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Dyne Therapeutics, Inc. (DYN) filed an 8-K current report with the SEC on September 29, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Additional one-year MAD data for DYNE-101 in the Phase 1/2 ACHIEVE trial for myotonic dystrophy type 1.
Dyne Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Additional one-year MAD data for DYNE-101 in the Phase 1/2 ACHIEVE trial for myotonic dystrophy type 1
- Mean baseline video hand-opening time disclosed for ACHIEVE registrational expansion cohort participants
- Press release and clinical data presentation furnished as Exhibits 99.1 and 99.2
Item 8.01 · Other Events
- One-year pooled ACHIEVE data showed sustained improvements in myotonia, function, strength and patient-reported outcomes
- vHOT improved 3.2 seconds at six months versus 0.4-second worsening for placebo, a 3.6-second relative improvement
- At 12 months, 5xSTS improved 1.2 seconds, 10MWR 0.3 seconds and QMT measures 4.8% predicted
- MDHI total score improved 25.2% at 12 months, including six central-nervous-system subscales
- No related serious treatment-emergent adverse events; ACHIEVE REC topline data expected Q1 2027 for potential accelerated-approval filing in Q3 2027
Item EX-99.1 · Exhibit EX-99.1
- One-year Phase 1/2 data strengthen z-basivarsen’s efficacy case across myotonia, function, strength and patient-reported outcomes
- vHOT improved 3.2 seconds at 6 months versus 0.4-second worsening on placebo, a 3.6-second relative benefit
- At 12 months, 5xSTS improved 1.2 seconds, 10MWR improved 0.3 seconds and QMT scores improved 4.8% predicted
- MDHI total score improved 25.2%, including CNS-related subscales; no related serious treatment-emergent adverse events identified
- Key catalyst remains Q1 2027 ACHIEVE REC topline data, potentially supporting U.S. Accelerated Approval submission in Q3 2027
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