Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Sarepta Therapeutics, Inc. due to allegations of violations of federal securities laws related to the safety of its product ELEVIDYS, with a deadline for investors to seek lead plaintiff status in a class action lawsuit by August 25, 2025 [3][5]. Group 1: Allegations and Legal Actions - The complaint alleges that Sarepta and its executives made false or misleading statements regarding the safety of ELEVIDYS, failing to disclose significant safety risks and adverse events associated with the treatment [5]. - The firm encourages investors who suffered losses exceeding $100,000 in Sarepta between June 22, 2023, and June 24, 2025, to discuss their legal rights [1][3]. Group 2: Stock Price Impact - Following a safety update on March 18, 2025, which reported a patient death after ELEVIDYS treatment, Sarepta's stock price fell by $27.81 per share, or 27.44%, closing at $73.54 [6]. - On April 4, 2025, after disclosing that EU authorities requested a review of the death, the stock price dropped by $4.18 per share, or 7.13%, closing at $54.43 [8]. - A second patient death was reported on June 15, 2025, leading to a significant stock price decline of $15.24 per share, or 42.12%, closing at $20.91 [10]. - Following an FDA Safety Communication on June 24, 2025, regarding the investigation of acute liver failure risks, the stock price fell by $1.52 per share, or 8.01%, closing at $17.46 [11].

Core Viewpoint - Sarepta Therapeutics is facing a class action lawsuit due to alleged misleading statements and undisclosed safety risks related to its gene therapy product ELEVIDYS, which has resulted in significant stock price declines following patient deaths and regulatory scrutiny [3][4][5][6][7]. Group 1: Company Overview - Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on developing treatments for Duchenne muscular dystrophy, including the gene therapy product ELEVIDYS [3]. Group 2: Allegations and Legal Actions - The class action lawsuit claims that Sarepta made false or misleading statements regarding ELEVIDYS, including significant safety risks and inadequate clinical trial protocols [3]. - The lawsuit highlights that adverse events related to ELEVIDYS forced Sarepta to pause recruitment and dosing in trials, which jeopardized regulatory approvals [3]. Group 3: Stock Price Impact - Following the disclosure of a patient death from acute liver failure on March 18, 2025, Sarepta's stock dropped more than 27% [4]. - An additional announcement on April 4, 2025, regarding a review by European regulatory authorities led to a further 7% decline in stock price [5]. - A second patient death reported on June 15, 2025, caused the stock price to decline over 42% [6]. - The FDA's Safety Communication on June 24, 2025, regarding the investigation of patient deaths resulted in an additional 8% drop in Sarepta's stock [7].

Core Viewpoint - A class action lawsuit has been filed against Sarepta Therapeutics, alleging securities fraud related to the company's gene therapy ELEVIDYS, which is intended to treat Duchenne muscular dystrophy. The lawsuit claims that Sarepta made false statements about the safety and revenue outlook of ELEVIDYS, misleading investors about its potential for broader application approval and growth in prescriptions [1][4][5]. Group 1: Allegations and Impact - The complaint alleges that Sarepta misled investors by claiming that ELEVIDYS was a safe therapy without significant risks, while failing to disclose serious safety concerns and adverse events associated with the treatment [4][5]. - Specific allegations include that ELEVIDYS posed significant safety risks, trial protocols failed to detect severe side effects, and that adverse events would lead to halted recruitment and increased regulatory scrutiny [5]. - Following the announcement of a patient death related to ELEVIDYS on March 18, 2025, Sarepta's stock price dropped by $27.81 per share, or 27.44%, closing at $73.54 [6]. Group 2: Subsequent Developments - On April 4, 2025, Sarepta disclosed that EU authorities requested a review of the death, leading to a halt in recruitment for some clinical studies, which caused the stock price to fall by $4.18 per share, or 7.13%, to close at $54.43 [7]. - A second patient death was reported on June 15, 2025, resulting in a significant stock price drop of $15.24 per share, or 42.12%, closing at $20.91 [8]. - The FDA issued a Safety Communication on June 24, 2025, regarding the investigation of acute liver failure risks associated with ELEVIDYS, leading to a further decline in stock price by $1.52 per share, or 8.01%, closing at $17.46 [9].

NEW YORK, June 26, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Sarepta Therapeutics, Inc. (NASDAQ: SRPT) for potential violations of the federal securities laws. If you invested in Sarepta, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/sarepta-therapeutics-inc-class-action. Why is Sarepta being Investigated? Sarepta is a biopharmaceutical company focused on developing treatment ...

Core Viewpoint - The FDA is investigating the risk of acute liver failure associated with Sarepta Therapeutics' Elevidys treatment, which has resulted in serious outcomes including hospitalization and death [1][2]. Group 1: FDA Investigation - The FDA has received two reports of fatal acute liver failure in non-ambulatory pediatric male patients with Duchenne Muscular Dystrophy (DMD) following treatment with Elevidys [2]. - The agency is evaluating the need for further regulatory action based on these reports [1]. Group 2: Patient Outcomes - In the reported cases, patients exhibited elevated transaminases and were hospitalized within two months after receiving Elevidys [3]. - Both fatalities appear to be directly related to the treatment with Elevidys [2]. Group 3: Analyst Reactions - HC Wainwright has reiterated a Sell rating for Sarepta, maintaining a price forecast of $10, citing the likelihood of the FDA requiring updated warnings regarding liver failure or death [4]. - The worst-case scenario for Sarepta would involve the FDA mandating the withdrawal of Elevidys from the U.S. market [4][5]. Group 4: Company Valuation - If Elevidys were to be withdrawn, analysts believe there would be little intrinsic value remaining in Sarepta [5]. - The skepticism from FDA officials regarding the initial approval of Elevidys suggests potential challenges for the company's continued marketing efforts [6]. Group 5: Stock Performance - Following the news, Sarepta's stock (SRPT) has seen a decline of approximately 9.96%, trading at $17.09 [6].

NEW YORK, June 24, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Sarepta Therapeutics, Inc. (NASDAQ: SRPT) for potential violations of the federal securities laws. If you invested in Sarepta, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/sarepta-therapeutics-inc-class-action. Why is Sarepta being Investigated? Sarepta is a biopharmaceutical company focused on developing treatment ...

Core Viewpoint - Sarepta Therapeutics, Inc. is under investigation for potential violations of federal securities laws related to the safety profile of its product Elevidys, which has been linked to fatal acute liver failure in patients [1][2]. Company Overview - Sarepta Therapeutics is a biopharmaceutical company focused on developing treatments for rare diseases, with Elevidys being its most significant product aimed at treating Duchenne muscular dystrophy [2]. Product Safety Concerns - The company has previously emphasized the safety of Elevidys, claiming that its benefits outweigh the risks. However, it has been revealed that Elevidys can cause fatal acute liver failure in some patients [2]. Stock Performance - Following the announcement of a patient's death due to acute liver failure on March 18, 2025, Sarepta's stock price dropped by $27.81, or over 27%, from $101.35 to $73.54 per share [3]. - After a second patient death was reported on June 15, 2025, Sarepta's stock fell by $15.24, or more than 42%, from $36.18 to $20.94 per share [3]. Legal Implications - Investors in Sarepta may have legal options available to them, as indicated by the investigation and the potential for class action lawsuits [4].

Core Insights - Sarepta Therapeutics provided a safety update on Elevidys, the only approved gene therapy for Duchenne muscular dystrophy, following a second case of acute liver failure resulting in death [1] - Investor hesitancy is attributed to uncertainty regarding the number of non-ambulatory patients treated and their risk of developing acute liver failure [2] - Analyst Sami Corwin downgraded Sarepta from Outperform to Market Perform due to concerns over revenue estimates and competition from other gene therapies [2][3] Company Developments - The company is taking steps to strengthen the safety profile of Elevidys in non-ambulatory patients after the reported cases of acute liver failure [1] - There is a growing concern that the penetration of the non-ambulatory population may not meet previous peak revenue estimates, impacting future revenue potential [3] - Sarepta's stock price decreased by 3.18% to $20.11, reflecting investor concerns over the safety profile and revenue outlook [4] Market Context - The potential entry of other AAV gene therapies for Duchenne muscular dystrophy by 2027 could further impact Sarepta's peak revenue estimates [3] - Early clinical data from competitors suggests they may have a safer profile with fewer liver-related side effects, increasing competitive pressure on Sarepta [3] - Despite expected strong interest among commercial ambulatory patients, the uncertainty surrounding non-ambulatory patient treatment is seen as a deterrent for investors [4]

Core Viewpoint - Sarepta Therapeutics, Inc. is under investigation for potential violations of federal securities laws related to the safety profile of its product Elevidys, which has been linked to fatal acute liver failure in patients [1][2]. Company Overview - Sarepta Therapeutics is a biopharmaceutical company focused on developing treatments for rare diseases, with Elevidys being its most significant product aimed at treating Duchenne muscular dystrophy [2]. Incident Timeline - On March 18, 2025, Sarepta announced the death of a patient treated with Elevidys due to acute liver failure, resulting in a stock price drop of $27.81, or over 27%, from $101.35 to $73.54 per share [3]. - Following a second patient death on June 15, 2025, Sarepta suspended certain shipments of Elevidys and paused dosing in an ongoing clinical trial, leading to a further stock decline of $15.24, or more than 42%, from $36.18 to $20.94 per share [3]. Legal Implications - Investors in Sarepta may have legal options available and are encouraged to submit their information to the investigating law firm, Bleichmar Fonti & Auld LLP, which operates on a contingency fee basis [4][5]. Law Firm Background - Bleichmar Fonti & Auld LLP is a prominent international law firm specializing in securities class actions and shareholder litigation, recognized for recovering significant amounts for clients in past cases [5].

Patients can't wait for the next breakthrough in medical research. An ELEVIDYS Safety Update in Non-Ambulatory Patients So neither will we. Doug Ingram President & CEO Louise Rodino-Klapac, PhD Executive Vice President, Head of R&D, Chief Scientific Officer June 16, 2025 ©SAREPTA THERAPEUTICS, INC. 2025. ALL RIGHTS RESERVED. 1 DILLON Living with Duchenne muscular dystrophy Doug Ingram ©SAREPTA THERAPEUTICS, INC. 2025. ALL RIGHTS RESERVED. 2 Forward-looking statements This presentation contains "forward-look ...