Dyne Therapeutics, Inc. Stock Price, News & Analysis

Dyne Therapeutics, Inc. (DYN) announced that DYNE-251, its investigational therapy for Duchenne muscular dystrophy (DMD), received FDA orphan drug and rare pediatric disease designations. This marks a significant step as DYNE-251 undergoes evaluation in the Phase 1/2 DELIVER clinical trial. The trial aims to enroll 46 males aged 4 to 16 with DMD mutations suitable for exon 51 skipping. Initial data is expected in the second half of 2023, focusing on safety and dystrophin levels. DYNE-251 uses a novel delivery method targeting muscle cells, showing promising results in preclinical studies, including a favorable safety profile and effective exon skipping.

Dyne Therapeutics (Nasdaq: DYN) announced key developments during the MDA Clinical & Scientific Conference held March 19-22, 2023. The company showcased its global Phase 1/2 clinical trials, ACHIEVE and DELIVER, evaluating DYNE-101 for myotonic dystrophy type 1 and DYNE-251 for Duchenne muscular dystrophy (DMD), respectively. Initial data from both trials is expected in the second half of 2023. Additionally, the FORCE™ platform demonstrated successful exon skipping and dystrophin restoration in preclinical models, indicating potential for treating DMD. The company aims to address the urgent need for better therapies in muscle diseases.

Dyne Therapeutics, a clinical-stage muscle disease company (Nasdaq: DYN), announced participation in several upcoming investor conferences. Management will engage in virtual fireside chats at the Oppenheimer 33rd Annual Healthcare Conference on March 13, 2023, at 2:40 p.m. ET; Stifel 2023 CNS Days on March 29, 2023, at 11:30 a.m. ET; and Guggenheim Genomic Medicines and Rare Disease Days on April 4, 2023, at 10:10 a.m. ET. live webcasts of these presentations will be available on the company’s website, with replays accessible for 90 days. Dyne focuses on innovative therapeutics for genetically driven muscle diseases, leveraging its FORCE™ platform.

On March 2, 2023, Dyne Therapeutics reported its fourth quarter and full year 2022 financial results, highlighting progress in its clinical trials for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD). The company holds a cash position of $256 million, expected to fund operations through 2024. R&D expenses increased to $142.8 million from $121.3 million year-over-year. Meanwhile, the net loss for Q4 2022 was $38.8 million, down from $51.8 million in Q4 2021. Significant clinical data readouts are anticipated in the second half of 2023, which may influence the company’s growth potential and stock performance.

Dyne Therapeutics (Nasdaq: DYN) announced that CEO Joshua Brumm will present at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 3:00 p.m. PT (6:00 p.m. ET) in San Francisco, CA. The presentation will be available via live webcast on Dyne's website, with a replay accessible for 30 days afterward. Dyne focuses on developing innovative therapeutics for genetically driven muscle diseases using its FORCE™ platform, targeting conditions like myotonic dystrophy type 1, Duchenne muscular dystrophy, and facioscapulohumeral muscular dystrophy.

Dyne Therapeutics (DYN) reported third quarter 2022 financial results, highlighting the initiation of clinical trials for its lead candidates, DYNE-101 and DYNE-251. The ACHIEVE trial for DM1 and the DELIVER trial for DMD are currently underway, with data expected in the second half of 2023. As of September 30, 2022, cash and equivalents totaled $248.1 million, projected to fund operations through 2024. Net loss was $41.4 million, or $0.80 per share, showing a slight improvement from a loss of $42.6 million in Q3 2021. The FDA granted Fast Track designation for DYNE-251.

Dyne Therapeutics, a clinical-stage company focused on muscle disease treatment, will present at several key investor conferences in November 2022. These include the Credit Suisse 31st Annual Healthcare Conference on November 9, Jefferies London Healthcare Conference and Stifel 2022 Healthcare Conference on November 16, and the Piper Sandler 34th Annual Healthcare Conference on November 29. Live webcasts of these presentations will be available on Dyne's investor website for 90 days.

Dyne Therapeutics (Nasdaq: DYN) announced today the FDA has granted Fast Track designation for DYNE-251, targeting Duchenne muscular dystrophy (DMD) mutations suited for exon 51 skipping. This designation aims to expedite DYNE-251's development, which is currently evaluated in the Phase 1/2 DELIVER trial. Results are anticipated in H2 2023, focusing on safety, tolerability, and dystrophin levels. DYNE-251 aims to address a critical need in DMD treatment, enhancing access to therapies with potentially transformative effects in muscle signaling and function.

Dyne Therapeutics (DYN) presented preclinical data for its Duchenne muscular dystrophy (DMD) programs at the World Muscle Society Congress. Key findings from the DYNE-251 candidate include robust exon skipping and dystrophin expression in animal models. Notably, dystrophin levels reached 90% in the diaphragm and 77% in the heart. The FORCE platform targets exon skipping for DMD mutations, with additional conjugates for other exons. Dyne anticipates reporting clinical data from the Phase 1/2 DELIVER trial in H2 2023, focusing on safety, tolerability, and dystrophin levels.