Business
Dyne Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights
- Recent Data from ACHIEVE Trial of DYNE-101 in DM1 and DELIVER Trial of DYNE-251 in DMD Demonstrated Compelling Impact on Key Disease Biomarkers and
About this update from Dyne Therapeutics, Inc.
[{"type":"text","content":"- Recent Data from ACHIEVE Trial of DYNE-101 in DM1 and DELIVER Trial of DYNE-251 in DMD Demonstrated Compelling Impact on Key Disease Biomarkers and Improvement in Multiple Functional Endpoints - - Strengthened Balance Sheet with $374 Million Public Offering Extending Projected Cash Runway At Least Into the Second Half of 2026 - WALTHAM, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the second quarter of 2024 and recent business highlights. “The second quarter of 2024 was an exciting one for our clinical programs and pipeline. We reported new clinical data from our ACHIEVE and DELIVER trials, demonstrating meaningful impact on key biomarkers and functional improvements that reflect best-in-class potential. We are evaluating the clinical profile of different dose and dose regimens with the goal of transforming treatment for individuals living with DM1 and DMD. Based on our compelling clinical data and productive regulatory interactions, we continue to pursue expedited approval pathways and plan to provide an update on the path to registration for both programs by year-end,” said John Cox, Dyne’s president and chief executive officer. “Additionally, we highlighted the modularity of our FORCE™ platform with the presentation of robust preclinical data supporting our FSHD program, and for the first time, showed the ability of our platform to deliver enzyme replacement therapy to muscle and CNS in a Pompe disease model. We also strengthened our balance sheet to support the promise of our portfolio.” Recent Highlights and Anticipated Milestones Phase 1/2 ACHIEVE Trial of DYNE-101 in myotonic dystrophy type 1 (DM1) In May 2024, Dyne reported positive clinical data from the ongoing ACHIEVE trial of DYNE-101 in adult patients with DM1. Efficacy data were based on 40 adult DM1 patients, including 12-month data from the 1.8 mg/kg Q4W (approximate ASO dose) cohort, 6-month data from the 3.4 mg/kg Q4W cohort, and 3-month data from the 5.4 mg/kg Q8W cohort.DYNE-101 demonstrated robust muscle delivery and dose-dependent, consistent splicing correction while also showing improvement in myotonia, muscle strength, and timed ...