Dyne: Accelerated Approval Of DYNE-101 Might Be Possible With Surrogate Biomarker
Portfolio Pulse from
Dyne Therapeutics has released positive biomarker and functional data from its phase 1/2 ACHIEVE study for DYNE-101, aimed at treating Myotonic Dystrophy Type 1. The FDA's acceptance of splicing correction as a surrogate biomarker could lead to an Accelerated Approval filing in 2026.
March 13, 2025 | 1:30 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Dyne Therapeutics' DYNE-101 has shown positive results in a phase 1/2 study for Myotonic Dystrophy Type 1. The FDA's acceptance of a surrogate biomarker could lead to Accelerated Approval in 2026.
The positive data from the phase 1/2 study and the FDA's acceptance of a surrogate biomarker significantly increase the likelihood of Accelerated Approval for DYNE-101. This is a positive development for Dyne Therapeutics, potentially boosting investor confidence and stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100