This section highlights FDA-related milestones and regulatory updates for drugs developed by AC Immune (ACIU).
Over the past two years, AC Immune has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ACI-24.060, ACI-35.030, ACI-7104.056, and PI-2620. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ACI-24.060 - FDA Regulatory Timeline and Events
ACI-24.060 is a drug developed by AC Immune for the following indication: To assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060.
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:
- ACI-24.060
- Announced Date:
- December 10, 2024
- Indication:
- To assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060
Announcement
AC Immune SA announced interim safety and tolerability data from the ABATE Phase 1b/2 trial of ACI-24.060 in individuals living with Down syndrome (DS). Targeting toxic forms of amyloid beta (Abeta), ACI-24.060 is an active immunotherapy covering Abeta 1-15 (excluding Abeta T-cell epitopes).
AI Summary
AC Immune SA announced encouraging interim safety and tolerability data from the ABATE Phase 1b/2 trial of ACI-24.060 in individuals with Down syndrome (DS). The trial focused on using this active immunotherapy, which targets toxic forms of amyloid beta by covering Abeta 1-15 while excluding T-cell epitopes. In the first two cohorts treated for up to one year, no serious adverse events related to the study drug were observed, and there were no cases of amyloid-related imaging abnormalities (ARIA).
Based on these promising findings, the company plans to open the high-dose cohort in DS patients. The results suggest that ACI-24.060 may offer a novel therapeutic option for managing brain Abeta pathology in a vulnerable population at risk for Alzheimer’s disease.
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ACI-35.030 - FDA Regulatory Timeline and Events
ACI-35.030 is a drug developed by AC Immune for the following indication: Alzheimer’s Disease (AD).
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:
- ACI-35.030
- Announced Date:
- September 17, 2024
- Indication:
- Alzheimer’s Disease (AD)
Announcement
AC Immune SA announced that it will receive the second ReTain-related milestone payment (CHF 24.6 million) under its agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company.
AI Summary
AC Immune SA announced that it will receive a second milestone payment of CHF 24.6 million from Janssen Pharmaceuticals, a Johnson & Johnson company. This payment was triggered by the rapid prescreening rate in the Phase 2b ReTain trial of its active-immunotherapy candidate ACI-35.030, now called JNJ-2056. The trial is testing the treatment in people with preclinical Alzheimer’s disease, a key stage where the disease is present but symptoms have not yet developed. With this contribution, milestone payments related to the trial now total CHF 40 million. AC Immune stated that the payment underscores the promise of their technology platforms and drug development capabilities in the fight against neurodegeneration. It also strengthens the company’s financial position, supporting ongoing efforts to reach several critical milestones in the fight against Alzheimer’s disease.
Read Announcement- Drug:
- ACI-35.030
- Announced Date:
- July 25, 2024
- Indication:
- Alzheimer’s Disease (AD)
Announcement
AC Immune SA announced that its active-immunotherapy candidate, ACI-35.030 (now called JNJ-2056), targeting the pathologic form of the Tau protein, phosphorylated Tau (pTau), has received Fast Track designation from the U.S. Food and Drug Administration (FDA).
AI Summary
AC Immune SA’s active immunotherapy candidate, ACI-35.030—now known as JNJ-2056—has received Fast Track designation from the U.S. FDA. This recognition is granted because the treatment specifically targets phosphorylated Tau (pTau), a toxic form of the Tau protein that is strongly linked to Alzheimer’s disease progression.
The Fast Track status could help speed up the development and regulatory review of JNJ-2056, increasing hope that the therapy will effectively delay or reduce the spread of the pathological pTau in Alzheimer’s patients. This move underlines the therapeutic potential of the candidate, which has already demonstrated its ability to target the harmful form of Tau while sparing the normal protein. Alongside this FDA milestone, AC Immune is advancing its strategy to treat early Alzheimer’s, reinforcing the focus on precision medicine for neurodegenerative diseases.
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ACI-7104.056 - FDA Regulatory Timeline and Events
ACI-7104.056 is a drug developed by AC Immune for the following indication: For Parkinson'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:
- ACI-7104.056
- Announced Date:
- April 2, 2025
- Indication:
- For Parkinson's Disease
Announcement
AC Immune SA announced additional interim safety and positive immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of patients with early Parkinson's disease (PD).
AI Summary
AC Immune SA announced encouraging interim results from its Phase 2 VacSYn trial for early Parkinson’s disease. The study focused on ACI-7104.056, the company’s wholly owned active immunotherapy candidate targeting pathological alpha-synuclein. Interim data showed that repeated immunizations led to a strong immune response, with anti-alpha-synuclein antibody levels increasing over 20 times higher than those seen in the placebo group after four doses. The trial also confirmed that the treatment is well tolerated, with only mild side effects such as injection site reactions and headaches reported. These findings support the boostability of the immune response and underline the potential of ACI-7104.056 as a best-in-class candidate for treating early Parkinson’s disease. AC Immune looks forward to further updates later in 2025 as the study continues to monitor safety and immunogenicity.
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PI-2620 - FDA Regulatory Timeline and Events
PI-2620 is a drug developed by AC Immune for the following indication: For Alzheimer's disease (AD).
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:
- PI-2620
- Announced Date:
- August 28, 2024
- Indication:
- For Alzheimer's disease (AD)
Announcement
AC Immune SA announced that its partner Life Molecular Imaging (LMI) has received Fast Track Designation for the Tau positron emission tomography (PET) diagnostic, [18F]PI-2620, from the U.S. Food and Drug Administration (FDA) in three neurodegenerative conditions.
AI Summary
AC Immune SA announced that its partner, Life Molecular Imaging (LMI), has received Fast Track Designation from the U.S. Food and Drug Administration for its Tau positron emission tomography diagnostic, [18F]PI-2620. This designation covers three serious neurodegenerative conditions: Alzheimer’s disease, progressive supranuclear palsy, and corticobasal degeneration. Fast Track status is designed to speed up the development and review process for medical tools that address unmet needs in serious illnesses.
[18F]PI-2620 is a next-generation PET imaging agent currently in Phase 3 trials for Alzheimer’s disease. It works by detecting abnormal Tau protein deposits in the brain, which are a key marker of these conditions. Early and accurate detection may lead to improved treatment outcomes, making this development a significant step forward in the fight against neurodegenerative diseases.
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