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Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), headquartered in Charlottesville, VA with additional offices in Indianapolis, IN and Newton, MA, is a clinical-stage biopharmaceutical company innovating in the field of Alzheimer's disease (AD) and other neurodegenerative disorders. Acumen's core focus is on the development of novel, disease-modifying treatments by targeting toxic soluble amyloid-beta oligomers (AβOs), which are believed to be a primary underlying cause of AD. The company’s lead therapeutic candidate, sabirnetug (ACU193), is a humanized monoclonal antibody designed to selectively target these AβOs, thereby preventing synaptic dysfunction and neurodegeneration.
Acumen's scientific founders are pioneers in AβO research, contributing to decades of understanding in the field. This extensive research has culminated in the development of sabirnetug, which demonstrated positive topline results from the Phase 1 INTERCEPT-AD clinical trial. The trial showed that sabirnetug is well-tolerated, with a favorable safety profile, and demonstrated statistically significant, dose-related amyloid plaque reduction, validating its proof-of-mechanism.
Currently, Acumen is advancing sabirnetug into the Phase 2 ALTITUDE-AD trial, which aims to further evaluate its clinical efficacy and safety in early Alzheimer's disease. The company is also planning a Phase 1 study to explore a subcutaneous dosing option, enhancing patient accessibility and treatment convenience.
Acumen Pharmaceuticals remains committed to advancing its pioneering research into practical therapeutic solutions. The company's strategic partnerships, including a recent collaboration with Lonza for the manufacturing of sabirnetug, underscore its dedication to bringing effective treatments to market. With a strong financial footing, including $296.6 million in cash and marketable securities as of March 31, 2024, Acumen is well-positioned to support its clinical and operational activities into the first half of 2027.
Acumen’s mission is driven by the urgent need for safe and effective treatment options for Alzheimer's patients. Their work continues to be fueled by robust scientific insights and a commitment to improving the lives of those afflicted by AD.
Acumen Pharmaceuticals (NASDAQ: ABOS) reported Q3 2024 financial results and business updates. The company expects to complete enrollment for its Phase 2 ALTITUDE-AD study of sabirnetug for early Alzheimer's disease in H1 2025. Cash position stands at $258.9 million as of September 30, 2024, expected to fund operations into H1 2027. Q3 financial results show R&D expenses increased to $27.2 million from $11.2 million year-over-year, while net loss widened to $29.8 million from $13.0 million. The company extended its collaboration with Lonza for potential commercial manufacturing of sabirnetug and appointed Amy Schacterle as Chief Regulatory Officer.
Acumen Pharmaceuticals (NASDAQ: ABOS) has announced its participation in the upcoming Stifel Healthcare Conference. The company's management will engage in a fireside chat on Monday, Nov. 18, 2024, at 11:30 a.m. ET. Acumen, a clinical-stage biopharmaceutical company, is developing a novel treatment targeting toxic soluble amyloid beta oligomers for Alzheimer's disease. The presentation will be accessible via live webcast on the company's website under the Investors tab and will remain available for 90 days following the event.
Acumen Pharmaceuticals (NASDAQ: ABOS) has announced its upcoming participation in the UBS Global Healthcare Conference. The company's management will engage in a fireside chat on Wednesday, Nov. 13, 2024, at 1:15 p.m. PT (4:15 p.m. ET). Acumen, a clinical-stage biopharmaceutical company, is developing a novel treatment targeting toxic soluble amyloid beta oligomers for Alzheimer's disease. The presentation will be accessible via live webcast on the company's website under the Investors tab and will remain available for 90 days.
Acumen Pharmaceuticals (NASDAQ: ABOS) has appointed Dr. Amy Schacterle as Chief Regulatory Officer & Head of Quality. Dr. Schacterle brings over 30 years of experience in regulatory affairs and quality assurance, with expertise in central nervous system diseases. She previously served as Senior VP of R&D Strategy at Sage Therapeutics, where she led regulatory efforts for the first postpartum depression treatment approval. She joins as the company advances its Alzheimer's disease therapeutic candidate, sabirnetug, which is currently in Phase 2 clinical trials across five countries. Dr. Schacterle replaces Dr. Janice Hitchcock, who is retiring after successfully leading the regulatory strategy for the Phase 1 INTERCEPT-AD study and Phase 2 ALTITUDE-AD study.
Acumen Pharmaceuticals (NASDAQ: ABOS), a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment, has scheduled its third quarter 2024 financial results release for November 12, 2024. The company will host a conference call and audio webcast at 8:00 a.m. ET on the same day to discuss business updates and financial performance. Interested participants must pre-register at least one day in advance to receive dial-in information.
Acumen Pharmaceuticals presented data on using pTau217 assay as an efficient screening tool for their Phase 2 ALTITUDE-AD clinical trial of sabirnetug for early Alzheimer's disease. The assay, with a threshold of ≥0.15 pg/mL, effectively identifies potential participants likely to have amyloid in the brain, reducing unnecessary amyloid PET scans and lumbar procedures. 74% of participants with elevated pTau217 met amyloid burden eligibility requirements, compared to 40% in their Phase 1 trial without this screening approach. The study is enrolling at 75 sites across multiple regions, with completion expected in first half of 2025.
Acumen Pharmaceuticals (NASDAQ: ABOS) announced a late-breaking presentation at the 17th Annual Clinical Trials on Alzheimer's Disease (CTAD) conference in Madrid. The presentation will focus on their screening approach using a validated plasma pTau217 assay in the ongoing Phase 2 ALTITUDE-AD clinical trial of sabirnetug (ACU193) for early Alzheimer's disease. The pTau217 biomarker indicates Alzheimer's pathology and is used as an initial screening tool to identify candidates for additional amyloid testing. The presentation will be delivered by Dr. Todd Feaster on October 31, 2024, at 9:30 a.m. CET.
Lucy Therapeutics (LucyTx) has appointed Kim Drapkin as Board Chair to guide the company's strategic direction as it enters clinical trial development. Drapkin brings over 25 years of experience in biotech and pharma, most recently serving as President and CEO of Graphite Bio. LucyTx, which develops small molecule therapies for complex neurological diseases, recently secured $12.5 million in additional funding, bringing its total to $37 million.
The company's approach involves analyzing various disease drivers, including mitochondrial, environmental, and genetic factors, to create detailed knowledge maps and identify unique drug targets. LucyTx currently has three drug discovery programs in its pipeline, with Investigational New Drug (IND) studies planned for next year, focusing on treatments for Rett syndrome, Parkinson's, and Alzheimer's disease.
Acumen Pharmaceuticals (NASDAQ: ABOS), a clinical-stage biopharmaceutical company, has announced its participation in the Bank of America CNS Therapeutics Virtual Conference. The company, which is developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment, will engage in a fireside chat on Monday, Oct. 7, 2024, at 8:00 a.m. ET.
Interested parties can access the live webcast of the event through the Investors tab on www.acumenpharm.com. The webcast will remain archived on the site for 90 days following the conference, allowing those unable to attend the live session to review the discussion at their convenience.
Acumen Pharmaceuticals (NASDAQ: ABOS) has extended its collaboration with Lonza to support the potential future commercial launch of sabirnetug (ACU193), a novel therapeutic targeting toxic soluble amyloid beta oligomers for early Alzheimer's disease treatment. The extended agreement builds upon their existing partnership for drug substance manufacturing and now includes drug product manufacturing services at Lonza's Visp, Switzerland site.
Sabirnetug, currently in Phase 2 clinical trials, is the first humanized monoclonal antibody to demonstrate selective target engagement of AβOs in Alzheimer's patients. Acumen is also evaluating a subcutaneous formulation in a Phase 1 study. The collaboration extension comes as Acumen advances its clinical programs with over 50 Phase 2 sites activated across the U.S., Canada, U.K. and EU.
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