Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
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 another form of muscular dystrophy.
FDA responded on Friday by asking the company to immediately halt all shipments of Elevidys. Company executives initially refused, noting that the latest death was not tied to Elevidys, its best-selling product.
Wall Street analysts said the company made the right decision to cooperate.
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.
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