FDA ChallengesThe path to resumption of Elevidys commercialization may be arduous due to additional clinical data requirements by the FDA.
Financial PressureWith $1.1B in outstanding convertible debt due in 2027 and cash totaling only $850M, the lack of an immediate-term revenue driver to fill the ELEVIDYS gap highlights the challenges that Sarepta will face to pay back its debt in two years, putting the company under significant financial pressure in the medium-term.
Safety ConcernsThree patient deaths related to acute hepatotoxicity following treatment have been reported, which might influence FDA's decisions.