PHILADELPHIA, July 10, 2025 (GLOBE NEWSWIRE) -- Berger Montague PC advises investors that a securities class action lawsuit has been filed against Organon & Co. (“Organon” or the “Company”) (NYSE: OGN) on behalf of purchasers of Organon securities between November 3, 2022 through April 30, 2025, inclusive (the “Class Period”). Investor Deadline: Investors who purchased or acquired Organon securities during the Class Period may, no later than JULY 22, 2025, seek to be appointed as a lead plaintiff representa ...

U.S. stock futures were lower this morning, with the Dow futures falling around 100 points on Thursday.Shares of Methode Electronics, Inc. MEI fell sharply in today's pre-market trading after the company reported a fourth-quarter adjusted EPS miss.Methode Electronics posted adjusted loss of 77 cents per share, missing market estimates of earnings of 4 cents per share, according to data from Benzinga Pro. The company' sales came in at $257.10 million versus estimates of $232.87 million.Methode Electronics sh ...

Core Insights - Pelthos Therapeutics Inc. has launched ZELSUVMI™ (berdazimer) topical gel, a novel treatment for molluscum contagiosum, which is the first prescription therapy approved for at-home use by patients and caregivers [1][7][10] - The product received Novel Drug designation from the U.S. FDA in January 2024 and is aimed at addressing a significant unmet medical need for patients suffering from this highly contagious viral skin condition [1][7][10] Company Overview - Pelthos Therapeutics is a biopharmaceutical company focused on commercializing innovative therapeutic products to meet high unmet patient needs [10] - The company’s lead product, ZELSUVMI, was approved by the U.S. FDA in 2024 and is designed to be safe and effective for treating molluscum contagiosum [10] Product Details - ZELSUVMI is a once-daily topical gel that releases nitric oxide, indicated for the treatment of molluscum contagiosum in patients aged one year and older [7][10] - The product was validated through a Phase 3 clinical trial involving 891 patients, showing nearly 33% complete clearance of lesions at week twelve compared to 19.7% in the control group [2][7] Market Need - Molluscum contagiosum affects an estimated 16.7 million people in the U.S., with up to 6 million new cases annually, primarily among children [4][5] - Many parents delay treatment due to the inconvenience of current procedural options, highlighting the need for an effective at-home treatment like ZELSUVMI [3][4] Commercial Strategy - Pelthos has initiated the ZelsuvmiGo patient support program to facilitate patient onboarding and provide resources for caregivers [3] - The company has hired 50 sales territory managers to promote ZELSUVMI to physicians treating high volumes of molluscum patients and has implemented extensive digital outreach efforts [3][5]

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]

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].

Core Insights - Cytokinetics is set to present five key studies related to aficamten at the European Society of Cardiology Congress 2025, highlighting its potential in treating obstructive hypertrophic cardiomyopathy (HCM) [1][4] - The MAPLE-HCM trial compares aficamten with metoprolol, focusing on exercise capacity in patients with left ventricular outflow tract (LVOT) obstruction [2][4] - A late-breaking presentation will address the incidence and impact of atrial fibrillation across three clinical trials involving aficamten [1][2] Presentation Details - The MAPLE-HCM presentation will be led by Dr. Pablo Garcia-Pavia on August 30, 2025, at 9:18 AM CEST in Madrid [2] - The late-breaking clinical science presentation on atrial fibrillation will be conducted by Dr. Ahmad Masri on August 31, 2025, at 4:45 PM CEST in Budapest [2] - Another presentation on the long-term efficacy and safety of aficamten will be given by Dr. Sara Saberi on August 31, 2025, at 5:40 PM CEST [2] Additional Research - A poster presentation will analyze the effect of aficamten compared to metoprolol on cardiac structure and function in symptomatic obstructive HCM [3] - An integrated safety analysis of aficamten in patients with obstructive HCM will also be presented [3] Company Overview - Cytokinetics is a biopharmaceutical company specializing in cardiovascular diseases, with over 25 years of experience in muscle biology [4] - The company is preparing for potential regulatory approvals and commercialization of aficamten following positive results from the SEQUOIA-HCM trial [4] - Cytokinetics is also developing other drug candidates targeting heart failure and muscular dystrophy [4]

Core Insights - Cognition Therapeutics, Inc. conducted a positive end-of-Phase 2 meeting with the FDA regarding zervimesine (CT1812) for Alzheimer's disease treatment [1][2] - The SHINE Study demonstrated safety and tolerability, meeting its primary endpoints with 153 participants [4] - Zervimesine has been adopted as the United States Adopted Name (USAN) for CT1812 [3] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [6] - The company is advancing zervimesine through various clinical studies, including ongoing trials for dementia with Lewy bodies and early Alzheimer's disease [6] Study Details - The SHINE Study was a double-blind, placebo-controlled Phase 2 trial that enrolled 153 adults with mild-to-moderate Alzheimer's disease, assessing cognitive and functional changes [4] - The study received approximately $30 million in grant support from the National Institute on Aging [5] Drug Mechanism - Zervimesine is an investigational oral medication that targets the toxic effects of Aβ and ɑ-synuclein proteins associated with neurodegenerative diseases [2][6] - The drug aims to slow disease progression and improve the quality of life for patients suffering from Alzheimer's and dementia with Lewy bodies [2]