other material
confidence high
sentiment positive
materiality 0.70
Sarepta to initiate pivotal Part B of MOMENTUM study for SRP-5051 in DMD patients
Sarepta Therapeutics, Inc.
- Positive FDA interactions enable early start of Part B of MOMENTUM study for SRP-5051.
- Part B expected to serve as pivotal study seeking accelerated approval for exon 51 skipping DMD patients.
- Study will enroll 20-40 patients, ages 7-21, both ambulatory and non-ambulatory.
- Company anticipates initiating Part B in Q4 2021; protocol submission next week.
- SRP-5051 is a next-generation PPMO therapy; prior Part A data suggested efficacy.