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Cowen Weighs In on Sarepta Therapeutics Inc (SRPT) in Light of More Regulatory Setbacks in DMD Field

Cowen analyst Ritu Baral‘s stance on eteplirsen, Sarepta Therapeutics Inc (NASDAQ:SRPT) pipeline drug for Duchenne Muscular Dystrophy, DMD, is unchanged. This comes after Santhera announced that the FDA considered Raxone’s, a competitor’s drug for DMD, data package insufficient for NDA submission.

The FDA required data from Santhera’s “Ph3 SIDEROS trial of Raxone in DMD patients either with or without concomitant glucocorticoid therapy for its NDA filing.” They initially intended to use this data as a “confirmatory study to expand the indication.”

The FDA’s strict stance on the data set they receive shows that the Agency will not be lenient with DMD indication and require a full dataset from appropriate trials. The analyst believes the FDA’s hesitation is due to “the...