Vinay Prasad Returns to FDA as Head of CBER Amid Tensions Over Sarepta's Gene Therapy Treatment

Vinay Prasad is returning to the FDA to lead the Center for Biologics Evaluation and Research. Prasad previously left the agency amid tensions over Sarepta's Duchenne's muscular dystrophy gene therapy treatment. Other gene therapy stocks include Capricor Therapeutics, Taysha Gene Therapies, and MeiraGTx.

WASHINGTON — Vinay Prasad is returning to the Food and Drug Administration (FDA) to resume his role overseeing vaccine, gene therapy, and blood product regulation. According to Health and Human Services spokesman Andrew Nixon, Dr. Prasad will lead the Center for Biologics Evaluation and Research (CBER) at the FDA's request. His return comes weeks after he left the agency amid escalating tensions related to a gene therapy product for Duchenne's muscular dystrophy made by Sarepta Therapeutics and a campaign launched by right-wing influencer Laura Loomer, which criticized Prasad's previous posts describing himself as liberal [1].

Prasad's return to the FDA coincides with significant developments in the gene therapy sector, particularly for Duchenne muscular dystrophy (DMD). Capricor Therapeutics (NASDAQ: CAPR) shares surged 9% following a recent FDA meeting to discuss the regulatory path for its lead cell therapy candidate, Deramiocel. The meeting, scheduled for August 11, 2025, is a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the approval process for Deramiocel, which is aimed at treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [2]. Analysts forecast a 125.88% upside from the current share price, with a current brokerage recommendation of "Outperform."

The Duchenne muscular dystrophy market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. The market size was valued at ~USD 2,150 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034) [3]. Companies like Capricor Therapeutics, Taysha Gene Therapies, and MeiraGTx are among the key players in the market, each developing innovative treatments for Duchenne muscular dystrophy.

References:
[1] https://www.statnews.com/2025/08/09/vinay-prasad-returns-to-the-fda-weeks-after-his-ouster/
[2] https://www.ainvest.com/news/capricor-therapeutics-shares-surge-fda-meeting-announcement-cell-therapy-2508/
[3] https://www.barchart.com/story/news/34000747/duchenne-muscular-dystrophy-market-set-to-grow-substantially-through-2034-delveinsight-projects-sarepta-therapeutics-santhera-pharma-reveragen-biopharma-pfizer-fibrogen-capricor-therapeutics