ABOS (Acumen Pharmaceuticals, Inc.) PDUFA Date | FDA Catalyst & Approval Status

Jul 15, 2026

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Acumen Pharmaceuticals Highlights Enhanced Brain Delivery™ (EBD™) Program Data and Early Alzheimer’s Disease Insights at the Alzheimer’s Association International Conference (AAIC®) 2026

Acumen Pharmaceuticals presented promising data at the AAIC 2026 regarding their Enhanced Brain Delivery (EBD) program. The bispecific antibodies developed showed significantly improved brain penetration compared to traditional anti-AβO antibodies. Additionally, the EBD candidate ACU401 exhibited substantial increases in brain exposure in non-human primate models, supporting further development for Alzheimer's disease treatment.

Jul 7, 2026

Acumen Pharmaceuticals to Present Data on Enhanced Brain Delivery™ (EBD™) Technology and Early Alzheimer’s Disease Insights at the Alzheimer’s Association International Conference (AAIC®) 2026

Acumen Pharmaceuticals will present key studies at the Alzheimer's Association International Conference 2026, focusing on their Enhanced Brain Delivery technology and insights into early Alzheimer's disease. The presentations include an oral session on bispecific antibodies and two poster sessions highlighting patient perspectives and drug delivery advancements. These efforts aim to improve treatment options for Alzheimer's disease.

Acumen Pharmaceuticals recently presented important findings on Alzheimer's disease treatment at the International Conference on Alzheimer's and Parkinson's Diseases. The research focuses on Enhanced Brain Delivery technology, novel biomarker evaluation, and the development of highly selective antibodies targeting toxic amyloid beta oligomers. A collaborative effort with JCR Pharmaceuticals aims to improve drug penetration across the blood-brain barrier, which could enhance therapeutic effectiveness. These advancements highlight Acumen's commitment to addressing key challenges in Alzheimer's drug development.

Mar 16, 2026

Acumen Pharmaceuticals Announces $35.75 Million Private Placement to Advance Potential Best-in-Class Molecules from Amyloid Beta Oligomer-Selective Enhanced Brain Delivery Portfolio Financing demonstrates conviction in o

Acumen Pharmaceuticals announced a $35.75 million private placement to further develop its Enhanced Brain Delivery (EBD) program targeting amyloid beta oligomers for Alzheimer's disease. Strong preclinical data supporting the program includes positive results from non-human primate studies, indicating significantly elevated brain exposure and low potential for anemia. The funding, led by RA Capital Management, is intended to support the nomination of a lead clinical candidate by mid-2027. This development highlights confidence in Acumen's innovative approach to treating Alzheimer's disease.

Mar 10, 2026

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Acumen Pharmaceuticals Reports Financial Results for the Year Ended

Acumen Pharmaceuticals reported its financial results for 2024, highlighting significant advances in the clinical development of its Alzheimer's treatment, sabirnetug (ACU193). Enrollment for the Phase 2 ALTITUDE-AD study was completed earlier than expected with results anticipated in late 2026. The company currently holds $231.5 million in cash, projected to sustain its operations until mid-2027. However, the company also reported a notable increase in net loss and R&D expenses over the previous year, reflecting continued investment in its clinical programs.

Mar 26, 2025

Acumen Pharmaceuticals Completes Enrollment of ALTITUDE-AD, a Phase 2 Clinical Trial of Sabirnetug (ACU193) in Early Alzheimer’s Disease

Acumen Pharmaceuticals has successfully completed enrollment for its Phase 2 clinical trial, ALTITUDE-AD, evaluating sabirnetug (ACU193) in early Alzheimer’s disease patients. The trial enrolled 542 participants across multiple countries and aims to assess the efficacy and safety of the treatment. Results, including efficacy and safety data, are expected to be reported in late 2026. This milestone underscores significant interest in Acumen's approach to targeting soluble amyloid beta oligomers, which are believed to contribute to neurodegeneration in Alzheimer's.

Acumen Pharmaceuticals to Report Fourth Quarter and Year-End 2024 Financial Results on March 27, 2025

Acumen Pharmaceuticals, Inc. has announced that it will report its fourth quarter and year-end financial results for 2024 on March 27, 2025. The company, focused on developing a therapeutic for Alzheimer's disease, will also host a conference call to provide a business and financial update. This event follows encouraging results from its Phase 1 clinical trial of ACU193, a monoclonal antibody targeting toxic amyloid beta oligomers.

Mar 19, 2025

Acumen Pharmaceuticals Announces Topline Results from Phase 1 Study of Subcutaneous Formulation of Sabirnetug in Healthy Volunteers

Acumen Pharmaceuticals announced positive topline results from a Phase 1 study on the subcutaneous formulation of sabirnetug, demonstrating its well-tolerance in healthy volunteers. The study showed that systemic exposure allows for further clinical development, highlighting the formulation's potential to improve patient convenience compared to intravenous administration. The company's commitment to advancing the clinical pipeline is underscored by the timely completion of this study. Sabirnetug targets toxic amyloid beta oligomers relevant to Alzheimer's disease treatment and is currently undergoing further evaluation in Phase 2 trials.

Mar 18, 2025

Acumen Pharmaceuticals CEO Discusses Novel Targeted Therapies for Alzheimer’s

Acumen Pharmaceuticals CEO Daniel O’Connell discussed the company's focus on targeted therapies for Alzheimer's Disease in an interview. The company is advancing sabirnetug, a monoclonal antibody targeting amyloid beta oligomers, and reported positive Phase I trial results. They are proceeding to a Phase II study involving approximately 540 patients, with completion of enrollment expected in the first half of 2025. O’Connell emphasized the critical need for next-generation treatments to address the significant unmet needs of Alzheimer's patients.

Mar 12, 2025

Acumen Pharmaceuticals has announced its first quarter 2024 financial results, highlighting the initiation of ALTITUDE-AD, a Phase 2 study of sabirnetug (ACU193) for early Alzheimer's disease. The company reported a net loss of $14.9 million, with cash reserves of $296.6 million projected to fund operations through mid-2027. Additionally, a Phase 1 study for a subcutaneous dosing option of sabirnetug is anticipated to commence in mid-2024. The positive safety and engagement data from earlier trials continue to stimulate interest in the drug's potential.

May 13, 2024

Acumen Pharmaceuticals to Participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference

Acumen Pharmaceuticals, Inc. will participate in a fireside chat at the H.C. Wainwright 2nd Annual BioConnect Conference on May 20, 2024. The company is known for developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease. Acumen's investigational product, sabirnetug (ACU193), recently reported positive outcomes in a Phase 1 clinical trial. This participation in the conference provides an opportunity for Acumen to engage with potential investors and discuss their advancements in Alzheimer's treatments.

May 8, 2024

Acumen Pharmaceuticals to Participate in the 2024 Bank of America Healthcare Conference

Acumen Pharmaceuticals, Inc. announced that it will participate in a fireside chat at the 2024 Bank of America Healthcare Conference on May 15, 2024. The firm is developing a novel therapeutic targeted at toxic soluble amyloid beta oligomers for Alzheimer's disease treatment. Acumen's investigational candidate, sabirnetug (ACU193), has shown promise following successful results from its Phase 1 trial, INTERCEPT-AD. The live webcast of the event will be available on Acumen's website and archived for 90 days.

May 8, 2024

Acumen Pharmaceuticals Announces First Patient Dosed in ALTITUDE-AD, a Phase 2 Clinical Trial of Sabirnetug (ACU193) in Early Alzheimer’s Disease

Acumen Pharmaceuticals has announced the first patient dosing in the ALTITUDE-AD Phase 2 clinical trial for sabirnetug (ACU193), a novel monoclonal antibody targeting amyloid beta oligomers in early Alzheimer's disease. This trial will evaluate the efficacy and safety of the treatment in approximately 540 patients. Positive Phase 1 results indicated a promising safety profile and dose-related amyloid plaque reduction. Acumen aims to explore further therapeutic options for Alzheimer's through this initiative.

May 7, 2024

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Acumen Pharmaceuticals to Report First Quarter Results on May 14, 2024

Acumen Pharmaceuticals, Inc. announced that it will report its first quarter 2024 financial results on May 14, 2024. The report will be accompanied by a conference call and live audio webcast to provide a business and financial update. The company is developing a therapy targeting toxic amyloid beta oligomers for Alzheimer's disease and has reported positive outcomes from a Phase 1 clinical trial for its candidate ACU193.

Apr 16, 2024

Acumen Pharmaceuticals Presents First Comprehensive Clinical and Biomarker Data for Sabirnetug (ACU193) at American Academy of Neurology 2024 Annual Meeting

Acumen Pharmaceuticals presented comprehensive clinical and biomarker data for its Alzheimer's treatment, sabirnetug (ACU193), during the AAN 2024 Annual Meeting. The data from the Phase 1 INTERCEPT-AD study showed a favorable safety profile and significant target engagement with toxic soluble amyloid beta oligomers. Encouraging changes were also noted in cerebrospinal fluid biomarkers and reduction of plaque load. Acumen is set to proceed with a Phase 2 trial named ALTITUDE-AD in the first half of 2024 based on these positive results.

Apr 4, 2024

Acumen Pharmaceuticals Collaborates with Lonza to Advance Sabirnetug for the Treatment of Alzheimer’s Disease

Acumen Pharmaceuticals has entered a collaboration with Lonza to manufacture sabirnetug (ACU193), a monoclonal antibody targeting toxic soluble amyloid beta oligomers for Alzheimer's disease. This partnership aims to expedite the clinical development and commercialization of sabirnetug, which is set for a Phase 2 clinical trial beginning in the first half of 2024. Lonza will utilize its advanced manufacturing facilities to produce the drug, leveraging its regulatory expertise and experience in antibody production.

Acumen Pharmaceuticals has entered a global collaboration with Halozyme to develop a subcutaneous formulation of its Alzheimer’s treatment, ACU193, using Halozyme's ENHANZE technology. This partnership follows encouraging results from Acumen's Phase 1 INTERCEPT-AD trial, suggesting the therapeutic's potential. The company plans to start human trials in mid-2024 to compare the new formulation with the existing intravenous method. The agreement involves future milestone payments to Halozyme, along with royalties on commercial sales.

Nov 2, 2023

Acumen Pharmaceuticals to Participate in the UBS Biopharma Conference

Acumen Pharmaceuticals, Inc. (ABOS) announced its participation in the UBS Biopharma Conference scheduled for November 9, 2023, where management will engage in a fireside chat. The company is focused on developing a therapeutic designed to target toxic soluble amyloid beta oligomers for Alzheimer's disease treatment. Acumen's investigational product candidate, ACU193, has shown positive results in a Phase 1 clinical trial. The live webcast will be accessible on their website and available for archiving after the event.

Acumen Pharmaceuticals reported its financial results for the first quarter of 2023, highlighting a focus on the Phase 1 INTERCEPT-AD clinical trial for its Alzheimer's treatment candidate ACU193. The company expects to share topline results from this trial in Q3 2023, with substantial cash reserves projected to support operations until 2025. Despite increased operational losses, Acumen continues to maintain a positive outlook on its developmental pipeline and anticipates further FDA interaction later this year.

May 4, 2023

Acumen Pharmaceuticals to Participate in 2023 Bank of America Healthcare Conference

Acumen Pharmaceuticals, Inc. will participate in the upcoming 2023 Bank of America Healthcare Conference on May 11, 2023, where management will engage in a fireside chat. The company is actively developing ACU193, a therapeutic monoclonal antibody targeting toxic soluble amyloid beta oligomers for Alzheimer’s disease. This participation underscores Acumen's commitment to advancing its clinical programs and engaging with investors and stakeholders in the healthcare sector.

May 2, 2023

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Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) has announced its participation in the Stifel 2023 Virtual CNS Days, scheduled for March 29, 2023. Management will engage in a fireside chat to discuss their therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer’s disease. This event is part of their efforts to advance the investigational product candidate ACU193, currently in Phase 1 clinical trials for early Alzheimer’s patients. The live webcast will be accessible on their website and archived for 14 days.

Mar 20, 2023

Acumen Pharmaceuticals to Report Fourth Quarter and Year-End 2022 Financial Results on March 27, 2023

Acumen Pharmaceuticals, Inc. announced that it will report its fourth quarter and year-end 2022 financial results on March 27, 2023. The company is currently developing a novel therapeutic for Alzheimer's disease, specifically targeting toxic soluble amyloid beta oligomers. A conference call and live audio webcast are scheduled to provide a business and financial update. Acumen's investigational product candidate, ACU193, aims to treat early Alzheimer's patients, reflecting the company's commitment to innovative treatments.

Mar 8, 2023

Acumen Pharmaceuticals to Participate in the Needham Neuroscience Forum

Acumen Pharmaceuticals, Inc. will participate in the Needham Virtual Neuroscience Forum on March 15, 2023. The company is focused on developing ACU193, a humanized monoclonal antibody targeting toxic amyloid beta oligomers for Alzheimer’s disease. The event will feature a fireside chat that will provide insights into their clinical research. Acumen's approach is grounded in pioneering research on Alzheimer’s pathology.

Feb 1, 2023

Corporate Presentation February 2023 1 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing

Acumen's February 2023 corporate presentation discusses the ongoing development of ACU193, an antibody product targeting early Alzheimer's disease. The company reported positive preliminary findings from its Phase 1 clinical trial, with expectations to complete enrollment by Q1 2023 and top-line results anticipated in Q3 2023. Acumen's cash balance is projected to support the advancement of ACU193 through multiple clinical milestones into 2025. The presentation highlighted Acumen's strategic goals and ongoing efforts to optimize the therapeutic potential of ACU193.

Jan 4, 2023

Acumen Pharmaceuticals Appoints Derrell Porter, M.D., to its Board of Directors

Acumen Pharmaceuticals has appointed Derrell Porter, M.D., to its Board of Directors. Dr. Porter, a physician-entrepreneur with over 20 years of experience in drug development, will support Acumen as it advances its clinical candidate ACU193 for Alzheimer’s disease. ACU193 is notably recognized for its targeted approach to address toxic soluble Aβ oligomers, which are implicated in Alzheimer's pathology. The company is executing a Phase 1 clinical trial for this investigational product after receiving Fast Track designation from the FDA.

Acumen Pharmaceuticals Reports Third Quarter 2022 Financial Results and Business Highlights INTERCEPT-AD, a Phase 1 clinical trial of ACU193 in patients with early Alzheimer s disease continues to progress Acumen anticip

Acumen Pharmaceuticals Reports Third Quarter 2022 Financial Results and Business Highlights Charlottesville, Va. and Carmel, In., Nov. 14, 2022 Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company focused on the development of novel targeted

Nov 7, 2022

Acumen Pharmaceuticals to Report Third Quarter 2022 Financial Results on Nov. 14, 2022

CHARLOTTESVILLE, Va. and CARMEL, Ind., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company focused on the development of novel targeted therapeutics for Alzheimer’s disease, today announced that the Company wil

Nov 1, 2022

Acumen Publishes Phase 1 Trial Design and Clinical Development Plan for ACU193, an Anti-Amyloid Beta Oligomer Antibody for Alzheimer’s Disease

CHARLOTTESVILLE, Va. and CARMEL, Ind., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) today announced that it published its development rationale and clinical development plan for ACU193, the first clinical-stage monoclonal antibody that selectively

Oct 24, 2022

ABOSFDA Updates

Acumen s ACU193, an Anti-Amyloid Beta Oligomer Antibody, Granted FDA Fast Track Designation for Alzheimer s Disease Charlottesville, Va. and Carmel, Ind. (

Acumen s ACU193, an Anti-Amyloid Beta Oligomer Antibody, Granted FDA Fast Track Designation for Alzheimer s Disease Charlottesville, Va. and Carmel, Ind. (October 24, 2022) Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) today announced that ACU193, the first clinical-stage monocl

Sep 12, 2022

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Corporate Overview September 2022 1 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Ac

Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen's goals, expectations, financial or other projections, intentions or beliefs is a forward-

Aug 15, 2022

Acumen Pharmaceuticals Reports Financial Results for Second Quarter 2022 and Business Highlights Topline results expected in the first half of 2023 from INTERCEPT-AD, a multi-center, randomized, double-blind, placebo-con

Acumen Pharmaceuticals Reports Financial Results for Second Quarter 2022 and Business Highlights Charlottesville, Va. and Carmel, In., August 15, 2022 Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company focused on the development of novel tar

Aug 8, 2022

Acumen Pharmaceuticals to Report Second Quarter 2022 Financial Results on August 15, 2022

CHARLOTTESVILLE, Va. and CARMEL, Ind., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical stage biopharmaceutical company focused on the development of novel targeted therapeutics for Alzheimer’s disease (AD), today announced that the Compan

Aug 1, 2022

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Acumen presents poster describing method to standardize amyloid beta oligomer assays supporting therapeutic development for early Alzheimer s disease Model designed to fill need for soluble amyloid beta oligomer referenc

Acumen presents poster describing method to standardize amyloid beta oligomer assays supporting therapeutic development for early Alzheimer s disease Model designed to fill need for soluble amyloid beta oligomer reference standards in bioanalytical assays Charlottesville, Va.

Jul 26, 2022

Corporate Overview 3Q 2021 Exhibit Acumen Safe Harbor Statement NOTES REGARDING THIS PRESENTATION This presentation may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations, and fina

Jul 1, 2021