Sarepta Boosted After Muscular Dystrophy Drug Critic Leaves FDA

Ronald Farkas, the head of a clinical review team at the Food and Drug Administration that argued against the approval of Sarepta Therapeutics’ (SRPT) eteplirsen, has reportedly left the agency, according to media reports. Oppenheimer analyst Michelle Gilson told investors that his departure is a positive signal for the company’s Duchenne drug and could mean that a decision is imminent.

DEBATE MAY BE OVER: Following several media reports, Oppenheimer’s Gilson told investors that her checks suggest that Ronald Farkas has indeed left the FDA and is no longer listed in the Department of Health and Human Services employee directory. The analyst believes this is a positive signal for Sarepta’s eteplirsen, for which the company is seeking approval for the treatment of Duchenne muscular dystrophy, since Farkas was largely regarded as an antagonistic figure at the drug’s advisory committee in May.

While the nature of his departure is unclear, Gilson believes he would not voluntarily leave unless the agency had come to a final conclusion in its eteplirsen review. The analyst noted that she continues to expect Sarepta’s Duchenne drug to be approved, and reiterated an Outperform rating on the shares. In a news report earlier.

TheStreet’s Adam Feuerstein voiced a similar opinion, saying Farkas’ departure “could be a sign that the internal agency debate over Sarepta’s drug is coming to an end, with officials advocating for approval getting their way.”

PRICE ACTION: In pre-market trading, shares of Sarepta are up over 14% to $29.25.