Sarepta (SRPT) PT Lowered to $23 at Baird as FDA Digs in for a Fight on Eteplirsen
Baird analyst Brian Skorney lowered his price target on Sarepta Therapeutic (NASDAQ: SRPT) to $23.00 (from $47.00) following new FDA briefing documents and increased ambiguity around timeline of confirmatory readout. The firm maintained an Outperform rating.
"Despite Sarepta's, advocates', KOLs', and politicians' attempts to convince FDA that the original assessment was inaccurate, the FDA stands firm in new briefing materials.," he commented. "This will only add more fuel to the AdCom fire brewing for April 25. We think eteplirsen will be rejected this go-around, but don't think the door is totally shut."
Upfront, the FDA's docs note that "we do not agree with the applicant's characterization of inaccuracies in the initial FDA briefing document," Skorney notes. "That about sums up the changes to the briefing documents," he said.
The analyst said the most troubling discussion revolves around the natural history data. "Farkas presented a new comparison, which suggests that exon-51 skippable patients may not have a worse prognosis, calling eteplirsen's 6MWD into question. FDA continues to advocate that natural history comparisons on motivation-driven endpoints should be made to placebo patients in controlled trials," he notes.
The analyst notes despite negativity, the FDA is accommodating advocates. "The new agenda incorporates 2.5 hours of open public hearing, following reports of at least 85 applications, and a later adjournment time of 6:30PM EDT," he notes. "During Sarepta's allotted time, Christine McSherry, Executive Director of the Jett Foundation and DMD mom, will speak on the patient perspective."
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Shares of Sarepta Therapeutic closed at $19.71 yesterday.