Neumora Therapeutics shares tumbled over 83% on Thursday after its experimental drug for major depressive disorder (MDD), navacaprant, failed to demonstrate significant benefits in the pivotal Phase 3 KOASTAL-1 study.
The study, one of three replicate trials in Neumora’s KOASTAL program, did not meet its primary endpoint of improvement in depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) after six weeks.
Additionally, navacaprant showed minimal difference from a placebo on the secondary endpoint assessing anhedonia using the Snaith-Hamilton Pleasure Scale (SHAPS).
Neumora’s shares fell to a 52-week low of $1.89 in early trading, the steepest decline since its September 2023 debut on the Nasdaq.
Despite the setback, navacaprant was reported to be safe and well-tolerated, with no serious adverse events or increased suicidal ideation observed.
CEO Henry Gosebruch stated the company would provide updates on its ongoing KOASTAL-2, KOASTAL-3, and KOASTAL-LT studies, as well as its broader pipeline at a later date.
The failure is a significant blow to navacaprant, which some analysts had seen as a potential game-changer in treating MDD, a condition affecting 21 million Americans annually.