on enhancing stockholder value. We remain committed to structuring our business for sustainable profitability and long-term growth. "

06:30 EST Roche expands hepatitis diagnostics portfolio - Roche announced the launch of Elecsys HBeAg quant, an immunoassay that is able to determine both the presence and quantity of the hepatitis B e antigen in human serum and plasma. "This launch means that, when combined with other laboratory results and clinical information, patients will now get confirmation on whether they have hepatitis B, and if so, to what extent, as well as treatment monitoring through one single assay. It is for use on the cobas e analysers in countries accepting the CE Mark," the company stated.

06:17 EST Lilium receives EASA Design Organization Approval - Lilium that it has received Design Organization Approval from its primary regulatory authority, the European Union Aviation Safety Agency, EASA. The award marks a major milestone for Lilium, positioning it at the forefront of the industry as a company authorized to hold a type-certificate for an eVTOL aircraft in Europe. Klaus Roewe, Lilium CEO, commented: "In many respects, today's announcement marks a cornerstone for Lilium and evidences our market leadership in advancing the aviation industry. Achieving Design Organization Approval reflects EASA's confidence in Lilium and differentiates us against others currently pursuing eVTOL development and regulatory approval. While we join a small, select group of companies qualified to develop commercial aircraft, today's announcement is especially significant for the global aviation industry as we are doing so by advancing sustainable regional air mobility. I appreciate the many Lilians and countless stakeholders that have played a pivotal role in us achieving today's milestone, and we look forward to further advancements towards commercialization of the Lilium Jet. I would like to thank our counterparts at EASA for their professional cooperation, which I believe will continue to be very beneficial for the industry moving forward."

06:04 EST NCR Atleos selected by ASDA as its ATM network partner - NCR Atleos announced that Asda Stores Limited, ASDA, has selected Atleos as its ATM network partner to provide its shoppers with easy, secure access to cash services. ASDA customers will soon be able to transact with over 1,200 Cashzone-branded Atleos owned and operated ATMs in more than 600 stores. By selecting the proven experts at Atleos to provide an end-to-end ATM solution, ASDA will reduce complexity and boost efficiency, while providing optimum availability and access for customers. ASDA will also leverage Atleos' sophisticated onscreen marketing at the ATM to promote its brand, offers and services.

05:41 EST Regeneron, Sanofi report Dupixent reduced COPD exacerbations in second trial - Regeneron (REGN) and Sanofi (SNY) announced that the second Dupixent investigational Phase 3 chronic obstructive pulmonary disease, or COPD, trial, or NOTUS, showed that Dupixent significantly reduced exacerbations, confirming results from the Phase 3 BOREAS trial. The NOTUS trial also confirmed that treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks. The NOTUS trial evaluated the investigational use of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled COPD and evidence of type 2 inflammation. These results were from an interim analysis and, given the efficacy of the primary endpoint, will be considered the primary analysis of the trial. Regeneron and Sanofi plan to submit the data from this replicate trial, along with results from the Phase 3 BOREAS trial to the FDA by the end of the year.