Sarepta Therapeutics Shares Jump 4.31% After FDA Biologics Chief Resignation
Dr. Vinay Prasad will leave the FDA’s Center for Biologics Evaluation and Research in April, a departure viewed as a regulatory tailwind for gene therapy sponsors relying on single-arm studies. Sarepta Therapeutics shares rose 4.31% to $17.43 on March 9 following the announcement, reflecting investor optimism about potential easing of external control requirements for rare disease drug reviews.
1. CBER Leadership Change
Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research since May 2025, is set to depart in April. His tenure featured notable interventions, including refusal-to-file letters and CRLs on gene therapies such as AMT-130 and RGX-121, prompting investor optimism for smoother future reviews.
2. Tailwind for Gene Therapy Sponsors
Prasad’s resignation is perceived as a catalyst for sponsors seeking approval via single-arm studies and external control data. Analysts highlight that previous denials of expedited pathways and control group methodologies may now face fewer hurdles, potentially accelerating review timelines for rare disease candidates.
3. Market Reaction and Sarepta Outlook
On March 9, Sarepta Therapeutics shares climbed 4.31% to close at $17.43, driven by hopes of regulatory flexibility. Sarepta’s portfolio, including exon-skipping treatments and its emerging micro-dystrophin gene therapy for Duchenne muscular dystrophy, stands to benefit from any relaxation in external control requirements.