Acrivon Therapeutics to Announce Clinical Update on its Ongoing Phase 2b Studies and Planned Confirmatory Phase 3 Trial for ACR-368, Initial Clinical Data on ACR-2316, and Other AP3 Pipeline Updates

Rhea-AI Summary

Acrivon Therapeutics (Nasdaq: ACRV) said it will present clinical updates in January 2026 covering ACR-368 and ACR-2316 and other AP3 pipeline news.

Key topics include an updated interim ACR-368 readout from the registrational-intent Phase 2b study, an update on a recently initiated tumor biopsy-independent Phase 2b arm, and the company’s planned confirmatory Phase 3 trial. The company will also provide initial Phase 1 data for ACR-2316 (WEE1/PKMYT1 inhibitor) covering safety, dosing regimen, and early clinical activity across AP3-prioritized solid tumors, plus nomination of a new preclinical development candidate with target disclosure for its AP3-driven cell cycle program.

Key Figures

ACR-368 trial stage Phase 2b Ongoing registrational-intent study referenced in the January 2026 update

Planned trial stage Phase 3 Planned confirmatory trial for ACR-368 mentioned in the update

ACR-2316 trial stage Phase 1 Ongoing study with initial clinical data to be provided

Update timing January 2026 When ACR-368, ACR-2316, and AP3 pipeline updates will be provided

Market Reality Check

$2.16 Last Close

Volume Volume 361,135 vs 20-day avg 452,029 (relative volume 0.8). normal

Technical Price 2.42 is trading above 200-day MA at 1.93, after a -5.84% 24h move.

Peers on Argus 1 Up

Peers are mixed: TPST +0.34%, PSTV +3.41%, RENB +19.33%, RADX -5.74%, TELO flat. Momentum scanner only flags RADX with a ~5% up move, reinforcing that ACRV’s setup appears stock-specific rather than a broad biotech rotation.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 13	Earnings and pipeline	Positive	-9.2%	Q3 2025 results, reduced net loss, and progress on ACR-368 and ACR-2316.
Oct 22	Clinical platform update	Positive	-2.5%	AP3 platform and preclinical ACR-2316 data with confirmed partial response.
Oct 01	Inducement grant	Neutral	+0.0%	Inducement stock options grant under Nasdaq Rule 5635(c)(4).
Aug 13	Earnings and pipeline	Positive	+6.1%	Q2 2025 results, strong cash balance, and encouraging clinical responses.

Pattern Detected

Recent news shows a split pattern: some positive updates led to gains, while other seemingly positive or neutral items saw selling pressure or flat trading.

Recent Company History

Over the last few months, Acrivon has steadily advanced ACR-368 and ACR-2316 while managing cash to fund operations into Q2 2027. Q2 2025 results with a $21.0M net loss and Q3 2025 with a $18.2M net loss both highlighted promising clinical signals. A clinical-platform update on Oct 22 saw a modest negative reaction, while Q2 earnings on Aug 13 were followed by a gain. Today’s clinical-update announcement fits this ongoing narrative of pipeline progression against a volatile share response history.

Market Pulse Summary

This announcement outlined a January 2026 pipeline update, including interim Phase 2b data for ACR-368, a planned confirmatory Phase 3 trial, initial Phase 1 clinical data for ACR-2316, and a new AP3-driven cell cycle candidate. It builds on earlier AP3 and ACR-2316 disclosures. Investors may watch how these data affect the program mix, cash runway discussed in recent filings, and whether later-stage designs align with prior clinical signals.

Key Terms

generative phosphoproteomics medical

"utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform"

Generative phosphoproteomics uses advanced computer models to read and produce likely patterns of protein phosphorylation — the chemical on/off tags that control cell behavior — from laboratory measurement data. For investors, it matters because these tools can speed and lower the cost of discovering drug targets, biomarkers or patient-testing methods by predicting experiments researchers would otherwise run in the lab, much like a smart map that forecasts traffic so you don’t have to drive every route to see where congestion occurs.

phosphoproteomics medical

"Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret"

Phosphoproteomics is the large-scale study of proteins that have phosphate tags attached, which act like on/off switches controlling cell behavior. Investors care because mapping these switches helps scientists identify disease mechanisms, drug targets, and biomarkers that can speed up development, improve patient selection, and increase the commercial potential of therapies or diagnostic tests—similar to inspecting a circuit board to find the best place to fix or upgrade a device.

wee1/pkmyt1 inhibitor medical

"ACR-2316, a potential first- and best-in-class WEE1/PKMYT1 inhibitor, including safety data"

A Wee1/PKMYT1 inhibitor is a drug that blocks two enzymes that act as cellular “brakes” controlling when a cell divides. By releasing those brakes, the medicine forces damaged or rapidly dividing cancer cells to attempt division before they are ready, which can lead to cell death; this makes the approach useful alone or paired with chemotherapy or radiation. For investors, these drugs are high-impact but often experimental, carrying potential for strong therapeutic benefit alongside safety and development risks.

phase 2b medical

"Updated interim ACR-368 clinical data from the ongoing registrational-intent Phase 2b study"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

phase 3 medical

"and the planned confirmatory Phase 3 trialInitial clinical data from the ongoing Phase 1 study"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 1 medical

"Initial clinical data from the ongoing Phase 1 study of ACR-2316"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

cell cycle medical

"new preclinical development candidate, including target disclosure, for Acrivon’s AP3-driven cell cycle program"

The cell cycle is the orderly set of steps a cell goes through to grow, copy its contents and divide into two new cells. For investors, understanding the cell cycle matters because many drugs and diagnostics aim to speed up, slow down or halt specific steps in this process — like targeting a broken assembly line — which affects a therapy’s potential effectiveness, safety profile and commercial value.

AI-generated analysis. Not financial advice.

WATERTOWN, Mass., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify global compound-specific, drug-regulated effects in the intact cell which is deployed for rational drug design and predictive clinical development, today announced it will be providing ACR-368 and ACR-2316 clinical data and other updates in January 2026.

Topics will include:

• Updated interim ACR-368 clinical data from the ongoing registrational-intent Phase 2b study as well as an update on the additional recently initiated tumor biopsy-independent Phase 2b arm, and the planned confirmatory Phase 3 trial
• Initial clinical data from the ongoing Phase 1 study of ACR-2316, a potential first- and best-in-class WEE1/PKMYT1 inhibitor, including safety data, dosing regimen, and early clinical activity across AP3-prioritized solid tumor types
• Nomination of new preclinical development candidate, including target disclosure, for Acrivon’s AP3-driven cell cycle program
  

About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 platform. The platform allows the company to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The Generative Phosphoproteomics AP3 platform is comprised of a growing suite of powerful, internally-developed tools, including the AP3 Data Portal, converting multimodal data into structured data for generative AI analyses, the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery, and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development.

Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2b trial for endometrial cancer. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment.

In addition to ACR-368, Acrivon is also leveraging its proprietary Generative Phosphoproteomics AP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as observed in preclinical studies against benchmark inhibitors. The Phase 1 trial of ACR-2316 is advancing with enrollment in the first three dose-escalation cohorts completed. Drug target engagement was observed at DL1 and 2 using the company’s clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkage observed at DL3. In addition, the company is advancing a preclinical program directed against an undisclosed cell cycle regulatory target.

Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our preclinical and clinical results, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Acrivon’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Acrivon undertakes no duty to update such information except as required under applicable law.

Investor and Media Contacts:
Adam D. Levy, Ph.D., M.B.A.
alevy@acrivon.com

Alexandra Santos
asantos@wheelhouselsa.com

FAQ

When will Acrivon (ACRV) release clinical updates on ACR-368 and ACR-2316?

Acrivon will provide clinical updates in January 2026.

What will Acrivon report about ACR-368 (ACRV) in January 2026?

An updated interim Phase 2b readout, an update on a tumor biopsy-independent Phase 2b arm, and plans for a confirmatory Phase 3 trial.

What initial data will Acrivon share on ACR-2316 (ACRV)?

Initial Phase 1 data including safety, dosing regimen, and early clinical activity across AP3-prioritized solid tumors.

Will Acrivon (ACRV) disclose new preclinical candidates at the January 2026 update?

Yes; the company will announce nomination of a new preclinical development candidate and disclose its target within the AP3 cell cycle program.

Does the ACR-368 update indicate a planned Phase 3 trial for ACRV?

The company will provide an update on its planned confirmatory Phase 3 trial for ACR-368.