JPMorgan Seeks Readability On Dyne Therapeutics’ DYNE-101 Growth, Regulatory Path – Dyne Therapeutics (NASDAQ:DYN)

JPMorgan analyst Tessa T Romero stays engaged in discussions about Dyne Therapeutics, Inc. DYN and its DYNE-101 program in DM1, addressing questions in regards to the subsequent step and potential worth creation.

Romero’s notice, issued Thursday, highlights Dyne’s plan to provoke a world Registrational Growth Cohort within the first half of 2026. This transfer goals to assist a submission for U.S. Accelerated Approval primarily based on biomarker and practical information.

The replace follows Dyne’s January announcement of recent information from its ongoing Part 1/2 ACHIEVE trial of DYNE-101 in DM1 sufferers, reinforcing the corporate’s progress towards key medical milestones.

“From our perspective, we proceed to ponder administration’s choice to proceed with the registrational enlargement cohort for DM1 with out receiving regulatory blessing on the protocol and counting on prior dialogue from Might 2024 to pursue an accelerated approval path within the U.S,” Romero writes.

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“Based mostly on our conversations, it looks like buyers typically share our sentiment and are in search of regulatory sign-off to achieve extra consolation,” the analyst added.

Romero nonetheless has issues in regards to the current information and the absence of a current replace or near-term plans for an additional information launch (the final one was on Dec. 6, 2024).

JPMorgan can also be contemplating how these outcomes would possibly affect the enlargement cohort, the confirmatory trial, and the broader aggressive panorama.

“Total, the extra outcomes from the part 1/2 ACHIEVE trial evaluating DYNE-101 in DM1 raised extra questions than solutions for us across the rising medical profile, and we search for progress that definitively derisks the lead asset and regulatory technique,” the analyst writes.

JPMorgan maintains the Impartial score on DYN, reducing the value goal from $18 to $17.

Worth Motion: DYN inventory is down 1.6% at $12.06 on the final examine Friday.

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