Celgene halts Phase III trial of mongersen for Crohn's

Celgene Corp. (NASDAQ:CELG) sank $7.41 to $128.55 in after-hours trading Thursday after it said it will discontinue a Phase III trial of mongersen (GED-0301) to treat Crohn’s disease. The company said it will wait to receive full data from a Phase II trial of mongersen in ulcerative colitis (UC) before determining next steps for the antisense oligonucleotide targeting SMAD family member 7 (MADH7; SMAD7).

Celgene will discontinue the Phase III REVOLVE trial and its extension study, SUSTAIN, and will not start the Phase III DEFINE trial to treat Crohn's disease. The decision follows an interim futility analysis and benefit-risk assessment by a DMC. Celgene said the committee did not identify any “meaningful safety imbalances."...