NMRA-215 / Neumora Therap - LARVOL DELTA

NMRA-215 (NLRP3 Inhibitor): Phase 1 Study Expected to Initiate by End of 2026 (The Manila Times) - "Neumora is developing NMRA-215 for the treatment of obesity and cardiometabolic disease. The Company expects to submit an IND in the fourth quarter of 2026 and to initiate a Phase 1 study by the end of 2026."

IND • New P1 trial • Obesity

Neumora Therapeutics Reports Favorable NMRA-215 Toxicology Results with Planned Clinical Advancement in 2026 (GlobeNewswire) - "Company plans to submit an IND in the fourth quarter of 2026 and to initiate Phase 1 study by the end of 2026...Neumora conducted a repeat 13-week toxicology study in rats following results from a prior study in which unexpected in-life adverse findings were observed in 5 of 142 animals. The Company opened a for-cause audit of that study which revealed various discrepancies resulting in a number of critical audit observations. In a repeat 13-week rat toxicology study in 162 animals, no instances of unexpected in-life adverse findings were observed. Based on the audit observations, the repeat study data and the results from the previously completed 28-day rat, 28-day dog and 13-week dog toxicology studies..."

IND • New P1 trial • Preclinical • Obesity

NMRA-215: 12-week diet induced obesity (DIO) study provides support for potential use in switch and maintenance settings; clinical studies expected to initiate in the first quarter of 2027 (Yahoo Finance) - "NMRA-215 demonstrated sustained, semaglutide-like weight loss in DIO mice at 12 weeks following a mechanism-of-action switch from semaglutide monotherapy to NMRA-215 monotherapy at week 8; Following a switch from a combination of semaglutide and NMRA-215 to NMRA-215 monotherapy alone at week 8, DIO mice maintained weight loss similar to mice who received semaglutide monotherapy for the entire study duration by week 12....In parallel, Neumora is repeating the 13-week rat toxicology study with a different contract research organization and now expects to bring NMRA-215 into the clinic in the first quarter of 2027. The Company will provide guidance on expected data readouts from the clinical program when it is initiated."

Preclinical • Obesity

Neumora Therapeutics Highlights NMRA-511 AD Agitation Signal, Maps Higher-Dose Plan for 2026 (Yahoo Finance) - "Neumora plans a higher‑dose MAD cohort in 2026, pivotal studies in 2027, and a switch to a QD extended‑release formulation to extend IP to 2046...NMRA-215 (NLRP3 inhibitor) targets weight loss via sustained brain IC90 exposure and the company expects Q3 2026 biomarker data to show brain coverage and cardiometabolic effects, positioning the asset for GLP‑1 combination or maintenance strategies...Broader pipeline and timing: a mid‑2026 update is expected for the M4 PAMs, a combined readout for KOASTAL 2 & 3 is due in Q2 2026..."

Biomarker • Clinical data • New trial • Trial status • Alzheimer's Disease • Obesity

Neumora Therapeutics Announces Class-Leading Weight Loss Demonstrated with NMRA-215 in Preclinical Diet-Induced Obesity Model (Neumora Press Release) - "NMRA-215 demonstrated class-leading weight loss of up to 19% as a monotherapy with semaglutide-like induction; NMRA-215 demonstrated best-in-class weight loss of up to 26% in combination with semaglutide; Class-leading weight loss driven by best-in-class pharmacology and brain penetration of NMRA-215; Neumora plans to initiate Phase 1 clinical study in the first quarter of 2026."

New P1 trial • Preclinical • Obesity