SAN DIEGO, July 1, 2025 /PRNewswire/ -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Sarepta Therapeutics, Inc. (NASDAQ; SRPT) securities between June 22, 2023 and June 24, 2025, both dates inclusive (the "Class Period"), have until August 25, 2025 to seek appointment as lead plaintiff of the Sarepta class action lawsuit.  Captioned Dolgicer v. Sarepta Therapeutics, Inc., No. 25-cv-05317 (S.D.N.Y.), the Sarepta class action lawsuit charges Sarepta as well as certain of Sarepta' ...

Core Insights - Cue Biopharma, Inc. has reported promising results from its Phase 1 trial of CUE-101, showing an overall response rate (ORR) of 50% in treatment-naïve patients with recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) [3] - The 12-month overall survival (OS) rate is 88%, indicating a significant reduction in the risk of death compared to historical data [3] - The median overall survival (mOS) is currently estimated at 32 months [3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics aimed at selectively engaging and modulating disease-specific T cells for treating autoimmune diseases and cancer [2][7] - The company's proprietary platform, Immuno-STAT™, is designed to harness the body's immune system without the adverse effects associated with broad systemic immune modulation [7] Product Details - CUE-101 is the most advanced clinical stage drug candidate from the CUE-100 series, designed to activate and expand HPV16 tumor-specific T cells [6] - The mechanism of action involves presenting two signals to T cells: one from the HPV E7 protein and another from an engineered IL-2 variant [6] - The CUE-100 series consists of Fc-fusion biologics that selectively target and activate tumor-specific T cells while minimizing systemic activation and potential toxicities [5] Clinical Trial Insights - The Phase 1 trial of CUE-101 is fully enrolled and evaluates the drug as a monotherapy and in combination with pembrolizumab (KEYTRUDA) for HPV16+ driven recurrent/metastatic HNSCC [6] - The trial results indicate that CUE-101 may represent a breakthrough therapeutic approach for patients battling HNSCC, as stated by the company's chief medical officer [4]

Core Viewpoint - ArriVent BioPharma, Inc. plans to offer and sell $75 million of its common stock and pre-funded warrants, with a potential additional 15% option for underwriters, to support its drug development and general corporate purposes [1][2]. Group 1: Offering Details - The public offering includes $75 million in common stock and pre-funded warrants, with a 30-day option for underwriters to purchase an additional 15% [1]. - Goldman Sachs, Citigroup, and Guggenheim Securities are the joint book-running managers for the offering [2]. - An automatic shelf registration statement was filed with the SEC on February 3, 2025, which became effective upon filing [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to support activities related to firmonertinib and other pipeline programs, as well as for working capital and general corporate purposes [2]. Group 3: Company Overview - ArriVent is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer treatment, with a strong emphasis on its lead candidate, firmonertinib [5].

Company Overview - Oruka Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for chronic skin diseases, particularly plaque psoriasis [1][4] - The company's mission is to provide patients with significant freedom from chronic skin conditions by achieving high rates of complete disease clearance with infrequent dosing, potentially as little as once or twice a year [4] Leadership Change - Laura Sandler has been promoted to Chief Operating Officer, having previously served as Senior Vice President of Operations since 2024 [1][2] - Ms. Sandler brings over 20 years of biopharmaceutical leadership experience, particularly in clinical operations and development strategy, and has been instrumental in advancing Oruka's programs into clinical trials [2][3] Strategic Focus - The company is advancing a proprietary portfolio of potentially best-in-class antibodies targeting the core mechanisms of plaque psoriasis and other dermatologic and inflammatory diseases [4] - Ms. Sandler expressed commitment to driving the company's programs forward with urgency, rigor, and high quality, aligning with the expectations of patients and investors [4][3]

Recruitment initiated into the Phase 2 opaganib plus darolutamide study in patients with advanced prostate cancer, sponsored by ANZUP, and supported by Bayer and Ramsay Hospital Research FoundationPrecision medicine approach: The 60-patient Phase 2 study uses the PCPro™ lipid biomarker test to identify patients with poor prognosis most likely to benefit from the combinationLed by Professor Lisa Horvath, the study is expected to recruit people at sites across Australia and New ZealandProstate cancer is the s ...

Core Insights - GRI Bio, Inc. has completed patient enrollment for its Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) [1][2] - The company is on track to report 6-week interim biomarker results in July 2025, with topline data expected in Q3 2025 [1][6] - GRI-0621 is being developed as a novel oral therapeutic targeting Natural Killer T (NKT) cells, which play a critical role in inflammatory and fibrotic diseases [8] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through NKT cell modulation [8] - The lead program, GRI-0621, is an inhibitor of iNKT cell activity aimed at addressing the unmet needs in IPF treatment [8] Study Design and Results - The Phase 2a study is a randomized, double-blind, placebo-controlled trial enrolling approximately 35 subjects, with a 2:1 randomization for GRI-0621 (4.5mg) versus placebo [3] - Primary endpoint focuses on safety and tolerability after 12 weeks, while secondary endpoints include changes in serum biomarkers and pharmacokinetics [3] - Interim safety results from the first 12 and 24 patients indicated that GRI-0621 is safe and well-tolerated, with no significant changes in lipid levels observed [4][5] Future Expectations - The company anticipates reporting 6-week interim biomarker data in July 2025, followed by topline results in Q3 2025 [6]

Core Insights - CytoDyn Inc. announced positive clinical findings for leronlimab in patients with advanced metastatic colorectal cancer (mCRC), with 3 out of 5 patients showing at least a partial response, including one complete response [1][3] - Dr. Benjamin Weinberg will present the final results at the ESMO Gastrointestinal Cancers Congress 2025 in Barcelona, Spain [2] - The results support the ongoing Phase II trial for relapsed/refractory microsatellite stable CRC, with the first patient recently dosed and additional patients being enrolled [3][5] Clinical Significance - The findings from the compassionate use protocol highlight a favorable safety profile for leronlimab and its potential clinical benefits in mCRC [3] - If confirmed, leronlimab could be effective for a variety of solid tumor types, and it has shown promise as a "priming" agent for patients with low PD-L1 levels who are unresponsive to checkpoint inhibitors [4] Company Overview - CytoDyn is a clinical-stage biotechnology company focused on developing leronlimab, a humanized IgG4 monoclonal antibody targeting CCR5, with applications in oncology, infectious diseases, and autoimmune conditions [6]

Core Insights - Esperion has appointed Craig Thompson, CEO of Cerevance, as an independent director on its Board of Directors, expanding the board to eight members [1][2]. Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing innovative medicines for cardiovascular disease, specifically targeting patients with elevated low-density lipoprotein cholesterol (LDL-C) [7]. - The company has developed the only FDA-approved oral, once-daily, non-statin medications for at-risk cardiovascular patients, supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial [7]. Leadership Experience - Craig Thompson brings over 20 years of biopharmaceutical leadership experience, with a strong background in pharmaceutical commercialization and clinical development, which aligns with Esperion's mission [2][3]. - Prior to joining Esperion, Mr. Thompson held leadership roles at various biotechnology companies, including Cerevance, Neurana Pharmaceuticals, and Anthera Pharmaceuticals, and has experience in global marketing at Pfizer and Merck [4][5][6]. Strategic Focus - The appointment of Mr. Thompson is expected to enhance Esperion's strategic insight and operational expertise as the company aims to expand its impact in cardiovascular and cardiometabolic drug development [2][3]. - Esperion is advancing its pre-clinical pipeline and focusing on developing ATP citrate lyase inhibitors (ACLYi), which are expected to enable rational drug design and the development of highly potent inhibitors [7][8].

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retina diseases [9] - The company has launched LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) in Europe, specifically in Germany and the UK, for the treatment of wet age-related macular degeneration (AMD) [9] Leadership Appointment - Bob Jahr has been appointed as the Chief Executive Officer (CEO) of Outlook Therapeutics and will also join the Board of Directors [1][2] - Lawrence A. Kenyon will continue in his role as Chief Financial Officer (CFO) and remain a member of the Board of Directors [1] Executive Experience - Mr. Jahr brings over 20 years of experience in the biopharmaceutical industry, having led commercial teams across various therapeutic areas including rare disease, oncology, and hematology [3] - He has a proven track record of managing multiple billion-dollar assets and franchises [3] Strategic Importance - The appointment of Mr. Jahr is seen as timely due to the ongoing commercial launch in Europe and the potential for U.S. FDA approval in the coming months [2] - Mr. Jahr expressed excitement about joining the company at a pivotal time, emphasizing the potential of LYTENAVA™ to transform the global retina market [4] Inducement Grant - The Board of Directors approved an option for Mr. Jahr to purchase 800,000 shares of common stock as an inducement for his employment [6] - The option will be issued on July 1, 2025, with an exercise price equivalent to the closing price of the stock on that date, vesting over four years [7]

Core Insights - Soleno Therapeutics, Inc. announced the selection of two abstracts for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025) regarding VYKAT™ XR (diazoxide choline) extended-release tablets, aimed at treating hyperphagia in individuals with Prader-Willi syndrome [1][2] Company Overview - Soleno Therapeutics is focused on developing and commercializing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product [10] - VYKAT XR was approved by the U.S. FDA on March 26, 2025, and is now available for patients in the U.S. [3] Product Information - VYKAT XR is indicated for treating hyperphagia in adults and pediatric patients aged 4 years and older with Prader-Willi syndrome [3] - The product's safety information includes contraindications for patients with known hypersensitivity to diazoxide or thiazides [4] Presentation Details - The first presentation at ENDO 2025 will focus on the glycemic outcomes of VYKAT XR in treating hyperphagia over four years [2] - The second presentation will characterize peripheral edema in individuals with Prader-Willi syndrome during long-term administration of VYKAT XR over 4.5 years [6] Health Implications - Prader-Willi syndrome is a rare genetic disorder affecting approximately 1 in 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [2] - The treatment with VYKAT XR aims to address the life-threatening aspects of hyperphagia and improve the quality of life for affected individuals [2]