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Neumora Therapeutics, Inc.

Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for brain diseases, neuropsychiatric disorders, and neurodegenerative diseases in the United States. Its lead product, navacaprant (NMRA-140), is a once-daily oral kappa opioid receptor antagonist in Phase 3 trials for major depressive disorder. The company also develops NMRA-511 (Phase 1b for agitation associated with dementia due to Alzheimer's disease), NMRA-861 and NMRA-898 (M4 muscarinic receptor positive allosteric modulators for schizophrenia and other neuropsychiatric disorders), and preclinical programs including NMRA-GCase for Parkinson's disease, NMRA-CK1d for amyotrophic lateral sclerosis, and NMRA-215, an oral NLRP3 inhibitor for obesity. Formerly RBNC Therapeutics, Inc., it changed its name to Neumora Therapeutics, Inc. in October 2021, was incorporated in 2019, and is headquartered in Watertown, Massachusetts.

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Biotech & Genomic Medicine▲

Neumora Reports Positive Toxicology Data for NMRA-215, Plans IND Filing in Q4 2026

Neumora Therapeutics reported positive preclinical toxicology data for its NLRP3 inhibitor NMRA-215, an oral drug candidate for obesity and cardiometabolic disease. A repeat 13-week rat study in 162 animals showed no in-life adverse findings, resolving earlier discrepancies from a prior study of 142 rats that had unexpected findings in five subjects. The company pooled these results with prior 28-day rat, 28-day dog, and 13-week dog studies that yielded similar conclusions. Neumora now plans to submit an investigational new drug application to the FDA in the fourth quarter of this year and begin a Phase 1 clinical trial by the end of 2026. Shares closed Monday at $1.66, up 11.41%, but fell 3.01% to $1.61 in pre-market trading.
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Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity Technology
NMRA · Technology · Positive Positive preclinical toxicology data for NMRA-215 resolves prior discrepancies and enables IND filing and Phase 1 trial.
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Clear Street Maintains Buy Rating on LB Pharmaceuticals with $45 Price Target

Clear Street maintained a Buy rating and a $45 price target for LB Pharmaceuticals, stating that Neumora Therapeutics' Phase 3 KOASTAL trial setback does not materially impact the outlook for LB-102. The firm highlighted that LB-102 is supported by established dopamine D2/D3 and serotonin 5-HT7 receptor activity, along with prior clinical evidence from related therapies. LB-102 has shown strong Phase 2 results in schizophrenia, and the company's broader opportunities across schizophrenia, bipolar disorder, and major depressive disorder remain unchanged. In its fiscal first quarter 2026 earnings, LB Pharmaceuticals reported a net loss of $19.1 million, with research and development expenses rising to $14.6 million and general and administrative expenses to $7.5 million. The company ended the quarter with approximately $365.6 million in cash, cash equivalents, and marketable securities, expected to fund operations into the second quarter of 2029.
LBRX · Capital · Positive Clear Street maintained Buy rating and $45 PT, citing strong Phase 2 results and unchanged outlook despite competitor setback.
NMRA · Technology · Negative Neumora's Phase 3 KOASTAL trial setback is mentioned as a context that does not affect LB-102, but it is a negative for Neumora itself.
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Biotech & Genomic Medicine▼

FDA Approves Spero and AbbVie Drugs, Neumora Halts Trial and Cuts Jobs, Biogen Buys RayThera

The biotech sector saw FDA approvals, study halts, layoffs, and deals this week. Spero Therapeutics and GSK won FDA approval for Utebzi, the first oral carbapenem for complicated urinary tract infections, while AbbVie's Allergan Aesthetics unit received expanded approval for SKINVIVE by JUVÉDERM to treat neck lines. Neumora Therapeutics halted its Phase 3 KOASTAL studies of Navacaprant in major depressive disorder after the drug failed to beat placebo and announced plans to lay off about 35% of its workforce. Biogen agreed to acquire RayThera in a deal valued at up to $1 billion to expand its immunology portfolio, with closing expected in the third quarter of 2026.
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Biotech & Genomic Medicine › Neuroscience & Neurodegenerative ▼Competition
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NMRA · Technology · Negative Neumora halted Phase 3 studies of Navacaprant after failing to beat placebo and plans 35% layoffs.
SPRO · Regulation · Positive Spero and GSK won FDA approval for Utebzi, the first oral carbapenem for complicated UTIs.
RayThera Inc. · Capital · Positive Biogen agreed to acquire RayThera in a deal valued at up to $1 billion, providing a significant premium and exit for shareholders.
BIIB · Capital · Positive Biogen agreed to acquire RayThera for up to $1 billion to expand immunology portfolio.
ABBV · Regulation · Positive AbbVie's Allergan unit received FDA expanded approval for SKINVIVE to treat neck lines.
GSK.LSE · Regulation · Positive GSK and Spero won FDA approval for Utebzi, the first oral carbapenem for complicated UTIs.
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Neumora Therapeutics expects combined top-line results from two late-stage depression trials in the second quarter of 2026

Neumora Therapeutics announced that two late-stage studies of its experimental depression treatment navacaprant, KOASTAL-2 and KOASTAL-3, were fully enrolled in the first quarter of 2026 with more than 400 patients in each trial. The company expects to report combined top-line results from the two studies in the second quarter of 2026, a major catalyst for the stock. Neumora also said NMRA-511 remains on track to report data in the second half of 2026 from a study in agitation linked to Alzheimer's disease, with a Phase 2 trial expected to begin in the first quarter of 2027, while Phase 1 data for NMRA-898 in healthy volunteers and patients with stable schizophrenia is also expected in the second half of 2026. The company ended the first quarter with 147.1 million dollars in cash and cash equivalents, which it expects to fund operations into the third quarter of 2027.
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Biotech & Genomic Medicine › Neuroscience & Neurodegenerative Technology
NMRA · Technology · Positive Two late-stage depression trials fully enrolled with top-line results expected in Q2 2026, a major catalyst.
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