Sarepta Therapeutics (SRPT) experienced a significant pre-market plunge of 11.74% on Monday, as investors reacted to news affecting gene therapy developers. The sharp decline comes amidst broader concerns in the biotechnology sector, particularly those focused on gene therapies.

The catalyst for this downturn appears to be the return of Dr. Vinay Prasad to his role as the top vaccine regulator at the U.S. Food and Drug Administration (FDA). Dr. Prasad's reputation for stringent regulatory oversight has sparked apprehension among investors about potential challenges for gene therapy approvals and ongoing clinical trials.

Sarepta Therapeutics, known for its focus on genetic medicines for rare diseases, may face increased scrutiny under Dr. Prasad's leadership at the FDA. This development has led to a sell-off not only in Sarepta's stock but also in other gene therapy companies, reflecting market concerns about the regulatory environment for these cutting-edge treatments. Investors will be closely watching for any statements from Sarepta or further details about the FDA's regulatory stance in the coming days.