Earnings summaries and quarterly performance for Dyne Therapeutics.
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Dyne Therapeutics Provides Update on DMD and DM1 Programs, Anticipates Key Data and Filings
DYN
Product Launch
Guidance Update
New Projects/Investments
- Dyne Therapeutics is preparing for significant milestones, with DMD registrational data expected this month (December 2025), an anticipated BLA filing in Q2 2026, and a potential launch in early 2027. The DM1 product is projected for a launch in early 2028.
- For its DMD program, the company previously demonstrated mean dystrophin numbers of 3.7% (unadjusted) and 8.7% (muscle-adjusted) at six months, which is substantially higher than the 0.3% historical bar for accelerated approval.
- The company also reported clear and strong functional trends in DMD patients, showing improvement from baseline at six months across measures such as NSAA, SV95C, time to rise, and 10-meter walk-run, with sustained improvement observed at 12 and 18 months.
- Dyne estimates the total US market opportunity for its Exon 51 DMD product to be 1,500-1,600 patients, encompassing current Eteplirsen users, those who discontinued treatment, and untreated patients.
- The company anticipates receiving a Priority Review Voucher (PRV), which has recently been valued at approximately $150 million.
5 days ago
Dyne Therapeutics Provides Updates on DMD and DM1 Programs, Anticipates Key Milestones
DYN
Product Launch
Guidance Update
New Projects/Investments
- Dyne Therapeutics expects to release top-line registrational data for its Duchenne Muscular Dystrophy (DMD) product this month (December 2025), with a Biologics License Application (BLA) filing targeted for Q2 2026 and a potential launch in early 2027.
- The DMD product demonstrated mean dystrophin numbers of 3.7% (unadjusted) and 8.7% (muscle-adjusted) at six months, substantially exceeding the 0.3% historical accelerated approval benchmark.
- The U.S. market for the DMD product is estimated at 1,500-1,600 patients, including current Eteplirsen users, discontinuations, and untreated individuals, with rapid switching anticipated due to strong data and monthly dosing.
- The company expects to secure a Priority Review Voucher (PRV) for the DMD program, which has recently been valued at approximately $150 million.
- For its Myotonic Dystrophy Type 1 (DM1) program, Dyne is currently enrolling a registrational cohort, with a projected launch in early 2028.
5 days ago
Dyne Therapeutics Provides Updates on DMD and DM1 Programs, Regulatory Timelines, and Market Opportunity
DYN
Product Launch
Guidance Update
- Dyne Therapeutics anticipates providing top-line registrational data for its DMD product this month (December 2025) and expects to file a Biologics License Application (BLA) in Q2 2026, with a potential launch in early 2027.
- For its DMD program, the company reported mean dystrophin numbers of 3.7% (not adjusted for muscle content) and 8.7% (adjusted for fat content) at six months, significantly exceeding the 0.3% historical bar for approval. Functional data showed clear trends and improvement from baseline at six months across multiple measures.
- The company estimates a significant market opportunity for its DMD product in the U.S., with approximately 400-500 patients currently on Eteplirsen, 300-400 patients who previously discontinued Eteplirsen, and an additional 800-900 untreated patients.
- Dyne Therapeutics expects to launch its DM1 product in early 2028 and is powered for vHOT (hand myotonia) and splicing correction as primary endpoints in its registrational cohort.
- The company believes it has a good chance of receiving a Priority Review Voucher (PRV), which has recently been valued around $150 million.
5 days ago
Dyne Therapeutics Provides Updates on DMD and DM1 Programs
DYN
Guidance Update
New Projects/Investments
Product Launch
- Dyne Therapeutics expects a DMD data readout for exon 51 in December, with a Biologics License Application (BLA) planned for Q2 2026 and a product launch in early 2027. The company's drug for DMD exon 51 has shown a 3.7% mean dystrophin improvement from baseline at 20 mg/kg, compared to Exondys 51's 0.3%.
- The market for DMD exon 51 encompasses 1,500-1,600 patients, with approximately 400 currently on Exondys 51.
- Enrollment for the DM1 Registrational Expansion Cohort is now projected to conclude in early Q2 2026, a delay from the previous end-of-2025 target, attributed to site capacity challenges. A Phase III study for DM1 is still scheduled to commence in Q1 2026.
- The primary endpoint for accelerated approval for DM1 has been changed to vHOT (video-oculography for hand myotonia) at six months, with the study powered for statistical significance on both vHOT and splicing correction.
- Dyne aims to differentiate its second-generation Fab technology in the market, focusing on CNS, splicing, and safety, and identifies growth opportunities beyond current programs, including other DMD exons and FSHD.
Nov 17, 2025, 3:00 PM
Dyne Therapeutics Provides Updates on DMD and DM1 Programs, Including Data Readouts and Enrollment Delays
DYN
New Projects/Investments
Guidance Update
Product Launch
- Dyne Therapeutics anticipates top-line registrational data for its Duchenne Muscular Dystrophy (DMD) program in December, with a Biologics License Application (BLA) targeted for Q2 2026 and a product launch in early 2027.
- The company's DMD drug for Exon 51 has demonstrated a 3.7% mean change from baseline in dystrophin at 20 mg/kg, significantly higher than the 0.3% seen with Exondys 51.
- Enrollment for the registrational expansion cohort of the DM1 Achieve study has been delayed to early Q2 2026 due to site capacity issues, though the company is closing in on 50% enrollment for the 60-patient cohort.
- A Phase 3 trial for the DM1 program is scheduled to begin in Q1 2026.
Nov 17, 2025, 3:00 PM
Dyne Therapeutics Provides Updates on DMD Data Readout, DM1 Enrollment, and Regulatory Timelines
DYN
Product Launch
Guidance Update
New Projects/Investments
- Dyne Therapeutics anticipates top-line registrational data for its Duchenne Muscular Dystrophy (DMD) program in December and plans to submit a Biologics License Application (BLA) in Q2 2026, aiming for a product launch in early 2027.
- Enrollment for the registrational expansion cohort of the Myotonic Dystrophy Type 1 (DM1) program (Achieve study) is now expected to be completed by early Q2 2026, a delay from the previous timeline, though the Phase 3 trial remains on track to initiate in Q1 2026.
- The company highlighted the DMD Exon 51 market opportunity of 1,500-1,600 patients, noting its drug previously demonstrated a 3.7% mean dystrophin improvement from baseline (unadjusted) at 20 mg/kg, compared to 0.3% for Exondys 51.
- For the DM1 program, the primary endpoint was changed to VIHT at six months, and the registrational expansion cohort was expanded to 60 patients to ensure statistical robustness.
Nov 17, 2025, 3:00 PM
Dyno Therapeutics Unveils Dyno-bn8 AAV Vector for Muscle Gene Therapies
DYN
Product Launch
New Projects/Investments
- Dyno Therapeutics announced Dyno-bn8, a novel AI-designed adeno-associated virus (AAV) gene delivery vector for skeletal and cardiac muscle gene therapies, demonstrating best-in-class potential.
- Non-human primate (NHP) study results showed Dyno-bn8 achieved therapeutic delivery at an exceptionally low dose of 5.2e12 vg/kg, a 25-fold reduction compared to existing therapies, with 81% transduction of skeletal muscle cells and 20% of cardiac cells.
- Dyno-bn8 offers improved safety potential through lower doses and engineered liver detargeting, and is easily manufacturable at large scale, compatible with existing AAV9-based processes.
- This breakthrough capsid is available to license for gene therapy developers and Dyno Frontiers Partners, potentially lowering manufacturing costs for curative gene therapies.
Nov 11, 2025, 3:45 PM
Dyne Provides Updates on DMD, DM1 Programs and Future Pipeline
DYN
Guidance Update
New Projects/Investments
Product Launch
- Dyne's DMD program is fully enrolled in its registrational cohort, pursuing accelerated approval, with top-line data anticipated very soon in December and a potential launch in early 2027.
- The DM1 program is currently enrolling in a registrational cohort for accelerated approval, though enrollment completion has been delayed to early Q2 of next year, with a projected launch in early 2028.
- In Phase 1/2, the DMD program demonstrated 3-4% dystrophin unadjusted (8-9% adjusted), approximately 10 times higher than current commercial drugs, alongside meaningful functional trends.
- The DM1 program showed significant functional improvement, with patients experiencing a 10% increase in strength at six months and 20% at twelve months in quantitative muscle testing.
- Dyne is also developing assets for other DMD exons and is serious about FSHD, with timelines expected in 2026.
Nov 11, 2025, 2:20 PM
Dyne Therapeutics Provides Updates on DMD and DM1 Programs and Future Pipeline
DYN
Product Launch
Guidance Update
New Projects/Investments
- Dyne anticipates top-line data for its DMD registrational cohort in December, with a projected launch in early 2027. Phase 1/2 data showed 3-4% dystrophin unadjusted (8-9% adjusted) and positive functional trends at the 20 mg/kg dose.
- Enrollment for the DM1 registrational cohort (targeting 60 patients) is now expected to be completed in early Q2 of next year (delayed from end of this year), with a projected launch in early 2028. Clinical data has shown 10-20% increases in strength and significant Myotonic Dystrophy Health Index (MDHI) improvement.
- The 20 mg/kg dose for DMD has demonstrated a favorable safety profile across over 1,000 doses and 70 patient years of data, following earlier SAEs observed at the 40 mg/kg dose.
- Dyne estimates the US market for DMD Exon 51 at 1,500-1,600 patients and the DM1 market at 30,000-40,000 patients. The company also plans to initiate two Phase 3 trials in late 2026 and provide timelines for its FSHD program this year.
Nov 11, 2025, 2:20 PM
Dyne Therapeutics Provides Updates on DMD and DM1 Programs and Future Pipeline
DYN
Product Launch
Guidance Update
New Projects/Investments
- Dyne Therapeutics expects top-line data for its Duchenne Muscular Dystrophy (DMD) program in December 2025, with a potential launch in early 2027. Phase 1/2 data previously showed 3-4% dystrophin unadjusted and 8-9% adjusted for muscle content.
- Enrollment for the 60-patient registrational cohort in the Myotonic Dystrophy Type 1 (DM1) program is now projected to be completed by early Q2 2026, a delay from the original target of end of 2025. A Phase 3 trial for DM1 is planned to commence in Q1 2026, with a potential launch in early 2028.
- The company is preparing for potential product launches by building an experienced commercial team and a robust supply chain.
- Dyne is also actively pursuing its Facioscapulohumeral Muscular Dystrophy (FSHD) program and intends to provide timelines for it in 2026.
Nov 11, 2025, 2:20 PM
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