Sarepta Therapeutics: Why Is SRPT Stock Crashing?

Group 1 - Sarepta Therapeutics' stock has dropped over 35% to below $13 after rejecting the FDA's request to halt shipments of Elevidys, following a third death linked to the gene therapy [2][3] - Elevidys accounts for 43% of Sarepta's total revenues and has traditional approval since June 2024 for ambulatory patients, making any regulatory challenges a significant threat to the company's existence [3] - FDA Commissioner Marty Makary's comments indicate a potential forced withdrawal of Elevidys if voluntary compliance is not achieved, raising concerns about the adequacy of recent $400 million restructuring cost savings against potential revenue losses [4] Group 2 - Sarepta's confrontational stance towards federal regulators is creating unprecedented uncertainty in the biotech sector, highlighting poor risk management at a critical regulatory juncture [5] - The situation emphasizes the inherent risks of investing in single stocks, suggesting that professionally managed portfolios may offer a more stable investment approach [5][6] - Regulatory risk is part of a broader risk assessment framework, with the Trefis High Quality Portfolio demonstrating better returns with less risk compared to the S&P 500 over the past four years [6]