Sarepta Therapeutics (NASDAQ: SRPT) experienced a 42% drop in shares on June 16, 2023, following the reported deaths of two patients related to its Duchenne muscular dystrophy gene therapy, Elevidys. Consequently, Sarepta and its partner Roche suspended both commercial and clinical use of Elevidys in non-ambulatory patients amid a safety review.
Elevidys, which had received FDA accelerated approval in June 2023 for ambulatory patients aged 4-5, generated 43% of Sarepta’s revenue last year, with projected peak sales over $3 billion now in jeopardy due to the restrictions. The company’s financial outlook is strained, holding $1.3 billion in debt and a market capitalization of $2.06 billion, alongside negative operating cash flow and net income margins.