Biotechs rally on Vinay Prasad’s exit from FDA

Some biotechs are rallying after it was reported by Stat News and others that Vinay Prasad, a top official at the US Food and Drug Administration, abruptly left the regulator.

Prasad’s sudden departure comes after the FDA’s back-and-forth on whether to allow shipments of Elevidys, a gene therapy for muscular dystrophy made by Sarepta Therapeutics that has been linked to two deaths.

It’s unclear who will replace Prasad or why he left, but the market appears to be pricing in a more drugmaker-friendly regulator to fill his role. Sarepta, Capricor Therapeutics, Replimune Group, Lexeo Therapeutics , UniQure, and others rallied on the news.

Prasad, who joined the agency in June, was characterized in conservative political circles as too strict on drug approval. It’s unclear what exactly his stance was in the Sarepta debacle, but prior to joining the FDA, Prasad harshly criticized the agency for approving the company’s flagship treatment for a type of muscular dystrophy. In recent days, Prasad had been ridiculed by the Wall Street Journal opinion page, which derisively referred to him as “a Bernie Sanders acolyte in MAHA drag,” as well as far-right activist Laura Loomer.