Neumora Plunges After Depression Drug Fails in Final-Stage Study
Thursday, Jan 2, 2025 8:36 am ET
Neumora Therapeutics, Inc. (NASDAQ: NMRA) shares plummeted on Tuesday following the announcement of disappointing results from its Phase 3 KOASTAL-1 Study of navacaprant for major depressive disorder (MDD). The study failed to meet its primary endpoint, showing no statistically significant improvement in depressive symptoms compared to placebo as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.

The study, which enrolled 383 patients, also missed its key secondary endpoint, with no significant difference between the drug and placebo in the change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) score. However, the drug was generally well-tolerated, with no serious adverse events reported.
The failed trial is a significant setback for Neumora, as navacaprant was positioned as the company's lead asset. The company's stock price fell by more than 32% during the week, closing at $10.79 on Thursday, according to data provided by S&P Global Market Intelligence. Neumora's market cap now stands at $1.71 billion, with a cash balance of $342 million as of Q3 2024, providing runway into mid-2026.
The gender-stratified analysis from the study revealed an intriguing data point: female participants showed a trending benefit (-14.0 vs -11.4 placebo) and statistically significant improvement in anhedonia (p=0.015). However, male participants paradoxically performed worse than placebo. This stark gender difference suggests potential biological mechanisms that warrant deeper investigation.

Neumora Therapeutics' executive vice president, head of research and development, Rob Lenz, expressed disappointment in the results but emphasized the need to investigate the gender-specific response pattern. "We are disappointed by the results from KOASTAL-1 as they were not consistent with the body of evidence supporting this mechanism in MDD. There is a lot to investigate from this study, in particular the contrast in drug and placebo responses in depressed mood and anhedonia in female participants compared to male participants," Lenz said.
The failed trial may impact Neumora's partnerships and collaborations in the neuroscience and biotech sectors, potentially leading to a reassessment of existing partnerships and reduced attractiveness to potential partners. The company may need to consider strategic adjustments, such as pivoting or restructuring its programs, exploring partnerships, or implementing cost-cutting measures, to maintain its long-term goals.
In conclusion, Neumora Therapeutics faces significant challenges following the failed trial of its lead asset, navacaprant. The company must now consider strategic adjustments to maintain its long-term goals and address the unmet needs of patients with MDD. The gender-specific efficacy signal observed in the trial could potentially provide a pathway forward, but it would likely require additional trials and extend the timeline to market. Investors will be watching closely as Neumora navigates this critical juncture in its development.