US biotech Sarepta Therapeutics (Nasdaq: SRPT) lost more than 50% of its market value between mid-July and last week, with an adverse event report and a US Food and Drug Administration (FDA) rejection of Vyondys 53 (golodirsen) contributing to the damage.
The FDA sent Sarepta a Complete Response Letter regarding the New Drug Application (NDA) for Vyondys 53 (golodirsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.
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