Neumora Halts Navacaprant Development After Three Phase III Failures in Major Depressive Disorder, Cuts 35% of Workforce
核心洞察
Neumora Therapeutics is discontinuing navacaprant after all three Phase III Koastal studies failed to meet primary efficacy endpoints in major depressive disorder (搜索).
In the Koastal-3 study, patients on placebo actually outperformed those receiving navacaprant on the MADRS depression rating scale.
The company will reduce its workforce by approximately 35% to achieve $10 million in annual cost savings, extending its cash runway into Q3 2027.
Neumora Therapeutics announced Monday that it will discontinue development of its experimental depression treatment navacaprant after two additional Phase III clinical studies—Koastal-2 and Koastal-3—failed to meet their primary efficacy goals. The decision, which follows the earlier failure of the Koastal-1 study reported at the start of 2025, marks a complete sweep of late-stage trial misses for the kappa opioid receptor (搜索) antagonist in major depressive disorder (搜索) (MDD).
Alongside the program termination, the company revealed plans to reduce its workforce by approximately 35% as part of a broader restructuring initiative aimed at lowering operating expenses.
Koastal Program Yields No Significant Benefit Over Placebo
In both Koastal-2 and Koastal-3, navacaprant did not achieve statistical significance on the primary endpoint—change in patients' Montgomery-Åsberg Depression Rating Scale (MADRS) scores by week 6—nor on key secondary endpoints. Notably, in the Koastal-3 study, patients in the placebo arm actually fared better on the depression rating measure than those receiving navacaprant, the company disclosed.
The Koastal-1 study had previously missed its primary endpoint, triggering an 80% single-day stock decline in early 2025. Following Monday's announcement of the Koastal-2 and Koastal-3 results, Neumora's stock fell an additional 45% to 98 cents, representing a roughly 95% decline from its early 2025 peak.
Restructuring and Pipeline Reprioritization
Chairman and CEO Paul L. Berns stated that Neumora remains "excited" about other near-term catalysts for the biotech's pipeline. With navacaprant discontinued, the company's development portfolio now includes NMRA-511, a V1a receptor (搜索) antagonist being investigated for Alzheimer's disease agitation; NMRA-898 (搜索), an M4 positive allosteric modulator as a potential schizophrenia treatment; and NMRA-215 (搜索), an NLRP3 (搜索) inhibitor targeting obesity and cardiometabolic disease.
The workforce reduction is expected to generate annual cost savings of approximately $10 million, with one-time restructuring expenses estimated at $2 million. Management indicated that these measures will extend the company's cash runway into the third quarter of 2027, strengthening its financial position following the depression program setback.