Doug Ingram, Sarepta CEO (Sarepta Therapeutics)

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.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA