Clinical Trial FailuresThe recent failure of the ESSENCE trial could put Vyondys 53 and Amondys 45 at risk of losing marketing authorization.
Market CompetitionElevidys faces continued growth pressure, with a dwindling and increasingly competitive patient pool, while Sarepta is forced to allocate non-revenue-generating doses to safety studies.
Regulatory ChallengesThe FDA's latest label action elevates Elevidys into a heightened-surveillance category, materially weakening the commercial narrative.