The U.S. Food and Drug Administration Commissioner Marty Makary confirmed on Friday that Dr. Vinay Prasad, head of its Center for Biologics Evaluation and Research (CBER), is set to leave his position in April.

• Moderna shares are trending higher. Why is MRNA stock advancing?

CBER is responsible for evaluating a wide spectrum of treatments, including cancer drugs, gene therapies and vaccines.

Several controversial decisions marked his tenure.

In May 2025, the FDA Commissioner named Dr. Prasad the next director of CBER. Dr. Prasad had stepped down on July 30. The FDA rehired Prasad in August 2025.

William Blair on Monday wrote that investors are positive on the news, given Dr. Prasad's “idiosyncratic decisions and interventions on drug reviews…”

Stocks To Watch

uniQure N.V. (NASDAQ:QURE) is trading up, given Dr. Prasad's involvement in denying an expedited review path for AMT-130 gene therapy in Huntington's disease, despite substantial patient and clinician lobbying

Regenxbio Inc. (NASDAQ:RGNX) is also up after receiving a CRL for RGX-121 in Hunter syndrome, as the FDA took issue with the validity of external control group usage to support approval.

William Blair analyst Matt Phipps wrote that Dr. Prasad personally signed the CRL; thus, his resignation could be viewed as a tailwind for rare disease sponsors looking to use single-arm studies and external controls as a potential regulatory approval path.

The analyst added that Dr. Prasad played a role in the issuance of the initial refuse-to-file letter for Moderna Inc.’s (NASDAQ:MRNA) mRNA-1010 influenza vaccine BLA filing.

With Dr. Prasad's departure, William Blair wrote that Moderna's mRNA-1010 could qualify for full approval in adults 65 and older. The approval could potentially spare the company from conducting an additional, costly vaccine efficacy study.

Solid Biosciences Inc (NASDAQ:SLDB) stock is up 12.15% at $7.57.

Capricor Therapeutics Inc. (NASDAQ:CAPR) stock is up 9.07%.

• In July, Capricor Therapeutics received an FDA Complete Response Letter (CRL) regarding its Deramiocel BLA, supported by data from the HOPE-2 trial.
• The agency specifically cited the BLA does not meet the statutory requirement for substantial evidence of effectiveness. The FDA said that additional clinical data is needed.
• In December 2025, the company shared the much-awaited topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel.
• Nearly 54% of patients showed slowing of skeletal muscle disease progression, and around 91% patients showed treatment effect on cardiomyopathy (heart function).

Crispr Therapeutics AG (NASDAQ:CRSP) stock is up 2.80% at $58.08.

Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock is up 4.31% at $17.43.

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