2026-01-20
Dyne Therapeutics
Regulatory Dyne Therapeutics Receives Orphan Drug Designation in Japan for Zeleciment Basivarsen (DYNE-101) for Myotonic Dystrophy Type 1 dyne-tx.com ↗
2025-10-06
Dyne Therapeutics
Results Dyne Therapeutics Announces Additional One-Year Clinical Data Demonstrating Functional Improvement from Phase 1/2 ACHIEVE Trial of Zeleciment Basivarsen (DYNE-101) for Myotonic Dystrophy Type 1 (DM1) dyne-tx.com ↗
2025-06-17
Dyne Therapeutics
Regulatory Dyne Therapeutics Announces FDA Breakthrough Therapy Designation for DYNE-101 and Updated Plan for Accelerated Approval in DM1 Following Type C Meeting dyne-tx.com ↗After our Type C meeting, we were granted Breakthrough Therapy Designation for DYNE-101 in DM1.
2025-01-21
Dyne Therapeutics
Regulatory Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1 dyne-tx.com ↗
2025-01-10
Dyne Therapeutics
Results Dyne Therapeutics Reports New Clinical Data Showing Compelling Impact on Multiple Measures of Myotonic Dystrophy Type 1 (DM1); Dyne Plans to Initiate Registrational Expansion Cohort to Support Potential Submission for U.S. Accelerated Approval for DYNE-101 in DM1 in H1 2026 dyne-tx.com ↗DYNE-101 continued to demonstrate a compelling impact on key disease biomarkers, including DMPK and splicing correction, reversal of disease progression across multiple functional endpoints, and a favorable safety profile.
2024-11-12
Dyne Therapeutics
Regulatory Dyne Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update dyne-tx.com ↗The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for DYNE-101, which is being evaluated in the ongoing, global Phase 1/2 ACHIEVE trial in adults with myotonic dystrophy type 1 (DM1).
2024-05-20
Dyne Therapeutics
Results Dyne Therapeutics Announces New Clinical Data from ACHIEVE Trial of DYNE-101 in DM1 and DELIVER Trial of DYNE-251 in DMD Demonstrating Compelling Impact on Key Disease Biomarkers and Improvement in Multiple Functional Endpoints dyne-tx.com ↗In Phase 1/2 ACHIEVE Trial, DYNE-101 Demonstrated Dose Dependent 27% Mean Splicing Correction Across All Patients in the 5.4 mg/kg Cohort at 3 Months
2024-01-03
Dyne Therapeutics
Results Dyne Therapeutics Announces Positive Initial Clinical Data from ACHIEVE Trial in DM1 Patients and DELIVER Trial in DMD Patients Demonstrating Promise of the FORCE™ Platform in Developing Therapeutics for Rare Muscle Diseases dyne-tx.com ↗In Phase 1/2 ACHIEVE Trial, DYNE-101 Demonstrated Dose-Dependent Splicing Correction, Muscle Delivery and DMPK Knockdown
2023-09-20
Dyne Therapeutics
Regulatory Dyne Therapeutics Receives FDA Orphan Drug Designation for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1 dyne-tx.com ↗today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for DYNE-101 for the treatment of myotonic dystrophy type 1 (DM1).
2023-05-25
Dyne Therapeutics
Regulatory Dyne Therapeutics Receives European Medicines Agency (EMA) Orphan Drug Designation for DYNE-101 dyne-tx.com ↗
2022-07-12
Dyne Therapeutics
Regulatory Dyne Therapeutics Announces Clearance of Clinical Trial Application for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1 dyne-tx.com ↗
2022-05-16
Dyne Therapeutics
Results Dyne Therapeutics Presents New In Vivo Data from DYNE-101 at ASGCT Annual Meeting Demonstrating Low Monthly Dosing Leads to Robust DMPK RNA Knockdown dyne-tx.com ↗These findings combined with previous data demonstrating correction of splicing, support the potential for DYNE-101 to be a disease-modifying therapy with low, infrequent dosing.
2021-09-20
Dyne Therapeutics
Results Dyne Therapeutics Presents New In Vivo Data for its Myotonic Dystrophy Type 1 Candidate (DYNE-101) Demonstrating Robust Splicing Correction During World Muscle Society 2021 Virtual Congress dyne-tx.com ↗In addition, the subcellular fractionation data we generated reinforce that DM1 is a nuclear RNA-driven disease and that DYNE-101 effectively acts in the nucleus.
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