-- Topline results from the CHASE trial expected by end of Q3 2025 -- -- Potential for CHASE to serve as a pivotal trial in support of a Biologics License Application (BLA) submission, contingent on positive results -- ARLINGTON, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced the completion of patient ...

Custom-built model will be trained using Revolution Medicines’ proprietary data to discover novel drug candidatesIambic to receive up to $25 million through a combination of upfront and expected near-term performance-based milestone payments for services related to Revolution Medicines’ access to Iambic’s industry-leading NeuralPLexer model for protein structure prediction REDWOOD CITY, Calif. and SAN DIEGO, July 09, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical o ...

SAN FRANCISCO, July 09, 2025 (GLOBE NEWSWIRE) -- DIMERx, Inc., a late-stage clinical biopharmaceutical company developing covalently bonded dimer therapeutics, today announced the appointment of Sergio Traversa, PharmD, as an Independent Director to its Board of Directors, effective June 25, 2025. Dr. Traversa currently serves as CEO of Relmada Therapeutics (Nasdaq: RLMD), a clinical-stage biotechnology company focused on developing transformative therapies for oncology-related and central nervous system co ...

Core Viewpoint - Werewolf Therapeutics is advancing its innovative approach to cancer treatment through conditionally activated therapeutics, specifically focusing on the WTX-124 molecule for renal cell carcinoma and other solid tumors [1][2][4]. Group 1: Company Overview - Werewolf Therapeutics, Inc. is a biopharmaceutical company focused on developing therapeutics that stimulate the immune system for cancer and immune-mediated conditions [4]. - The company utilizes its proprietary PREDATOR platform to create conditionally activated molecules that selectively activate in the tumor microenvironment while remaining inactive in peripheral tissues [4]. - The most advanced product candidates include WTX-124 and WTX-330, which are designed for the treatment of solid tumors and Non-Hodgkin Lymphoma, respectively [4]. Group 2: Clinical Development and Research - Dr. Randi Isaacs, Chief Medical Officer, will present at the KidneyCAN 7th Annual Kidney Cancer Research Summit, focusing on the early clinical findings of WTX-124 [1][2]. - WTX-124 is a tumor-activated IL-2 INDUKINE molecule aimed at improving the therapeutic index by maximizing anti-tumor activity while minimizing systemic side effects [2]. - The "Full Moon Moment" campaign supports ongoing national trials for WTX-124, which is actively enrolling patients with advanced or metastatic renal cell carcinoma [3]. Group 3: Clinical Trial Outcomes - Early responses in clinical trials have been reported, including a patient with cutaneous squamous cell carcinoma who has been in remission for over a year [3]. - The campaign emphasizes the potential outcomes of the INDUKINE molecules in activating tumor-killing properties within the tumor microenvironment [3].

Core Insights - Rhythm Pharmaceuticals announced positive topline results from its Phase 2 trial of bivamelagon, showing significant BMI reductions in patients with acquired hypothalamic obesity [2][3] - The company plans to engage with regulatory authorities for a Phase 3 trial design and has requested an End-of-Phase 2 meeting with the U.S. FDA [7] Group 1: Trial Results - Bivamelagon achieved BMI reductions of -9.3% in the 600mg cohort and -7.7% in the 400mg cohort at 14 weeks [1][4] - A post-hoc analysis indicated that the BMI reductions from bivamelagon were consistent with those achieved by setmelanotide in similar patient populations [3][5] - Patients reported a mean reduction of -2.8 points in hunger scores in both the 600mg and 400mg cohorts [1][3] Group 2: Safety and Tolerability - The trial demonstrated safety and tolerability consistent with MC4R agonism, with limited instances of localized hyperpigmentation observed [4][6] - The most common adverse events included mild diarrhea and nausea, with one serious adverse event reported [6] Group 3: Next Steps and Regulatory Plans - Rhythm plans to seek input from U.S. and EU regulatory authorities regarding the Phase 3 trial design for bivamelagon [7] - The company is refining the formulation of bivamelagon to potentially improve tolerability before initiating the Phase 3 trial [7] Group 4: Company Background - Rhythm Pharmaceuticals is focused on transforming the lives of patients with rare neuroendocrine diseases and has in-licensed bivamelagon from LG Chem, Ltd [2][13] - The company’s lead asset, setmelanotide, is already approved for treating certain types of obesity [13][14]

BRIDGEWATER, N.J., July 09, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that the Company will release its second quarter 2025 financial results on Tuesday, August 5, 2025, prior to market open. The Company will host an audio webcast at 8:30 a.m. ET. The financial results and live webcast will be accessible through the Investor Relations section of the Company's website at https://investors.amneal.com. I ...

GAITHERSBURG, Md., July 09, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has enrolled the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol-Associated Liver Disease (ALD). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist in development for the treat ...

Core Insights - Theratechnologies Inc. reported strong demand for EGRIFTA SV with record high patient enrollments, achieving nearly $37 million in revenue for the first half of fiscal 2025 despite a supply shortage impact of $10-$12 million in Q1 [2][6][28] - The company is set to launch EGRIFTA WR, an improved version of EGRIFTA SV, in Q3 2025, leveraging the momentum from the past year [2][29] - The company has withdrawn its Fiscal 2025 revenue and Adjusted EBITDA guidance due to an announced acquisition by an affiliate of Future Pak [3] Financial Performance - For Q2 2025, consolidated revenue was $17.7 million, a decrease of 19.5% year-over-year, while the first half revenue was $36.8 million, down 3.9% from the previous year [6][24] - EGRIFTA SV net sales in Q2 2025 were $11.1 million, down 31.3% from $16.2 million in Q2 2024, while Trogarzo net sales increased by 13.4% to $6.6 million [5][10] - Adjusted EBITDA for Q2 2025 was $906,000, down from $5.5 million in Q2 2024, primarily due to increased spending and lower revenues from EGRIFTA SV [20][34] Cost Structure - Cost of goods sold for Q2 2025 was $4.7 million, representing 26.5% of revenue, compared to 20.7% in Q2 2024 [12][13] - R&D expenses decreased significantly to $2.6 million in Q2 2025 from $4.7 million in Q2 2024, attributed to reduced spending in oncology and F8 formulation programs [14][15] - Selling expenses increased to $6.8 million in Q2 2025, driven by higher compensation expenses related to market preparations [17][18] Net Loss and Financial Position - The company reported a net loss of $4.5 million for Q2 2025, compared to a net profit of $987,000 in Q2 2024, with a total net loss of $4.3 million for the first half of 2025 [24][27] - As of May 31, 2025, cash amounted to $9.5 million, with positive cash flows from operating activities of $2.7 million, indicating improved liquidity [26][27] Future Outlook - The company anticipates that existing cash and cash equivalents will be sufficient to fund operations for at least the next 12 months [26][30] - The successful transition from EGRIFTA SV to EGRIFTA WR is critical for meeting future revenue and EBITDA targets [29][30]

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-ascendin ...

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 ...