An­oth­er Duchenne clin­i­cal hold gets lift­ed, this time at Dyne Ther­a­peu­tics

Clin­i­cal holds have ham­pered a host of tri­als test­ing treat­ments for Duchenne mus­cu­lar dy­s­tro­phy, but one biotech is get­ting the go-ahead to start its study five and a half months af­ter the ini­tial road­block.

The FDA cleared Dyne Ther­a­peu­tics’ first clin­i­cal tri­al in boys with a cer­tain type of Duchenne mus­cu­lar dy­s­tro­phy, the Mass­a­chu­setts biotech said Tues­day morn­ing, send­ing shares $DYN up near­ly 10% be­fore the open­ing bell. The reg­u­la­tor had re­quest­ed more clin­i­cal and non-clin­i­cal in­for­ma­tion back in Jan­u­ary, but the biotech has been mum on de­tails of what ex­act­ly the agency want­ed to look at be­fore sign­ing off on the Phase I/II tri­al.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER