Dyne Therapeutics, Inc. Stock Price, News & Analysis

Dyne Therapeutics (Nasdaq: DYN) has received FDA Fast Track designation for DYNE-101, their treatment candidate for myotonic dystrophy type 1 (DM1). The designation follows positive clinical data from their ongoing Phase 1/2 ACHIEVE global trial, which showed substantial functional benefits and splicing correction in patients.

The company plans to submit for U.S. Accelerated Approval in H1 2026. The Fast Track status enables more frequent FDA communications, rolling review of marketing applications, and potential eligibility for Accelerated Approval and Priority Review. This development pathway aims to expedite the delivery of DYNE-101 to DM1 patients, for whom there are currently no approved therapies.

Dyne Therapeutics (DYN) has announced significant progress in its Phase 1/2 ACHIEVE trial of DYNE-101 for myotonic dystrophy type 1 (DM1). The company plans to initiate a global Registrational Expansion Cohort with a 6.8 mg/kg Q8W dose, targeting a potential U.S. Accelerated Approval submission in H1 2026.

The clinical data showed substantial functional benefits across multiple measures, including DMPK knockdown, splicing correction, and improvements in myotonia, strength, and mobility. The trial demonstrated a favorable safety profile across 56 patients, with most adverse events being mild or moderate.

The company will proceed with a placebo-controlled Registrational Expansion Cohort including approximately 32 patients. Additionally, Dyne reported progress on DYNE-251 for Duchenne muscular dystrophy, pursuing U.S. Accelerated Approval with dystrophin as surrogate endpoint, with data expected in late 2025.

Dyne Therapeutics (Nasdaq: DYN), a clinical-stage neuromuscular disease company, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. John Cox, the company's president and chief executive officer, will deliver a presentation on Wednesday, January 15, 2025, at 10:30 a.m. PT (1:30 p.m. ET).

The presentation will be accessible through a live webcast on the Investors & Media section of Dyne's website. Interested parties can view the replay for 30 days after the presentation through the company's investor relations portal at investors.dyne-tx.com.

Dyne Therapeutics focuses on developing innovative life-transforming therapeutics for individuals affected by genetically driven diseases.

Dyne Therapeutics (Nasdaq: DYN) has announced plans to release new clinical data from its Phase 1/2 ACHIEVE clinical trial on January 10, 2025. The company will host a webcast and investor conference call at 8:00 a.m. ET on the same day, with a press release to be issued before the event. The presentation will be accessible through the Events & Presentations page on Dyne's website, with a replay available for 90 days afterward. An accompanying slide presentation will also be provided for investors.

Dyne Therapeutics (DYN) reported Q3 2024 financial results and clinical progress. The FDA cleared the IND application for DYNE-101, currently in Phase 1/2 ACHIEVE trial for DM1 with 56 participants. New trial data is expected in January 2025. The company is enrolling a registrational cohort for DYNE-251 at 20 mg/kg following positive efficacy data in DMD patients. Financial highlights include cash position of $723.7 million, R&D expenses of $92.8 million, and net loss of $97.1 million ($0.96 per share) for Q3 2024.

Dyne Therapeutics (Nasdaq: DYN), a clinical-stage muscle disease company, has announced its participation in three major upcoming investor conferences. The company will participate in fireside chats at the Guggenheim Inaugural Healthcare Innovation Conference on November 13 in Boston, the Stifel 2024 Healthcare Conference on November 19 in New York, and the Piper Sandler 36th Annual Healthcare Conference on December 3 in New York. Live webcasts of all presentations will be available on Dyne's website, with replays accessible for 90 days.

Dyne Therapeutics (Nasdaq: DYN) is presenting data at the 29th Annual Congress of the World Muscle Society, showcasing the potential of its FORCE™ platform for neuromuscular diseases. Key highlights include:

1. DYNE-251 for DMD: Demonstrated dose-dependent exon skipping, dystrophin expression, and functional improvements. The 20 mg/kg cohort showed 3.7% mean absolute dystrophin expression (8.7% adjusted for muscle content).

2. DYNE-101 for DM1: Exhibited robust muscle delivery, dose-dependent splicing correction, and improvements in myotonia, muscle strength, and patient-reported outcomes.

3. DYNE-302 for FSHD: Preclinical data showed durable DUX4 suppression and functional benefits in a mouse model.

4. Pompe disease: Preclinical data demonstrated potential for enzyme replacement therapy delivery to muscle and CNS.

Both DYNE-251 and DYNE-101 have shown favorable safety profiles in clinical trials.

Dyne Therapeutics (Nasdaq: DYN), a clinical-stage muscle disease company, has announced its participation in Chardan's 8th Annual Genetic Medicines Conference. The event is scheduled to take place in New York on Monday, September 30, 2024. Dyne's management team will engage in a fireside chat at 2:00 p.m. ET.

The company, which focuses on developing innovative life-transforming therapeutics for people with genetically driven diseases, will provide a live webcast of the presentation. Interested parties can access the webcast through the Investors & Media section of Dyne's official website. For those unable to attend the live event, a replay will be available for 90 days following the presentation.

The Schall Law Firm, a national shareholder rights litigation firm, is investigating potential securities law violations by Dyne Therapeutics, Inc. (NASDAQ:DYN). The investigation stems from Dyne's September 3, 2024 press releases, which announced positive clinical data from its DELIVER trial for DYNE-251 in Duchenne muscular dystrophy patients. However, on the same day, the company revealed that its CMO, COO, and CBO were stepping down. This news caused Dyne's stock to plummet by 30.7%, significantly impacting investors. The Schall Law Firm is encouraging affected shareholders to participate in the investigation and discuss their rights.