Neumora Shares Plunge As Navacaprant Misses Key Endpoints In Major Depressive Disorder Trial

Neumora Therapeutics

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(RTTNews) - Shares of Neumora Therapeutics, Inc. (NMRA) are down more than 80% at $1.81 in premarket trading Thursday, following the release of topline results from its Phase 3 KOASTAL-1 study of Navacaprant for major depressive disorder.

The study failed to demonstrate a statistically significant improvement in its primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. The key secondary endpoint of a statistically significant change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) scale was also not met.

Despite the disappointing topline results, navacaprant showed an efficacy signal in female participants, and the company plans further analysis of these findings. Navacaprant, a highly selective kappa opioid receptor antagonist, was generally well-tolerated, with no serious adverse events reported.

Importantly, there was no signal for increased suicidal ideation or behavior compared to placebo. Treatment-emergent adverse events (TEAEs) were minimal, and treatment discontinuation rates were low for both the drug and placebo groups, the company noted.

The KOASTAL-1 study enrolled 383 adults with MDD and is the first of three pivotal Phase 3 studies.

Neumora plans to provide additional updates on the navacaprant development program at the J.P. Morgan Healthcare Conference in January 2025.

The company remains committed to its broad pipeline of novel brain disease treatments. The ongoing KOASTAL-2, KOASTAL-3, and KOASTAL-LT studies will continue, with patients who completed KOASTAL-1 invited to enroll in the long-term safety extension study, KOASTAL-LT.

NMRA closed Tuesday's (Dec. 31, 2024) trading at $10.60, down 4.16%. In premarket trading, the stock is down 82.55% at $1.85.