tiprankstipranks
Trending News
More News >
Advertisement
Advertisement

Dyne Therapeutics Gains FDA Breakthrough Designation for DYNE-251

Story Highlights
Dyne Therapeutics Gains FDA Breakthrough Designation for DYNE-251

Elevate Your Investing Strategy:

  • Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.

Dyne Therapeutics ( (DYN) ) just unveiled an update.

On August 4, 2025, Dyne Therapeutics announced that the FDA granted Breakthrough Therapy Designation to DYNE-251 for treating Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping. This designation, based on data from the DELIVER clinical trial, highlights DYNE-251’s potential to significantly improve treatment outcomes by enabling the production of near full-length dystrophin. The designation provides Dyne with enhanced FDA support, including priority review eligibility, which could expedite the drug’s development and approval process. Dyne has completed enrollment for the DELIVER trial’s expansion cohort, with data expected in late 2025 and a potential Biologics License Application submission anticipated in early 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 is a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Average Trading Volume: 2,929,391

Technical Sentiment Signal: Sell

Current Market Cap: $1.43B

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

Disclaimer & DisclosureReport an Issue

Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App
1