NEW YORK, July 17, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Rocket Pharmaceuticals, Inc. ("Rocket" or the "Company") (NASDAQ: RCKT) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Rocket investors who were adversely affected by alleged securities fraud between February 27, 2025 and May 26, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/rocket-pharmaceuti ...

Core Points - Hemostemix Inc has announced a non-brokered private placement increasing gross proceeds to $3,000,000 due to oversubscriptions [1] - Each Unit in the placement is priced at $0.10 and includes one Common Share and one Warrant, with the Warrant exercisable at $0.15 for two years [2] - Certain directors of Hemostemix are participating in the Offering, which is classified as a related party transaction under MI 61-101 [3] Financial Details - The proceeds from the private placement will be used to repay CD1 at a 50% discount to face value ($1,250,000) and for general working capital [4] - The Company has a history of clinical studies, with seven studies involving 318 subjects, demonstrating the efficacy of its VesCell™ therapy [5] Company Overview - Hemostemix is focused on autologous stem cell therapy and has developed VesCell™ (ACP-01), which has shown significant clinical results in treating various cardiovascular conditions [5] - The Company has received recognition as a Technology Pioneer by the World Economic Forum and has published results in ten peer-reviewed publications [5]

Core Viewpoint - NKGen Biotech has formed a strategic partnership with HekaBio to accelerate the development of its autologous NK cell therapy, troculeucel, in Japan, targeting neurodegenerative diseases such as Alzheimer's and Parkinson's [1][2][3] Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing innovative autologous and allogeneic NK cell therapeutics, headquartered in Santa Ana, California [6] - HekaBio is a Japan-based healthcare platform that accelerates patient access to global medicines and MedTech, focusing on early-stage opportunities in CNS, oncology, and healthy longevity [8][9] Product Development - Troculeucel is an autologous, non-genetically modified cell therapy positioned to be a first-in-class treatment for several intractable neurodegenerative diseases [1][4] - The therapy is expected to be offered to patients in Japan on an accelerated path due to favorable regenerative medicine regulations, with first dosing aimed within the next 12 months [4][5] Regulatory and Clinical Strategy - HekaBio will lead all clinical trials in Japan and manage regulatory activities with the Pharmaceuticals and Medical Devices Agency for pre-market approval of troculeucel [3][4] - The partnership aims to leverage HekaBio's expertise to meet regulatory requirements and establish local manufacturing partnerships for effective commercialization [5]

Company Restructuring - Sarepta Therapeutics' shares surged over 20% in morning trading [1] - The company will reduce its workforce as part of a restructuring plan [1] - Sarepta Therapeutics is pausing several developmental projects [1]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Sarepta Therapeutics, Inc. securities between June 22, 2023, and June 24, 2025, of the upcoming lead plaintiff deadline on August 25, 2025, for a class action lawsuit [1]. Group 1: Class Action Details - Investors who purchased Sarepta securities during the specified Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and those wishing to serve as lead plaintiff must act by August 25, 2025 [3]. - Investors can join the class action by visiting the provided link or contacting the law firm directly for more information [6]. Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting its own achievements in this area [4]. - The firm has secured significant settlements for investors, including over $438 million in 2019 alone, and has been consistently ranked among the top firms for securities class action settlements [4]. Group 3: Case Specifics - The lawsuit alleges that Sarepta made false and misleading statements regarding its gene therapy product, ELEVIDYS, which posed significant safety risks and failed to detect severe side effects during trials [5]. - The adverse events related to ELEVIDYS treatment led to a halt in recruitment and dosing in trials, attracting regulatory scrutiny and increasing risks around the therapy's approvals [5].

SAN FRANCISCO, July 17, 2025 (GLOBE NEWSWIRE) -- When, on May 27, 2025, Rocket Pharmaceuticals (NASDAQ: RCKT) revealed that the FDA put a clinical hold on its Phase 2 pivotal trial for RP-A501, an experimental therapy intended to treat patients with a rare gene disorder called Danon disease, investors in the company’s shares saw their investment crash over 60% that day. Danon disease is a multi-organ lysosomal-associated disorder leading to early death due to heart disorder. Since the May 27 announcement, a ...

Key Takeaways AstraZeneca's anselamimab missed the primary endpoint in both phase III CARES studies for AL amyloidosis. The drug showed a clinically meaningful benefit in a prespecified subgroup, but details remain undisclosed. AZN plans a full analysis of the data and will present findings at an upcoming medical meeting.AstraZeneca (AZN) reported disappointing results from two late-stage studies that evaluated its investigational light chain depleter antibody, anselamimab, in certain patients with a rare ...

OSE Immunotherapeutics Launches Newsletter for Individual Shareholders NANTES, France, July 17, 2025, 6:30pm CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs, today launched the inaugural edition of its Newsletter, designed specifically for individual shareholders and investors in France and internationally. " This year, OSE Immunotherape ...

NEW YORK, July 17, 2025 (GLOBE NEWSWIRE) -- Class Action Attorney Juan Monteverde with Monteverde & Associates PC (the “M&A Class Action Firm”), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report. The firm is headquartered at the Empire State Building in New York City and is investigating Onconetix, Inc. (NASDAQ: ONCO) related to its merger with Ocuvex Therapeutics, Inc. Upon completion of the proposed transaction, e ...

Core Viewpoint - Sarepta Therapeutics is experiencing a stock price increase following an update on the label expansion efforts for Elevidys, its gene therapy for Duchenne muscular dystrophy, despite the FDA's request for a black box warning regarding acute liver injury and failure [1][10]. Label Expansion and FDA Interaction - The FDA has requested a black box warning for Elevidys, which Sarepta agrees to, resolving material issues with the ambulant portion of the label [2][10]. - A Sarepta committee is reviewing cases of acute liver failure and is exploring enhanced immunosuppressive regimens for non-ambulant patients [3][4]. Financial Restructuring - Sarepta announced a strategic restructuring plan aimed at prioritizing programs and achieving approximately $400 million in annual cost reductions, with a workforce reduction of 36% impacting around 500 employees [5]. - The restructuring is projected to lower average annual non-GAAP R&D and SG&A expenses to between $800 million and $900 million starting in 2026 [5]. Financial Performance - Preliminary financial highlights for Q2 2025 show total net product revenue of $513 million, with Elevidys contributing $282 million [6]. - As of June 30, the company reported cash and investments of approximately $850 million [6]. Strategic Focus - The company is shifting its focus towards chronically administered therapies for neurodegenerative and pulmonary diseases, pausing several gene therapy programs for limb-girdle muscular dystrophy [7]. - Sarepta plans to submit a Biologics License Application for SRP-9003 for LGMD type 2E/R4 later this year [7]. Management Changes - In conjunction with the restructuring, Sarepta appointed Ian Estepan as President and Chief Operating Officer and Ryan Wong as CFO [9]. Analyst Insights - Analysts from William Blair suggest that the FDA's request for a black box warning indicates that complete removal of Elevidys from the market is unlikely, leading to increased investor confidence in the company's ability to manage long-term debts [10]. - There are expectations of short-term challenges for Elevidys as patients and doctors exhibit hesitation, with cautious investor sentiment until early results from the ENDEAVOR trial are available [10][11].