Core Insights - Sarepta Therapeutics is conducting a conference call to discuss its strategic restructure and updates regarding the ELEVIDYS label [2][3] Company Overview - Douglas S. Ingram, the CEO, is leading the discussion and will provide insights into the company's future direction and developments [3]

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Capricor Therapeutics, Inc. due to allegations of violations of federal securities laws related to misleading statements about its lead drug candidate, deramiocel, and its regulatory status with the FDA [3][5]. Group 1: Legal Investigation and Claims - The law firm is encouraging investors who suffered losses exceeding $50,000 in Capricor between October 9, 2024, and July 10, 2025, to discuss their legal options [1]. - A federal securities class action has been filed against Capricor, with a deadline of September 15, 2025, for investors to seek the role of lead plaintiff [3][8]. - The complaint alleges that Capricor and its executives made false and misleading statements regarding the drug deramiocel and its FDA approval process [5]. Group 2: Regulatory Issues and Stock Performance - On July 11, 2025, Capricor announced it received a Complete Response Letter (CRL) from the FDA, denying its Biologics License Application (BLA) due to insufficient evidence of effectiveness and the need for additional clinical data [6]. - Following the announcement of the CRL, Capricor's stock price fell from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025, indicating a significant market reaction to the news [7]. Group 3: Company Background - Faruqi & Faruqi, LLP is a national securities law firm with a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [4].

Core Viewpoint - Shares of Sarepta Therapeutics experienced a significant decline of over 30% due to concerns regarding the future of its approved gene therapy treatment, Elevidys, following FDA intervention [1][2]. Group 1: FDA Actions - The FDA is requesting Sarepta Therapeutics to voluntarily halt all shipments of Elevidys, indicating potential regulatory challenges for the product [1]. - FDA Commissioner Marty Makary mentioned that the agency is evaluating whether Elevidys should remain on the market [2]. Group 2: Patient Safety Concerns - The FDA is investigating two patient deaths associated with Elevidys, raising serious safety concerns about the gene therapy [2]. - Additionally, Sarepta reported a third death linked to a different experimental gene therapy, further complicating the company's situation [2].

NEW YORK, July 18, 2025 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP announces that a shareholder has filed a securities class action lawsuit on behalf of investors (the “Class”) who purchased or acquired the securities of Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR) between October 9, 2024 and July 10, 2025, inclusive.For more information, submit a form at Capricor Therapeutics, Inc. Shareholder Class Action Lawsuit, email Investor Relations Manager Peter Allocco at pallocco@bernl ...

Shares of Sarepta Therapeutics plummeted Friday following a report that a third patient has died during a clinical trial for one of its medications. https://t.co/b4EzEu4AXX ...

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over 5 years of experience in covering biotech, healthcare, and pharma, and has compiled detailed reports on more than 1,000 companies [1]

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Key Takeaways REGN shares are down 22.8% YTD due to weak Eylea sales and pipeline disappointments. Eylea faces intense competition from Vabysmo and biosimilars, with HD version uptake still ramping up. Dupixent and new oncology approvals offer some support, but setbacks in COPD and lymphoma drugs persist. Shares of Regeneron Pharmaceuticals, Inc. (REGN) have lost 22.6% year to date against the industry’s growth of 0.6%. The stock has underperformed the medical sector and S&P 500 Index in this timeframe.A ...

Key Takeaways KYMR stock soared 70.7% in 3 months, outperforming its industry and the broader market. A new $750M collaboration with GILD on CDK2 degraders has fueled investor enthusiasm. Despite a Sanofi setback, KYMR earned a $20M milestone and eyes key pipeline advances in 2025-2026.Shares of Kymera (KYMR) have surged 70.7% in the past three months compared with the industry’s gain of 9.7%. The stock has also outperformed the sector and the S&P 500 index during this timeframe.This clinical-stage biotec ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...