JPMorgan analyst Tessa T Romero remains engaged in discussions about Dyne Therapeutics, Inc. (NASDAQ:DYN) and its DYNE-101 program in DM1, addressing questions about the next step and potential value creation.
Romero’s note, issued Thursday, highlights Dyne’s plan to initiate a global Registrational Expansion Cohort in the first half of 2026. This move aims to support a submission for U.S. Accelerated Approval based on biomarker and functional data.
The update follows Dyne’s January announcement of new data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101 in DM1 patients, reinforcing the company’s progress toward key clinical milestones.
“From our perspective, we continue to ponder management’s decision to proceed with the registrational expansion cohort for DM1 without receiving regulatory blessing on the protocol and relying on prior dialogue from May 2024 to pursue an accelerated approval path in the U.S,” Romero writes.
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“Based on our conversations, it seems like investors generally share our sentiment and are looking for regulatory sign-off to gain more comfort,” the analyst added.
Romero still has concerns about the existing data and the absence of a recent update or near-term plans for another data release (the last one was on Dec. 6, 2024).
JPMorgan is also considering how these results might impact the expansion cohort, the confirmatory trial, and the broader competitive landscape.
“Overall, the additional results from the phase 1/2 ACHIEVE trial evaluating DYNE-101 in DM1 raised more questions than answers for us around the emerging clinical profile, and we look for progress that definitively derisks the lead asset and regulatory strategy,” the analyst writes.
JPMorgan maintains the Neutral rating on DYN, lowering the price target from $18 to $17.
Price Action: DYN stock is down 1.6% at $12.06 at the last check Friday.
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