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H.C. Wainwright reiterated its Buy rating and $38.00 price target on Dyne Therapeutics (NASDAQ:DYN) Wednesday following the company’s regulatory and trial updates for its DYNE-101 program. Currently trading at $10.86, the stock appears undervalued according to InvestingPro analysis, with analysts setting targets ranging from $14 to $66.
The research firm highlighted several factors that may have led to the consideration of visual hand opening time (vHOT) as an endpoint for accelerated approval of DYNE-101. While CASI (a measure of splicing correction) might reflect treatment effect, the FDA may not be convinced of a direct relationship between CASI and patient function. The company, with a market capitalization of $1.23 billion and a beta of 1.16, has seen its shares decline by approximately 67% over the past year.
H.C. Wainwright noted that DM1 (myotonic dystrophy type 1) is a heterogeneous disease, which introduces variability across patients and potential ambiguity in predicting trial outcomes. The firm pointed to consistent impacts on vHOT across the clinical landscape, including data from Avidity, PepGen, and Dyne’s 6.8 mg/kg dosing.
DYNE-101 demonstrated approximately 40% improvement in vHOT at 6 months relative to baseline, which H.C. Wainwright indicated was similar to results shown in proof-of-concept trials by competitors. The firm suggested this consistency might explain why the FDA sees potential in vHOT as an endpoint.
The increase in Dyne’s registrational expansion cohort to 60 patients allows for sufficient statistical power for vHOT specifically while enabling detection of trends in secondary endpoints, according to H.C. Wainwright. The firm believes having vHOT as a primary endpoint for accelerated approval is encouraging for Dyne’s clinical and commercial strategy. InvestingPro data shows the company maintains a "Fair" overall financial health score, with particularly strong cash flow metrics. Discover more detailed financial insights and exclusive ProTips about Dyne Therapeutics with an InvestingPro subscription.
In other recent news, Dyne Therapeutics announced that its investigational treatment DYNE-101 for myotonic dystrophy type 1 (DM1) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The company plans to pursue Accelerated Approval following new data from its ACHIEVE clinical trial, with expectations to complete enrollment by the fourth quarter of 2025. Oppenheimer analysts have assumed coverage of Dyne Therapeutics with an Outperform rating and set a price target of $34, noting progress in its DM1 and Duchenne muscular dystrophy (DMD) programs. Evercore ISI has also initiated coverage with an Outperform rating and a $46 price target, highlighting increased confidence in Dyne’s Accelerated Approval pathway for DM1. Stifel analysts maintain a Buy rating with a $66 target, following discussions with Dyne’s management about the company’s regulatory and clinical advancements. H.C. Wainwright adjusted its price target to $38, reflecting ongoing regulatory discussions and trial expansions for DYNE-101. These developments underscore significant regulatory and clinical progress for Dyne Therapeutics in its pursuit of advancing treatments for genetic disorders.
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