NEWTON, Mass. - Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a biopharmaceutical company focused on Alzheimer's disease treatments, announced the appointment of Amy Schacterle, Ph.D., as Chief Regulatory Officer & Head of Quality. Dr. Schacterle, with over three decades of experience in regulatory affairs and quality assurance, will report directly to President & Chief Development Officer Jim Doherty.
Dr. Schacterle's previous roles include leadership positions at Sage Therapeutics and Sunovion Pharmaceuticals, where she was instrumental in obtaining the first-ever treatment approval for postpartum depression. Her appointment comes as Acumen progresses with its Alzheimer's therapeutic candidate, sabirnetug, which is currently in a Phase 2 clinical trial.
The company also expressed gratitude to retiring Vice President of Regulatory Affairs, Janice Hitchcock, Ph.D., for her contributions, particularly in advancing sabirnetug from IND to Phase 2 and leading FDA and EMA interactions.
Acumen's investigational product, sabirnetug (ACU193), is a humanized monoclonal antibody targeting toxic soluble amyloid beta oligomers, considered triggers of Alzheimer's disease pathology. Following positive results from its Phase 1 trial INTERCEPT-AD, the company is advancing the drug through the ongoing Phase 2 ALTITUDE-AD trial in early symptomatic Alzheimer's patients.
The press release also contained forward-looking statements regarding the therapeutic potential and clinical efficacy of sabirnetug, as well as development plans. However, these statements are subject to risks and uncertainties, including those associated with the discovery and development of human therapeutics and broader geopolitical and macroeconomic conditions.
Acumen's filings with the Securities and Exchange Commission provide additional details on these risks. The company, based in Newton, Mass., emphasizes its commitment to improving the lives of patients with early Alzheimer's disease through its research and development efforts. This announcement is based on a press release statement from Acumen Pharmaceuticals, Inc.
In other recent news, Acumen Pharmaceuticals has been making significant strides in its clinical trials and financial status. The biopharmaceutical firm recently presented new data from its Phase 2 ALTITUDE-AD clinical trial for early Alzheimer's disease. The presentation focused on the company's use of a plasma pTau217 assay, a biomarker for Alzheimer's disease, as a screening tool for trial participants. Acumen's Alzheimer's drug candidate, sabirnetug, is currently undergoing this Phase 2 study, with enrollment progressing well and completion expected in 2025.
The company has also initiated a Phase 1 study for a subcutaneous version of sabirnetug, aiming to increase dosing flexibility. Financially, Acumen holds a strong position, with $281 million in cash and marketable securities, expecting its funds to last until the first half of 2027.
Acumen has also expanded its partnership with Lonza, a global manufacturing partner, to prepare for the potential commercial launch of sabirnetug. Analyst firms Stifel, H.C. Wainwright, and BTIG have maintained their Buy ratings on Acumen, reflecting confidence in the potential of sabirnetug. These recent developments highlight Acumen Pharmaceuticals' ongoing efforts to advance its Alzheimer's disease treatment candidate through clinical trials and prepare for possible commercial distribution.
InvestingPro Insights
As Acumen Pharmaceuticals (NASDAQ: ABOS) advances its Alzheimer's disease treatment candidate, sabirnetug, through clinical trials, investors may find value in examining the company's financial health. According to InvestingPro data, Acumen's market capitalization stands at $180.24 million, reflecting its position as a small-cap biopharmaceutical company.
InvestingPro Tips reveal that Acumen holds more cash than debt on its balance sheet, which could be crucial for funding ongoing clinical trials and regulatory processes. This financial cushion may prove valuable as the company progresses its lead candidate through the costly drug development pipeline.
However, it's important to note that Acumen is quickly burning through cash, a common characteristic of early-stage biopharmaceutical companies investing heavily in research and development. This is further evidenced by the company's negative gross profit of -$56.45 million over the last twelve months as of Q2 2024, highlighting the substantial costs associated with drug development.
Despite these financial challenges, Acumen has shown a strong return over the last month, with a 26.58% price total return. This recent performance may reflect investor optimism about the company's progress and the potential of sabirnetug.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights. In fact, there are 8 more InvestingPro Tips available for Acumen Pharmaceuticals, providing a deeper understanding of the company's financial position and market performance.
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