Pfizer DMD Gene Therapy Phase III Trial Faces A US Delay; Can Sarepta Close The Gap?
Sarepta Hopes To Meet With FDA Midyear
Pfizer disclosed that a Phase III trial for the gene therapy has been unable to start in the US because of questions from the FDA, even while enrollment in 15 sites outside the US is under way.
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Deal Snapshot: Pfizer has 12 months to evaluate a pair of AAV capsids from Voyager’s TRACER platform for use as delivery mechanisms in gene therapy candidates for neurologic and CV indications.
Pfizer said it expects to generate $26bn in annual revenues from the COVID-19 vaccine BNT162b2 and is leveraging the platform to build out a durable business.
After Pfizer saw increased risks in a surveillance study of Xeljanz, three other products have also seen their user fee dates pushed back; if FDA were to convene an expert panel, it could lead to more consistent labeling across the class, as requested in a recent citizen petition.