Neumora Therapeutics, Inc. (NASDAQ:NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced key pipeline updates and anticipated 2026 milestones that support the Company's mission to redefine neuroscience drug development with the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients living with brain diseases.
"2025 was a productive and strategically important year for Neumora, as we advanced our pipeline of novel mechanism therapies, prioritized obesity as the lead indication for our highly brain-penetrant NLRP3 inhibitor, NMRA-215, expanded our M4 PAM franchise with two new programs in clinical development, progressed the Phase 3 program for navacaprant, and produced compelling data for NMRA-511 – all while continuing to strengthen our financial foundation," said Paul L. Berns, co-founder, chairman and chief executive officer of Neumora. "This progress set up important expected milestones across our programs. We are entering a catalyst-rich period that I believe will meaningfully shape the future of Neumora, as well as the future of treatment for several underserved disease areas. Supported by a strong team, we are well-positioned to execute on our goal to advance a next generation of therapies for people living with brain diseases."
2026 PIPELINE STRATEGY
Navacaprant: Planned joint readout of KOASTAL-2 and -3 in second quarter of 2026
Neumora today announced that it plans to increase enrollment in each of the KOASTAL studies, targeting up to 25 percent enrollment beyond the original target of 332, as the study protocols permit. The Company expects a joint topline data readout for both KOASTAL-2 and KOASTAL-3 in the second quarter of 2026 and believes this approach optimizes assessment of navacaprant efficacy in major depressive disorder in the KOASTAL program.
NMRA-215: Plans to initiate Phase 1 clinical program following class-leading preclinical data
Neumora expects to initiate a clinical program evaluating NMRA-215 monotherapy and combination therapy for the treatment of obesity in the first half of 2026. The Company expects to report weight loss data following treatment with NMRA-215 around the end of 2026.
M4 Positive Allosteric Modulator (PAM) Franchise: Progressing Phase 1 clinical studies for NMRA-898 and NMRA-861
Neumora expects to provide a comprehensive M4 franchise update in mid-2026, including potentially advancing development of one or both programs.
NMRA-511: Reported positive results from Phase 1b study in Alzheimer's disease (AD) agitation
In January 2026, NMRA-511, an oral, highly potent, brain-penetrant and selective antagonist of the vasopressin 1a receptor (V1aR) met the goal of the Phase 1b study, demonstrating a clinically meaningful effect size in people with AD agitation. In the study, NMRA-511 demonstrated a favorable tolerability and safety profile with no reports of somnolence or sedation.
KEY BUSINESS UPDATES
The Company is in a strong financial position and expects its cash, cash equivalents and marketable securities to support operations into the third quarter of 2027.