Every material Form 8-K Dyne Therapeutics, Inc. has filed with the SEC since July 29, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Dyne Therapeutics reported a third-quarter 2026 net loss of $193.6 million, or $1.06 per share, up from $108.0 million, or $0.76 per share, a year earlier. The increase reflects higher research and development and general and administrative costs as the company prepares for a possible U.S. launch of z-rostudirsen, and the filing reports $1.134 billion in cash and marketable securities.
Q3 2026 net loss was $193.6 million, or $1.06 per share, compared with $108.0 million, or $0.76 per share, in Q3 2025.
R&D expenses rose to $161.7 million from $97.2 million, driven by manufacturing for z-rostudirsen and Phase 3 trial costs.
G&A expenses rose to $35.3 million from $16.7 million, mainly for launch preparation and higher headcount.
Cash, cash equivalents and marketable securities were $1.134 billion at September 30, 2026, which the company says will fund operations into Q2 2028.
Dyne Therapeutics reported additional one-year clinical data from the Phase 1/2 ACHIEVE trial of z-basivarsen in myotonic dystrophy type 1 (DM1), based on a pooled group of 25 to 26 participants from several dose cohorts. The company also disclosed a mean baseline hand-opening time of 8.3 seconds for the 71 participants in the registrational expansion cohort, whose topline data are still expected in the first quarter of 2027. The results are not from a single registrational-dose group, and the filing says only 8 of 26 pooled participants received the registrational dose for the full 12 months.
Pooled group's hand myotonia (vHOT) improved 3.2 seconds from baseline at 6 months, versus a 0.4-second increase in the placebo group (N=14).
At 12 months, the pooled group improved 1.2 seconds on the 5xSTS test and 4.8% on the QMT total score relative to baseline.
Only 8 of 26 pooled participants received the 6.8 mg/kg registrational dose for the full 12 months analyzed.
Topline data from the 71-participant registrational expansion cohort are planned for the first quarter of 2027.
Dyne Therapeutics reported a second-quarter 2026 net loss of $178.6 million, or $1.08 per share, up from $110.9 million, or $0.97 per share, a year earlier, as research and development and general and administrative costs rose. The FDA accepted the company's Biologics License Application for z-rostudirsen in exon 51 DMD for review with Priority Review, with a PDUFA target action date of January 21, 2027, and the company expects cash to fund operations into the second quarter of 2028.
Net loss of $178.6 million, or $1.08 per share, for Q2 2026, versus $110.9 million, or $0.97 per share, in Q2 2025.
R&D expenses were $152.2 million versus $99.2 million; G&A expenses were $29.5 million versus $16.6 million.
FDA accepted the BLA for z-rostudirsen in exon 51 DMD with Priority Review; PDUFA target action date is January 21, 2027.
Cash, cash equivalents and marketable securities were $898.5 million at June 30, 2026; a July 2026 offering of 21,045,000 shares at $20.50 per share raised gross proceeds of approximately $431 million.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.
Only material 8-Ks get a brief: results, deals, executive changes, restructuring, impairments, delisting notices, restatements, cybersecurity incidents and other disclosed events. Routine filings (vote results, exhibits only) are skipped. Every Dyne Therapeutics, Inc. filing is on SEC EDGAR ↗. 8-K briefs of other companies →