This section highlights FDA-related milestones and regulatory updates for drugs developed by Acumen Pharmaceuticals (ABOS).
Over the past two years, Acumen Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ACU193 and Sabirnetug. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ACU193 - FDA Regulatory Timeline and Events
ACU193 is a drug developed by Acumen Pharmaceuticals for the following indication: For Early Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ACU193
- Announced Date:
- March 27, 2025
- Indication:
- For Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals, provided a business update.
AI Summary
Acumen Pharmaceuticals provided a business update, highlighting significant progress in advancing sabirnetug as a potential treatment for early Alzheimer’s disease. The company announced that patient enrollment for the 540-participant Phase 2 ALTITUDE‐AD study was completed ahead of schedule, and topline results are expected in late 2026. Additionally, recent Phase 1 data from a subcutaneous formulation of sabirnetug showed promising safety and dosing results, supporting further development of this more convenient administration option.
CEO Daniel O’Connell expressed pride in the team’s progress and emphasized the company’s focus on transforming the standard of care for early Alzheimer’s disease. The strong cash position—totaling $231.5 million as of December 31, 2024—provides adequate support for ongoing clinical and operational activities through the first half of 2027.
Read Announcement- Drug:
- ACU193
- Announced Date:
- March 26, 2025
- Indication:
- For Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals,announced the completion of enrollment in its ALTITUDE-AD Phase 2 trial of sabirnetug (ACU193) in patients with early Alzheimer's disease.
AI Summary
Acumen Pharmaceuticals announced that it has successfully completed enrollment for its ALTITUDE-AD Phase 2 trial of sabirnetug (ACU193) in patients with early Alzheimer's disease. The clinical trial enrolled 542 patients from the United States, Canada, the European Union, and the United Kingdom. Participants are being randomized to receive one of two dosage levels of sabirnetug or a placebo, with the primary endpoint focused on the change in the Integrated Alzheimer’s Disease Rating Scale (iADRS) at 18 months. The trial, which is randomized, double-blind, and placebo-controlled, aims to assess the efficacy and safety of sabirnetug in slowing cognitive and functional decline in early Alzheimer's patients. Acumen's President and CEO, Daniel O’Connell, expressed optimism about the enrollment milestone, noting the strong interest from both the scientific community and patients. Topline results are expected in late 2026.
Read Announcement- Drug:
- ACU193
- Announced Date:
- January 9, 2025
- Indication:
- For Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals, announced that the Journal of Prevention of Alzheimer's Disease published the results of the Phase 1 INTERCEPT-AD clinical trial demonstrating that sabirnetug (ACU193) was generally well-tolerated with dose- and exposure-dependent target engagement and reduction in amyloid plaques.
AI Summary
Acumen Pharmaceuticals announced that the Journal of Prevention of Alzheimer’s Disease published positive Phase 1 INTERCEPT-AD trial results for sabirnetug (ACU193). The study showed that sabirnetug was generally well-tolerated in patients with early Alzheimer’s disease. It demonstrated dose- and exposure-dependent target engagement, meaning that higher doses led to a more significant effect on the toxic amyloid beta oligomers. Additionally, patients in the higher dose cohorts experienced statistically significant reductions in amyloid plaques. These encouraging outcomes highlight sabirnetug’s potential as a next-generation antibody treatment for early symptomatic Alzheimer’s disease by selectively targeting the harmful soluble forms of amyloid beta. The results build a strong foundation for the continued clinical development of sabirnetug and support further research in its ongoing Phase 2 ALTITUDE-AD clinical trial.
Read Announcement- Drug:
- ACU193
- Announced Date:
- September 26, 2024
- Indication:
- For Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals, Inc. announced today that it has extended its collaboration with Lonza to enable the potential future commercial launch of sabirnetug (ACU193).
AI Summary
Acumen Pharmaceuticals, Inc. has extended its collaboration with Lonza to support the potential future commercial launch of sabirnetug (ACU193). This extension builds on a successful partnership where Lonza manufactured the drug substance for clinical studies. Now, Lonza will also provide drug product manufacturing services for both ongoing clinical supply and potential commercial production. The manufacturing will take place at their state-of-the-art Visp, Switzerland facility and will include quality control and stability testing under cGMP conditions.
Sabirnetug is a promising humanized monoclonal antibody that targets toxic soluble amyloid beta oligomers, which are believed to play a significant role in early Alzheimer’s disease. This advancement in manufacturing is a key step as Acumen works on developing sabirnetug into a next-generation treatment for early Alzheimer’s disease, advancing its clinical programs and future commercial opportunities.
Read Announcement- Drug:
- ACU193
- Announced Date:
- July 29, 2024
- Indication:
- For Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals, 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 administrations of sabirnetug in healthy volunteers.
AI Summary
Acumen Pharmaceuticals recently announced a significant milestone in its Phase 1 study. The first subject has now been dosed with a subcutaneous formulation of sabirnetug (ACU193). This trial is designed to compare the pharmacokinetics (PK) of subcutaneous administration with the traditional intravenous route in healthy volunteers.
The subcutaneous formulation incorporates Halozyme’s proprietary ENHANZE® technology. This technology employs a recombinant human hyaluronidase enzyme (rHuPH20) that enables larger injection volumes, leading to improved dispersion and absorption. Acumen aims to offer a more convenient delivery option that could benefit patients by enhancing treatment flexibility and adherence, especially for those with Alzheimer’s disease.
Read Announcement- Drug:
- ACU193
- Announced Date:
- July 28, 2024
- Indication:
- For Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals, announced new findings from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193).
AI Summary
Acumen Pharmaceuticals recently shared promising results from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193), a novel treatment for early Alzheimer’s disease. The study focused on patients with early symptoms and found that sabirnetug engages its target by binding to toxic soluble amyloid beta oligomers, thought to drive neuronal damage in Alzheimer’s. Researchers observed that multiple doses of sabirnetug significantly lowered levels of synaptic proteins linked to injury, supporting its proposed mechanism of action.
The study also introduced an ultra-sensitive assay that accurately measures small amounts of sabirnetug in cerebrospinal fluid. These findings highlight the potential of sabirnetug as a best-in-class therapy and will guide future clinical trials, including an ongoing Phase 2 study, as the company continues to explore new treatments for Alzheimer’s disease.
Read Announcement- Drug:
- ACU193
- Announced Date:
- July 11, 2024
- Indication:
- For Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals, announced that the Company will present patient experience and biomarker data from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193) at the Alzheimer's Association International Conference (AAIC®) 2024 taking place in Philadelphia and online from July 28 – Aug. 1, 2024.
AI Summary
Acumen Pharmaceuticals announced it will present new data at the Alzheimer's Association International Conference (AAIC®) 2024, which will take place in Philadelphia and online from July 28 to August 1, 2024. The company will share patient experience and biomarker data from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193), a novel humanized monoclonal antibody designed to target toxic soluble amyloid beta oligomers associated with early Alzheimer’s disease. The presentations will include insights from qualitative interviews with patients and their study partners, as well as biomarker analyses and a highly sensitive immunoassay developed to detect sabirnetug levels in cerebrospinal fluid. The data aim to inform future clinical trials and support sabirnetug’s progression as a potential best-in-class treatment for early symptoms of Alzheimer’s disease.
Read Announcement- Drug:
- ACU193
- Announced Date:
- May 8, 2024
- Indication:
- Alzheimer's Disease
Announcement
Acumen Pharmaceuticals, Inc. announced that the first patient has been dosed with sabirnetug (ACU193) in the ALTITUDE-AD Phase 2 clinical trial designed to evaluate the clinical efficacy and safety of sabirnetug in patients with early AD.
Read Announcement
Sabirnetug - FDA Regulatory Timeline and Events
Sabirnetug is a drug developed by Acumen Pharmaceuticals for the following indication: for Early Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Sabirnetug
- Announced Date:
- July 10, 2025
- Indication:
- for Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals, will present new findings at the upcoming Alzheimer's Association International Conference (AAIC®) 2025 in Toronto.
Read Announcement- Drug:
- Sabirnetug
- Announced Date:
- April 2, 2025
- Indication:
- for Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals, presented extended results from its validated research-use plasma pTau217 assay to screen potential participants in the ongoing Phase 2 ALTITUDE-AD clinical trial of sabirnetug, showing this strategy has performed as intended.
AI Summary
Acumen Pharmaceuticals recently presented extended results from its validated research-use plasma pTau217 assay, a tool used to screen potential participants for its ongoing Phase 2 ALTITUDE-AD clinical trial of sabirnetug. The trial is evaluating sabirnetug, a novel treatment targeting toxic soluble amyloid beta oligomers implicated in early Alzheimer’s disease. The data, presented at the International Conference on Alzheimer’s and Parkinson’s Diseases in Vienna, showed that the pTau217 assay enrichment strategy performed as intended. Dr. Eric Siemers, Chief Medical Officer of Acumen, emphasized that this approach helped reduce the need for more invasive procedures such as amyloid PET scans and CSF testing. This efficient screening process not only makes the trial process less burdensome for patients and site staff but also supports the robust development program for sabirnetug, reinforcing its potential as a next-generation Alzheimer’s therapy.
Read Announcement- Drug:
- Sabirnetug
- Announced Date:
- March 19, 2025
- Indication:
- for Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals announced topline results from its Phase 1 study comparing pharmacokinetics (PK) between subcutaneous (SC) and intravenous (IV) formulations of sabirnetug in healthy volunteers.
AI Summary
Acumen Pharmaceuticals announced positive topline results from its Phase 1 study comparing the pharmacokinetics of sabirnetug given by subcutaneous (SC) versus intravenous (IV) infusion in healthy volunteers. The study showed that weekly SC administration of sabirnetug was well-tolerated, with proper systemic exposure that supports its continued clinical development. In the study, 12 subjects received a single 2,800 mg IV dose, while 16 subjects were given four weekly 1,200 mg SC doses. The most common reaction to the SC injection was a mild injection-site reaction, which resolved on its own and did not lead to serious safety concerns. These findings suggest that the SC formulation could offer a more convenient treatment option compared to IV administration, potentially reducing the treatment burden for patients as the clinical development of sabirnetug proceeds.
Read Announcement- Drug:
- Sabirnetug
- Announced Date:
- January 9, 2025
- Indication:
- for Early Alzheimer's Disease
Announcement
Acumen Pharmaceuticals, announced that Phase 2 ALTITUDE-AD clinical trial of sabirnetug is ongoing with enrollment completion expected 1H 2025
AI Summary
Acumen Pharmaceuticals announced that its Phase 2 ALTITUDE-AD clinical trial for sabirnetug (ACU193) is currently underway, with enrollment expected to complete in the first half of 2025. This study targets early Alzheimer’s disease and will assess the drug’s efficacy and safety in approximately 540 adults aged 50 to 90 across 75 sites in the U.S., Canada, the U.K., and the EU. The trial is designed as a randomized, double-blind, placebo-controlled study, continuing the promising work from earlier Phase 1 findings.
Results from the Phase 1 INTERCEPT-AD study demonstrated that sabirnetug selectively engaged its target—amyloid beta oligomers—in a dose-dependent manner and reduced amyloid plaques in higher dose groups. These findings have laid a strong foundation for the ongoing Phase 2 trial, underscoring sabirnetug’s potential as a next-generation antibody treatment for early Alzheimer’s disease.
Read Announcement
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