Shares of Sarepta Therapeutics jumped 25% on Monday as a backing by the U.S. health regulator's advisers increased the certainty of an accelerated approval for the company's gene therapy for a muscle-wasting genetic disorder.
jumped 25% on Monday as a backing by the U.S. health regulator's advisers increased the certainty of an accelerated approval for the company's gene therapy for a muscle-wasting genetic disorder.
"We are increasingly optimistic that SRP-9001 will be granted accelerated approval, especially as the panel voted in concordance with how we think senior leaders at the agency view the application," said SVB Securities analyst Joseph Schwartz. TD Cowen analyst Ritu Baral expects an approval for the therapy, especially considering the FDA leadership's interest in promoting biomarker-based accelerated approvals for gene therapies.in March the regulator is moving to encourage the use of disease-related biomarkers that may predict efficacy for gene therapies for diseases with small patient populations rather than waiting for definitive proof of patient benefit.
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