NEWTON, Mass., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that it will present new findings at the upcoming 18th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference taking place in San Diego. The presentations include Acumen’s recruitment strategies for its Phase 2 ALTITUDE-A ...

NEWTON, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that the first participant has been dosed in the open-label extension (OLE) portion of its Phase 2 ALTITUDE-AD clinical trial evaluating sabirnetug (ACU193) in people with early Alzheimer's disease. The open-label extension provid ...

Core Insights - Acumen Pharmaceuticals reported strong operational progress in Q3 2025, focusing on its Phase 2 trial of sabirnetug and the Enhanced Brain Delivery program [2][5] - The company aims to translate advanced science into innovative medicines for Alzheimer's disease while maximizing shareholder value [2] - Anticipated non-clinical data in early 2026 and topline results from the ALTITUDE-AD Phase 2 study in late 2026 are expected to provide insights into the role of amyloid beta oligomers in Alzheimer's disease [2][5] Recent Highlights - The first patient is expected to be dosed in the open-label extension of the ALTITUDE-AD trial in November 2025 [6] - George Golumbeski, Ph.D., was appointed as Chairman of the Board, bringing over 30 years of biotechnology experience [6] - Acumen has exclusive rights to develop up to two candidates in partnership with JCR Pharmaceuticals for Enhanced Brain Delivery therapy [6] Financial Results - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $136.1 million, down from $166.2 million as of June 30, 2025, expected to support operations into early 2027 [5][14] - Research and Development (R&D) expenses decreased to $22.0 million in Q3 2025 from $27.2 million in Q3 2024, primarily due to reduced costs associated with the ALTITUDE-AD trial [6][14] - General and Administrative (G&A) expenses were $4.5 million for Q3 2025, down from $5.0 million in Q3 2024, attributed to lower legal and recruiting expenses [6][7] Loss and Equity - Loss from operations was $26.5 million for Q3 2025, compared to $32.3 million for Q3 2024, reflecting decreased R&D expenses [14] - Net loss for Q3 2025 was $26.5 million, down from $29.8 million in Q3 2024 [14] - Total stockholders' equity as of September 30, 2025, was $93.2 million, a decrease from $181.8 million as of December 31, 2024 [18]

Core Insights - Acumen Pharmaceuticals has appointed Dr. George Golumbeski as Chairman of its Board of Directors, bringing over 30 years of biopharmaceutical experience to the company [1][2] - The company is focused on developing novel therapeutics targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease treatment, with ongoing Phase 2 trials for its product candidate, sabirnetug (ACU193) [3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing treatments for Alzheimer's disease, specifically targeting AβOs, which are implicated in the disease's pathology [3] - The company is advancing its investigational product candidate, sabirnetug, in the ALTITUDE-AD Phase 2 clinical trial, following positive results from its Phase 1 trial [3] - Acumen is also exploring a subcutaneous formulation of sabirnetug using Halozyme's ENHANZE® drug delivery technology and collaborating with JCR Pharmaceuticals on an Enhanced Brain Delivery therapy [3] Leadership and Strategic Direction - Dr. Golumbeski's experience includes significant roles in business development at Celgene, Novartis, and Elan Pharmaceuticals, with a focus on neurology and neurodegeneration [2] - The addition of Dr. Golumbeski expands Acumen's Board to eight members, aligning with the company's growth objectives and upcoming catalysts in its clinical programs [1][2]

Core Insights - Acumen Pharmaceuticals is set to report its third quarter 2025 financial results on November 12, 2025, and will host a conference call for updates [1] - The company is focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease [3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company headquartered in Newton, Massachusetts [3] - The company is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody, in a Phase 2 clinical trial for early symptomatic Alzheimer's disease patients [3] - Acumen's scientific founders have pioneered research on amyloid beta oligomers, which are believed to be early triggers of Alzheimer's disease pathology [3] - The company is also exploring a subcutaneous formulation of sabirnetug using Halozyme's ENHANZE drug delivery technology and collaborating with JCR Pharmaceuticals for Enhanced Brain Delivery therapy [3]

Core Insights - After-hours trading in the biotech and therapeutics sector saw significant price movements, particularly among small- and mid-cap companies, driven by clinical updates and strategic announcements [1] Company Summaries - **Cyclerion Therapeutics, Inc. (CYCN)**: Shares surged 48.01% to $4.47 after announcing a strategic relaunch focused on neuropsychiatric therapies, including a licensing agreement with MIT for its treatment-resistant depression program. The stock had closed at $3.02, down 0.66% during regular trading. A Phase 2 trial for the TRD program is expected to start in 2026, with initial data anticipated in 2027 [2][3] - **Clearside Biomedical Inc. (CLSD)**: The stock rose 6.82% to $4.23 after a regular session close of $3.96, despite a 9.79% decline during the day. The increase followed presentations at the EURETINA Congress regarding its Phase 2b ODYSSEY trial for wet age-related macular degeneration. The next key catalyst is the initiation of the Phase 3 trial, incorporating FDA feedback [3][4] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares increased by 11.50% to $0.32 after closing at $0.287, following a 6.61% decline during regular trading. The price action comes ahead of the company's participation in the Lytham Partners Fall 2025 Investor Conference [4][5] - **Acumen Pharmaceuticals, Inc. (ABOS)**: The stock advanced 5.69% to $1.30 after a regular session close of $1.23, despite a 3.91% decline during the day. The company reported that topline data from its Phase 2 ALTITUDE-AD trial is on track for late 2026 and plans to decide on advancing a preclinical candidate in early 2026 [5][6] - **PepGen Inc. (PEPG)**: Shares rose 5.13% to $2.05 after closing at $1.95, following an 8.02% decline during the day. The company completed patient dosing in its Phase 1 FREEDOM-DM1 trial and is on track to report topline data in early Q4 2025 [6][7] - **Corcept Therapeutics Inc. (CORT)**: The stock gained 4.54% to $87.10 after a regular session close of $83.32. The company announced it will present late-breaking data from its Phase 3 ROSELLA trial at the 2025 ESMO Annual Meeting. Two upcoming PDUFA dates were confirmed for relacorilant in hypercortisolism and platinum-resistant ovarian cancer [7][8][9]

Core Viewpoint - Acumen Pharmaceuticals is advancing its clinical-stage biopharmaceutical efforts focused on developing novel therapeutics targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease treatment, with significant operational progress and financial updates reported for Q2 2025 [1][2]. Recent Highlights - The company expects to report topline results for the ALTITUDE-AD Phase 2 study investigating sabirnetug (ACU193) for early Alzheimer's disease in late 2026 [4]. - A decision to advance an oligomer-targeted Enhanced Brain Delivery (EBDTM) product candidate is anticipated in early 2026 [4]. - As of June 30, 2025, Acumen had cash, cash equivalents, and marketable securities totaling $166.2 million, projected to support operations into early 2027 [4]. Financial Results - Research and Development (R&D) expenses for Q2 2025 were $37.1 million, up from $19.5 million in Q2 2024, primarily due to increased manufacturing and clinical trial costs [10]. - General and Administrative (G&A) expenses decreased slightly to $4.6 million in Q2 2025 from $4.8 million in Q2 2024 [10]. - The net loss for Q2 2025 was $41.0 million, compared to a net loss of $20.5 million in Q2 2024 [10]. Operational Innovations - Acumen implemented a two-step screening process in the ALTITUDE-AD trial using plasma pTau217 biomarker assay testing, achieving approximately 40% reduction in total screening costs across U.S. and Canadian sites [5]. - Sabirnetug demonstrated an 8,750-fold selectivity for Aβ1-42 stabilized oligomers over Aβ1-40 monomers, supporting its mechanism of action [5]. Collaboration and Development - Acumen entered a collaboration with JCR Pharmaceuticals to develop an oligomer-targeted Enhanced Brain Delivery therapy, combining sabirnetug with JCR's blood-brain barrier-penetrating technology [5].

Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment [3] - The company is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody, currently in Phase 2 clinical trial ALTITUDE-AD for early symptomatic Alzheimer's disease patients [3] - Acumen's scientific founders have pioneered research on amyloid beta oligomers, which are recognized as early triggers of Alzheimer's disease pathology [3] Recent Developments - Acumen Pharmaceuticals will report its second quarter 2025 financial results on August 12, 2025, and will host a conference call and live audio webcast at 8:00 a.m. ET for a business and financial update [1] - The company is also investigating a subcutaneous formulation of sabirnetug using Halozyme's ENHANZE® drug delivery technology [3] - Acumen is collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery therapy for Alzheimer's disease utilizing a transferrin-receptor-targeting technology [3]

Core Insights - Acumen Pharmaceuticals has reported a 40% reduction in clinical trial screening costs through the implementation of a blood-based pTau217 screening assay in its Phase 2 ALTITUDE-AD study for early Alzheimer's disease [1][3][4] - The company’s investigational product, sabirnetug, has demonstrated superior selectivity for soluble amyloid beta oligomers (AβOs) compared to other treatments, indicating a differentiated mechanism of action [5][6] Company Overview - Acumen Pharmaceuticals is focused on developing therapies targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease, with its lead candidate being sabirnetug (ACU193) [10] - The company has received Fast Track designation from the U.S. FDA for sabirnetug, which is currently in a Phase 2 clinical trial [7][10] Clinical Trial Details - The ALTITUDE-AD trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of sabirnetug in slowing cognitive decline in early Alzheimer's disease patients [9] - The trial has enrolled 542 participants across the U.S., Canada, the EU, and the UK, with a focus on improving patient-centric and cost-effective trial execution strategies [9][2] Screening Process Efficiency - The two-step screening process using plasma pTau217 biomarker testing resulted in 48% of participants meeting the threshold for confirmatory testing, with 81% of those passing the initial screening meeting amyloid positivity eligibility [4][3] - This innovative approach has led to strong enrollment rates and reduced the need for unnecessary amyloid PET scans and lumbar punctures [4][3] Mechanism of Action - Sabirnetug targets soluble AβOs, which are believed to be a significant factor in the neurodegenerative process of Alzheimer's disease, potentially slowing neurodegeneration and preventing synapse loss [5][7] - The product has shown an 8,750-fold selectivity for Aβ1-42 stabilized oligomers over Aβ1-40 monomers, highlighting its targeted action [6]

Core Viewpoint - Acumen Pharmaceuticals has entered into a collaboration with JCR Pharmaceuticals to develop an Enhanced Brain Delivery therapy targeting amyloid beta oligomers for Alzheimer's disease treatment [1][2][3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease [1][13] - The lead program, sabirnetug (ACU193), is a humanized monoclonal antibody that selectively targets AβOs, which are linked to neurodegeneration in Alzheimer's disease [4][11] Collaboration Details - The collaboration aims to combine Acumen's AβO-targeted antibody expertise with JCR's blood-brain barrier-penetrating technology, J-Brain Cargo, to enhance therapeutic delivery to the brain [2][7] - Acumen has an exclusive option to develop up to two candidates from this collaboration, with preclinical data expected in early 2026 [7][10] Technology Insights - J-Brain Cargo technology utilizes receptor-mediated transcytosis to deliver drugs to the central nervous system, applicable to various therapeutic modalities [3][14] - JCR's technology has previously led to an approved therapy in Japan, demonstrating its efficacy and safety profile [3][14] Clinical Trials - Acumen is currently conducting the ALTITUDE-AD Phase 2 clinical trial, which has enrolled 542 patients with early Alzheimer's disease, with topline results expected in late 2026 [5][12] - The Phase 1 INTERCEPT-AD trial showed that sabirnetug was well-tolerated and demonstrated significant amyloid plaque reduction compared to placebo [4][5] Financial Terms - Under the collaboration agreement, JCR will receive an upfront payment and may earn additional payments based on development milestones and royalties from future sales [10]