Latest news with #gene therapy
Yahoo
a day ago
- Business
- Yahoo
Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
(Reuters) -Sarepta Therapeutics shares surged more than 30% before the bell on Tuesday, as analysts said the resumption of U.S. shipments for its muscular gene therapy partially removes financial headwinds and decreases the risk of market withdrawal. The company said on Monday it would resume shipments of Elevidys — approved in the U.S. to treat a rare condition called Duchenne muscular dystrophy — to patients who can walk. U.S. shipments to patients who cannot walk independently are still halted, following the death of two teenage boys earlier this year. These incidents brought heightened regulatory scrutiny to Sarepta in recent weeks, while the pause of shipments raised concerns about the future of Elevidys — the company's largest revenue generator. Sarepta's announcement followed the U.S. Food and Drug Administration's recommendation that the voluntary hold on shipments be removed after a probe showed the death of an 8-year-old boy in Brazil was not related to Elevidys. Wall Street analysts said the resumption of shipments would allow Sarepta to fulfill its near-term payments to partner Arrowhead and maintain access to its debt facilities. "The FDA's recommendation and the resumption of commercial treatment in the U.S. virtually eliminate the risk of Elevidys being formally withdrawn from the market," said William Blair analyst Sami Corwin. While the decision allows some patients to regain access to the treatment, analysts warned that patients and doctors could show hesitancy in light of the recent hit to reputation. "It remains to be seen how the news headlines regarding the patient deaths will affect commercial interest in the near term," Corwin said. Sarepta's partner Roche had also stopped Elevidys shipments in certain countries outside the U.S. Shares of Sarepta surged 36% to $18.85 in premarket trading. They have fallen more than 80% since the first Elevidys-related death was reported in March. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Reuters
a day ago
- Business
- Reuters
Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
July 29 (Reuters) - Sarepta Therapeutics (SRPT.O), opens new tab shares surged more than 30% before the bell on Tuesday, as analysts said the resumption of U.S. shipments for its muscular gene therapy partially removes financial headwinds and decreases the risk of market withdrawal. The company said on Monday it would resume shipments of Elevidys — approved in the U.S. to treat a rare condition called Duchenne muscular dystrophy — to patients who can walk. U.S. shipments to patients who cannot walk independently are still halted, following the death of two teenage boys earlier this year. These incidents brought heightened regulatory scrutiny to Sarepta in recent weeks, while the pause of shipments raised concerns about the future of Elevidys — the company's largest revenue generator. Sarepta's announcement followed the U.S. Food and Drug Administration's recommendation that the voluntary hold on shipments be removed after a probe showed the death of an 8-year-old boy in Brazil was not related to Elevidys. Wall Street analysts said the resumption of shipments would allow Sarepta to fulfill its near-term payments to partner Arrowhead (ARWR.O), opens new tab and maintain access to its debt facilities. "The FDA's recommendation and the resumption of commercial treatment in the U.S. virtually eliminate the risk of Elevidys being formally withdrawn from the market," said William Blair analyst Sami Corwin. While the decision allows some patients to regain access to the treatment, analysts warned that patients and doctors could show hesitancy in light of the recent hit to reputation. "It remains to be seen how the news headlines regarding the patient deaths will affect commercial interest in the near term," Corwin said. Sarepta's partner Roche (ROG.S), opens new tab had also stopped Elevidys shipments in certain countries outside the U.S. Shares of Sarepta surged 36% to $18.85 in premarket trading. They have fallen more than 80% since the first Elevidys-related death was reported in March.
Al Arabiya
2 days ago
- Business
- Al Arabiya
Sarepta will resume gene therapy shipments after fda review of recent patient death
Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would resume shipping its gene therapy for some patients following a brief pause requested by regulators. The Food and Drug Administration said it recommended lifting the hold for young patients with Duchennes muscular dystrophy who are still able to walk. Regulators had requested the pause after the deaths of two older teenagers who were taking the therapy. The FDA also said in a statement it determined that a recently reported death of an 8-year-old boy was unrelated to the therapy. Company shares surged more than 16 percent after the announcement to 13.86 in afterhours trading. The jump is the latest in a series of drastic stock movements triggered by changing fortunes for the company's best-selling product. Elevidys is the first gene therapy approved in the US for Duchennes muscular dystrophy–the fatal muscle-wasting disease that affects boys and young men resulting in early death. It received accelerated approval in 2023 for a narrow range of young patients and was expanded last year for use in older patients including those who can no longer walk. The FDA decision Monday significantly improves Elevidys' sales outlook in the near-term, Jefferies analyst Andrew Tsai told investors in a note after the announcement. 'The street will feel relieved about the situation suggesting meaningful stock upside potential.' Sarepta's therapy has been under scrutiny from regulators after two teenage boys died earlier this year from acute liver injury–a known side effect of the treatment. The FDA then requested a pause in shipments of the drug after the death of a third patient taking a different Sarepta therapy. FDA officials have suggested the company will need to provide new study data on safety to resume Elevidys' use in older patients. 'The FDA will continue to work with the sponsor regarding non-ambulatory patients which remains subject to a voluntary hold following two deaths,' FDA said in its statement.
Yahoo
2 days ago
- Business
- Yahoo
Sarepta will resume gene therapy shipments after FDA review of recent patient death
WASHINGTON (AP) — Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would resume shipping its gene therapy for some patients, following a brief pause requested by regulators. The Food and Drug Administration said it recommended lifting the hold for young patients with Duchenne's muscular dystrophy who are still able to walk. Regulators had requested the pause after the deaths of two older teenagers who were taking the therapy. The FDA also said in a statement it determined that a recently reported death of an 8-year-old boy was unrelated to the therapy. Company shares surged more than 16% after the announcement to $13.86 in afterhours trading. The jump is the latest in a series of drastic stock movements triggered by changing fortunes for the company's best-selling product. Elevidys is the first gene therapy approved in the U.S. for Duchenne's muscular dystrophy, the fatal muscle-wasting disease that affects boys and young men, resulting in early death. It received accelerated approval in 2023 for a narrow range of young patients and was expanded last year for use in older patients, including those who can no longer walk. The FDA decision Monday 'significantly improves Elevidys' sales outlook in the near-term,' Jefferies analyst Andrew Tsai told investors, in a note after the announcement. 'The street will feel relieved about the situation, suggesting meaningful stock upside potential.' Sarepta's therapy has been under scrutiny from regulators after two teenage boys died earlier this year from acute liver injury, a known side effect of the treatment. The FDA then requested a pause in shipments of the drug after the death of a third patient taking a different Sarepta therapy. FDA officials have suggested the company will need to provide new study data on safety to resume Elevidys' use in older patients. 'The FDA will continue to work with the sponsor regarding non-ambulatory patients, which remains subject to a voluntary hold, following two deaths,' FDA said in its statement. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
The Independent
2 days ago
- Business
- The Independent
Sarepta will resume gene therapy shipments after FDA review of recent patient death
Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would resume shipping its gene therapy for some patients, following a brief pause requested by regulators. The Food and Drug Administration said it recommended lifting the hold for young patients with Duchenne's muscular dystrophy who are still able to walk. Regulators had requested the pause after the deaths of two older teenagers who were taking the therapy. The FDA also said in a statement it determined that a recently reported death of an 8-year-old boy was unrelated to the therapy. Company shares surged more than 16% after the announcement to $13.86 in afterhours trading. The jump is the latest in a series of drastic stock movements triggered by changing fortunes for the company's best-selling product. Elevidys is the first gene therapy approved in the U.S. for Duchenne's muscular dystrophy, the fatal muscle-wasting disease that affects boys and young men, resulting in early death. It received accelerated approval in 2023 for a narrow range of young patients and was expanded last year for use in older patients, including those who can no longer walk. The FDA decision Monday 'significantly improves Elevidys' sales outlook in the near-term,' Jefferies analyst Andrew Tsai told investors, in a note after the announcement. 'The street will feel relieved about the situation, suggesting meaningful stock upside potential.' Sarepta's therapy has been under scrutiny from regulators after two teenage boys died earlier this year from acute liver injury, a known side effect of the treatment. The FDA then requested a pause in shipments of the drug after the death of a third patient taking a different Sarepta therapy. FDA officials have suggested the company will need to provide new study data on safety to resume Elevidys' use in older patients. 'The FDA will continue to work with the sponsor regarding non-ambulatory patients, which remains subject to a voluntary hold, following two deaths,' FDA said in its statement. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
