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Axsome Therapeutics to Report Second Quarter 2025 Financial Results on August 4
Globenewswire· 2025-07-09 11:00
NEW YORK, July 09, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the second quarter of 2025 on Monday, August 4, 2025, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate in the live ...
Genfit: Half-Year Report of Liquidity Contract with Crédit Industriel et Commercial
Globenewswire· 2025-07-08 20:10
Company Overview - GENFIT is a biopharmaceutical company focused on improving the lives of patients with rare and life-threatening liver diseases, with a strong emphasis on unmet medical needs [2] - The company has a diversified and rapidly expanding R&D portfolio, particularly targeting Acute-on-Chronic Liver Failure (ACLF) with five assets under development [2] - GENFIT has expertise in developing high-potential molecules and has achieved accelerated approval for its drug Iqirvo® (elafibranor) for Primary Biliary Cholangitis (PBC) [2] Financial Summary - As of June 30, 2025, the liquidity contract with Crédit Industriel et Commercial reported total trading of €398,484.67 [4] - The buy side recorded 1,412,901 shares traded for a total amount of €5,016,550.43, while the sell side recorded 1,419,301 shares for €5,061,074.96 [4] - The total number of trades during the first half of 2025 was 2,673 on the buy side and 1,894 on the sell side [4] Research and Development Focus - GENFIT's ACLF franchise includes five assets: VS-01, G1090N, SRT-015, CLM-022, and VS-02-HE, which utilize different mechanisms of action [2] - The company also targets other serious diseases such as cholangiocarcinoma (CCA), urea cycle disorder (UCD), and organic acidemia (OA) [2] - GENFIT has a diagnostic franchise that includes NIS2+® for Metabolic dysfunction-associated steatohepatitis (MASH) and TS-01 focusing on blood ammonia levels [2] Market Position - GENFIT is headquartered in Lille, France, with additional offices in Paris, Zurich, and Cambridge, MA [2] - The company is listed on the Nasdaq Global Select Market and Euronext regulated market in Paris [2] - In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the company [2]
Rhythm Pharmaceuticals To Announce Topline Results from Phase 2 Trial Evaluating Oral MC4R Agonist Bivamelagon in Acquired Hypothalamic Obesity
Globenewswire· 2025-07-08 20:01
Core Insights - Rhythm Pharmaceuticals is set to disclose topline results from a Phase 2 trial evaluating bivamelagon for acquired hypothalamic obesity on July 9, 2025 [1][2] Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases [4] - The company's lead asset, IMCIVREE® (setmelanotide), is approved for treating obesity related to specific genetic conditions [4][5] - Rhythm is advancing a clinical development program for setmelanotide and other investigational MC4R agonists, including bivamelagon and RM-718 [4] Bivamelagon Phase 2 Trial Details - The Phase 2 trial is a randomized, placebo-controlled, double-blind study involving 28 patients aged 12 and older [3] - Patients received daily oral doses of bivamelagon (200 mg, 400 mg, or 600 mg) or placebo for 14 weeks [3] - The primary endpoint is the change in body mass index after 14 weeks of treatment, with an option for patients to continue therapy for up to 52 weeks [3]
ZyVersa Therapeutics Announces a Warrant Inducement Transaction for $2.0 Million in Gross Proceeds
Globenewswire· 2025-07-08 16:30
Core Viewpoint - ZyVersa Therapeutics, Inc. has entered into a warrant inducement agreement with an institutional investor, which includes the immediate exercise of existing warrants and the issuance of new warrants at a reduced exercise price of $0.67, generating approximately $2.0 million in gross cash proceeds for working capital and corporate purposes [1][2]. Group 1 - The agreement involves the immediate exercise of Series A-2 Warrants for up to 957,200 shares and Series A-3 Warrants for up to 2,105,265 shares at an exercise price of $0.67 [1]. - The investor will receive new Series A-4 Warrants to purchase up to 6,124,930 shares, which will be exercisable upon stockholder approval and will expire five years from that date [2]. - The transaction is expected to close on or about July 9, 2025, pending customary closing conditions [2]. Group 2 - A.G.P./Alliance Global Partners served as the exclusive financial advisor for this transaction [3]. - The new warrants were offered in a private placement under an exemption from the registration requirements of the Securities Act, and the company plans to file a registration statement with the SEC for the resale of common stock upon exercise of the new warrants [4]. Group 3 - ZyVersa Therapeutics is a clinical stage specialty biopharmaceutical company focused on developing first-in-class drugs for renal and inflammatory diseases, utilizing proprietary technologies such as Cholesterol Efflux Mediator™ VAR 200 and Inflammasome ASC Inhibitor IC 100 [6].
MBIO Soars on Orphan Drug Nod for Investigational Brain Cancer Therapy
ZACKS· 2025-07-08 15:41
Key Takeaways MBIO's MB-101 received FDA Orphan Drug status for astrocytomas and glioblastoma treatment. The CAR-T cell therapy showed durable responses in the phase I GBM study, including 2 complete responses. MBIO plans a 2026 phase I study of MB-109, a combo of MB-101 and MB-108, pending financing or partnership.Shares of Mustang Bio (MBIO) skyrocketed 180.7% on Monday after the company announced that the FDA granted Orphan Drug designation to its investigational candidate, MB-101, which is being devel ...
IOVA NOTICE: Iovance Biotherapeutics Shareholders are Notified of the Pending Class Action Lawsuit -- Contact BFA Law by July 14 Court Deadline (NASDAQ:IOVA)
GlobeNewswire News Room· 2025-07-08 12:46
Core Viewpoint - A lawsuit has been filed against Iovance Biotherapeutics, Inc. and certain senior executives for potential violations of federal securities laws, specifically related to the company's performance and treatment timelines for its melanoma drug Amtagvi [1][2]. Company Overview - Iovance Biotherapeutics is a commercial-stage biopharmaceutical company focused on developing treatments for melanoma and other solid tumor cancers [3]. Product Launch and Issues - Iovance launched its key melanoma treatment, Amtagvi, in February 2024, but has faced challenges with its authorized treatment centers (ATCs) [3]. - The company claimed that its ATCs would drive demand for Amtagvi; however, there were long timelines for patient treatment initiation and ineffective patient identification, leading to high patient drop-offs [4]. Financial Performance - On May 8, 2025, Iovance reported disappointing financial results for the first quarter of 2025 and revised its full-year 2025 revenue guidance downward due to "recent launch dynamics" and high patient drop-off rates [5]. - Following the announcement, Iovance's stock price fell over 44%, from $3.17 per share to $1.75 per share within a day [6].
OGN NOTICE: Organon & Co. Shareholders are Notified of the Pending Class Action Lawsuit -- Contact BFA Law by July 22 Court Deadline (NYSE:OGN)
GlobeNewswire News Room· 2025-07-08 12:45
NEW YORK, July 08, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Organon & Co. (NYSE: OGN) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Organon you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/organon-co-class-action. Investors have until July 22, 2025, to ask the Court to be appointed to lea ...
Esperion Reaches Settlement Agreement with Third ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
Globenewswire· 2025-07-08 12:00
ANN ARBOR, Mich., July 08, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Accord Healthcare Inc. This agreement resolves the patent litigation brought by Esperion against Accord Healthcare Inc. in response to Accord Healthcare Inc’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Accord Healthcare Inc. has agreed ...
Nuvectis Pharma Announces Successful Completion of a Drug-Drug Interaction Study in Healthy Volunteers Supporting NXP900's Potential as a Combination Partner with Leading Therapies
Globenewswire· 2025-07-08 12:00
Drug-drug interaction (“DDI”) clinical studies help identify the potential for side effects, or in some cases, reduced therapeutic efficacy, that may be caused by interactions between different drugs.The market leading epidermal growth factor receptor (“EGFR”) and anaplastic lymphoma kinase (“ALK”) inhibitors for the treatment of non-small cell lung cancer (“NSCLC”) are substrates of the Cytochrome P450 (“CYP”) enzyme CYP3A, and therefore their combination with drugs that are strong inducers of CYP3A is t ...
Akebia Therapeutics to Present at the H.C. Wainwright 4th Annual Kidney Virtual Conference
Globenewswire· 2025-07-08 12:00
CAMBRIDGE, Mass., July 08, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that Nik Grund, Chief Commercial Officer, will participate in a Fireside Chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, July 14 at 10:00 AM EDT. A webcast of the presentation can be accessed through the “Investors” section of Akebia’s website at https://ir.akebia.com ...