Sarepta (SRPT): Accelerated Approval Seen Pending Dystrophin Data Analysis - Oppenheimer
Oppenheimer analyst, Christopher Marai, reiterated his Outperform rating after Sarepta Therapeutic (NASDAQ: SRPT) announced the FDA has requested dystrophin data (n=13) from ongoing PROMOVI confirmatory trial of eteplirsen, prior to making an approval decision. SRPT indicated to us biopsies have been completed but need to be analyzed, expected to take ~3 weeks (consistent with 180-week biopsy analysis). No change to Outperform rating or $60 PT
The analyst views this request as positive, and consistent with the prior view that FDA is convinced:
1) accelerated approval can be supported by dystrophin production
2) that some dystrophin is better than no dystrophin, and even small amounts (as in the case of exon-44 vs other-exons) can be "reasonably expected" to result in clinical benefit
3) trends in clinical benefit over four years support dystrophin data
They anticipate success, believing dystrophin production data is reproducible and anticipate accelerated approval in next 3 months.
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Shares of Sarepta Therapeutic closed at $16.05 yesterday.