JUPITER, Fla., July 10, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that its partner Pelthos Therapeutics Inc. (NYSE American: PTHS) has commercially launched ZELSUVMI™ (berdazimer) topical gel 10.3%, the first and only FDA-approved at-home treatment for molluscum contagiosum. The Company has earned a $5 million milestone payment from Pelthos following the commercial launch of ZELSUVMI. “Molluscum impacts millions of people in the U.S., particularly children. ...

NEWTON, Mass., July 10, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), will present new findings at the upcoming Alzheimer's Association International Conference (AAIC®) 2025 in Toronto. The presentations include a cost savings analysis of the use of pTau217 as a screening tool in Acumen’s Phase 2 ALTITUDE-AD trial ...

Core Viewpoint - The article discusses a class action lawsuit against Sarepta Therapeutics, alleging violations of the Securities Exchange Act of 1934 due to misleading statements regarding the safety and efficacy of its gene therapy product, ELEVIDYS, during a specified class period [1][3]. Company Overview - Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on developing therapies for Duchenne muscular dystrophy, including the gene therapy ELEVIDYS [2]. Allegations of the Lawsuit - The lawsuit claims that Sarepta and its executives made false or misleading statements about ELEVIDYS, including significant safety risks, failure to detect severe side effects, and the potential for halting clinical trials due to adverse events [3]. - Specific incidents cited include: - On March 18, 2025, a patient treated with ELEVIDYS suffered acute liver failure leading to death, causing Sarepta's stock to drop over 27% [4]. - On April 4, 2025, Sarepta disclosed that EU authorities requested a review of the death, leading to a further stock decline of over 7% [5]. - On June 15, 2025, a second patient died from acute liver failure, prompting Sarepta to suspend shipments and pause dosing, resulting in a stock drop of over 42% [6]. - On June 24, 2025, the FDA announced an investigation into the risk of acute liver failure associated with ELEVIDYS, causing an additional stock decline of over 8% [7]. Legal Process - The Private Securities Litigation Reform Act of 1995 allows investors who purchased Sarepta securities during the class period to seek appointment as lead plaintiff in the lawsuit, representing the interests of all class members [8].

Core Insights - OS Therapies is making significant progress in its clinical-stage oncology programs, particularly with the OST-HER2 immunotherapy for recurrent, pulmonary metastatic osteosarcoma, with an End of Phase 2 Meeting scheduled with the FDA on August 27, 2025 [2][7] - The company has confirmed a Scientific Advice Meeting with the European Medicines Agency regarding the OST-HER2 program, which is a critical step for obtaining a centralized marketing authorization in Europe [3][7] - All patients in the Phase 1 clinical study of OST-504 have completed treatment, with updated clinical data expected in the second half of 2025 [4][7] Regulatory Updates - The FDA has granted an End of Phase 2 Meeting to review clinical data for OST-HER2, with the company aiming to align with the FDA for a rolling review Biologics Licensing Application under the Accelerated Approval Program [2][7] - A Scientific Advice Meeting with the EMA is confirmed, which is essential for the Centralized Procedure for marketing authorization across European Member States [3] - The company plans to pursue a Conditional Marketing Authorization in the UK through the MHRA's Innovative Licensing and Access Pathway, contingent on a successful meeting on July 31, 2025 [3] Clinical Development - The OST-HER2 program utilizes a HER2-bioengineered form of Listeria monocytogenes to stimulate an immune response against HER2-expressing cancer cells [5] - The company has completed a Phase 1 clinical study of OST-504, a prostate cancer-specific immunotherapy, with data expected to be reported later in 2025 [4][8] - OST-HER2 has received various designations from regulatory bodies, including Rare Pediatric Disease Designation and Fast-Track designation from the FDA [9] Strategic Focus - The company aims to obtain regulatory approval for OST-HER2 before the expiration of the rare pediatric disease priority review voucher program, which could provide significant non-dilutive funding [5] - OS Therapies intends to focus capital on the OST-HER2 approval while advancing other clinical programs without significant capital deployment [5] - The company is also advancing its next-generation Antibody Drug Conjugate platform, known as tunable ADC, which features tailored antibody-linker-payload candidates [10]

Hot Line Presentation of MAPLE-HCM to Elaborate on Positive Topline Results in Patients with Obstructive Hypertrophic Cardiomyopathy Late Breaking Clinical Science Session to Present Incidence and Impact of Atrial Fibrillation Across Three Clinical Trials of Aficamten in Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced five presentations related to aficamten at the European Society of Cardiology C ...

Core Viewpoint - Jazz Pharmaceuticals has announced the appointment of Renee Gala as the new President and CEO, effective August 11, 2025, succeeding co-founder Bruce Cozadd, who will remain as Chairperson of the Board [1][3]. Company Leadership Transition - The Board of Directors conducted a thorough search for the new CEO, focusing on both internal and external candidates, ultimately selecting Renee Gala due to her exceptional leadership qualities and experience [3]. - Bruce Cozadd, who has been with the company for 22 years, expressed pride in the company's journey and confidence in Gala's ability to lead Jazz into its next growth phase [3][4]. Renee Gala's Background - Renee Gala has over 30 years of experience in finance, strategy, corporate development, and commercialization, having served as CFO and COO at Jazz Pharmaceuticals since 2020 and 2023, respectively [2][4]. - Prior to joining Jazz, Gala held leadership roles at GRAIL Inc. and Theravance Biopharma, showcasing a strong background in the life sciences sector [4][5]. Company Strategy and Vision - Gala emphasized the company's commitment to transforming patient lives through innovative medicines and highlighted the potential for growth within Jazz's market-leading portfolio and promising pipeline [3][6]. - The company aims to continue its focus on corporate development and external innovation to drive value for patients and shareholders [3][6].

PURCHASE, N.Y., July 10, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. The objective of this meeting was to review results from the Phase 2 study of zervimesine (CT1812) and to discuss plans for a Phase 3 program that would support a new drug application (NDA) for zervimesine ...

Core Viewpoint - Pharvaris is advancing its late-stage development of deucrictibant, an oral bradykinin B2 receptor antagonist, targeting unmet needs in bradykinin-mediated diseases, with topline data from the RAPIDe-3 Phase 3 study expected in Q4 2025 and a potential NDA submission in H1 2026 [1][2][4] Group 1: Study and Data - The RAPIDe-3 study has achieved target enrollment, and the topline data announcement is now anticipated in the fourth quarter of 2025 [2] - The study evaluates deucrictibant immediate-release capsules (20 mg) for on-demand treatment of angioedema attacks in approximately 120 participants aged 12 and older, including those with C1 inhibitor deficiency [2][3] - Primary endpoints include time to onset of symptom relief and other measures of symptom resolution and safety [2][3] Group 2: Drug Development - Deucrictibant is being developed in two formulations: an extended-release tablet for prophylactic treatment and an immediate-release capsule for rapid treatment [3][4] - The drug has received orphan drug designation from the FDA and the European Commission for treating bradykinin-mediated angioedema [3] Group 3: Company Overview - Pharvaris aims to provide injectable-like efficacy and placebo-like tolerability through oral therapies for bradykinin-mediated angioedema [4] - The company is conducting multiple pivotal Phase 3 studies, including CHAPTER-3 for prevention and RAPIDe-3 for on-demand treatment of HAE attacks [4]

BOSTON, July 10, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) (“Rhythm”), a global, commercial-stage biopharmaceutical company dedicated to transforming the lives of patients living with rare neuroendocrine diseases, today announced the pricing of its upsized public offering of 2,058,824 shares of its common stock at a public offering price of $85.00 per share. In addition, Rhythm also granted the underwriters a 30-day option to purchase up to an additional 308,823 shares of common s ...

Core Viewpoint - Soleno Therapeutics, Inc. plans to offer and sell $200 million of its common stock in an underwritten public offering, with an additional option for underwriters to purchase up to $30 million more [1][2]. Group 1: Offering Details - The public offering is subject to market conditions, and there is no assurance regarding the completion or terms of the offering [1]. - Goldman Sachs & Co. LLC and Guggenheim Securities are acting as the joint book-running managers for the offering [2]. - The shares will be offered under a registration statement previously filed with the SEC, and a preliminary prospectus will be made available [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund the commercialization of VYKAT™ XR, the first approved therapy for hyperphagia in Prader-Willi syndrome, which received FDA approval on March 26, 2025 [3]. - Proceeds will also support regulatory and market development activities in the EU, further R&D efforts, and general corporate purposes, including working capital and potential acquisitions [3][6].