Dazucorilant

Dazucorilant, a cortisol modulator, failed to slow ALS progression in a Phase 2 trial, showing no significant difference over placebo. Gastrointestinal side effects were more common with dazucorilant. Five deaths occurred in the placebo group compared to none in the high-dose group. Participants are now in an open-label extension study. Complete results will be presented at a scientific conference next year.

Corcept Therapeutics announced results from the DAZALS study, a Phase 2 trial evaluating dazucorilant in ALS patients. The study did not meet its primary endpoint, but showed fewer deaths in the 300 mg arm compared to placebo. An open-label extension study will continue, with overall survival assessed in 2025. Dazucorilant has Fast Track Designation from the FDA.

Corcept announced results from the DAZALS Phase 2 trial of dazucorilant in ALS patients, which did not meet its primary endpoint. Dazucorilant showed more gastrointestinal upset and no deaths in the 300 mg arm vs. 5 in placebo. An open-label extension study continues, with overall survival to be assessed in March 2025. Dazucorilant has Fast Track Designation by the FDA.

Corcept Therapeutics reports Q3 2024 revenue of $182.5M, up 48% YoY, and increases 2024 revenue guidance to $675-$700M. Net income per share is $0.41 (diluted), with cash and investments at $547.6M. The company plans to submit an NDA for relacorilant this quarter, supported by Phase 3 GRADIENT trial results.