FDA's Vinay Prasad Returns, Sending Biotech Stocks Down

Biotech shares have fallen after ousted regulator Vinay Prasad's return to the FDA. Prasad's confrontational approach and overruling of scientific review staff sparked criticism. His return has led to a decline in shares of Sarepta Therapeutics, Capricor Therapeutics, and Replimune Group. Prasad left the FDA in July due to a conservative backlash to his handling of safety issues tied to Sarepta's gene therapy.

Biotech shares have experienced a significant downturn following the news of Vinay Prasad's return to the U.S. Food and Drug Administration (FDA). Prasad, who had been ousted from his position in July, is set to resume his role as the head of the Center for Biologics Evaluation and Research (CBER) [1]. His return has sparked concerns among investors, particularly for companies like Sarepta Therapeutics, Capricor Therapeutics, and Replimune Group, which have seen their shares fall notably.

Prasad's tenure at the FDA was marked by a confrontational approach and his tendency to overrule scientific review staff. These actions drew criticism from various quarters, including conservatives who questioned his alignment with the Trump administration's agenda [2]. His handling of safety issues tied to Sarepta Therapeutics' gene therapy, specifically the gene therapy Elevidys, was a key point of contention. Prasad and FDA Commissioner Marty Makary had requested that Sarepta cease shipping its treatment for Duchenne muscular dystrophy after reports of patient deaths [3].

The return of Prasad has led to a decline in the stock prices of biotech companies. Sarepta Therapeutics' stock dropped by 4.3%, Capricor Therapeutics fell by 7.5%, and Replimune Group experienced a 7% decline in share value [2]. The market's reaction reflects investor concerns about the potential impact of Prasad's regulatory approach on the biopharma industry.

The FDA's regulatory environment is crucial for the biotech sector, and a consistent approach is necessary for the industry to thrive. The frequent turnover in leadership and regulatory changes have raised concerns about the stability and predictability of FDA policies [3]. Prasad's past criticism of the FDA and his involvement in the Sarepta controversy have further fueled these concerns.

Investors and financial professionals are closely monitoring the situation to understand how Prasad's return will affect regulatory policies and the biotech sector. The stability and predictability of FDA regulations are key factors that influence investment decisions in the biotech industry.

References:
[1] https://www.fiercepharma.com/pharma/vinay-prasad-back-fda-after-surprise-ouster-will-he-stay-time
[2] https://www.bloomberg.com/news/articles/2025-08-11/vinay-prasad-s-return-to-fda-sends-biotech-shares-tumbling
[3] https://www.biospace.com/drug-development/sareptas-woes-put-the-stalwart-aav-under-a-harsh-light