Dyne shares fall 14.66% after Novartis DM1 trial misses primary endpoint

  • Novartis reported that its global Phase 3 HARBOR study failed to meet its primary endpoint.
  • 14.66%: Dyne shares fell to $20.72 at publication, according to Benzinga Pro data.
  • Dyne plans additional ACHIEVE data presentations and topline registrational-cohort data in the first quarter of 2027.

Dyne Therapeutics shares fell after Novartis reported that its global Phase 3 HARBOR study of del-desiran for myotonic dystrophy type 1 (DM1) failed to show a statistically significant improvement over placebo on video hand opening time (vHOT), the trial’s primary endpoint and a measure of hand myotonia. Dyne is developing z-basivarsen, also known as DYNE-101, an antisense oligonucleotide (genetic-targeting drug) linked to an antigen-binding fragment that binds transferrin receptor 1 to deliver treatment to muscle and the central nervous system. The company plans to present additional one-year ACHIEVE data at two medical meetings, while topline data from its blinded registrational expansion cohort are planned for the first quarter of 2027. Dyne has also begun the Phase 3 HARMONIA trial, designed to support traditional U.S. approval and ex-U.S. marketing applications.

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