- Rafael Holdings Inc's RFL Rafael Pharmaceuticals Inc announced that the AVENGER 500 Phase 3 trial for CPI-613 (devimistat) did not meet its primary endpoint of significant improvement in overall survival in pancreatic cancer patients.
- Data from 528 patients showed the median overall survival of 11.1 months in the treatment arm, compared to 11.7 months in the control arm.
- Devimistat is also being evaluated in a Phase 3 trial in patients with relapsed or refractory acute myeloid leukemia (AML).
- After a pre-specified interim analysis, the independent data monitoring committee has recommended that the trial be stopped due to lack of efficacy.
- "We are disappointed by the results of these two Phase 3 trials with devimistat. We plan to work in collaboration with Rafael Pharmaceuticals to evaluate the data further," said Ameet Mallik, CEO, Rafael Holdings Inc.
- Price Action: RFL shares are down 79.90% at $6.06 during the market session on the last check Thursday.
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