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Neumora's Navacaprant Fails KOASTAL-1 MDD Trial, Shares Drop 83% Despite Female Efficacy Signal

Jan 2, 2025, 12:41 PM

Neumora Therapeutics Inc. announced that its experimental drug, navacaprant, failed to meet the primary and key secondary endpoints in the Phase 3 KOASTAL-1 study for the treatment of major depressive disorder (MDD). The study did not demonstrate a statistically significant improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 or the Snaith-Hamilton Pleasure Scale (SHAPS) score compared to placebo. Despite the overall failure, an efficacy signal was observed in female participants. Following the announcement, Neumora's shares dropped significantly, with the stock declining by as much as 83%. The company, with a cash balance of $342 million as of the end of the third quarter, has a financial runway into mid-2026. Neumora plans to further analyze the results and share updates at the upcoming J.P. Morgan Healthcare Conference. The company is also continuing with two other ongoing Phase 3 trials, KOASTAL-2 and KOASTAL-3, as well as the KOASTAL-LT study, as part of its pivotal program for navacaprant.