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AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)

Key Takeaway: AC Immune has received FDA Fast Track Designation for its anti-alpha-synuclein immunotherapy, ACI-7104, aimed at treating early Parkinson's Disease. The company plans to expand its ongoing Phase 2 VacSYn study to additional sites in the USA following Investigational New Drug clearance. Recent interim results have shown promising safety outcomes.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA Fast Track Designation granted for ACI-7104.
  • Ongoing Phase 2 VacSYn study expanding to USA.
  • Recent interim results indicate safety.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+16%
120-day peak, hindsight
Typical move
6.6%
average across 8 past catalysts
Lead asset
ACI-7104.056 at Dose A
Phase 2 · Parkinson Disease

Full Press Release Details

AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD) Ongoing Phase 2 VacSYn study to expand to sites in USA with Investigational New Drug (IND) clearance Recent positive interim results showed safety and

Frequently Asked Questions

What is ACI-7104?

ACI-7104 is an anti-alpha-synuclein active immunotherapy developed by AC Immune.

What designation did ACI-7104 receive from the FDA?

ACI-7104 received FDA Fast Track Designation for treating early Parkinson's Disease.

What is the VacSYn study?

The VacSYn study is a Phase 2 clinical trial evaluating ACI-7104.

Where will the VacSYn study expand?

The VacSYn study will expand to additional sites in the USA.

What were the recent results of ACI-7104?

Recent interim results from the study indicated positive safety outcomes.

Last updated: Aug 11, 2026