earnings
confidence high
sentiment neutral
materiality 0.65
Dyne Therapeutics Q3 net loss $108M; DMD topline data expected Dec 2025; DM1 enrollment delayed to early Q2 2026
Dyne Therapeutics, Inc.
2025-Q3 EPS reported
-$2.74
- Net loss $108.0M ($0.76/share) vs $97.1M ($0.96/share) in Q3 2024; R&D $97.2M, G&A $16.7M.
- Cash $791.9M; reaffirms runway into Q3 2027 covering first commercial launch and BLA submissions.
- Topline data from DELIVER REC (z-rostudirsen in DMD) on track for Dec 2025; BLA submission Q2 2026, launch Q1 2027.
- ACHIEVE REC enrollment (z-basivarsen in DM1) now expected early Q2 2026 (shift from Q4 2025) due to US site activation.
- FDA granted Breakthrough Therapy Designation for z-rostudirsen in Aug 2025; one-year DM1 data presented at WMS.