FDA Issues Clinical Hold On Dyne's IND For Duchenne Muscular Dystrophy Program

The FDA has placed a clinical hold on Dyne Therapeutics Inc's DYN investigational New Drug (IND) application to initiate a clinical trial of DYNE-251 in patients with Duchenne muscular dystrophy (DMD) amenable to skipping exon 51. 

• Dyne received a clinical hold letter from the FDA on Friday, January 14, requesting additional clinical and non-clinical information for DYNE-251. 
• The Company expects to submit to the FDA its response with data from existing and ongoing studies in Q2 of 2022.
• Related: Dyne Therapeutics Highlights New Preclinical Data For Duchenne Muscular Dystrophy Program.
• If satisfactory to the FDA, dosing patients in a Phase 1/2 multiple ascending dose trial of DYNE-251 by mid-2022 per its current guidance.
• As previously announced, the Company expects to submit an IND for DYNE-101 in myotonic dystrophy type 1 (DM1) during Q1 of 2022 and dosing patients in a planned MAD clinical trial mid-2022.
• Price Action: DYN shares are down 15.1% at $7.89 during the market session on the last check Tuesday.