Coverage LimitationsThere could be a considerable lack of coverage for the nonambulatory and older DMD patient populations, leading to a limited total addressable market (TAM) for ELEVIDYS.
Payer RejectionsSome payers have rejected label expansion coverage for Elevidys beyond the initial label population of ambulatory DMD patients ages 4-5.
Study Design ConcernsUpdated Elevidys Phase 3 EMBARK results draw questions, raising concerns about the effectiveness of the study's design.