2 biotech stocks plummet more than 25% after the FDA rejects their drug applications
for its hemophilia A gene therapy valoctocogene roxaparvovec. The FDA is requesting more data on the durability of the drug candidate with its primary endpoint being annualized bleeding rate.
The expected timeline of when BioMarin will have the data the FDA is requesting in its CRL will be in late 2021 or early 2022, based on when the last patient will complete the two-year follow-up to its ongoing phase 3 study.Markets InsiderSomething is loading.By clicking ‘Sign up’, you agree to receive marketing emails from Business Insider as well as other partner offers and accept our
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