JPMorgan Seeks Clarity On Dyne Therapeutics' DYNE-101 Expansion, Regulatory Path

Benzinga
2025.03.21 17:38
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JPMorgan analysts express concerns over Dyne Therapeutics' DYNE-101 strategy for DM1, citing regulatory uncertainty and investor apprehension regarding data updates. Analyst Tessa T Romero notes plans for a global Registrational Expansion Cohort in 2026 to support U.S. Accelerated Approval, but questions the lack of regulatory approval for the protocol. Investors seek clarity on regulatory sign-off, and Romero highlights the need for definitive progress to alleviate concerns. JPMorgan maintains a Neutral rating on DYN, lowering the price target from $18 to $17, with DYN stock down 1.6% at $12.06.