Latest news with #ENVISION
Yahoo
16-07-2025
- Business
- Yahoo
Sarepta Therapeutics Halts ELEVIDYS Shipments for Non-Ambulatory DMD Patients
Sarepta Therapeutics Inc. (NASDAQ:SRPT) is one of the best low priced pharma stocks to buy now. Towards the end of June, Sarepta Therapeutics started facing a temporary suspension of shipments for ELEVIDYS, which is its gene therapy for Duchenne muscular dystrophy/DMD, specifically for non-ambulatory patients. This decision was announced around June 16 and followed two reported cases of fatal acute liver failure in non-ambulatory patients who received the treatment. The most recent death involved a 15-year-old patient. These severe side effects have led Sarepta to pause the ENVISION Phase 3 confirmatory trial (SRP-9001-303), which includes both older ambulatory and non-ambulatory individuals, to allow for protocol updates and regulatory discussions. A laboratory technician in a white coat holding a microscope and examining a vial of biopharmaceuticals. DMD primarily affects males, with symptoms typically appearing between the ages of 2 and 3. It progresses rapidly and leads to the gradual loss of muscle function in the skeletal, heart, and lung muscles. DMD is caused by a mutation in the DMD gene, which is responsible for producing dystrophin, a protein vital for muscle cell integrity. Sarepta Therapeutics Inc. (NASDAQ:SRPT) is a commercial-stage biopharmaceutical company that discovers and develops RNA-targeted therapeutics, gene therapies, and other genetic therapeutic modalities for the treatment of rare diseases. While we acknowledge the potential of SRPT as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Business Wire
03-07-2025
- Business
- Business Wire
SRPT INVESTOR NOTICE: Robbins Geller Rudman & Dowd LLP Announces that Sarepta Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead the Sarepta Class Action Lawsuit
SAN DIEGO--(BUSINESS WIRE)--The law firm of Robbins Geller Rudman & Dowd LLP Sarepta class action lawsuit. Captioned Dolgicer v. Sarepta Therapeutics, Inc., No. 25-cv-05317 (S.D.N.Y.), the Sarepta class action lawsuit charges Sarepta as well as certain of Sarepta's top executives with violations of the Securities Exchange Act of 1934. If you suffered substantial losses and wish to serve as lead plaintiff of the Sarepta class action lawsuit, please provide your information here: CASE ALLEGATIONS: Sarepta is a commercial-stage biopharmaceutical company. According to the complaint, during the Class Period, Sarepta was engaged in the development of therapies to treat Duchenne muscular dystrophy ('Duchenne'), including ELEVIDYS (a prescription gene therapy intended for a limited category of people with Duchenne). The Sarepta Therapeutics class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) ELEVIDYS posed significant safety risks to patients; (ii) ELEVIDYS trial regimes and protocols failed to detect severe side effects; and (iii) the severity of adverse events from ELEVIDYS treatment would cause Sarepta to halt recruitment and dosing in ELEVIDYS trials, attract regulatory scrutiny, and create greater risk around the therapy's present and expanded approvals. The Sarepta class action lawsuit further alleges that on March 18, 2025, Sarepta revealed that a patient treated with ELEVIDYS suffered acute liver failure leading to death, which represented 'a severity of acute liver injury not previously reported for ELEVIDYS.' On this news, the price of Sarepta stock fell more than 27%, according to the complaint. Then, on April 4, 2025, the Sarepta class action lawsuit further alleges that Sarepta disclosed that European Union member country authorities had requested that the independent data monitoring committee meet to review the death announced on March 18, 2025, resulting in Sarepta halting recruitment and dosing in some of the ELEVIDYS clinical studies. On this news, the price of Sarepta stock fell more than 7%, according to the complaint. Thereafter, on June 15, 2025, Sarepta disclosed that a second patient had died of acute liver failure following treatment with ELEVIDYS, leading to Sarepta suspending shipment of ELEVIDYS for non-ambulatory patients and pausing dosing of ELEVIDYS in the ENVISION clinical study to evaluate the protocol in accordance with the U.S. Food and Drug Administration ('FDA'), according to the complaint. The Sarepta class action lawsuit alleges that on this news, the price of Sarepta stock fell more than 42%. Finally, the Sarepta class action lawsuit further alleges that on June 24, 2025, the FDA issued a Safety Communication announcing it had received reports of two deaths and was investigating the risk of acute liver failure with serious outcomes following treatment with ELEVIDYS. On this news, the price of Sarepta stock fell more than 8%, according to the complaint. THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Sarepta securities during the Class Period to seek appointment as lead plaintiff in the Sarepta class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Sarepta class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Sarepta class action lawsuit. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Sarepta class action lawsuit. ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world's leading law firms representing investors in securities fraud and shareholder litigation. Our Firm has been ranked #1 in the ISS Securities Class Action Services rankings for four out of the last five years for securing the most monetary relief for investors. In 2024, we recovered over $2.5 billion for investors in securities-related class action cases – more than the next five law firms combined, according to ISS. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs' firms in the world, and the Firm's attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information: Past results do not guarantee future outcomes. Services may be performed by attorneys in any of our offices.
Business Wire
27-06-2025
- Business
- Business Wire
SRPT INVESTOR ALERT: Robbins Geller Rudman & Dowd LLP Announces that Sarepta Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead the Sarepta Class Action Lawsuit
SAN DIEGO--(BUSINESS WIRE)--The law firm of Robbins Geller Rudman & Dowd LLP Sarepta class action lawsuit. Captioned Dolgicer v. Sarepta Therapeutics, Inc., No. 25-cv-05317 (S.D.N.Y.), the Sarepta class action lawsuit charges Sarepta and certain of Sarepta's top executives with violations of the Securities Exchange Act of 1934. If you suffered substantial losses and wish to serve as lead plaintiff of the Sarepta class action lawsuit, please provide your information here: CASE ALLEGATIONS: Sarepta is a commercial-stage biopharmaceutical company. According to the complaint, during the Class Period, Sarepta was engaged in the development of therapies to treat Duchenne muscular dystrophy ('Duchenne'), including ELEVIDYS (a prescription gene therapy intended for a limited category of people with Duchenne). The Sarepta Therapeutics class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) ELEVIDYS posed significant safety risks to patients; (ii) ELEVIDYS trial regimes and protocols failed to detect severe side effects; and (iii) the severity of adverse events from ELEVIDYS treatment would cause Sarepta to halt recruitment and dosing in ELEVIDYS trials, attract regulatory scrutiny, and create greater risk around the therapy's present and expanded approvals. The Sarepta class action lawsuit further alleges that on March 18, 2025, Sarepta revealed that a patient treated with ELEVIDYS suffered acute liver failure leading to death, which represented 'a severity of acute liver injury not previously reported for ELEVIDYS.' On this news, the price of Sarepta stock fell more than 27%, according to the complaint. Then, on April 4, 2025, the Sarepta class action lawsuit further alleges that Sarepta disclosed that European Union member country authorities had requested that the independent data monitoring committee meet to review the death announced on March 18, 2025, resulting in Sarepta halting recruitment and dosing in some of the ELEVIDYS clinical studies. On this news, the price of Sarepta stock fell more than 7%, according to the complaint. Thereafter, on June 15, 2025, Sarepta disclosed that a second patient had died of acute liver failure following treatment with ELEVIDYS, leading to Sarepta suspending shipment of ELEVIDYS for non-ambulatory patients and pausing dosing of ELEVIDYS in the ENVISION clinical study to evaluate the protocol in accordance with the U.S. Food and Drug Administration ('FDA'), according to the complaint. The Sarepta class action lawsuit alleges that on this news, the price of Sarepta stock fell more than 42%. Finally, the Sarepta class action lawsuit further alleges that on June 24, 2025, the FDA issued a Safety Communication announcing it had received reports of two deaths and was investigating the risk of acute liver failure with serious outcomes following treatment with ELEVIDYS. On this news, the price of Sarepta stock fell more than 8%, according to the complaint. THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Sarepta securities during the Class Period to seek appointment as lead plaintiff in the Sarepta class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Sarepta class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Sarepta class action lawsuit. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Sarepta class action lawsuit. ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world's leading law firms representing investors in securities fraud and shareholder litigation. Our Firm has been ranked #1 in the ISS Securities Class Action Services rankings for four out of the last five years for securing the most monetary relief for investors. In 2024, we recovered over $2.5 billion for investors in securities-related class action cases – more than the next five law firms combined, according to ISS. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs' firms in the world, and the Firm's attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information: Past results do not guarantee future outcomes. Services may be performed by attorneys in any of our offices.
Boston Globe
16-06-2025
- Health
- Boston Globe
Sarepta reports second patient death after treatment with Duchenne gene therapy
Advertisement The company said early Sunday it was working with experts to come up with an enhanced immunosuppressive regimen that could make the therapy, called Elevidys, safer for non-ambulatory patients. It said it would talk with the Food and Drug Administration about the the proposed regimen. Sarepta also said it was pausing dosing in an ongoing clinical trial of Elevidys, called ENVISION, that's focused on older ambulatory and non-ambulatory patients. The company did not disclose the age of the person who died, but a statement indicated it was a male patient. Duchenne almost always affects boys, More than 900 patients have received Elevidys overall. 'We are deeply saddened by the loss of a second patient and extend our heartfelt condolences to the patient's family and his care team during this incredibly difficult time,' Louise Rodino-Klapac, Sarepta's chief scientific officer, said in a statement. Advertisement 'We know how much hope families place in new treatment options like Elevidys — and we are committed to honoring that hope by acting swiftly, guided by scientific rigor and the insights of leading experts, to strengthen safety for all future patients,' she added. The death is certain to add additional scrutiny to Elevidys has become a key medicine caught up in the debate about regulatory flexibility — with patients and some government officials advocating for speeding treatments to patients with rare diseases who have few options — and effectiveness standards that drugs have traditionally had to clear to win approval. At the FDA, a top official, Peter Marks In the case of Elevidys, the dispute centered on efficacy, with the treatment appearing safe in clinical trials. However, Sarepta studied the therapy largely in young children, and the risks of gene therapy generally increase with age. When the FDA granted its approval, some experts raised concerns about the treatment's safety in older patients. FDA reviewers noted last year that Sarepta submitted data for only 16 patients over the age of 8 and only eight patients who were non-ambulatory. They highlighted that there were no significant safety differences in those older, non-ambulatory patients, but that 'the limited safety data limits meaningful assessment.' Advertisement The FDA's new leadership under the Trump administration
Business Insider
15-06-2025
- Business
- Business Insider
Sarepta suspends non-ambulatory Elevidys shipments after second death
Sarepta (SRPT) Therapeutics provided a safety update regarding Elevidys, an FDA approved gene therapy for patients with Duchenne muscular dystrophy. The company announced a second reported case of acute liver failure resulting in death. The cases of ALF to date have both occurred in non-ambulatory individuals with Duchenne. Sarepta is temporarily suspending shipments of Elevidys for non-ambulatory patients while an enhanced immunosuppressive regimen is evaluated, discussed with regulatory bodies, and put in place. For ambulatory patients, no treatment changes are being proposed and the current practice of administering corticosteroids before and after Elevidys infusion, along with post-treatment monitoring, remains the same. Sarepta has also voluntarily paused dosing in the ENVISION clinical study. FDA concurs with this action, the company said. 'The pause will allow for the evaluation of a protocol amendment to incorporate an enhanced immunosuppressive regimen for the non-ambulatory patient cohort and incorporate any additional feedback from the FDA. Regulatory alignment is needed before screening and dosing in ENVISION may resume,' Sarepta added. The company is working to immediately convene an independent group of leading experts in Duchenne and liver health to consider an enhanced immunosuppression regimen for Elevidys.
