Sarepta Therapeutics' stock plummeted by over a third after reporting mixed Q3 results, including two drug failures and delayed test outcomes, despite strong sales of its gene therapy Elevidys. The company plans to seek traditional FDA approval for Amondys 45 and Vyondys 53, but uncertainties around regulatory and reimbursement issues persist. Meanwhile, sales of Elevidys exceeded expectations, though the outlook remains uncertain amid regulatory and demand challenges.
Sarepta Therapeutics sold its entire stake in Arrowhead Pharmaceuticals to improve its cash position amid challenges with its gene therapy product, Elevidys, leading to a significant drop in Arrowhead's stock price and raising concerns about Sarepta's financial outlook and future drug development prospects.
Sarepta's stock surged after the FDA allowed the company to resume shipments of its gene therapy drug Elevidys for Duchenne muscular dystrophy, following a voluntary pause for safety review. The stock closed up 14.2%, though it has declined significantly this year.
Sarepta Therapeutics' shares rebounded after the FDA approved the resumption of shipments for its gene therapy Elevidys in the US for ambulatory patients with Duchenne muscular dystrophy, easing concerns about liquidity and market withdrawal, though shipments for non-ambulatory patients remain halted following recent deaths and regulatory scrutiny.
Sarepta's stock dropped after the FDA indicated it will require additional clinical testing for its gene therapy Elevidys, following recent safety concerns and patient deaths, raising concerns about setting a dangerous precedent for gene therapies. The company has already halted sales of Elevidys for certain patients, and the situation continues to create uncertainty for its future and the gene therapy industry.
Sarepta Therapeutics announced it will voluntarily halt all shipments of its gene therapy Elevidys in the U.S. to address FDA concerns following patient deaths and label updates, leading to a significant stock decline and raising questions about its future prospects and regulatory relationships.
Sarepta Therapeutics announced it will temporarily pause all shipments of its Elevidys gene therapy in the U.S. following the death of a patient who received a different experimental treatment, after initially refusing to halt shipments despite regulatory requests.
Sarepta's stock declined after refusing the FDA's request to halt shipments of its gene therapy Elevidys, following patient deaths and safety concerns. The FDA's actions, including halting studies and revoking platform designations, are seen by some analysts as influenced more by public outcry than science. Despite safety issues in older, sicker patients, Sarepta reports no new safety signals in ambulatory patients, but the situation has delayed upcoming therapies and extended timelines.
Stock futures are rising ahead of a busy week of earnings reports, with notable movements in Sarepta, Verizon, Block, Tesla, Domino's, and Cleveland-Cliffs, amid ongoing trade developments and company-specific news such as Sarepta's drug shipment issues and Verizon's strong earnings.
Sarepta Therapeutics announced it will continue shipping its gene therapy Elevidys for Duchenne muscular dystrophy despite the FDA's request to halt shipments, indicating ongoing disputes over the drug's approval or safety concerns.
The FDA is expected to request Sarepta Therapeutics to halt shipments of its Duchenne muscular dystrophy gene therapy, Elevidys, following safety concerns and patient deaths related to liver failure, which may lead to a market withdrawal amid ongoing safety investigations.
Shares of Sarepta Therapeutics dropped over 30% after the FDA indicated it might halt shipments of its gene therapy Elevidys due to safety concerns and ongoing investigations into patient deaths, casting doubt on the future of the treatment for Duchenne Muscular Dystrophy.
Two teenage boys and a 51-year-old man have died after receiving different Sarepta gene therapies, raising safety concerns about the company's treatments for muscular dystrophy and related conditions, leading to market withdrawals and investigations.
Sarepta Therapeutics reported a third patient death due to acute liver failure after receiving its gene therapy, adding to recent fatalities of two teenage boys, which has led to stock decline and increased regulatory scrutiny, including a warning label from the FDA.
Sarepta Therapeutics announced a restructuring plan including 500 layoffs and a warning label update for its gene therapy Elevidys after two patient deaths, leading to a 35% stock increase despite slightly lower sales forecasts.
