Research analysts covering AC Immune.
Recent press releases and 8-K filings for ACIU.
AC Immune Reports Favorable Interim Results for ACI-7104 Phase 2 Study in Parkinson's Disease
ACIU
- AC Immune announced favorable interim results from Part 1 of its Phase 2 VacSYn study of ACI-7104.056 for early Parkinson's disease.
- The study demonstrated a favorable safety and tolerability profile, with no serious adverse events related to the study drug.
- ACI-7104.056 achieved a 100% responder rate for antibodies against modified alpha-synuclein, which were boostable and crossed the blood-brain barrier.
- Biomarkers, including alpha-synuclein and NfL in CSF, showed stabilization, suggesting a potential slowing of Parkinson's disease pathology, with plasma GFAP and DaT-SPECT imaging also showing trends of disease stabilization.
- Clinical measures, specifically the MDS-UPDRS Part III total score, suggested a trend towards stabilization of motor symptoms, supporting further development of the program.
Dec 11, 2025, 2:00 PM
AC Immune Announces Positive Interim Phase 2 Results for Parkinson's Immunotherapy ACI-7104
ACIU
New Projects/Investments
- AC Immune (ACIU) announced positive interim results from Part 1 of its Phase 2 clinical trial for ACI-7104, an active immunotherapy targeting alpha-synuclein in early idiopathic Parkinson's disease.
- The study demonstrated a favorable safety and tolerability profile, with no serious adverse events considered related to the study drug.
- ACI-7104 achieved a 100% responder rate, with antibody levels significantly increasing up to week 76 and crossing the blood-brain barrier, reaching 500-fold increased antibody titers over baseline at week 76.
- Treatment with ACI-7104 showed a stabilization of disease-relevant biomarkers and a trend to slowing of disease progression in clinical measures, with the MDS-UPDRS Part III score remaining stable over 74 weeks, against an expected annual increase of 2-4 points. DaT-SPECT imaging also showed no change in treated patients, compared to an expected 8-12% annual decline.
- AC Immune is evaluating an accelerated development pathway for ACI-7104 towards registration and plans to include U.S. sites in the next study.
Dec 11, 2025, 2:00 PM
AC Immune Announces Positive Interim Results from ACI-7104 Phase Two Trial
ACIU
New Projects/Investments
- AC Immune announced positive interim results from part one of its vaccine phase two trial evaluating ACI-7104, an anti-alpha-synuclein active immunotherapy, in early Parkinson's disease patients.
- The compound demonstrated a favorable benefit-risk ratio, was safe and well-tolerated, and showed a 100% responder rate with antibodies crossing into the CSF.
- Interim analysis indicated stabilization of disease-relevant biomarkers and clinical measures, suggesting a potential for meaningful clinical benefit and slowing of disease progression.
- AC Immune plans to discuss a potential accelerated development pathway towards registration with regulatory agencies for ACI-7104, which is wholly owned by the company.
- The company's cash balance finances operations until the end of Q3 2027.
Dec 11, 2025, 2:00 PM
AC Immune reports positive interim Phase 2 data for Parkinson's disease immunotherapy
ACIU
Product Launch
New Projects/Investments
- AC Immune SA announced positive interim safety and immunogenicity data from its Phase 2 VacSYn clinical trial for ACI-7104.056, an active immunotherapy candidate for early Parkinson's disease (PD), on December 11, 2025.
- The trial demonstrated a clear safety profile with no clinically relevant safety issues reported and met immunogenicity targets with a 100% responder rate.
- Results suggest that ACI-7104.056 could potentially slow the rate of progression of PD, with disease-related biomarkers indicating stabilization of PD pathology and trends toward disease modification.
- AC Immune plans to seek regulatory feedback to accelerate the development plan towards registration, with final data from Part 1 of the VacSYn trial expected in mid-2026.
Dec 11, 2025, 12:04 PM
AC Immune Highlights Pipeline Progress and Financial Runway
ACIU
New Projects/Investments
Guidance Update
- AC Immune's pipeline includes several Phase 2 products and a Phase 3 diagnostics program, built on its super antigen and Morphomer platforms.
- The company has generated over $430 million from partnerships, with potential for more than $4 billion in additional milestones and royalties, and has cash to fund operations until Q3 2027.
- Key upcoming milestones by the end of 2025 include 12-month data for the ABATE trial (ACI-24), immunogenicity, biomarker, and clinical outcome results for the wholly-owned ACI-7104, and data for alpha-synuclein and TDP-43 tracers.
- The company plans to submit IND/CTA for its small molecule programs by December 2025, with clinical trials expected to start early next year.
- AC Immune's anti-Tau morphomer, partnered with Eli Lilly, demonstrated significant efficacy in mouse models by reducing Tau pathology and neurotoxicity, with a decision on the clinical lead molecule expected by year-end.
Nov 18, 2025, 9:30 AM
AC Immune Provides Pipeline Update and Financial Outlook at Jefferies London Healthcare Conference
ACIU
New Projects/Investments
Guidance Update
- AC Immune has a financial runway until Q3 2027 and has generated over $430 million from partnerships, with potential for more than $4 billion in additional milestones and royalties.
- The company's pipeline features three Phase 2 active immunotherapy programs and a Phase 3 diagnostics program, including lead assets ACI-35.030 (partnered with Johnson & Johnson) and ACI-24 (partnered with Takeda), both with FDA fast-track designation.
- Significant data readouts and milestones are expected by the end of 2025, including immunogenicity, biomarker, pharmacodynamic, and clinical results for the wholly-owned Phase 2 ACI-7104 program, 12-month data communication for the ABATE trial (ACI-24), and data for alpha-synuclein and TDP-43 tracers.
- AC Immune plans to submit IND/CTA for its small molecule programs (intracellular targeting) by December 2025, with clinical trials anticipated to begin in early 2026. The company is also preparing for Part 2 of the ACI-7104 clinical study, which will involve over 150 patients and aims for Phase 3 development, with an intent to keep it in-house.
Nov 18, 2025, 9:30 AM
AC Immune Reports Q3 2025 Financial Results and Corporate Update
ACIU
Earnings
Layoffs
Guidance Update
- AC Immune reported a net loss of CHF 15.9 million for the three months ended September 30, 2025, compared to a net income of CHF 5.5 million in the comparable 2024 period. This change was primarily due to the recognition of a CHF 24.6 million milestone payment from Janssen in Q3 2024.
- As of September 30, 2025, the company had cash resources of CHF 108.5 million, which are projected to fund operations until the end of Q3 2027, excluding potential milestone payments.
- Following a strategic review, AC Immune reduced its workforce by approximately 30% to focus investments on high-value assets, contributing to the extended cash runway.
- Research & development (R&D) expenses for Q3 2025 were CHF 13.1 million, down from CHF 14.5 million in Q3 2024, while general & administrative (G&A) expenses decreased slightly to CHF 3.6 million from CHF 3.8 million in the same periods.
Nov 4, 2025, 12:00 PM
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