Sarepta Therapeutics (Nasdaq: SRPT) has suffered a further share-busting setback over its attempts to gain accelerated US Food and Drug Administration approval for eteplirsen as a treatment for certain patients with Duchenne muscular dystrophy (DMD).
Shares in the US RNA-based drug developer dropped by nearly 50% on Thursday after FDA briefing documents repeated earlier concerns over the strength of its marketing application.
Updated documents have been provided to the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee ahead of its meeting on Monday.
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