RFL - Rafael shares dive 70% after devimistat fails main goal in late-stage adenocarcinoma trial

Rafael Holdings (NYSE:RFL) shares plummeted more than 70% premarket after the company's CPI-613 (devimistat) failed to meet the primary endpoint of significant improvement in overall survival in patients with metastatic adenocarcinoma of the pancreas in a late-stage trial. In the Phase 3 trial, 528 patients were randomized to receive either devimistat in combination with modified FOLFIRINOX ((mFFX)) in the treatment arm or FOLFIRINOX (FFX) alone in the control arm. Devimistat given with mFFX did not significantly improve overall survival (HR=0.95, p=0.66) compared to FFX alone. The median overall survival in the treatment arm was 11.1 months, compared to 11.7 months in the control arm. Devimistat is also being evaluated in a multi-national Phase 3 randomized clinical trial, ARMADA 2000, in patients with relapsed or refractory acute myeloid leukemia (AML). Following a pre-specified interim analysis, the independent data monitoring committee has recommended the trial be stopped due to lack of efficacy. "We are disappointed by the

For further details see:

Rafael shares dive 70% after devimistat fails main goal in late-stage adenocarcinoma trial