AC Immune (NASDAQ: ACIU) gains FDA Fast Track, IND clearance for Parkinson’s drug ACI-7104
Rhea-AI Filing Summary
AC Immune SA reports that the U.S. FDA has granted Fast Track designation and cleared the IND application for its wholly owned anti‑alpha‑synuclein active immunotherapy ACI‑7104 for early‑stage Parkinson’s disease. ACI‑7104 is designed to induce alpha‑synuclein‑specific antibodies that preferentially recognize aggregated, neuron‑toxic species.
The therapy is being evaluated in the adaptive, biomarker‑based VacSYn Phase 2 trial, with final Part 1 week‑100 results expected in H2 2026. Interim Part 1 data at 76 weeks showed ACI‑7104 was safe and well tolerated, achieved a 100% immunogenicity responder rate, and provided early signals of activity. A $4 million research grant from the Vijay and Marie Goradia Charitable Foundation supports extending Part 1 for an additional two years to assess long‑term safety and efficacy.
Positive
- FDA Fast Track designation and IND clearance for ACI‑7104 in early‑stage Parkinson’s disease validate the program’s potential and may accelerate development and regulatory interactions.
- Interim Phase 2 VacSYn data showed ACI‑7104 was safe and well tolerated with a 100% immunogenicity responder rate, plus early signals of activity in Parkinson’s disease.
- A $4 million research grant from the Vijay and Marie Goradia Charitable Foundation funds a two‑year extension of the VacSYn trial to assess long‑term safety and efficacy.
- AC Immune highlights a partnered pipeline with over $4.5 billion in potential milestone payments, underscoring substantial non‑dilutive funding opportunities from collaborations.
Negative
- None.
Filing Explained
The August 11 Form 6-K states that the report, excluding the press-release exhibit, is incorporated by reference into AC Immune’s identified Form F-3 and Form S-8 registration statements from the filing date, making this disclosure part of those filings.
Key Figures
Key Terms
Fast Track designation regulatory
Investigational New Drug (IND) regulatory
active immunotherapy medical
immunogenicity medical
NLRP3 inflammasome medical
oligomeric a-syn medical
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FAQ
What did AC Immune (ACIU) announce regarding ACI-7104 and the FDA?
What are the key interim Phase 2 VacSYn results for ACI-7104 reported by ACIU?
When will AC Immune (ACIU) report full Part 1 week-100 results from the VacSYn trial?
How is the VacSYn trial for ACI-7104 being expanded with IND clearance in the USA?
What external funding did AC Immune (ACIU) receive to support the ACI-7104 program?
What broader pipeline and partnership potential does AC Immune (ACIU) highlight?
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August, 2026
Commission file number: 001-37891
AC IMMUNE SA
(Exact Name of Registrant as Specified in Its Charter)
EPFL Innovation Park
Building B
1015 Lausanne, Switzerland
(Address of Principal Executive Offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
On August 11, 2026, AC Immune SA issued a press release announcing that it has received Fast Track designation and clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, ACI-7104, for the treatment of early-stage Parkinson’s disease (PD).
ACI-7104 is designed to induce a-syn-specific antibodies, preferentially recognizing aggregated a-syn species that are toxic to neurons. The candidate is currently being investigated in the VacSYn Phase 2 trial, an adaptive, biomarker-based study in patients with early-stage Parkinson’s disease, with final Part 1 week-100 results on track to be announced in H2.
This Report on Form 6-K (excluding Exhibit 99.1) shall be deemed to be incorporated by reference into the registration statements on Form F-3 (File Nos. 333-227016, 333-249655 and 333-277940) and Form S-8 (File Nos. 333-213865, 333-216539 and 333-233019) of AC Immune SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
Exhibit | | Description |
99.1 | | Press Release dated August 11, 2026 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| AC IMMUNE SA | |
| | |
| By: | /s/ Martin Zuegel |
| | Name: Martin Zuegel |
| | Title: Interim Chief Executive Officer |
| | |
| | |
| By: | /s/ Christopher Roberts |
| | Name: Christopher Roberts |
| | Title: Chief Financial Officer |
| | |
Date: August 11, 2026 | | |
Exhibit 99.1
PRESS RELEASE
AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)
Lausanne, Switzerland, August 11, 2026 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company developing targeted therapeutics for neurodegenerative diseases, today announced that it has received Fast Track designation and clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, ACI-7104, for the treatment of early-stage Parkinson’s disease (PD).
ACI-7104 is designed to induce a-syn-specific antibodies, preferentially recognizing aggregated a-syn species that are toxic to neurons. The candidate is currently being investigated in the VacSYn Phase 2 trial, an adaptive, biomarker-based study in patients with early-stage Parkinson’s disease, with final Part 1 week-100 results on track to be announced in H2.
Martin Zügel, interim CEO of AC Immune SA, commented: “Fast Track designation and IND clearance from the FDA are important achievements for ACI-7104, one of our wholly-owned programs, given its potential to address the significant unmet need in Parkinson’s. We look forward to working closely with the FDA as we advance ACI-7104 through its ongoing clinical development towards potentially delivering a much-needed treatment option for patients.”
FDA Fast Track designation reflects the early interim Phase 2 data demonstrating safety, tolerability and immunogenicity, and providing first signals that targeting underlying a-syn pathology with an active immunotherapy could potentially impact PD. The interim results, reported for Part 1 of the study at 76 weeks, successfully demonstrated ACI-7104 was safe and well tolerated, with no clinically relevant safety issues being reported. Targets were also met for immunogenicity with a 100% responder rate. AC Immune recently announced a $4 million research grant from the Vijay and Marie Goradia Charitable Foundation to support the extension of Part 1 of the VacSYn trial, enabling the assessment of long-term safety and efficacy of ACI-7104 for an additional two years.
Günther Staffler, Executive Vice President, Development at AC Immune SA, commented: “ACI-7104 represents a promising active immunotherapy designed to target pathological a-syn for the treatment of prodromal and early PD. The FDA’s decision signifies the growing importance of the program including the positive interim Phase 2 findings. This is a key regulatory milestone for the program, and we look forward to delivering the full results from Part 1 of the VacSYn trial in the coming months.”
Exhibit 99.1
PRESS RELEASE
About ACI-7104
ACI-7104 is an optimized formulation of AC Immune’s anti-a-syn predecessor active immunotherapy which generated an antibody response against pathological oligomeric a-syn to inhibit spreading and downstream neurodegeneration in early Parkinson’s disease. The accumulation of alpha-synuclein protein aggregates has been shown to cause inflammatory stress in cells and contributes to the degeneration of neurons in the brain, linking it to the development of neurodegenerative diseases such as Parkinson’s Disease.
About AC Immune SA
AC Immune (NASDAQ: ACIU) is a clinical stage biopharmaceutical company developing a pipeline of products, including both active immunotherapies and small molecules, targeting key misfolded proteins and pathways for the treatment of multiple neurodegenerative diseases. The company has a growing focus on its wholly owned proprietary clinical-stage programs, including: ACI-7104, an active immunotherapy targeting α-synuclein (α-syn) in Parkinson's disease; and ACI-19764, a small molecule inhibitor of the NLRP3 inflammasome. In addition, an early-stage small molecule development program targeting intracellular a-syn is advancing towards the clinic.
ACIU has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding and >$4.5 billion in potential milestone payments. ACIU’s pharma-partnered programs, all in Alzheimer’s disease, include: a collaboration on ACI-24, an active immunotherapy targeting Abeta; a collaboration on ACI-35 targeting phospho-Tau; and a collaboration developing brain-penetrant small molecule drugs targeting intracellular pathologic Tau.
All trademarks used or mentioned in this release are protected by law. The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.
For further information, please contact:
SVP, Investor Relations & Corporate Communications | |
International Media Optimum Strategic Communications |
|
Exhibit 99.1
PRESS RELEASE
Phone: +44 (0) 20 4566 8543 |
Forward looking statements
This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.