Neumora Therapeutics Inc. (NASDAQ:NMRA) on Monday said it is discontinuing development of its lead depression candidate, navacaprant, after two Phase 3 studies failed to achieve statistical significance on both primary and key secondary endpoints in patients with major depressive disorder (MDD).
The clinical-stage biopharmaceutical company said it will now focus on advancing the rest of its pipeline while implementing cost-cutting measures aimed at extending its cash runway.
Phase 3 Studies Fall Short
The Phase 3 KOASTAL-2 and KOASTAL-3 trials enrolled 430 and 422 adults with MDD, respectively.
Both studies evaluated navacaprant 80 mg against placebo, with the primary endpoint measuring change from baseline to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS).
MADRS measures the severity of depressive episodes in patients with mood disorders.
In KOASTAL-2, patients receiving navacaprant recorded a change from baseline of -12.2 compared with -12.0 for placebo, resulting in a least-squares mean difference of -0.3 and a p-value of 0.813.
In KOASTAL-3, patients treated with navacaprant showed a change from baseline of -10.1 versus -10.8 for placebo. The least-squares mean difference was 0.7 with a p-value of 0.480.
The company also reported results from a pre-specified analysis of 426 patients enrolled after study optimizations introduced in early 2025.
In that group, navacaprant and placebo produced identical changes from baseline of -12.1, with a least-squares mean difference of 0.0 and a p-value of 0.976.
Despite the efficacy results, navacaprant was reported to be safe and generally well tolerated, with a safety profile consistent with prior studies.
Neumora Pipeline Priorities Remain Intact
Following the setback, Neumora said it remains focused on advancing several clinical programs.
The company expects to complete a multiple ascending dose cohort study of NMRA-511, a V1a receptor antagonist it is developing for Alzheimer’s disease agitation, in the fourth quarter of 2026.
The results will guide dose selection for a Phase 2b dose-ranging study that the company plans to initiate before year-end.
Neumora also expects to report Phase 1 data for NMRA-898, an M4 positive allosteric modulator for schizophrenia, during the second half of 2026.
The company plans to complete a repeat 13-week rat toxicology study for NMRA-215, its NLRP3 inhibitor for obesity, by mid-2026, provide an update in August 2026, and initiate clinical studies before the end of the year.
Workforce Reduction To Lower Costs For Neumora
Neumora announced plans to reduce its workforce by approximately 35%, a move that the company expects will generate about $10 million in annualized cost savings.
The company expects approximately $2 million in one-time restructuring costs to offset those savings partially.
The company said it expects its current cash and cash equivalents to fund operations into the third quarter of 2027 and support multiple anticipated clinical milestones across its remaining portfolio.
NMRA Price Action: Neumora Therapeutics shares were down 44.86% at $0.98 at the time of publication on Monday, according to Benzinga Pro data.
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