Dyne Therapeutics reports Q3 net loss $97.1M; IND cleared for DYNE-101; registrational cohort enrolling for DYNE-251

Dyne Therapeutics, Inc.

2024-Q3 EPS reported -$2.49

Net loss $97.1M ($0.96 per share) vs $60.2M ($0.99) in Q3 2023; R&D expenses rose to $92.8M from $55.3M.
FDA cleared IND for DYNE-101 in DM1; Phase 1/2 ACHIEVE trial fully enrolled through 6.8 mg/kg Q8W cohort (56 participants).
New ACHIEVE data (splicing, vHOT, functional measures) expected early January 2025; pursuing accelerated approval using splicing surrogate.
Enrolling 20 mg/kg Q4W registrational cohort (n=32) in DELIVER trial for DMD exon 51; seeks accelerated approval based on dystrophin.
Cash $723.7M at Sept 30, 2024; expected to fund operations at least into H2 2026.

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