Sarepta CEO Doug Ingram pins gene therapy delay on Covid-burdened FDA, can't offer timeline for fix
There are few dull days when it comes to Sarepta and the FDA.
The muscular dystrophy-focused biotech, whose back-and-forth travails with the agency have stoked controversy, said late Wednesday that the FDA requested a new assay for potency for the Phase III trial of their Duchenne gene therapy, a requirement that could delay the study’s start and set them back in a race with Pfizer. Then yesterday, CEO Doug Ingram said that the pandemic and an overburdened FDA contributed heavily to that delay and that the same factors make it difficult to forecast when they’ll be back on track.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.