Dyne Therapeutics (DYN) PT Lowered to $50 at H.C. Wainwright

H.C. Wainwright analyst Andrew Fein lowered the price target on Dyne Therapeutics (NASDAQ: DYN) to $50.00 (from $60.00) while maintaining a Buy rating.

The analyst commented: "We recently did a KOL event on DM1 “Taking a Scientific Approach to Understand DM1 and DMD Therapeutic Landscape” which raised a question, does the vHOT-centric design of the ACHIEVE REC and the forthcoming Phase 3 trial create a structural gap between what FDA requires for accelerated approval and what payers will actually reimburse? Note that vHOT measures hand-opening time as a proxy for myotonia, and it was agreed upon with FDA in the Type C meeting as the path to accelerated approval. The problem, as our KOL framed it, is that myotonia is not the burden that most DM1 patients actually care about. In fact a meaningful proportion of patients have adapted to their myotonia to the point where they neither complain about it nor reliably take existing myotonia treatments when prescribed. Therefore, our KOL thought that asking payers to reimburse a chronic therapy on the back of a myotonia improvement signal alone is a difficult commercial ask. EMA, in particular, is expected to look well beyond vHOT before granting broad market access. We revisit our PoS assumptions for DM1 for now, as we wait for the Phase 3 trial design update in the upcoming MDA conference, which reduces our PT from $60 to $50."

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