FDA slaps a hold on Log­icBio and its gene edit­ing plans — shares tum­ble

The FDA tends to err on the side of cau­tion with new ther­a­peu­tic ap­proach­es. Log­icBio — with its ex­per­i­men­tal tech­nique en­gi­neered to har­ness the cell’s nat­ur­al DNA re­pair process to in­te­grate a cor­rec­tive gene di­rect­ly in­to pa­tients chro­mo­somes — is the lat­est in the agency’s crosshairs.

The com­pa­ny —  which re­cent­ly had a meet­ing with the FDA ahead of its ap­pli­ca­tion to be­gin tri­als in hu­mans with its lead ex­per­i­men­tal ther­a­py for the treat­ment of methyl­malonic acidemia (MMA) — has been slapped with a clin­i­cal hold on the pro­gram, pend­ing the res­o­lu­tion of cer­tain clin­i­cal and non­clin­i­cal ques­tions.

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