@Davisite over at IMU posted about a new lead at the FDA having...

@Davisite over at IMU posted about a new lead at the FDA having a chilling effect on biostocks:

FDA chooses Dr. Vinay Prasad to lead biologics, vaccines division

Biotech stocks tumbled more than 5% in the hours after the announcement as industry analysts called Prasad an “anti-establishment” choice and noted that he has also questioned the FDA’s used of accelerated approval processes for certain medicines.

Sarepta Therapeutics, manufacturer of one of those accelerated new medicines, saw its stock fall by nearly a quarter. Prasad has been critical of the FDA’s decision to approve Sarepta’s Elevidys, a multimillion-dollar gene therapy to treat Duchenne muscular dystrophy, despite what he saw as limited evidence of its benefits.

Prasad co-wrote a post last year that said, “Despite its high cost and potential toxicity, the clinical benefits of Elevidys remain uncertain.”

Under his leadership, the biologics division could bring more scrutiny and requirements to developers creating new gene therapies. Earlier this year, Prasad said he wanted to see more stringent reviews, writing on X that “The FDA did nothing to speed gene therapy, other than talk about how they will use uncontrolled endpoints. But we want to speed effective gene therapy, not ineffective gene therapy. The FDA had no solution for that.”

Biotech stocks were “nearly as weak” Tuesday as they were the day after President Trump announced that Kennedy would lead HHS, Mizuho Group analyst Jared Holz wrote in a note to investors.