Zinger Key Points
- BMO forecasts DYNE-101 peak global sales of $4.3 billion by 2035.
- Dyne plans to start a Registrational Expansion Cohort in H1 2026 for potential accelerated approval.
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On Tuesday, BMO Capital Markets initiated coverage on Dyne Therapeutics, Inc. DYN, focused on developing therapies for genetically driven neuromuscular diseases.
The company’s FORCE platform is designed to overcome limitations in delivery to muscle tissue and the central nervous system (CNS).
Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
In January, Dyne Therapeutics revealed new data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101, the company’s lead candidate, in patients with myotonic dystrophy type 1 (DM1).
Dyne plans to begin a global Registrational Expansion Cohort with the potential to support a submission for U.S. Accelerated Approval based on biomarker and functional data in H1 2026.
Dyne leverages TfR1 Fab-conjugation for drug delivery to muscles. TfR1 is highly expressed in muscle cells. BMO analyst Kostas Biliouris acknowledges potential safety risks associated with TfR1-targeting (anemia, hemorrhage, kidney injury) but notes that the safety in Dyne’s clinical data appears acceptable.
Analyst Biliouris says Dyne’s major catalyst and investor debate revolves around the FDA’s decision on the DM1 regulatory pathway, as this dictates whether Dyne could enter the DM1 market concurrently or behind its competitor Avidity Biosciences, Inc RNA
BMO assumes a traditional approval pathway and sees the DM1 market as large enough to accommodate multiple players, and Dyne could differentiate via potential CNS benefits.
BMO has initiated with an Outperform rating and a price target of $50.
The analyst models around $4.3 billion DYNE-101 peak-risk unadjusted WW sales in 2035.
Price Action: DYN stock is up 2.16% at $12.29 at the last check Wednesday.
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