Acrivon Therapeutics Stock Price, News & Analysis

Acrivon Therapeutics, Inc. (Nasdaq: ACRV) is a clinical stage biopharmaceutical company focused on discovering and developing precision oncology medicines. The company states that it utilizes its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform to match drug candidates to patients whose tumors are predicted to be sensitive to each specific medicine. Acrivon describes itself as designing drug candidates through a mechanistic match to tumor biology and advancing them into clinical development.

A core element of Acrivon’s approach is the AP3 platform, which is engineered to interpret and quantify compound-specific, drug-regulated pathway activity levels inside intact cells in an unbiased manner. According to the company, AP3 generates large volumes of proprietary quantitative phosphoproteomic data and converts multimodal data into structured data for generative AI analyses. The platform includes internally developed tools such as the AP3 Data Portal, the AP3 Kinase Substrate Relationship Predictor, the AP3 KaiSR ensemble model, and the AP3 Interactome. Acrivon states that these capabilities are used for pathway-based drug design, indication finding, and prediction of response, as well as for the creation of drug-specific OncoSignature companion diagnostics.

Lead program: ACR-368 (prexasertib)

Acrivon’s lead clinical candidate is ACR-368, also known as prexasertib. The company describes ACR-368 as a selective small molecule inhibitor targeting CHK1 and CHK2 that is being evaluated in a potentially registrational Phase 2 or Phase 2b trial in endometrial cancer. Acrivon reports that this trial is a multicenter, registrational-intent study in patients with recurrent high-grade endometrial cancer who have received prior platinum-based chemotherapy and immune checkpoint inhibitor treatment. The program includes arms that use ACR-368 as monotherapy in biomarker-positive patients identified by its OncoSignature assay, as well as an arm combining ACR-368 with ultra-low dose gemcitabine (ULDG) as a tumor sensitizer in biomarker-unselected patients with limited prior lines of therapy.

The company states that the U.S. Food and Drug Administration has granted Fast Track designation for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. In addition, the FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for identifying patients with endometrial cancer who may benefit from ACR-368 treatment. Acrivon reports that its ACR-368 OncoSignature test has been evaluated in preclinical studies, including blinded, prospectively designed analyses on pretreatment tumor biopsies from past third-party Phase 2 trials in ovarian cancer.

Across multiple company communications, Acrivon highlights interim data from its Phase 2b endometrial cancer study, including confirmed overall response rates and disease control rates in OncoSignature-positive patients who had progressed on prior chemotherapy and anti-PD-1 therapy. The company also emphasizes observed responses in patients with aggressive histologies and large tumors and notes that it is planning or has submitted a protocol for a confirmatory Phase 3 trial of ACR-368 in combination with an anti-PD-1 agent in frontline endometrial cancer subjects.

Second clinical-stage asset: ACR-2316 (WEE1/PKMYT1 inhibitor)

Acrivon’s second clinical-stage asset is ACR-2316, which the company describes as a novel, potent, selective WEE1/PKMYT1 inhibitor. According to Acrivon, ACR-2316 was rationally designed using the AP3 platform and structure–activity relationship (SAR) insights to achieve desirable anti-tumor pathway effects inside the cell. Preclinical data presented by the company indicate that ACR-2316 aims to achieve strong activation of CDK1 and CDK2, as well as PLK1, to drive pro-apoptotic tumor cell death, and that it has shown differentiated and superior preclinical activity versus benchmark WEE1 and PKMYT1 inhibitors in cancer models.

Clinically, ACR-2316 is being evaluated in an ongoing Phase 1 monotherapy dose-escalation trial in certain solid tumor types that Acrivon prioritizes based on AP3-predicted sensitivity. The company reports that multiple dose levels have been cleared without dose-limiting toxicities, with evidence of drug target engagement at early dose levels based on clinical mass-spectrometry-based AP3 profiling and approximate dose proportionality in plasma pharmacokinetic analyses. Acrivon has disclosed initial clinical activity, including tumor shrinkage and partial responses in endometrial cancer and other AP3-prioritized solid tumor types, during dose escalation.

Preclinical and discovery pipeline: cell cycle and CDK11

Beyond its two clinical assets, Acrivon describes a preclinical pipeline driven by its AP3 platform and co-crystallography-based design. The company reports a cell cycle program directed against undisclosed targets and has announced the nomination of ACR-6840, an internally discovered development candidate targeting CDK11. According to Acrivon, ACR-6840 is a potential first-in-class oral CDK11 inhibitor designed using AP3 to achieve specific on-target pathway effects, and the company has indicated plans for an investigational new drug (IND) submission for this candidate.

Acrivon also notes that it continues to initiate additional internal programs utilizing the AP3 platform, including a potential first-in-class cell cycle drug discovery program for an undisclosed target. The company presents AP3 as enabling the identification of novel therapeutic targets, rational design of compounds with optimized pathway effects, and the assessment of compound-induced resistance mechanisms.

Generative Phosphoproteomics AP3 platform and AI capabilities

The Generative Phosphoproteomics AP3 platform is central to Acrivon’s stated business model. The company explains that AP3 measures compound-specific effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner, generating high-resolution quantitative phosphoproteomic data. This data is then analyzed using computational tools and generative AI models such as the AP3 KaiSR ensemble model, which Acrivon describes as predicting and expanding actionable kinase–substrate relationships across the human kinome and assessing compound-induced pathway activity states.

According to Acrivon, these capabilities allow AP3 to support multiple functions: pathway-based drug design, indication finding, response prediction, identification of rational drug combinations, and development of proprietary OncoSignature companion diagnostics. The company has presented data indicating that AP3 can be used to understand global pharmacodynamic effects of compounds like ACR-2316, uncover mechanisms underlying preclinical activity, and prioritize tumor types for clinical evaluation.

Regulatory and clinical development context

Acrivon’s public disclosures emphasize that it is a clinical stage company, with both ACR-368 and ACR-2316 in human trials and additional programs in preclinical development. The company highlights that ACR-368 is in a registrational-intent Phase 2 or Phase 2b trial in endometrial cancer, with biomarker-selected and biomarker-unselected arms, and that it has obtained FDA Fast Track designation for ACR-368 monotherapy and FDA Breakthrough Device designation for the ACR-368 OncoSignature assay in endometrial cancer. For ACR-2316, Acrivon reports ongoing Phase 1 dose escalation in AP3-prioritized solid tumor types, with early signs of clinical activity.

Acrivon also notes that it has presented scientific and preclinical data at major oncology and drug discovery conferences, including the AACR Annual Meeting and the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. These presentations have focused on AP3-based analyses, the AP3 KaiSR model, and mechanistic data for ACR-2316 and other programs.

Business model and focus

Based on its disclosures, Acrivon’s business model centers on precision oncology drug discovery and development using its AP3 platform. The company indicates that it applies AP3 to design and advance internally discovered compounds, to select tumor types and patient populations predicted to be sensitive to its agents, and to develop companion diagnostics such as OncoSignature tests. Revenue-generating activities are not detailed in the provided materials, and the company’s communications focus on research and development activities, clinical trial progress, and platform capabilities.

ACRV stock and sector classification

Acrivon Therapeutics, Inc. trades on Nasdaq under the ticker symbol ACRV. In the supplied classification, the company is associated with the industry "Research and Development in Biotechnology" within the broader sector "Professional, Scientific, and Technical Services." As a clinical stage biopharmaceutical and biotechnology company, its value proposition to investors is closely tied to the progress of its oncology pipeline, the performance of its AP3 platform, and regulatory milestones such as designations and trial outcomes.

Key concepts and terminology

• Generative Phosphoproteomics AP3: Acrivon’s proprietary platform for measuring and analyzing drug-regulated pathway activity in intact cells and using generative AI for pathway-based drug design and indication selection.
• OncoSignature: Drug-specific companion diagnostic assays developed using AP3 to identify patients whose tumors are predicted to be sensitive to Acrivon’s drug candidates, including ACR-368.
• ACR-368 (prexasertib): A selective CHK1/CHK2 inhibitor in a potentially registrational Phase 2 or Phase 2b trial in endometrial cancer, with FDA Fast Track designation and an associated OncoSignature assay with FDA Breakthrough Device designation.
• ACR-2316: A clinical-stage WEE1/PKMYT1 inhibitor designed using AP3 for strong activation of CDK1, CDK2, and PLK1 and evaluated in a Phase 1 monotherapy trial in AP3-prioritized solid tumor types.
• ACR-6840: An internally discovered, AP3-enabled preclinical development candidate targeting CDK11, described by the company as a potential first-in-class oral CDK11 inhibitor.

FAQs about Acrivon Therapeutics, Inc. (ACRV)

What does Acrivon Therapeutics, Inc. do?
Acrivon Therapeutics, Inc. is a clinical stage biopharmaceutical company that states it discovers and develops precision oncology medicines. It reports using its proprietary Generative Phosphoproteomics AP3 platform to design drug candidates and match them to patients whose tumors are predicted to be sensitive to each specific treatment.

What is the AP3 platform?
According to Acrivon, the Generative Phosphoproteomics AP3 platform measures compound-specific effects on the tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner. The company explains that AP3 generates large-scale phosphoproteomic data and uses tools such as the AP3 Data Portal, AP3 Kinase Substrate Relationship Predictor, AP3 KaiSR model, and AP3 Interactome for pathway-based drug design, indication selection, and development of OncoSignature diagnostics.

What is ACR-368?
ACR-368, also known as prexasertib, is Acrivon’s lead clinical candidate. The company describes it as a selective small molecule inhibitor of CHK1 and CHK2 being evaluated in a potentially registrational Phase 2 or Phase 2b trial in endometrial cancer. Acrivon reports that the trial includes biomarker-selected and biomarker-unselected arms and that the U.S. FDA has granted Fast Track designation for ACR-368 monotherapy in endometrial cancer based on OncoSignature-predicted sensitivity.

What is the ACR-368 OncoSignature assay?
The ACR-368 OncoSignature assay is a companion diagnostic developed by Acrivon using its AP3 platform. The company states that the assay is designed to identify patients with endometrial cancer who may benefit from ACR-368 treatment. According to Acrivon, the FDA has granted Breakthrough Device designation for this assay for use in endometrial cancer, and the test has been evaluated in preclinical and retrospective biopsy studies.

What is ACR-2316?
Acrivon identifies ACR-2316 as its second clinical-stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor. The company reports that ACR-2316 was rationally designed using AP3 to achieve strong activation of CDK1, CDK2, and PLK1 and to induce pro-apoptotic tumor cell death, with differentiated preclinical activity versus benchmark inhibitors. It is being studied in a Phase 1 monotherapy trial in AP3-prioritized solid tumor types, with early clinical activity and tumor shrinkage reported.

What is ACR-6840?
ACR-6840 is described by Acrivon as an internally discovered, AP3-derived preclinical development candidate that targets CDK11. The company characterizes ACR-6840 as a potential first-in-class oral CDK11 inhibitor and has indicated plans for an IND submission, according to its public statements.

How does Acrivon use AI in drug discovery?
Acrivon reports that its AP3 platform incorporates generative AI and machine learning, including the AP3 KaiSR model, to predict kinase–substrate relationships and compound-induced pathway activity states. The company states that these tools help it design compounds with desired pathway effects, identify sensitive tumor types, and develop companion diagnostics, thereby supporting rational drug discovery and development.

What regulatory designations has Acrivon received?
Based on the company’s disclosures, the U.S. FDA has granted Fast Track designation for the investigation of ACR-368 as a monotherapy in endometrial cancer patients selected by OncoSignature-predicted sensitivity. The FDA has also granted Breakthrough Device designation for the ACR-368 OncoSignature assay for identifying endometrial cancer patients who may benefit from ACR-368 treatment.

In which industry and sector is Acrivon classified?
In the provided classification, Acrivon Therapeutics, Inc. is associated with the industry "Research and Development in Biotechnology" within the sector "Professional, Scientific, and Technical Services." Its activities, as described by the company, focus on clinical stage biopharmaceutical and biotechnology research and development.

What is the stock symbol for Acrivon Therapeutics, Inc.?
Acrivon Therapeutics, Inc. trades on Nasdaq under the ticker symbol ACRV. The company’s public communications link the performance of ACRV stock to the progress of its precision oncology pipeline and the evolution of its AP3 platform and companion diagnostics.