MM&M

Dyne Therapeutics’ Duchenne muscular dystrophy treatment shows promise

Dyne Therapeutics’ experimental treatment for Duchenne muscular dystrophy (DMD) showed promise in new data from a small Phase 1/2 trial dubbed DELIVER, the pharma announced this week. The drug, ...
The American Journal of Managed Care

DYNE-251 Granted FDA Breakthrough Therapy Designation for DMD

DYNE-251 received FDA breakthrough therapy designation for DMD, showing promising clinical evidence of improvement over existing therapies. The DELIVER trial demonstrated sustained functional ...
FierceBiotech

Dyne another day: DMD therapy back on track after FDA lifts clinical hold

Duchenne muscular dystrophy-focused Dyne Therapeutics is back on track to move its first asset into the clinic in the coming weeks after the FDA lifted a clinical hold on the drug. The agency hit the ...
Nasdaq

Dyne Therapeutics Announces FDA Breakthrough Therapy Designation for DYNE-101 and Updated Plan for Accelerated Approval in DM1 Following Type C Meeting

- Based on Type C meeting and new data, Dyne submitted revised ACHIEVE trial protocol to FDA elevating vHOT to primary endpoint for U.S. Accelerated Approval - - New positive clinical data from Phase ...