The sudden departure of Vinayak Prasad as director of the FDA's Center for Biologics Evaluation and Research has sent ripples through the cell and gene therapy (CGT) sector. Prasad's tenure, marked by a conservative approach to drug approvals, contributed to controversial rejections including Replimune's skin cancer therapy RP1 and setbacks for Capricor Therapeutics. Analysts forecast potential benefits for CGT developers like Sarepta Therapeutics following his exit, underscoring the significant influence of regulatory leadership on biotech stocks. This development reflects ongoing tensions within the FDA amid leadership changes and differing philosophies on clinical trial standards.