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 ...

Core Insights - Pomerantz LLP is investigating claims on behalf of investors of Sarepta Therapeutics, focusing on potential securities fraud or unlawful business practices by the company and its officers [1][5] Company Developments - On March 18, 2025, Sarepta disclosed the death of a patient with Duchenne muscular dystrophy following treatment with its drug ELEVIDYS, resulting in a stock price drop of $27.81 per share, or 27.44%, closing at $73.54 [3] - On June 16, 2025, Sarepta reported a second fatality from acute liver failure in a patient treated with ELEVIDYS, leading to the halting of its ongoing clinical trial and a temporary suspension of the drug's distribution for non-ambulatory patients. This news caused Sarepta's stock price to fall by $15.24 per share, or 42.12%, closing at $20.94 [4]

Core Viewpoint - Sarepta Therapeutics faces significant challenges following the second death linked to its DMD treatment ELEVIDYS, leading to a suspension of shipments for non-ambulatory patients and a drastic drop in stock price [1][2][4]. Group 1: Sarepta Therapeutics - The recent death of a patient due to acute liver failure after treatment with ELEVIDYS marks a second tragic incident, raising serious concerns about the safety of the drug [1]. - Following the incident, Sarepta suspended shipments of ELEVIDYS for non-ambulatory patients and withdrew its revenue guidance, resulting in a stock price decline of over 42% [2][4]. - ELEVIDYS accounted for 61% of Sarepta's total revenue of $612 million last quarter, with sales growth of 180%, making the suspension a critical blow to the company's financial outlook [5]. - Despite the suspension, only 15% of ELEVIDYS patients have been non-ambulatory, allowing Sarepta to continue selling to the majority of its patient base [6]. - The company is working on an enhanced regimen to mitigate the risk of liver failure, pending FDA approval, with hopes to provide guidance during its Q2 earnings call [7][8]. Group 2: Solid Biosciences - Solid Biosciences, developing a potentially safer alternative to ELEVIDYS called STG-003, saw its shares rise over 11% following Sarepta's news, indicating investor confidence in its prospects [3][10]. - STG-003 has shown high efficacy in early-stage trials, with the highest average microdystrophin expression among DMD gene therapies to date, positioning it as a strong contender in the market [10]. - Liver safety concerns are prevalent in gene therapies, with ELEVIDYS causing elevated liver enzymes in about 30% of patients, while STG-003 appears to be less damaging to the liver [11]. - Solid plans to meet with the FDA in Q4 2025 to discuss the potential for accelerated approval of STG-003, which could expedite its entry into the market [13].

NEW YORK, June 18, 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 Insights - Sarepta Therapeutics experienced a significant stock decline of 42% following the announcement of a second patient death linked to its gene therapy, Elevidys, leading to the suspension of its use in non-ambulatory patients for safety reviews [2][3] - Roche's reassessment of the safety profile prompted the immediate cessation of commercial distribution and a pause in ongoing clinical trials until risk mitigation measures are established [3] - Elevidys, which accounted for 43% of Sarepta's total revenues last year, was projected to achieve peak sales exceeding $3 billion, but these expectations are now under threat due to the restricted patient population [5] Financial Overview - Sarepta's financial situation was already precarious, with an operating cash flow margin of negative 25% and a net income margin of negative 11%, despite average revenue growth exceeding 40% over the past three years [6] - The company carries $1.3 billion in debt against a market capitalization of $2.06 billion, resulting in a debt-to-equity ratio of 63% [6] - The stock has seen extreme volatility, dropping from a 52-week high of approximately $172 to around $20, highlighting the risks associated with reliance on a limited number of drug revenues [7] Investment Considerations - The recent safety concerns surrounding Elevidys, combined with the company's heavy reliance on a single revenue source and significant cash burn, create a highly speculative investment environment [8] - While Sarepta's low valuations may attract contrarian investors, the investment carries substantial risks, making it suitable only for those with a high risk tolerance [8] - Investors may consider diversified investment strategies, such as the Trefis High Quality Portfolio, which spreads risk across multiple companies and sectors, rather than concentrating on individual stocks [9][10]

Company Performance - Sarepta Therapeutics, Inc. (NASDAQ: SRPT) experienced a significant decline in stock price, down 40% in pre-market trading on June 16th, and further dropped over 47% after the market opened [1] Market Context - The decline in Sarepta's stock is noted in the context of a broader market environment, where momentum plays a crucial role in investment strategies, particularly in the technology sector [1]