Dyne Therapeutics’ DYNE-101 Secures the US FDA’s Fast Track Designation for Treating DM1
Shots:
- The US FDA has granted FTD to DYNE-101 for treating myotonic dystrophy type 1 (DM1). US Accelerated Approval is anticipated to submit in H1’26
- DYNE-101 is being tested in the global P-I/II ACHIEVE trial for DM1
- DYNE-101 is an antisense oligonucleotide (ASO) linked to an antibody fragment (Fab) that targets the transferrin receptor 1 (TfR1) on muscle cells
Ref: Dyne Therapeutics | Image: Dyne Therapeutics
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