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Dyne Therapeutics Granted Breakthrough Therapy Designation

Story Highlights
  • Dyne Therapeutics received FDA Breakthrough Therapy Designation for DYNE-101 in DM1.
  • Dyne updated its plan for U.S. Accelerated Approval of DYNE-101, with trial revisions and new data.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Dyne Therapeutics Granted Breakthrough Therapy Designation

Elevate Your Investing Strategy:

Dyne Therapeutics ( (DYN) ) has issued an update.

On June 17, 2025, Dyne Therapeutics announced that the FDA granted Breakthrough Therapy Designation to DYNE-101 for treating myotonic dystrophy type 1 (DM1). Following a Type C meeting with the FDA and analysis of new long-term data, Dyne updated its plan for obtaining U.S. Accelerated Approval for DYNE-101. The company has revised the ACHIEVE trial protocol, elevating video hand opening time (vHOT) as the primary endpoint. The Registrational Expansion Cohort of the ACHIEVE trial will enroll 60 participants and aims to support a potential Accelerated Approval submission in late 2026. New long-term data from the trial showed sustained improvements in myotonia and other endpoints, with DYNE-101 demonstrating a favorable safety profile. Dyne also updated its cash runway guidance, expecting sufficient funds to support operations into the fourth quarter of 2026.

The most recent analyst rating on (DYN) stock is a Buy with a $46.00 price target. To see the full list of analyst forecasts on Dyne Therapeutics stock, see the DYN Stock Forecast page.

Spark’s Take on DYN Stock

According to Spark, TipRanks’ AI Analyst, DYN is a Neutral.

Dyne Therapeutics’ stock score reflects its current financial health as a pre-revenue biotech, burdened by losses but supported by a strong balance sheet and recent strategic leadership changes. Technical indicators suggest bearish trends, yet the potential for future breakthroughs could alter its trajectory.

To see Spark’s full report on DYN stock, click here.

More about Dyne Therapeutics

Dyne Therapeutics, Inc. is a clinical-stage company focused on developing treatments for genetically driven neuromuscular diseases. The company is actively working on DYNE-101, an investigational therapeutic aimed at treating myotonic dystrophy type 1 (DM1), utilizing an antisense oligonucleotide conjugated to a fragment antibody for targeted delivery to muscle and the central nervous system.

Average Trading Volume: 2,598,104

Technical Sentiment Signal: Sell

Current Market Cap: $1.57B

Find detailed analytics on DYN stock on TipRanks’ Stock Analysis page.

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