Dyne Therapeutics: Strategic Shift to vHOT and FDA Support Bolster Buy Rating

Stifel Nicolaus analyst Paul Matteis has maintained their bullish stance on DYN stock, giving a Buy rating on June 10.

Paul Matteis has given his Buy rating due to a combination of factors that suggest Dyne Therapeutics is on a promising path forward. The company has shifted its primary focus from splicing to vHOT for the DYNE-101 registrational cohort, which is seen as a strategic move that could reduce clinical risk. This pivot is supported by strong vHOT data that surpass previous splicing results, and the recent receipt of Breakthrough Therapy Designation from the FDA indicates regulatory support for this approach.
Additionally, Dyne Therapeutics has announced an upsized study following a Type C meeting with the FDA, aiming for accelerated approval with a revised protocol that leverages vHOT as an intermediate clinical endpoint. This change is expected to streamline the approval process, with data anticipated by mid-2026 and a BLA submission by late 2026. The company’s decision to increase patient enrollment further strengthens the study’s power, and recent data show sustained benefits on vHOT and other functional measures, bolstering confidence in the potential success of the registrational cohort.

In another report released on June 10, Raymond James also initiated coverage with a Buy rating on the stock with a $37.00 price target.