-
FDA accepts Dyne's BLA for DYNE-251 in DMD exon 51 skipping; Priority Review granted
FDA accepted BLA for z-rostudirsen (DYNE-251) to treat Duchenne muscular dystrophy amenable to exon 51 skipping.
-
Barry E. Greene elected to Dyne Therapeutics board; receives option for 57,463 shares
Elected as Class I director effective June 22, 2026, to serve until 2027 annual meeting.
-
Dyne Therapeutics expands Hercules debt facility to $400M, borrows $50M on June 16, 2026
Expanded loan facility to aggregate $400M with two new $50M tranches and increased final tranche by $25M.
-
Dyne Therapeutics shareholders approve doubling of authorized shares to 400M
Shareholders elected David Lubner, Brian Posner, Jason Rhodes as Class III directors to three-year terms.
-
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 elects Vikram Karnani as Class II director effective Dec 22, 2025
Vikram Karnani elected to the Board as an independent director; term expires at 2028 Annual Meeting.
-
Dyne Therapeutics prices upsized $350M public offering at $18.44/share
Priced 18,980,478 shares at $18.44/share; gross proceeds $350M.
-
Dyne Therapeutics: DELIVER trial meets primary endpoint; dystrophin 5.46% of normal; BLA submission Q2 2026
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.
-
Dyne Therapeutics Q3 net loss $108M; DMD topline data expected Dec 2025; DM1 enrollment delayed to early Q2 2026
Net loss $108.0M ($0.76/share) vs $97.1M ($0.96/share) in Q3 2024; R&D $97.2M, G&A $16.7M.
-
Dyne Therapeutics elects Brian Posner as Class III director
Brian Posner elected to Board effective Oct 1, 2025; term runs until 2026 annual meeting.
-
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 Therapeutics shareholders elect Hurwitz, Kersten; approve say-on-pay
Edward Hurwitz elected with 62.9M votes for, 27.4M withheld; Dirk Kersten with 58.3M for, 32.0M withheld.
-
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.
-
Dyne Therapeutics reports FY2024 net loss $317.4M; advances DYNE-101 and DYNE-251 toward accelerated approval
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).
-
Dyne Therapeutics reports Q3 net loss $97.1M; IND cleared for DYNE-101; registrational cohort enrolling for DYNE-251
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 upsizes ATM offering from $200M to $300M; $101.2M already sold
Filed prospectus supplement to sell up to $300M common stock via ATM with Jefferies, up from $200M.
-
Dyne Therapeutics initiates registrational cohorts after positive Phase 1/2 DELIVER data; leadership changes
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 shareholders elect three Class I directors, ratify Deloitte as auditor
Carlo Incerti, M.D. elected with 61,028,245 votes for, 8,752,856 withheld, 5,235,919 broker non-votes.
-
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: DYNE-101 achieves 27% splicing correction at 3 months; DYNE-251 shows 3.22% dystrophin expression in DMD
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.
-
Dyne Therapeutics appoints John Cox as President and CEO, succeeding Joshua Brumm
John Cox appointed President and CEO effective March 25, 2024; also elected Class I director.
-
Dyne Therapeutics FY2023 net loss $235.9M; positive DM1/DMD data and $345M offering extend runway to 2025
Q4 net loss $66.6M ($1.09/shr) vs $38.8M ($0.74/shr) YoY; FY2023 net loss $235.9M ($3.95/shr).
-
Dyne Therapeutics prices $300M public offering of 17.15M shares at $17.50/share
Gross proceeds ~$300.1M from 17,150,000 shares; net proceeds ~$281.6M after discounts and expenses.
-
Dyne Therapeutics suspends ATM offering; had raised $92.2M from prior sales
Company notified Jefferies it suspended and terminated the ATM prospectus dated Nov 17, 2021.
-
Dyne Therapeutics announces positive initial clinical data from ACHIEVE and DELIVER trials
DYNE-101 in ACHIEVE trial: 19% mean splicing correction at 3.4 mg/kg at 3 months; 3.8 sec myotonia benefit at 1.8 mg/kg at 6 months.
-
Dyne reports Q3 net loss $60.2M, cash $157.8M; clinical data due Jan 2024
Cash, cash equivalents and marketable securities of $157.8M; funding expected through 2024.
-
Dyne Q2 net loss $64.9M ($1.08/sh); cash $207.7M; clinical data on track for H2 2023
Net loss of $64.9M ($1.08 per share) vs $52.3M ($1.01) in Q2 2022.
-
Dyne Therapeutics director Lawrence Klein resigns; shareholders elect new directors and ratify auditor
Dr. Lawrence Klein resigned from Dyne Therapeutics board effective May 24, 2023, citing no disagreement with the company.
-
Dyne Therapeutics Q1 net loss $44.2M; on track for initial trial data H2 2023
Net loss $44.2M ($0.78/share) vs $35.6M ($0.69) in Q1 2022.
-
Dyne Therapeutics confirms no deposits or accounts at Silicon Valley Bank
Disclosure made on March 10, 2023.
-
Dyne Therapeutics reports FY2022 net loss $168.1M; cash $256M; data readouts H2 2023
Cash, cash equivalents and marketable securities $256.0M as of Dec 31, 2022; expected to fund operations through 2024.
-
Dyne Therapeutics Q3 net loss $41.4M; Phase 1/2 trials for DM1 and DMD underway with data H2 2023
Net loss of $41.4M ($0.80 per share) vs $42.6M ($0.83) in Q3 2021; cash $248.1M funds operations through 2024.
-
Dyne doses first patient in DYNE-251 DMD trial, initiates DYNE-101 DM1 trial, defers FSHD IND
First patient dosed in Phase 1/2 DELIVER trial of DYNE-251 for DMD exon 51 skipping; registrational trial targeting ~46 patients.
-
Dyne Therapeutics Q2 net loss $52.3M; advances DYNE-251 and DYNE-101 trials
Net loss of $52.3M ($1.01 per share) vs. $30.0M ($0.58) in Q2 2021; R&D expenses rose to $46.7M from $23.9M.
-
FDA lifts clinical hold on Dyne's IND for DYNE-251 in Duchenne muscular dystrophy
FDA cleared IND and lifted clinical hold for DYNE-251, targeting exon 51 skipping in DMD.
-
Dyne Therapeutics shareholders elect Hurwitz and Kersten to board, ratify auditor
Edward Hurwitz elected as Class II director: 20,392,039 for, 7,406,127 withheld, 3,170,612 broker non-votes.
-
Dyne Therapeutics Reports Q1 2022 Net Loss of $35.6M and Provides Clinical Milestones
Net loss for Q1 2022 was $35.6 million ($0.69 per share) vs. $25.0 million in Q1 2021.
-
Dyne Therapeutics reports FY2021 net loss $149.3M; cash to H2 2024; pipeline milestones outlined
Net loss of $149.3M for 2021 ($2.93/share) vs $59.4M in 2020; R&D spend $121.3M.