Official drug approval announcements from FDA or equivalent regulatory bodies

Neumora's Navacaprant Fails in KOASTAL-1 Phase 3 Trial; Shares Plunge 83%

Jan 2, 2025, 01:40 PM

Neumora Therapeutics (NMRA) shares plummeted by up to 83% after the company 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). This marks the company's first late-stage readout. The study did not demonstrate a statistically significant improvement in the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6, nor in the key secondary endpoint of the Snaith-Hamilton Pleasure Scale (SHAPS) score. Despite the setback, Neumora is continuing with two other identical Phase 3 trials, KOASTAL-2 and KOASTAL-3. Some analysts expressed skepticism over the company's interpretation of subgroup analyses suggesting efficacy in women but not in men. The failure of navacaprant, which targets the kappa opioid receptor (KOR) antagonist pathway, underscores the challenges in developing new treatments for depression and comes amid tough competition in the KOR antagonist space.