Hailshadow Sarepta Therapeutics ( NASDAQ: SRPT ), which markets drugs for Duchenne muscular dystrophy (DMD), traded higher in the premarket Thursday following three consecutive sessions of losses after Pfizer ( NYSE: PFE ) said its candidate for the neuromuscular disorder failed in a Phase 3 trial. In a press release late Wednesday, New York-based Pfizer ( PFE ) said its gene therapy candidate, fordadistrogene movaparvovec, did not reach the primary endpoint in boys aged 4–7 years with DMD. Pfizer ( PFE ) shares moved marginally lower following the announcement, while Sarepta ( SRPT ) inched higher on low volumes.
Elevidys, a gene therapy developed by Sarepta ( SRPT ) with Roche ( OTCQX:RHHBY ) ( OTCQX:RHHBF ), is currently under FDA priority review. In June 2023, the FDA granted accelerated approval for Elevidys with a narrower-than-expected label for children aged 4–5 with DMD. The FDA decision on whether to grant the one-time therapy full approval with a broader label is expected on or before June 21, 2024.
More on Pfizer, Roche, etc. Pfizer: Headwinds Dissipating, New Obesity Pipeline Update Coming Soon Pfizer Inc. (PFE) CEO Albert Bourla presents at Goldman Sachs 45th Annual Global Healthcare Conference (Transcript) Pfizer: Surging Cancer Rates Will Boost Revenues Pfizer Duchenne muscular dystrophy gene therapy fails in phase 3 Pfizer, Flagship to collaborate on obesity drug discovery.
