Highest-materiality recent filing
Dyne Therapeutics completes enrollment of ACHIEVE registrational cohort with 71 DM1 patients
Registrational expansion cohort (REC) enrolled 71 participants; topline data expected Q1 2027.
Dyne Q1 net loss $120.9M; BLA for z-rostudirsen on track for Q2 2026
Net loss of $120.9M ($0.73 per share) vs $115.4M ($1.05) in Q1 2025.
Dyne posts FY2025 net loss $446M; z-rostudirsen BLA submission on track for Q2 2026
Net loss $446.2M ($3.47/share) for FY2025 vs $317.4M ($3.37/share) in FY2024; R&D expense $398.3M.
Dyne Therapeutics reports preliminary cash of ~$1.1B as of Dec 31, 2025
Preliminary unaudited cash, cash equivalents and marketable securities of approximately $1.1 billion as of December 31, 2025.
Dyne Therapeutics prices upsized $350M public offering at $18.44/share
Priced 18,980,478 shares at $18.44/share; gross proceeds $350M.
Primary endpoint met: muscle content-adjusted dystrophin expression 5.46% of normal (p<0.0001), replicating 7-fold increase from MAD portion.
Dyne Therapeutics borrows $50M under amended Hercules loan; up to $125M additional available
Borrowed $50M second tranche under amended Loan and Security Agreement with Hercules Capital.
Net loss $108.0M ($0.76/share) vs $97.1M ($0.96/share) in Q3 2024; R&D $97.2M, G&A $16.7M.
FDA Breakthrough Therapy Designation for DYNE-251 in Duchenne MD
FDA granted Breakthrough Therapy Designation to DYNE-251 for DMD amenable to exon 51 skipping.
Dyne Q2 net loss $110.9M extends cash runway into Q3 2027 on $215M offering
Net loss $110.9M ($0.97/sh) vs $65.1M ($0.70) in Q2 2024; R&D expenses $99.2M.
Dyne Therapeutics prices $200M public offering of 24.2M shares at $8.25/share
Gross proceeds of $200M; net proceeds ~$187M ($215.2M if underwriters exercise 30-day option for 3.6M additional shares).
Dyne Therapeutics enters $275M loan agreement with Hercules Capital; $100M funded immediately
Initial tranche of $100M funded on June 27, 2025; additional tranches up to $175M available upon milestones and lender discretion.
FDA Breakthrough Therapy Designation for DYNE-101 in DM1; revised Accelerated Approval path
FDA granted Breakthrough Therapy Designation to DYNE-101 for myotonic dystrophy type 1 (DM1).
Dyne Q1 net loss $115.4M ($1.05/sh); advances DM1 & DMD toward 2026-2027 approvals
Cash $677.5M; expects funding operations into H2 2026.
Dyne Therapeutics appoints Erick Lucera as CFO; outgoing CFO Richard Scalzo to consult
Erick Lucera named CFO and Treasurer, effective March 31, 2025; previously CFO of Editas Medicine and AVEO Pharmaceuticals.
FDA granted Fast Track designation for DYNE-101 in DM1; registrational expansion cohort enrollment planned mid-2025.
Dyne reports $642M cash, positive DYNE-101 DM1 data, H1 2026 submission path
Preliminary cash, equivalents, and marketable securities ~$642M as of Dec 31, 2024 (unaudited).
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.
DYNE-251 (20 mg/kg Q4W) showed mean absolute dystrophin 3.71% of normal (unadjusted), >10x eteplirsen's 0.3% (cross-trial caution).
Dyne Q2 net loss $65.1M, cash $778.8M; ACHIEVE/DELIVER data positive
Q2 2024 net loss $65.1M ($0.70/sh) vs $64.9M ($1.08/sh) in Q2 2023.
Dyne Therapeutics prices $325.5M public offering of 10.5M shares at $31.00 per share
Gross proceeds of $325.5M; net proceeds estimated at $305.4M ($351.4M if underwriters' option is fully exercised).
DYNE-101 5.4 mg/kg Q8W showed 27% mean splicing correction across 22-gene panel at 3 months, all participants responded.
Dyne Therapeutics Q1 net loss $65.6M; cash $453.5M; clinical trials on track for H2 data
Net loss $65.6M ($0.81 per share) vs $44.2M ($0.78) in Q1 2023.
On March 20, 2025, Dyne Therapeutics, Inc. (the “Company”) announced that its Board of Directors (the “Board”) had appointed Erick Lucera as Chief Financial Officer and Treasurer of the Company, effective as of March 31, 2025 (the “Effective Date”).
Jonathan McNeill, M.D., the Company’s Chief Business Officer, and Susanna High, the Company’s Chief Operating Officer, each notified the Company of their intention to resign their employment.
Jonathan McNeill, M.D., the Company’s Chief Business Officer, and Susanna High, the Company’s Chief Operating Officer, each notified the Company of their intention to resign their employment.
Max materiality 0.85 · Median 0.75 · Most common event other_material