Shares of Celgene Corp. (CELG) were down 7.7% to $125.50 in premarket trading on Friday, Oct. 20, after the Summit, N.J.-based firm said Thursday that it was discontinuing the GED-0301 (mongersen) Phase 3 Revolve study in Crohn’s disease and the extension trial.
Celgene made the decision following the recommendation of the data-monitoring committee, which evaluated the overall benefit/risk during a recent interim futility analysis. “There were no meaningful safety imbalances identified in the analysis,” the company said.
Celgene also said that at this time the Phase 3 Define study in Crohn’s disease will not be initiated.
“CELG discontinued GED-0301 and we expect stock to trade down — though widespread buyside expectations were low on this program already,” Jefferies LLC Michael J. Yee wrote in a Thursday note.
Yee added that Celgene’s third-quarter results “become important next week” and he expects an increasing focus on potential M&A and other key Phase 3 assets. Celgene is scheduled to release its third-quarter numbers on Oct. 26.
Meanwhile, shares of Organovo Holdings Inc. (ONVO) rose 12.9% to $1.58 after the San Diego firm presented preclinical data that show survival and sustained functionality of its 3D bioprinted human liver tissue when implanted into diseased animal models.
In other news, RedHill Biopharma Ltd. (RDHL) said the U.S. Food and Drug Administration has given orphan drug designation to Mesupron (upamostat) for the adjuvant treatment of pancreatic cancer. The company’s American depositary receipts were up 8.8% to $9.55.