Joshua Brumm, Dyne Therapeutics CEO

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.

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