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AC Immune Initiates Final Cohort in Ongoing Phase 1b/2 ABATE Trial of Anti-Abeta Active Immunotherapy to Treat Alzheimer's Disease

(Positive)
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AC Immune (NASDAQ: ACIU) dosed the first patient in Cohort AD4 of the Phase 1b/2 ABATE trial and triggered a $12 million milestone from Takeda. AD4 will enroll 36 patients for 12 months (plus 6-month follow-up) and could expand to ~112 patients. 12-month data from AD1–AD3 are expected in Q2 2026. Under the Takeda agreement, AC Immune received a $100 million upfront payment and is eligible for up to $2.1 billion in further milestones and tiered double-digit royalties on sales.

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Positive

  • $12M milestone payment triggered by dosing first AD4 patient
  • Received $100M upfront payment from Takeda
  • Eligible for up to $2.1B in development and commercial milestones
  • 12-month data readouts from AD1–AD3 expected in Q2 2026
  • AD4 initial cohort expands safety and biomarker dataset to 36 patients

Negative

  • Further clinical development rights and funding hinge on Takeda exercising its option
  • ABATE remains early-stage (Phase 1b/2); efficacy in delaying AD not yet demonstrated
  • Planned AD4 expansion to ~112 patients is conditional, not guaranteed

News Market Reaction – ACIU

+3.41%
2 alerts
+3.41% Session close to close
$318.04M Market Cap
0.0x Rel. Volume

In the Apr 30 session, ACIU gained 3.41%, reflecting a moderate positive market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement advances AC Immune’s ABATE program by starting Cohort AD4 in prodromal Alzheimer’s...
Analysis

This announcement advances AC Immune’s ABATE program by starting Cohort AD4 in prodromal Alzheimer’s disease, triggering a $12 million milestone from Takeda and expanding the dataset by up to 112 additional patients. It builds on earlier cohorts totaling 74 patients, with 12‑month data expected in Q2 2026. Historically, the company has combined de‑risking collaborations and early‑stage clinical readouts, so progress of ABATE and other pipeline trials remains a key metric to watch.

Key Figures

Milestone payment: $12 million Prodromal AD cohorts enrollment: 74 patients Initial AD4 cohort size: 36 patients +4 more
7 metrics
Milestone payment $12 million Triggered by first patient treated in ABATE Cohort AD4
Prodromal AD cohorts enrollment 74 patients Cohorts AD1–AD3 received ACI-24 at escalating doses
Initial AD4 cohort size 36 patients Treated for 12 months plus 6-month follow-up
Potential total AD4 size 112 patients Possible expansion of Cohort AD4 in ABATE trial
Data readout timing Q2 2026 12-month data from ABATE Cohorts AD1–AD3 expected
Upfront payment $100 million Received from Takeda under option and license agreement
Potential milestones $2.1 billion Additional development, commercial and sales-based milestones

Historical Context

5 past events · Latest: Apr 07 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Apr 07 Collaboration amendment Positive +15.2% Lilly Morphomer Tau amendment with CHF 10M upfront and large milestones.
Mar 19 Clinical data update Positive -4.5% First in vivo PET images of TDP‑43 pathology with favorable safety profile.
Mar 13 Earnings and update Neutral +0.5% Full‑year 2025 results with pipeline progress and extended cash runway.
Mar 05 Conference participation Neutral -3.9% Announcement of Parkinson’s symposium and TDP‑43 PET‑tracer presentation.
Feb 24 Trial initiation Positive +7.5% First participant dosed in Phase 1 trial of NLRP3 inhibitor ACI‑19764.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Positive R&D and partnership updates have often aligned with gains, while some clinically positive data have seen short-term price weakness.

Recent Company History

Over recent months, AC Immune reported several milestones, including a Lilly Morphomer Tau amendment on Apr 7, 2026 that coincided with a +15.19% move. Earlier, positive TDP‑43 PET Phase 1 data on Mar 19, 2026 saw a -4.53% reaction, showing at least one divergence between upbeat clinical news and stock performance. A Phase 1 NLRP3 trial initiation on Feb 24, 2026 aligned with a +7.51% gain. Today’s ABATE cohort initiation adds another clinical milestone alongside this established partnership‑heavy strategy.

Key Terms

phase 1b/2, active immunotherapy, immunogenicity, pharmacodynamic, +4 more
8 terms
phase 1b/2 medical
"ongoing Phase 1b/2 ABATE trial of ACI-24"
Phase 1b/2 is a combined early-stage human study that first checks a drug’s safety and side effects in a small group and then expands to test whether it shows signs of working in patients. Think of it as a product test that first confirms it’s safe to use, then looks for early evidence of benefit; positive results can significantly reduce clinical risk and increase a company’s value, while negative results raise the opposite.
active immunotherapy medical
"anti-Abeta active immunotherapy to treat Alzheimer's disease"
Active immunotherapy is a medical approach that trains a patient’s own immune system to recognize and attack disease, often by exposing it to a target that mimics the threat. Think of it like coaching the body's guard dogs to spot a specific intruder; for investors it matters because successful therapies can create durable, high-value treatments but also carry high clinical and regulatory risk and long development timelines.
immunogenicity medical
"encouraging early safety and immunogenicity data to date"
Immunogenicity is the ability of a substance, such as a vaccine or medication, to provoke an immune response in the body. It matters to investors because high immunogenicity can affect the effectiveness and safety of a product, potentially leading to increased costs or regulatory challenges. Understanding immunogenicity helps assess the long-term viability and market potential of pharmaceutical and biotech investments.
pharmacodynamic medical
"to assess its safety, tolerability, immunogenicity and pharmacodynamic effects"
Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.
randomized, double-blind, placebo-controlled medical
"ongoing ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial"
A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.
prodromal medical
"ABATE is assessing ACI-24 in subjects with prodromal AD"
An early phase of illness marked by subtle, often nonspecific signs or changes that occur before the full disease develops; these early indicators may be biological measurements, mild symptoms, or imaging findings rather than a clear diagnosis. Investors care because detecting or treating a prodromal stage can create new markets for diagnostics and therapies, change clinical trial design and approval pathways, and act like an early warning light that alters a product’s commercial potential.
biomarker medical
"expanding the safety and biomarker efficacy data set"
A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.
royalties financial
"entitled to receive tiered double-digit royalties on worldwide net sales"
Payments made to the owner of an asset or intellectual property each time that asset is used or a product is sold, often calculated as a percentage of sales or a set amount per unit. Royalties matter to investors because they create predictable, ongoing income streams and affect a company’s cash flow and valuation—like a landlord collecting rent or an author getting a steady cut whenever a book is sold.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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AC Immune Initiates Final Cohort in Ongoing Phase 1b/2 ABATE Trial of Anti-Abeta Active Immunotherapy to Treat Alzheimer's Disease

  • Treatment of first patient in Cohort AD4 in ABATE trial triggers $12 million milestone payment
  • Allows evaluation of potential for precision prevention of neurodegenerative diseases
  • Data from ABATE Cohorts AD1, AD2 and AD3 after 12 months treatment expected Q2 2026

Lausanne, Switzerland, April 30, 2026 -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced it dosed the first patients in Cohort AD4 in the ongoing Phase 1b/2 ABATE trial. As a result, AC Immune will receive a $12 million milestone payment from Takeda under the partners’ exclusive, worldwide option and license agreement for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24 for the treatment of Alzheimer’s disease (AD).

ABATE is assessing ACI-24 in subjects with prodromal AD and in adults with Down syndrome (DS). AD4 includes subjects with prodromal AD.

Dr. Andrea Pfeifer, CEO of AC Immune SA, said: “This milestone underscores the progress in our Phase 1b/2 ABATE trial of ACI-24. AD4 will build on the encouraging early safety and immunogenicity data to date. It allows further evaluation of the potential of ACI-24 and, more broadly, our precision prevention approach to neurodegenerative diseases, which encompasses a pipeline of active immunotherapies and intracellular-targeted small-molecule therapeutics to intervene at the earliest stages of disease.”

ACI-24 is an anti-Abeta active immunotherapy candidate designed to induce a robust antibody response against the toxic forms of Abeta believed to drive plaque formation and AD progression. By inducing plaque clearance and efficiently inhibiting plaque formation in the brain, ACI-24 has the potential to delay or slow AD progression.

ACI-24 is being investigated in the ongoing ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial to assess its safety, tolerability, immunogenicity and pharmacodynamic effects. Data so far show that ACI-24 is generally safe and well tolerated, and that it has generated anti-Abeta antibody responses at all tested doses.

Cohorts AD1, AD2 and AD3 enrolled a total of 74 patients who received ACI-24 at escalating dose levels. The 12-month data readouts from Cohorts AD1, AD2 and AD3 are expected later in Q2 2026. Cohort AD4 will include an initial group of 36 patients treated for 12 months, with follow-up of 6 months, significantly expanding the safety and biomarker efficacy data set. A subsequent expansion of the AD4 cohort could potentially see the total number of subjects reach approximately 112 patients.

AC Immune is responsible for conducting the ABATE trial. Following the potential option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization.

Under the terms of the agreement with Takeda, AC Immune received an upfront payment of $100 million and is eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately $2.1 billion, if all related milestones are achieved over the course of the agreement. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales.

About ACI-24

This product is AC Immune’s anti-Abeta active immunotherapy candidate. The ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial of ACI-24 for treatment of Alzheimer’s disease (AD) continues fully blinded (NCT05462106). Enrolled patients are required to have a diagnosis of prodromal AD: MCI due to AD according to the National Institute on Aging Alzheimer’s Association (NIA-AA) criteria, and a PET scan at screening must be consistent with the presence of amyloid pathology. Patients will be randomized to one of several doses of ACI-24 or placebo. Following multiple data safety monitoring board (DSMB) reviews, no safety concerns have been raised to date, consistent with previous results. Very encouraging immunogenicity has been shown with clear evidence of anti-Abeta antibody responses against toxic Abeta species observed in the blinded data.

About AC Immune SA 

AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its pipeline of first- and best-in-class assets, which currently features a range of therapeutic and diagnostic programs, including candidates in Phase 2 and Phase 3 development. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties.

SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CA, CN, CH, EU, GB, JP, KR, NO, RU and SG.

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

Gary Waanders, Ph.D., MBA
AC Immune
Phone: +41 21 345 91 91
Email: gary.waanders@acimmune.com





 
International Media

Chris Maggos
Cohesion Bureau
Phone: +41 79 367 6254
Email: chris.maggos@cohesionbureau.com
 

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. 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.

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FAQ

What milestone did AC Immune (ACIU) trigger by dosing the first patient in ABATE Cohort AD4?

AC Immune triggered a $12 million milestone payment. According to the company, the payment follows dosing the first patient in Cohort AD4 under the Takeda option and license agreement for ACI-24.

When will AC Immune (ACIU) report the 12-month ABATE data for Cohorts AD1–AD3?

AC Immune expects 12-month data readouts in Q2 2026. According to the company, those readouts cover safety, immunogenicity and biomarker data from the 74 patients across AD1–AD3.

How many patients will Cohort AD4 include in the ABATE trial (ACIU) and what is the schedule?

AD4 will initially include 36 patients treated for 12 months with a 6-month follow-up. According to the company, a later expansion could increase the total to approximately 112 subjects.

What are AC Immune's (ACIU) financial terms with Takeda relating to ACI-24?

AC Immune received a $100 million upfront payment and is eligible for up to $2.1 billion in milestones plus tiered double-digit royalties. According to the company, additional fees depend on option exercise and milestone achievement.

What early clinical results has AC Immune (ACIU) reported for ACI-24 so far?

AC Immune reports ACI-24 is generally safe, well tolerated and generated anti-Abeta antibody responses at tested doses. According to the company, these findings come from the initial cohorts in the randomized, placebo-controlled ABATE trial.