Latest news with #Sarepta Therapeutics
CTV News
19 minutes ago
- Business
- CTV News
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File) WASHINGTON — Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following several patient deaths. The decision, announced late Monday, comes just days after the company rebuffed FDA regulators in an extremely unusual decision that alarmed investors and analysts. Sarepta CEO Doug Ingram said the company seeks a 'productive and positive' relationship with FDA and that 'maintaining that productive working relationship required this temporary suspension.' The Cambridge, Massachusetts-based company said it would ' temporarily pause all shipments' of its gene therapy Elevidys for muscular dystrophy at the close of business Tuesday. It's the latest in a series of highly irregular moves that have rocked company shares for weeks and forced it to lay off hundreds of staffers. 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. The one-time treatment was initially approved for boys age 4 and younger who could still walk. Last year, FDA expanded approval to older patients who are no longer able to walk. The therapy was already under FDA scrutiny after two teenage boys died earlier this year from acute liver injury, a known side effect of the treatment. Then the company last week disclosed a third death with a different therapy: a 51-year-old patient who was enrolled in a company trial for a another form of muscular dystrophy. FDA responded by asking the company to immediately halt all shipments of Elevidys. Wall Street analysts said the company made the right move. Defying the FDA would have 'irreparably damaged the company's relationship with FDA under the current leadership and administration,' TD Cowen analyst Ritu Baral told investors in a note Tuesday. Baral estimated the pause in distribution would last three to six months. The FDA has the authority to pull drugs from the market, but the process can take months or even years. Instead, the agency usually makes an informal request and companies almost always comply. Even in the rare cases when drugmakers haven't cooperated, the FDA has prevailed after public hearings and appeals. ___ Matthew Perrone, The Associated Press
Yahoo
an hour ago
- Business
- Yahoo
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
WASHINGTON (AP) — Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following several patient deaths. The decision, announced late Monday, comes just days after the company rebuffed FDA regulators in an extremely unusual decision that alarmed investors and analysts. Sarepta CEO Doug Ingram said the company seeks a 'productive and positive' relationship with FDA and that 'maintaining that productive working relationship required this temporary suspension.' The Cambridge, Massachusetts-based company said it would ' temporarily pause all shipments' of its gene therapy Elevidys for muscular dystrophy at the close of business Tuesday. It's the latest in a series of highly irregular moves that have rocked company shares for weeks and forced it to lay off hundreds of staffers. 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. The one-time treatment was initially approved for boys age 4 and younger who could still walk. Last year, FDA expanded approval to older patients who are no longer able to walk. The therapy was already under FDA scrutiny after two teenage boys died earlier this year from acute liver injury, a known side effect of the treatment. Then the company last week disclosed a third death with a different therapy: a 51-year-old patient who was enrolled in a company trial for a another form of muscular dystrophy. FDA responded by asking the company to immediately halt all shipments of Elevidys. Wall Street analysts said the company made the right move. Defying the FDA would have 'irreparably damaged the company's relationship with FDA under the current leadership and administration,' TD Cowen analyst Ritu Baral told investors in a note Tuesday. Baral estimated the pause in distribution would last three to six months. The FDA has the authority to pull drugs from the market, but the process can take months or even years. Instead, the agency usually makes an informal request and companies almost always comply. Even in the rare cases when drugmakers haven't cooperated, the FDA has prevailed after public hearings and appeals. ___ 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. Matthew Perrone, The Associated Press
Al Arabiya
an hour ago
- Business
- Al Arabiya
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following several patient deaths. The decision announced late Monday comes just days after the company rebuffed FDA regulators in an extremely unusual decision that alarmed investors and analysts. Sarepta CEO Doug Ingram said the company seeks a productive and positive relationship with FDA and that maintaining that productive working relationship required this temporary suspension. The Cambridge Massachusetts-based company said it would temporarily pause all shipments of its gene therapy Elevidys for muscular dystrophy at the close of business Tuesday. It's the latest in a series of highly irregular moves that have rocked company shares for weeks and forced it to lay off hundreds of staffers. 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. The one-time treatment was initially approved for boys age 4 and younger who could still walk. Last year FDA expanded approval to older patients who are no longer able to walk. The therapy was already under FDA scrutiny after two teenage boys died earlier this year from acute liver injury–a known side effect of the treatment. Then the company last week disclosed a third death with a different therapy: a 51-year-old patient who was enrolled in a company trial for another form of muscular dystrophy. FDA responded by asking the company to immediately halt all shipments of Elevidys. Wall Street analysts said the company made the right move. 'Defying the FDA would have irreparably damaged the company's relationship with FDA under the current leadership and administration,' TD Cowen analyst Ritu Baral told investors in a note Tuesday. Baral estimated the pause in distribution would last three to six months. The FDA has the authority to pull drugs from the market, but the process can take months or even years. Instead, the agency usually makes an informal request and companies almost always comply. Even in the rare cases when drugmakers haven't cooperated, the FDA has prevailed after public hearings and appeals.
Yahoo
an hour ago
- Business
- Yahoo
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
WASHINGTON (AP) — Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following several patient deaths. The decision, announced late Monday, comes just days after the company rebuffed FDA regulators in an extremely unusual decision that alarmed investors and analysts. Sarepta CEO Doug Ingram said the company seeks a 'productive and positive' relationship with FDA and that 'maintaining that productive working relationship required this temporary suspension.' The Cambridge, Massachusetts-based company said it would ' temporarily pause all shipments' of its gene therapy Elevidys for muscular dystrophy at the close of business Tuesday. It's the latest in a series of highly irregular moves that have rocked company shares for weeks and forced it to lay off hundreds of staffers. 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. The one-time treatment was initially approved for boys age 4 and younger who could still walk. Last year, FDA expanded approval to older patients who are no longer able to walk. The therapy was already under FDA scrutiny after two teenage boys died earlier this year from acute liver injury, a known side effect of the treatment. Then the company last week disclosed a third death with a different therapy: a 51-year-old patient who was enrolled in a company trial for a another form of muscular dystrophy. FDA responded by asking the company to immediately halt all shipments of Elevidys. Wall Street analysts said the company made the right move. Defying the FDA would have 'irreparably damaged the company's relationship with FDA under the current leadership and administration,' TD Cowen analyst Ritu Baral told investors in a note Tuesday. Baral estimated the pause in distribution would last three to six months. The FDA has the authority to pull drugs from the market, but the process can take months or even years. Instead, the agency usually makes an informal request and companies almost always comply. Even in the rare cases when drugmakers haven't cooperated, the FDA has prevailed after public hearings and appeals. ___ 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. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Independent
an hour ago
- Business
- The Independent
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following several patient deaths. The decision, announced late Monday, comes just days after the company rebuffed FDA regulators in an extremely unusual decision that alarmed investors and analysts. Sarepta CEO Doug Ingram said the company seeks a 'productive and positive' relationship with FDA and that 'maintaining that productive working relationship required this temporary suspension.' The Cambridge, Massachusetts-based company said it would ' temporarily pause all shipments' of its gene therapy Elevidys for muscular dystrophy at the close of business Tuesday. It's the latest in a series of highly irregular moves that have rocked company shares for weeks and forced it to lay off hundreds of staffers. 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. The one-time treatment was initially approved for boys age 4 and younger who could still walk. Last year, FDA expanded approval to older patients who are no longer able to walk. The therapy was already under FDA scrutiny after two teenage boys died earlier this year from acute liver injury, a known side effect of the treatment. Then the company last week disclosed a third death with a different therapy: a 51-year-old patient who was enrolled in a company trial for a another form of muscular dystrophy. FDA responded by asking the company to immediately halt all shipments of Elevidys. Wall Street analysts said the company made the right move. Defying the FDA would have 'irreparably damaged the company's relationship with FDA under the current leadership and administration,' TD Cowen analyst Ritu Baral told investors in a note Tuesday. Baral estimated the pause in distribution would last three to six months. The FDA has the authority to pull drugs from the market, but the process can take months or even years. Instead, the agency usually makes an informal request and companies almost always comply. Even in the rare cases when drugmakers haven't cooperated, the FDA has prevailed after public hearings and appeals. ___ 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.
