Washington – Shares of drug manufacturer Sarepta Therapeutics continued to drown on Tuesday, as the company said it would comply with a food and drug administration request to prevent the shipment of its gene therapy after the deaths of several patients.
Decision declared late Monday night, the FDA regulators by the company come only a few days after the rebuke in a very unusual decision that worried the investors and analysts.
Sarpta CEO Dag Ingram said that the company wants a “productive and positive” relationship with the FDA and “needs this temporary suspension to maintain that productive work relationship.”
The company at Cambridge, Massachusetts stated that it would “temporarily stop all shipments” of her gene therapy elevidis for a business close to business on Tuesday.
It is the latest in a series of highly irregular moves that shaved the company’s shares for weeks and forced it to close hundreds of employees.
Alidis’ first gene therapy in the US is approved in the US for ducchain muscle dystrophy, which is a deadly muscle-rebellion disease that affects boys and young men, resulting in early deaths. One -time treatment was initially approved for the age of 4 and less than the age of the boys that could still walk. Last year, the FDA expanded approval to older patients that are no longer able to walk.
After the death of two teenage boys after the death of two teenage boys from a known side effects of treatment, therapy was already under the FDA investigation. The company then revealed a third death with a separate therapy last week: a 51 -year -old patient who was nominated for a company testing for a other form of muscle dystrophy.
The FDA on Friday asked the company to stop all the appearance of elevidis immediately. Company officials initially refused, given that the latest death was not tied to Alidis, its best selling products.
Wall Street analysts said the company took the right decision to cooperate.
TD Cowen analyst Ritu Bral on Tuesday told investors in a note on Tuesday, “Defining the FDA would cause irreplacement to the company’s relationship with the FDA under the current leadership and administration. ,
Baral estimated that the break in distribution would last for three to six months.
The FDA has the right to pull drugs from the market, but the process may take months or years. Instead, the agency usually makes an informal request and companies almost always comply. Even in rare cases when drug manufacturers have not cooperated, the FDA has become strong after public hearing and appeal.
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