Celgene Corporation (NASDAQ: CELG) stock lost over 9.9% this morning (as of October 19th, 2017; Source: Google finance) as their GED-0301 (mongersen) phase III REVOLVE trial (CD-002) in Crohn’s disease (CD) and the extension trial (SUSTAIN, CD-004) would discontinue.
The group is stopping the trials post an October recommendation of the Data Monitoring Committee, which assessed overall benefit/risk during a recent interim futility analysis.
They are not initiating phase III DEFINE trial (CD-003) in Crohn’s disease and waiting to review the full dataset from the phase II trial with GED-0301 in ulcerative colitis (UC) to determine next steps.
The group is disappointed with the results of REVOLVE, and focusing on their portfolio of novel medicines for patients suffering from this disease and other inflammatory bowel disorders.
On the other side, the STEPSTONE open-label study, ozanimod showed a decent clinical and endoscopic improvements in patients with moderately to severely active Crohn’s disease at week 12. Management reported that the new STEPSTONE findings would further validate their hypothesis of ozanimod in Crohn’s disease and the latest data from the TOUCHSTONE study shows the potential of ozanimod to offer an ongoing efficacy in ulcerative colitis at 92 weeks. Both studies results shows that the group would execute a pivotal studies of ozanimod in Crohn’s disease and ulcerative colitis in hopes of advancing oral treatment options for these patients.
The TOUCHSTONE open-label extension study, ozanimod showed clinically meaningful results in moderately to severely active ulcerative colitis across multiple measures of disease activity through week 92. TOUCHSTONE participants in all three treatment arms made an ongoing open-label extension if they did not respond to treatment post the induction phase, relapsed during the maintenance phase or completed the maintenance phase (170 of the 197 patients). The safety and tolerability profile of ozanimod in both studies has been consistent with their earlier reported studies of ozanimod
Analysts from Robert W. Baird downgraded the stock to “Neutral” as compared to their earlier “Outperform” rating and gave a price target of $136 price target. The group would be releasing their third quarter of 2017 results in the October 26th, 2017.