Chardan Capital Markets Reiterates Buy Rating on Dyne Therapeutics (DYN)

Chardan Capital Markets analyst Keay Nakae reiterated a Buy rating and $50.00 price target on Dyne Therapeutics (NASDAQ: DYN)

The analyst comments "Dyne announced additional safety and efficacy data in the phase I/ II DELIVER trial of DYNE-251 in DMD patients amenable to exon 51 skipping in a poster presentation at the Muscular Dystrophin Association Clinical and Scientific Conference. DYN-251 utilizes Dyne's proprietary FORCE design platform to leverage the selectivity of a Fab against TfR1, conjugated to a PMO, facilitating RNA therapeutics for targets outside the liver to the muscle and CNS. Dyne's updated functional data follow the 20mg/kg cohort out to 12 months, and 10 mg/kg cohort out to 18 months (with the 10mg/kg cohort's dose being increased to 20mg/kg after 12 months). Both groups outperform placebo in the Stride Velocity 95th Centile (SV95C) with the latest data demonstrating that the stride velocity remains stable between months 12 and 18 in the treated patients (Exhibit 1). Recall, SV95C is a digital objective outcome measure of ambulatory performance accepted as a primary endpoint for DMD clinical trials in Europe. Other functional improvements were also observed in the NSAA, timed rise from floor and timed 10-meter walk/run test, which demonstrated concordant sustained improvements over placebo (Exhibit 2). While these changes don't seem to correlate perfectly with dose, with the 20mg/kg showing a weaker effect compared to the 10mg/kg dose at some timepoints, there is decent concordance with improvements across both cohorts, which is maintained out to 18 months. The updated safety data showed that DYNE-251 has an acceptable safety profile, with no increases in Treatment Emergent Adverse Events (TEAEs) in the 10 mg/kg or 20 mg/kg cohorts since November 2024 cutoff, and one new TEAE in the 40 mg/kg cohort which Management attributed to the patient having pneumonia and unrelated to DYNE-251 treatment (Exhibit 3). We are encouraged by the data for DYNE-251 to date and believe that the Company remains well positioned to secure regulatory approval for this indication. The Company is moving forward with the 20mg/kg Q4W dose for the registrational cohort of DYNE-251, which has now completed enrollment of 32 patients randomized 3:1. Based on recent feedback from the FDA, Dyne continues to pursue U.S. Accelerated Approval based on dystrophin as a surrogate endpoint. Dyne has shown a 3.27% increase in exon 51 skipping in the 20mg/kg cohort at month 6 in the phase I/II with an 8.72% increase in dystrophin expression (adjusted for muscle content and normalized to myosin heavy chain)."

For an analyst ratings summary and ratings history on Dyne Therapeutics click here. For more ratings news on Dyne Therapeutics click here.

Shares of Dyne Therapeutics closed at $12.05 yesterday.

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