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Neumora Therapeutics, Inc. (Nasdaq: NMRA) is a clinical-stage biopharmaceutical company pioneering a new approach to treating brain diseases. Founded to address the global brain disease crisis, Neumora focuses on developing innovative therapies for neuropsychiatric and neurodegenerative disorders, areas with significant unmet medical needs.
Neumora's therapeutic pipeline comprises seven clinical and preclinical neuroscience programs targeting novel mechanisms of action. These programs aim to treat a broad range of underserved conditions, with ongoing projects for major depressive disorder (MDD), bipolar depression (BPD), Alzheimer's disease agitation, and schizophrenia, among others.
One of Neumora's leading candidates is Navacaprant (NMRA-140), a selective kappa opioid receptor (KOR) antagonist. Currently in Phase 3 clinical trials under the KOASTAL program, Navacaprant is being evaluated for its efficacy as a monotherapy for MDD. The company aims to extend its application to other neuropsychiatric disorders, including BPD.
Another notable program involves NMRA-266, a positive allosteric modulator of the M4 muscarinic receptor, being developed for schizophrenia. Despite a recent clinical hold due to safety findings in preclinical studies, Neumora is collaborating with the FDA to resolve these issues and is progressing with additional compounds within its M4 franchise.
Neumora's financial condition remains robust, with $519.5 million in cash and marketable securities as of September 30, 2023, projected to fund operations into 2026. The company reported a net loss of $53.0 million for Q3 2023, reflecting increased R&D expenses due to the advancement of clinical programs.
Recent achievements include a successful initial public offering and multiple clinical milestones. The company is on track to achieve significant milestones in 2024 and 2025, including data readouts from its Phase 3 navacaprant program and Phase 1 data from NMRA-266.
Neumora's mission is to redefine neuroscience drug development by leveraging an integrated suite of translational, clinical, and computational tools to create precision medicine approaches. This innovative strategy aims to improve treatment outcomes and quality of life for patients suffering from debilitating brain diseases.
Neumora Therapeutics (Nasdaq: NMRA), a clinical-stage biopharmaceutical company developing seven clinical and pre-clinical brain disease programs, has scheduled its third quarter 2024 financial results conference call and webcast for Tuesday, November 12, 2024, at 8:00 a.m. ET. The event will include a business update and will be available on the company's website, with a replay archived for up to 30 days. Participants are encouraged to register at least 10 minutes before the call.
Neumora Therapeutics (Nasdaq: NMRA) announced a roundtable discussion on the neuropsychiatric treatment landscape and the role of kappa opioid receptor antagonists (KORAs) in neuropsychiatry. The event, featuring leading experts, will take place on September 12, 2024, at 8:00 a.m. ET.
The discussion will focus on the potential of navacaprant, Neumora's KORA candidate, in treating neuropsychiatric disorders. The company is currently conducting a Phase 3 KOASTAL program for navacaprant in major depressive disorder (MDD) and a Phase 2 study in bipolar depression. Neumora expects to report topline data from the KOASTAL-1 Phase 3 study in Q4 2024.
The event will cover topics including Neumora's mission and pipeline, the role of kappa opioid receptors in MDD, navacaprant's Phase 2 data, and potential indications beyond MDD and bipolar depression.
Neumora Therapeutics (NMRA) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Phase 3 KOASTAL-1 study data for navacaprant in major depressive disorder (MDD) expected in Q4 2024.
2. Ongoing clinical studies in MDD, bipolar depression, and Alzheimer's disease agitation.
3. Strong financial position with $371.6 million in cash, cash equivalents, and marketable securities, expected to support operations into 2026.
4. Q2 2024 R&D expenses increased to $48.6 million from $32.8 million in Q2 2023.
5. Net loss for Q2 2024 was $58.7 million, compared to $38.5 million in Q2 2023.
6. Narrowed guidance to submit an IND for an additional M4 compound in H1 2025.
Neumora Therapeutics has initiated a Phase 1b study evaluating NMRA-511 for treating agitation in Alzheimer's disease (AD). NMRA-511, an oral antagonist of the vasopressin 1a receptor (V1aR), was well-tolerated in prior studies with no serious adverse events. The Phase 1b study, starting with healthy elderly adults and then AD patients, aims to assess safety, tolerability, and efficacy. The study will measure changes in agitation using the Cohen-Mansfield Agitation Inventory. Neumora expects to report topline data in the second half of 2025.
Neumora Therapeutics has initiated a Phase 2 clinical trial for navacaprant, targeting bipolar depression. The company aims to evaluate the safety and efficacy of the 80 mg oral KOR antagonist, which previously showed promise in treating major depressive disorder (MDD). The trial will involve 60 patients and focus on improvements in depressive symptoms and anhedonia, with results expected in the second half of 2025. Additionally, navacaprant is in Phase 3 development for MDD, with data from the KOASTAL-1 study anticipated in Q4 2024. This study could lead to broader applications for navacaprant in bipolar disorder.
Neumora Therapeutics, Inc. (Nasdaq: NMRA) reported strong financial results for Q1 2024 with $423.0 million in cash, guidance narrowed to Q4 2024 for Phase 3 data from KOASTAL-1 study with navacaprant in MDD, and multiple upcoming clinical study initiations. The company is well-positioned with a robust pipeline targeting neuropsychiatric and neurodegenerative diseases.
Neumora Therapeutics, Inc. (Nasdaq: NMRA) will participate in two investor conferences in May: BofA Securities Healthcare Conference 2024 and RBC Capital Markets Global Healthcare Conference. The company's therapeutic pipeline includes seven clinical and pre-clinical brain disease programs.
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