Neumora Therapeutics, Inc. is a clinical-stage biotechnology company. It offers a precision medicine approach for brain diseases through the integration of data science and neuroscience. The firm focuses on advancing medicines for therapeutically relevant targets implicated in CNS diseases, targeting novel mechanisms of action with best-in-class pharmacology. The company was founded by Paul L. Berns, Carol Suh and Mike Poole in November 2019 and is headquartered in Watertown, MA.
相关临床试验
7
0 进行中
药物批准
0
批准总数
监管机构
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监管机构数
成立时间
2019
已完成
6
85.7%
终止
1
14.3%
暂无批准数据
- Neumora Therapeutics is discontinuing navacaprant after all three Phase III Koastal studies failed to meet primary efficacy endpoints in major depressive disorder. - In the Koastal-3 study, patients on placebo actually outperformed those receiving navacaprant on the MADRS depression rating scale. - The company will reduce its workforce by approximately 35% to achieve $10 million in annual cost savings, extending its cash runway into Q3 2027. - Neumora will redirect resources toward pipeline programs in Alzheimer's disease agitation, schizophrenia, and cardiometabolic disease.
- Neumora Therapeutics announced positive Phase 1b results for NMRA-511, an oral vasopressin 1a receptor antagonist, demonstrating clinically meaningful effect sizes in treating Alzheimer's disease agitation. - The drug showed particularly strong efficacy in patients with elevated anxiety, achieving placebo-adjusted CMAI score reductions of -7.6 and -5.6 at weeks 6 and 8 respectively. - NMRA-511 demonstrated a favorable safety profile with no reports of somnolence or sedation and only 2.5% treatment discontinuation due to adverse events. - The company plans to advance development with higher dose studies and extended-release formulation development in 2026, followed by Phase 2/3 dose-ranging trials.
- Neumora Therapeutics announced key 2026 milestones including joint topline readouts for KOASTAL-2 and -3 studies of navacaprant in major depressive disorder expected in the second quarter. - The company plans to initiate Phase 1 clinical trials for NMRA-215, a brain-penetrant NLRP3 inhibitor, for obesity treatment in the first half of 2026 following class-leading preclinical data. - NMRA-511 demonstrated clinically meaningful effects on AD agitation in Phase 1b studies, with the company advancing its M4 PAM franchise programs NMRA-898 and NMRA-861. - The company maintains a strong financial position with cash reserves expected to support operations into the third quarter of 2027.
- Neumora Therapeutics has launched a Phase 1 single-ascending dose/multiple-ascending dose study of NMRA-898, the second M4 muscarinic receptor positive allosteric modulator in its schizophrenia-focused franchise. - NMRA-898 is structurally distinct from NMRA-861 and demonstrated no convulsions in preclinical studies across multiple species, offering potential best-in-class pharmacology for neuropsychiatric disorders. - The company now has two M4 PAMs in clinical development, providing strategic flexibility to advance one or both programs based on safety and pharmacokinetic data expected by mid-2026. - This approach targets the M4 muscarinic receptor rather than traditional D2 dopamine receptor blockade, potentially avoiding serious side effects that cause 75% of schizophrenia patients to discontinue current medications within 18 months.
- I-Mab appointed three seasoned biotech executives to key leadership positions, including Dr. Robert Lenz and Ms. Xin Liu to the Board of Directors and Dr. Ken Takeshita to the Scientific Advisory Board. - The company established a new Research and Development Committee chaired by Dr. Lenz to accelerate innovation and guide strategic development of its immuno-oncology pipeline. - These leadership changes come as I-Mab advances givastomig, a bispecific antibody targeting Claudin 18.2-positive gastric cancers that showed strong anti-tumor activity in Phase 1 trials.
- Brenig Therapeutics appointed David L. Lucchino as CEO and Tien Dam, M.D., as Chief Medical Officer to advance its neurodegenerative disease pipeline. - The company acquired BT-409, a brain-penetrant NLRP3 inhibitor from Mwyngil Therapeutics, targeting neuroinflammation in Parkinson's disease and other conditions. - Brenig's lead candidate BT-267, a selective LRRK2 inhibitor for Parkinson's disease, continues advancing through clinical development with promising brain penetration and safety profiles. - The new NLRP3 inhibitor program will enter pre-IND studies with plans to advance into Phase 1 safety trials.
- Neumora Therapeutics has initiated a Phase 1 single-ascending dose/multiple-ascending dose study of NMRA-861, a highly potent and selective positive allosteric modulator of the M4 muscarinic receptor for schizophrenia treatment. - The investigational drug demonstrated potential best-in-class pharmacology with no convulsions observed in preclinical studies across multiple species, including rabbits, dogs, and rats. - NMRA-861 targets the M4 muscarinic receptor to elicit antipsychotic effects without the side effects associated with traditional antipsychotics that primarily block D2 dopamine receptors. - The company expects to report Phase 1 data in the first quarter of 2026, including safety, tolerability, and pharmacokinetic data confirming potential for once-daily dosing and central nervous system penetration.
- Belgian biotech Galapagos has abandoned its planned separation into two companies, citing unfavorable "regulatory and market conditions" that prompted a strategic reassessment. - Henry Gosebruch, former CEO of Neumora Therapeutics, has been appointed as Galapagos' new chief executive, replacing Paul Stoffels who will transition to a non-executive chairman role earlier than planned. - With approximately €3.3 billion ($3.4 billion) in cash reserves, Galapagos will now pursue "transformative" business development opportunities while exploring strategic options for its cell therapy portfolio.
• Johnson & Johnson has terminated Phase III VENTURA trials for aticaprant as an add-on therapy for major depressive disorder due to insufficient efficacy, despite previous projections of $1-5 billion in peak annual sales. • The setback impacts J&J's goal of becoming the top neuroscience company by 2030, though the company remains committed to exploring aticaprant's potential in other therapeutic areas with high unmet needs. • The failure raises doubts about kappa opioid receptor antagonists in depression treatment, affecting other companies like Neumora Therapeutics, whose similar drug navacaprant also failed in Phase III trials earlier this year.
- Neumora Therapeutics undergoes significant leadership changes with Paul L. Berns, co-founder and executive chair, assuming the role of CEO and chairman of the Board effective February 14, 2025. - The clinical-stage biopharmaceutical company is advancing seven neuroscience programs, with three clinical-stage programs expected to deliver data readouts in 2025, including Phase 3 results for navacaprant in depression. - Joshua Pinto, Ph.D., has been appointed as president, while Bill Aurora, Pharm.D., and Michael Milligan take on roles as chief operating and development officer and chief financial officer, respectively.
