other material
confidence high
sentiment positive
materiality 0.85
Dyne reports $642M cash, positive DYNE-101 DM1 data, H1 2026 submission path
Dyne Therapeutics, Inc.
- Preliminary cash, equivalents, and marketable securities ~$642M as of Dec 31, 2024 (unaudited).
- DYNE-101 in DM1: 6.8 mg/kg Q8W dose showed robust splicing correction at 3 months and sustained functional improvements.
- DYNE-101 safety: 855 doses administered, >72 patient-years follow-up; no related serious TEAEs.
- Plans ~32-patient Registrational Expansion Cohort for DYNE-101 in mid-2025; U.S. accelerated approval submission targeted H1 2026.
- DYNE-251 for DMD exon 51: FDA supports dystrophin as surrogate endpoint; data from 20 mg/kg cohort expected late 2025.