secwatch.observer — SEC 8-K summary
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Issuer:     Dyne Therapeutics, Inc. (DYN)
CIK:        0001818794
Form:       8-K
Filed at:   2026-07-29T20:35:16+00:00
Accession:  0001193125-26-323940
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Dyne Therapeutics reports Q2 2026 net loss of $178.6M; BLA for z-rostudirsen accepted with Priority Review
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- Net loss of $178.6M ($1.08 per share) vs $110.9M ($0.97) in Q2 2025.
- BLA for z-rostudirsen (exon 51 DMD) accepted by FDA with Priority Review; PDUFA date Jan 21, 2027.
- Completed enrollment of 71 participants in ACHIEVE registrational expansion cohort for z-basivarsen in DM1; topline data Q1 2027.
- IND cleared for DYNE-302 in FSHD; Phase 1 trial planned.
- Cash, cash equivalents and marketable securities $898.5M as of June 30, 2026; expected cash runway into Q2 2028.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1818794/000119312526323940/0001193125-26-323940-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1818794/000119312526323940/dyn-20260729.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-323940

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer