NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ: SRPT).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Sarepta and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On Ma ...

NEW YORK, April 29, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ: SRPT). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Sarepta and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On Ma ...

LOS ANGELES, April 24, 2025 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Sarepta Therapeutics, Inc. ("Sarepta" or "the Company") (NASDAQ: SRPT) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Sarepta admitted on March 18, 2025, that a young patient with Duchenne ...

Core Viewpoint - Kessler Topaz Meltzer & Check, LLP is investigating potential violations of federal securities laws related to Sarepta Therapeutics following the death of a patient after treatment with its gene therapy, ELEVIDYS [1][2]. Group 1: Company Overview - Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is facing scrutiny after a 16-year-old boy died from acute liver failure post-treatment with its gene therapy [1]. - The company's stock price experienced a significant decline of $27.81 per share, or 27.44%, closing at $73.54 per share on March 18, 2025, following the news of the patient's death [2]. Group 2: Legal Investigation - Kessler Topaz Meltzer & Check, LLP is actively investigating the situation on behalf of Sarepta investors, focusing on potential securities law violations [1]. - The law firm has a history of prosecuting class actions related to securities fraud and has recovered billions for investors [3].

Core Insights - The recent developments in the treatment of Duchenne muscular dystrophy (DMD) highlight significant changes in the market dynamics, particularly concerning the gene therapy ELEVIDYS by Sarepta Therapeutics and the emerging competitor Solid Biosciences [1][3]. Company Overview - Sarepta Therapeutics is the only company with an FDA-approved gene therapy for DMD, known as ELEVIDYS, which has seen rapid sales growth, nearly tripling from Q4 2023 to Q4 2024, reaching $384 million in revenue [2][3]. - Solid Biosciences is positioned as a potential challenger in the DMD treatment space, with its drug SGT-003 showing promising safety and efficacy data [3][10]. Recent Events - A tragic incident involving a patient treated with ELEVIDYS, who suffered acute liver failure leading to death, has raised safety concerns about the drug, causing Sarepta's shares to drop over 27% [4][5]. - Following this incident, the European Union has temporarily halted three clinical trials of ELEVIDYS, although there is optimism that trials may resume after a thorough investigation [6][7]. Competitive Landscape - Solid Biosciences has reported no serious side effects in its clinical trials for SGT-003, with a notable absence of acute liver injury, which could provide a competitive edge over ELEVIDYS [8][10]. - The capsid used in SGT-003, SLB101, has demonstrated five times more effective delivery to muscle cells compared to the capsid in ELEVIDYS, while using a 25% lower dose, potentially indicating a safer profile [9][10]. Market Potential - Solid Biosciences is targeting a significant market opportunity, with projected sales for ELEVIDYS expected to reach around $2 billion by 2025, which presents a substantial upside for Solid if it can successfully enter this market [13]. - The current market cap of Solid Biosciences is approximately $240 million, suggesting significant growth potential if the company can capitalize on its promising data and secure regulatory approvals [13]. Future Outlook - Solid Biosciences plans to dose a total of 10 patients by early Q2 and 20 by the end of the year, aiming for accelerated regulatory approval discussions with the FDA later this year [11][12].

Core Insights - The biotech industry presents opportunities for significant returns in short timeframes due to clinical or regulatory advancements, with several companies projected to see substantial share price increases in the next year [1][2] Group 1: CRISPR Therapeutics - CRISPR Therapeutics is a leading gene-editing company that received approval for its therapy Casgevy, the first CRISPR-based medicine, but has struggled with sales post-approval due to complex administration [3][4] - Wall Street's average price target for CRISPR Therapeutics is $84.62, indicating a potential upside of 159%, making it a long-term investment consideration despite short-term volatility [4][5] - The company has a promising pipeline, including potential treatments for type 1 diabetes and cancer, appealing to risk-tolerant investors [5] Group 2: Iovance Biotherapeutics - Iovance Biotherapeutics specializes in cancer therapies using tumor-infiltrating lymphocytes and gained U.S. approval for Amtagvi to treat melanoma, achieving $164.1 million in revenue in 2024 [6][7] - The stock has a price target of $20.91, suggesting a potential upside of 543%, with upcoming regulatory approvals and a large patient base in the U.S. as catalysts for growth [7][8] - Iovance could be an attractive option for patient investors, given its innovative approach and potential for further clinical successes [9] Group 3: Regeneron - Regeneron is a well-established biotech firm facing challenges with its key product Eylea due to competition, but has a price target of $914.55, indicating a 50% upside [10] - A legal battle over Eylea's biosimilar could significantly impact share prices, while the success of Dupixent and a robust pipeline enhance its investment appeal [11][12] - The company has initiated a dividend program and continues share buybacks, reinforcing its position as a strong long-term investment [12] Group 4: Sarepta Therapeutics - Sarepta Therapeutics focuses on gene therapies for rare diseases and recently launched Elevidys, but faced a setback with a patient death linked to liver failure [13][14] - Despite the controversy, the average price target remains at $165.35, suggesting an upside of 182%, contingent on clarifying the cause of the patient's death [14][15] - Given the current uncertainty surrounding Elevidys, caution is advised for potential investors until more information is available [15]

Core Viewpoint - Sarepta Therapeutics' shares fell over 6% following the European Medicines Agency (EMA) placing a clinical hold on studies for Elevidys, a gene therapy for Duchenne muscular dystrophy (DMD), due to a patient's death post-treatment [1][2]. Company Overview - Elevidys is a one-shot gene therapy developed in collaboration with Roche, and it is the first of its kind for DMD in the United States [4][9]. - The therapy has shown significant sales potential, contributing nearly 60% to Sarepta's total revenues in Q4 2024, with expectations of $2.9-$3.1 billion in net product revenues for 2025, two-thirds of which are anticipated from Elevidys [6]. Clinical Developments - The clinical hold was initiated after a patient's death attributed to acute liver failure, with ongoing investigations into the potential role of a recent CMV infection [2][3]. - Enrollment and dosing in three studies evaluating Elevidys at EU sites have been paused until the cause of death is fully analyzed [3]. Market Impact - Concerns regarding the clinical hold may lead to increased hesitance among doctors to prescribe Elevidys, potentially hindering its market adoption in the U.S. and delaying its launch in the EU [5]. - Year-to-date, Sarepta's shares have decreased nearly 52%, contrasting with a 1% growth in the industry [7]. Product Portfolio - Sarepta's portfolio includes four approved therapies for DMD, with Elevidys being a major contributor to revenue growth, having generated approximately $821 million in 2024 compared to $200 million the previous year [9][10]. - Other therapies in the portfolio, such as Exondys 51, Vyondys 53, and Amondys 45, have also seen strong demand and are expected to address nearly a third of all DMD patients in the U.S. [10].

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fid ...

NEW YORK, March 26, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ: SRPT). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Sarepta and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On M ...

Core Viewpoint - Sarepta Therapeutics is facing significant challenges, particularly following a 20% drop in share price due to concerns surrounding its key product, Elevidys, after a patient suffered fatal liver failure [1][5]. Group 1: Company Overview - Sarepta Therapeutics specializes in gene therapies for Duchenne muscular dystrophy (DMD), with Elevidys being its most important product targeting the genetic causes of the disorder [3]. - Elevidys received full U.S. approval for ambulatory DMD patients aged 4 and older, but is under accelerated approval for non-ambulatory patients, requiring further clinical trials to confirm efficacy [4]. Group 2: Recent Developments - A young patient treated with Elevidys experienced fatal acute liver failure, raising concerns about the treatment's safety, despite liver injury being a known risk [5]. - In Q4, Sarepta reported revenue of $658.4 million, a 66% increase year-over-year, with Elevidys contributing $384.2 million, accounting for over 50% of total revenue [5]. Group 3: Market Reaction and Future Outlook - The market reacted negatively to the news of the patient death, creating uncertainty around Elevidys' future sales and prescribing trends [5][7]. - Despite the incident, the company noted that the patient had a recent cytomegalovirus infection, which could have contributed to the liver failure, suggesting that the situation may not be solely attributable to Elevidys [6]. - The worst-case scenario would involve regulators pulling Elevidys from the market, but this is considered unlikely due to the lack of alternative effective treatments for DMD [7]. - Sarepta has other DMD treatments in development, but Elevidys was expected to be the primary growth driver, making the current uncertainty a risk for the company's stock [8].