"Of the 28 million Americans with AUD, over 6 million have progressed to ALD, a condition for which there are no approved treatments and few in development," said Dr. Loomba. "Alcohol-related liver mortality is highest in patients with comorbid obesity, highlighting the urgent need for a liver-directed therapy that can also drive weight loss. The robust reductions in body weight, liver fat and VCTE and the low rates of adverse event discontinuation in the recently completed IMPACT Phase 2b MASH trial suppor ...

Q2 2025 total revenue of $17.7 million, and $36.8 million for the first six months of Fiscal 2025Positive Adjusted EBITDA1 for the fifth straight quarterSubsequent to quarter end, Theratechnologies entered into a definitive agreement to be acquired by an affiliate of Future Pak MONTREAL, July 09, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today reported business highlights and financial result ...

NMRA-861 has potential best-in-class pharmacology, which may enable a more favorable therapeutic profile No convulsions observed in pre-clinical studies conducted in multiple species, including rabbits WATERTOWN, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven brain disease programs including three clinical-stage programs, today announced the initiation of a Phase 1 single- ascendi ...

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 ...

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), July 8, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the half-year report of the liquidity contract with Crédit Industriel et Commercial. Under the liquidity contract GENFIT has with Crédit Industriel et Commercial, the following resources appeared on the liquidity account as of June 30, 2025: 201 ...

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]

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].

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 ...

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].

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 ...