Shares of Sarepta Therapeutics (SRPT) plummeted 25.93% in intraday trading on Tuesday, following the U.S. Food and Drug Administration's (FDA) announcement of a key appointment that has sent shockwaves through the gene therapy sector.
The FDA named Dr. Vinay Prasad, an oncologist known for his criticism of the agency and his skepticism towards COVID-19 vaccine mandates, as the new director of its Center for Biologics Evaluation and Research (CBER). This crucial role oversees the regulation of vaccines, gene therapies, and blood supply, raising concerns among investors about the future regulatory landscape for companies like Sarepta, which specializes in gene therapies.
The appointment appears to have triggered a broader sell-off in the gene therapy and vaccine sectors. Other companies in the space, such as Moderna, Pfizer, and smaller gene therapy developers like Taysha Gene Therapies, also experienced significant stock declines. The market reaction suggests widespread uncertainty about how Dr. Prasad's appointment might influence the approval and regulation of gene therapies going forward, potentially impacting Sarepta's product pipeline and future prospects.