Did The FDA Make A Mistake? Sarepta's Elevidys Approval Under Scrutiny

Core Viewpoint - The FDA is investigating the risk of acute liver failure associated with Sarepta Therapeutics' Elevidys treatment, which has resulted in serious outcomes including hospitalization and death [1][2]. Group 1: FDA Investigation - The FDA has received two reports of fatal acute liver failure in non-ambulatory pediatric male patients with Duchenne Muscular Dystrophy (DMD) following treatment with Elevidys [2]. - The agency is evaluating the need for further regulatory action based on these reports [1]. Group 2: Patient Outcomes - In the reported cases, patients exhibited elevated transaminases and were hospitalized within two months after receiving Elevidys [3]. - Both fatalities appear to be directly related to the treatment with Elevidys [2]. Group 3: Analyst Reactions - HC Wainwright has reiterated a Sell rating for Sarepta, maintaining a price forecast of $10, citing the likelihood of the FDA requiring updated warnings regarding liver failure or death [4]. - The worst-case scenario for Sarepta would involve the FDA mandating the withdrawal of Elevidys from the U.S. market [4][5]. Group 4: Company Valuation - If Elevidys were to be withdrawn, analysts believe there would be little intrinsic value remaining in Sarepta [5]. - The skepticism from FDA officials regarding the initial approval of Elevidys suggests potential challenges for the company's continued marketing efforts [6]. Group 5: Stock Performance - Following the news, Sarepta's stock (SRPT) has seen a decline of approximately 9.96%, trading at $17.09 [6].