By Josh Nathan-Kazis

Biotech investors seemed to be taking the sudden departure of a top Food and Drug Administration official late Tuesday as a good sign for the sector, but increasing turmoil at the FDA could worsen the picture for drugmakers over the coming months.

A spokesperson for the Department of Health and Human Services confirmed that Dr. Vinay Prasad, who led the FDA's Center for Biologics Evaluation and Research and was a close ally of FDA Commissioner Dr. Marty Makary, had departed less than three months into his role.

The departure came days after conservative commentators launched attacks on Prasad over the FDA's response to deaths of patients taking Elevidys, a gene therapy from Sarepta Therapeutics that treats Duchenne muscular dystrophy, a fatal and progressive illness.

Sarepta shares were up 15.4% on Wednesday, with Prasad's departure looking like a victory for the company. Other gene therapy stocks were up, too, including uniQure, up 14.5%, and Rocket Pharmaceuticals, up 11%. The SPDR S&P Biotech ETF, which tracks the biotech sector, was up 2.2%.

That investor enthusiasm seems shortsighted.

There's no telling who Makary and health secretary Robert F. Kennedy Jr. will choose to fill the role next, and no assurance they will be more lenient in their regulatory approach, or more friendly to the biotech industry, than Prasad.

What's more, Prasad's departure is yet another disruption for an agency that's been wracked by layoffs and leadership changes, and heightens worries about its ability to hit deadlines for approval decisions.

Even more concerning are the signs of turmoil at CBER in recent weeks, as the agency has whipsawed in its decisions about Sarepta's Elevidys. They point to a heated political environment that could make the routine regulatory work of the FDA increasingly difficult.

Prasad, a hematologist-oncologist who came to the FDA from the University of California San Francisco, had been a combative, controversial voice before entering the agency, known for his harsh criticism of the government response to the Covid-19 pandemic. He replaced Dr. Peter Marks, a well-known career official who had been seen as friendly to biotech.

Once inside the FDA, though, Prasad has been seen by biotech analysts as a generally logical and comprehensible regulator.

"We felt Dr. Prasad thought more rationally (and conservatively) around FDA approvals, requiring sponsors to produce more supporting clinical evidence," Jefferies analyst Andrew Tsai wrote early Wednesday. "As such, events have seemed relatively more predictable under Prasad, as there was a sense of structure, framework, and merit behind CBER's decisions."

With Prasad's departure, everything gets more uncertain. As one of the top officials at the agency, Prasad has been a prominent voice on recent changes to how the agency approves Covid-19 shots, among other policy decisions.

"The lack of continuity in senior leadership at CBER is concerning as it could impact the agency's ability to meet review timelines and could lead to inconsistencies in the regulation of products," William Blair analyst Sami Corwin wrote Wednesday.

The sequence of events surrounding Elevidys in recent weeks, meanwhile, suggests deep internal divisions within the agency amid intense pressure from conservative s.

Worries about the safety of Elevidys had grown in recent months after the deaths of two young patients, and Sarepta voluntarily stopped shipping the treatment for older patients in June. On July 18, following Sarepta's acknowledgment that another patient had died in a trial of a different Sarepta gene therapy, the FDA asked Sarepta to stop all shipments of Elevidys. Sarepta initially refused, but then reversed itself days later, saying on July 21 that it would stop sending all doses of Elevidys.

On July 25, FDA said it was investigating the third death of a patient who had received Elevidys. Sarepta said at the time that the death was unrelated to the patient's treatment.

Meanwhile, conservative commentators targeted Prasad, whose division within FDA was responsible for regulating Elevidys. The Wall Street Journal's editorial board, in a July 27 editorial opposing the shipment halt, wrote that Prasad thinks families "can't be trusted to make their own decisions about risks and benefits." The same day, the Journal's opinion section ran a column that called Prasad "a Bernie Sanders Acolyte in MAHA Drag" in its headline.

A day later, on July 28, the FDA reversed course, announcing it was recommending that Sarepta continue shipping Elevidys for younger patients. Sarepta said it would comply.

The regulatory zigzags are head-scratching, but point to a fracture between positions taken by Prasad, who has advocated higher standards for drug approvals, and the more traditional conservative position that favors giving patients the option of making their own decisions based on evidence.

Prasad didn't respond to a request for comment. A spokesman for HHS said that Prasad "didn't want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family."

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

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July 30, 2025 13:14 ET (17:14 GMT)

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