Shares of Sarepta Therapeutics (SRPT) are set to open sharply lower, plummeting 18.72% in pre-market trading on Wednesday. The significant drop comes in the wake of a double blow to the gene therapy developer: disappointing first-quarter results coupled with lowered revenue guidance, and concerns over a new FDA appointment.

Sarepta reported a larger-than-expected loss for the first quarter of 2025. The company posted an adjusted loss of $3.42 per share, significantly wider than the analyst consensus estimate of a $0.95 loss. Despite reporting revenue of $744.86 million, which beat expectations, Sarepta lowered its 2025 total net product revenues guidance to $2.3 billion to $2.6 billion, down from the previous forecast of $2.9 billion to $3.1 billion. CEO Doug Ingram cited "headwinds" faced by the company, prompting actions to address these challenges.

Adding to the pressure, the U.S. Food and Drug Administration named Dr. Vinay Prasad as the new director of its Center for Biologics Evaluation and Research (CBER), which oversees the regulation of gene therapies and vaccines. Prasad, known for his criticism of the FDA and skepticism towards certain medical practices, raised concerns among investors about potential stricter regulations in the gene therapy sector. This appointment sent shockwaves through the biotech industry, with several gene therapy developers experiencing significant stock declines.