Commercial PerformanceElevidys' 1Q24 revenue missed the Street consensus and showed flat quarter-over-quarter sales, indicating potential short-term commercial challenges for the product.
Drug Safety ConcernsPfizer's gene therapy for DMD has been linked to cardiac-related SAEs/death, marking a second reported fatality and raising safety concerns among regulators and investors.
Regulatory HurdlesFDA is seen as unlikely to approve the use of Elevidys for non-ambulatory patients without further data, potentially limiting the drug's market expansion and future revenue growth.