Dyne Therapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2018-01-01
- Employees
- 141
- Market Cap
- $4.4B
- Website
- http://www.dyne-tx.com
- Introduction
Dyne Therapeutics Inc is a biotechnology company focused on providing therapeutics for patients with genetically driven diseases. The company overcomes the limitations of muscle tissue delivery and modern oligonucleotide therapeutics for muscle diseases. The company is developing therapies for muscle disorders like Myotonic dystrophy, Duchenne muscular dystrophy, and Facioscapulohumeral muscular dystrophy. The company's product candidates are DYNE-101 and DYNE-251, both are in the ongoing phase 1/2 clinical trial.
Dyne Plans to Initiate Registrational Expansion Cohort to Support Potential Accelerated Approval
Dyne Therapeutics announced positive clinical data from its Phase 1/2 ACHIEVE trial for DYNE-101 in DM1, showing splicing correction and functional improvements. Plans for a global Registrational Expansion Cohort aim for U.S. Accelerated Approval by H1 2026. DYNE-251 for DMD is also advancing, with data expected late 2025 for potential early 2026 submission.
Dyne Plans to Initiate Registrational Expansion Cohort to Support Potential Submission for DYNE-101 in DM1 and DYNE-251 for DMD
Dyne Therapeutics announced positive clinical data from its Phase 1/2 ACHIEVE trial for DYNE-101 in DM1, showing splicing correction and functional improvements. Plans for a global Registrational Expansion Cohort aim for U.S. Accelerated Approval by H1 2026. DYNE-251 for DMD is also advancing, with data expected late 2025 for potential early 2026 submission.
Dyne Plans to Initiate Registrational Expansion Cohort to Support Potential Submission for Accelerated Approval
Dyne Therapeutics announced positive clinical data for DYNE-101 in DM1, showing splicing correction and functional improvements, aiming for U.S. Accelerated Approval by H1 2026. DYNE-251 for DMD targets accelerated approval with dystrophin as a surrogate endpoint, expecting data late 2025 for early 2026 submission.
Dyne Therapeutics stock tumbles following trial data
Dyne Therapeutics' stock fell 25% despite positive Phase 1/2 ACHIEVE trial results for DYNE-101, targeting myotonic dystrophy type 1, due to investor concerns over 6-month splicing correction data inconsistencies. The company plans for accelerated approval submissions by 2026 and is advancing its DYNE-251 program for Duchenne muscular dystrophy.
Dyne Therapeutics Reports Positive Data From ACHIEVE Study Of DYNE-101 In Myotonic Dystrophy Type 1
Dyne Therapeutics announced positive Phase 1/2 ACHIEVE trial results for DYNE-101 in treating myotonic dystrophy type 1, showing significant impact on disease biomarkers. Plans for a Registrational Expansion Cohort aim for accelerated approval by early 2026.
Dyne Therapeutics, Inc. Announces New Clinical Data from Its Phase 1/2 ACHIEVE Trial for DYNE-101 in DM1 Patients
Dyne Therapeutics announced positive Phase 1/2 ACHIEVE trial results for DYNE-101 in DM1 patients, showing significant biomarker impact, functional improvements, and a favorable safety profile. A global Registrational Expansion Cohort aims for U.S. Accelerated Approval by 2026, based on splicing correction and functional data.
Dyne Therapeutics Advances Clinical Trials for DM1 and DMD
Dyne Therapeutics reports positive Phase 1/2 ACHIEVE trial results for DYNE-101 in treating myotonic dystrophy type 1, with plans for a global Registrational Expansion Cohort aiming for U.S. Accelerated Approval by 2026. The DELIVER trial for DYNE-251 in Duchenne muscular dystrophy also shows favorable safety data, targeting accelerated approval submissions in early 2026.
Dyne Therapeutics Reports New Clinical Data Showing
Dyne Therapeutics announced positive clinical data for DYNE-101 in DM1, showing splicing correction and functional improvements, aiming for U.S. Accelerated Approval by H1 2026. DYNE-251 for DMD targets accelerated approval with dystrophin as a surrogate endpoint, expecting data by late 2025. Both programs aim for regulatory submissions in 2026.
Dyne Plans to Initiate Registrational Expansion Cohort to Support Potential Submission for DYNE-101 in DM1 and DYNE-251 in DMD
The ACHIEVE trial for DYNE-101 in DM1 showed significant splicing correction and functional improvements, with a favorable safety profile. A 6.8 mg/kg Q8W dose was selected for further evaluation, aiming for U.S. Accelerated Approval. DYNE-251 in DMD also demonstrated safety and efficacy, with plans for a Registrational Expansion Cohort.
Dyne Therapeutics presents new data from Phase 1/2 ACHIEVE trial of DYNE-101
Dyne Therapeutics announced positive Phase 1/2 ACHIEVE trial results for DYNE-101 in myotonic dystrophy type 1, showing significant biomarker and functional improvements, and a favorable safety profile. A global Registrational Expansion Cohort is planned for H1 2026, aiming for U.S. Accelerated Approval.
© Copyright 2025. All Rights Reserved by MedPath