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Dyne Gets FDA Fast-Track Status for Neuromuscular Product Candidate

Dyne Therapeutics received fast-track designation from the Food and Drug Administration for a treatment of myotonic dystrophy type 1, a neuromuscular disease.

The Waltham, Mass., developer of biotech treatments for muscle diseases said its DYNE-101 product candidate, which is currently being tested in an early-stage Phase 1/2 clinical trial, received the fast-track designation, which the agency uses to expedite development of drugs for unmet needs.

Dyne noted the fast-track status will make its drug eligible for a rolling review, enabling it to submit sections of the Biologic License Application for review as they are ready, rather than the company needing to complete all development steps before receiving input from the FDA.

Dyne anticipates filing for accelerated approval of the treatment in the first half of 2026.

DYNE-101 is an investigational therapeutic for the treatment of DM1, designed based on the principles of the FORCE platform. It consists of a TfR1-binding fragment antibody conjugated to a gapmer antisense oligonucleotide (ASO) designed to target nuclear DMPK RNA for RNAse H-mediated degradation.

"Myotonic dystrophy type 1 is a devastating disease with no approved therapies," said Doug Kerr, chief medical officer of Dyne, in a statement.

Myotonic dystrophy is a genetic condition that causes muscle wasting and other debilitating symptoms.

Shares of Dyne was up 6.2% premarket.

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