Analysts downgraded Sarepta as FDA pause on Elevidys raises regulatory uncertainty, leading to significant stock pressure and valuation cuts.

Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug ...

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the ...

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...

Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty Makary’s pick to be the nation’s top drug regulator.

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators. The company said late Monday ...

Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an unrelated drug.

The FDA appears to have won its staring contest with Sarepta over shipments of Elevidys, after the company blinked and agreed ...

Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.