Acumen Pharmaceuticals(ABOS)

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Acumen Pharmaceuticals Presents Innovative Trial Screening Advancements Utilizing pTau217 Assay in Phase 2 Study of Sabirnetug for Early Alzheimer's Disease at the 17th Annual Clinical Trials on Alzheimer's Disease Conference
GlobeNewswire News Room· 2024-10-31 12:05
Core Insights - Acumen Pharmaceuticals presented updated data on the pTau217 assay, highlighting its effectiveness in screening participants for the ALTITUDE-AD clinical trial, which reduces unnecessary amyloid PET scans and lumbar punctures for ineligible individuals [1][2][4] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease [9] - The company is headquartered in Newton, Massachusetts, and is advancing its investigational product candidate, sabirnetug (ACU193), in the ongoing Phase 2 clinical trial ALTITUDE-AD [9] Clinical Trial Details - ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of sabirnetug in approximately 540 adults aged 50 to 90 years [2][8] - The trial is currently enrolling participants at 75 sites across the U.S., Canada, EU, and U.K., with expected completion of enrollment in the first half of 2025 [2][8] pTau217 Assay Insights - The pTau217 assay serves as an enrichment tool, classifying participants most likely to be eligible for the ALTITUDE-AD study, with a threshold established at ≥0.15 pg/mL [4] - More than half of potential participants have been excluded due to pTau217 results below this threshold, while 74% of those with results ≥0.15 pg/mL met eligibility requirements following confirmatory assessments [4] Clinical Trial Process Improvement - The pTau217 screening assay is designed to reduce the burden on patients by minimizing invasive procedures and unnecessary radiation exposure, thus streamlining the trial enrollment process [2][3] - The study's design aims to enhance the patient experience while advancing next-generation treatments for Alzheimer's disease [5]
Acumen Pharmaceuticals to Deliver Late-Breaking Presentation at 17th Annual Clinical Trials on Alzheimer's Disease (CTAD) Conference
GlobeNewswire News Room· 2024-10-23 12:00
Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease (AD) treatment [5] - The company is headquartered in Newton, Massachusetts, and is advancing its investigational product candidate, sabirnetug (ACU193), in the ongoing Phase 2 clinical trial ALTITUDE-AD [5] Product Information - Sabirnetug (ACU193) is a humanized monoclonal antibody that selectively targets toxic soluble AβOs, which are believed to be early triggers of Alzheimer's disease pathology [3][5] - The drug has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of early AD [3] Clinical Trial Details - The ALTITUDE-AD study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial initiated in 2024, designed to evaluate the efficacy and safety of sabirnetug infusions administered every four weeks [4] - The trial aims to enroll approximately 540 individuals with early Alzheimer's disease, including those with mild cognitive impairment or mild dementia due to AD [4] - The study is currently ongoing at multiple investigative sites across the United States, Canada, the UK, and the European Union [4] Biomarker Utilization - Acumen will present updated data on the use of a validated plasma pTau217 assay as a screening tool for potential participants in the ALTITUDE-AD trial [2] - The pTau217 biomarker indicates AD pathology and is used to identify individuals who qualify for additional amyloid testing [2] Upcoming Presentation - A late-breaking presentation will be held on October 31, 2024, at the 17th Annual Clinical Trials on Alzheimer's Disease (CTAD) conference, focusing on the participant screening process in the ALTITUDE-AD study [1][3]
Acumen Pharmaceuticals to Host Virtual R&D Day on Oct. 2, 2024
GlobeNewswire News Room· 2024-09-25 20:00
Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease (AD) treatment [4] - The company is headquartered in Newton, Massachusetts and is advancing its investigational product candidate, sabirnetug (ACU193), in an ongoing Phase 2 clinical trial named ALTITUDE-AD [4] Upcoming Event - Acumen will host a virtual R&D Day on October 2, 2024, at 10:00 a.m. ET, to present its strategic vision and discuss the mechanistic rationale, pre-clinical, and clinical data supporting the development of sabirnetug for early AD [1] - The event will feature discussions from Acumen's management and scientific leadership, along with external key opinion leaders on the current treatment paradigm and unmet needs in early Alzheimer's disease [2] Clinical Development - Sabirnetug is a humanized monoclonal antibody that selectively targets toxic soluble AβOs and is currently in Phase 2 clinical trials after positive results in its Phase 1 trial, INTERCEPT-AD [4] - The ongoing Phase 2 ALTITUDE-AD trial is investigating sabirnetug in early symptomatic Alzheimer's disease patients [4]
Acumen Pharmaceuticals Inc(ABOS.US)Thoughts post 2Q24 & a thesis revisit: cutting PT to $6 on lowered sabirnetug estimates amid class setbacks, remains Buy
UBS· 2024-08-15 03:50
Investment Rating - The report maintains a "Buy" rating for Acumen Pharmaceuticals Inc with a 12-month price target (PT) lowered to $6 from $14 [4][8]. Core Insights - The investment thesis has been updated following the 2Q24 earnings report, with a focus on the execution of Phase 2 (P2) trials for sabirnetug (ACU193) as a key driver for stock performance [2][6]. - The overall sentiment in the Alzheimer's disease (AD) market remains low, influenced by regulatory setbacks and slow commercial uptake of competing products [3][9]. - Despite the challenges, the report highlights that Acumen Pharmaceuticals has sufficient cash to fund operations into the first half of 2027, with P2 trial enrollment exceeding expectations [6][7]. Summary by Sections Investment Rating - 12-month rating: Buy - 12-month price target: $6.00 (previously $14.00) [4]. Financial Performance - Current stock price as of August 14, 2024: $2.46 - Market capitalization: $0.14 billion - Expected revenues for 12/24E: $21 million [5]. Market and Competitive Landscape - The AD market is sizable but has seen a decline in clinical trials and investigational drugs in 2024 compared to 2023 [3]. - Regulatory risks have increased following the EMA refusal of Leqembi, impacting overall market sentiment [3][9]. Company-Specific Developments - Acumen Pharmaceuticals reported a cash position of $281.4 million, sufficient to support ongoing trials [6]. - Management noted that the P2 ALTITUDE-AD study is progressing faster than expected, with positive feedback on the trial design [6][7]. Valuation Adjustments - Peak sales estimates for sabirnetug have been lowered from $6.8 billion to $2.4 billion due to anticipated lower commercial uptake [9][10]. - The probability of success (PoS) for sabirnetug has been increased from 15% to 20% based on evolving clinical data [9][10].
Acumen Pharmaceuticals(ABOS) - 2024 Q2 - Quarterly Report
2024-08-13 20:42
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ___________________________ FORM 10-Q ___________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_________to_________ Commission File Number: 001-40551 ___________________________ Acume ...
Acumen Pharmaceuticals(ABOS) - 2024 Q2 - Earnings Call Transcript
2024-08-13 15:17
Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q2 2024 Earnings Conference Call August 13, 2024 8:00 AM ET Company Participants Dan O’Connell - Chief Executive Officer Matt Zuga - Chief Financial Officer, Chief Business Officer Dr. Jim Doherty - President, Chief Development Officer Dr. Eric Siemers - Chief Medical Officer. Alex Braun - Head of Investor Relations Conference Call Participants Tom Shrader - BTIG Cameron Bozdog - Bank of America Samantha Schaeffer - Cantor Fitzgerald Trung Huynh - UBS Ananda Ghos ...
Acumen Pharmaceuticals(ABOS) - 2024 Q2 - Quarterly Results
2024-08-13 11:48
Exhibit 99.1 Acumen Pharmaceuticals Reports Second Quarter 2024 Financial Results and Business Highlights • Actively enrolling subjects in ALTITUDE-AD, a Phase 2 study to investigate sabirnetug (ACU193) for the treatment of early Alzheimer's disease • Dosed the first subject in a Phase 1 study to support subcutaneous administration of sabirnetug in July 2024 with topline results anticipated in the first quarter of 2025 • Cash, cash equivalents and marketable securities of $281.4 million as of Jun. 30, 2024, ...
Acumen Pharmaceuticals: Healthy Cash Runway And Market Potential In Alzheimer's
Seeking Alpha· 2024-07-30 00:38
Jonathan Kitchen Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) is a clinical-stage biopharmaceutical company that develops innovative treatments for AD, specifically targeting toxic soluble AβOs that accumulate in the brain, producing synapse deterioration, tau hyper-phosphorylation, and inflammation. These factors contribute to neuronal death, leading to cognitive and functional impairments. ABOS’s leading drug candidate, Sabirnetug, is a monoclonal antibody designed to neutralize AβOs to preserve neurona ...
Acumen Pharmaceuticals Announces First Subject Dosed in Phase 1 Study of Subcutaneous Sabirnetug (ACU193) for Early Alzheimer's Disease
Newsfilter· 2024-07-29 11:00
NEWTON, Mass., July 29, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) in the brain for the treatment of Alzheimer's disease (AD), today announced that the first subject has been dosed with a subcutaneous formulation of sabirnetug (ACU193) in a Phase 1 pharmacokinetic (PK) comparison study. The study plans to compare the PK between subcutaneous and intravenous ad ...
Acumen Pharmaceuticals Presents Patient Experience and Biomarker Data from Phase 1 INTERCEPT-AD Study at the Alzheimer's Association International Conference (AAIC®) 2024
Newsfilter· 2024-07-28 11:30
NEWTON, Mass., July 28, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer's disease (AD), today announced new findings from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193). The research highlights the experiences of patients in the clinical trial to inform development of future trials, biomarker data to support sabirnetug's ...