Acrivon Therapeutics Strengthens its Precision Medicine Therapeutics Capabilities with Launch of Internal CLIA-Certified Laboratory

Rhea-AI Summary

Acrivon Therapeutics (Nasdaq: ACRV) has completed and received CLIA certification for a wholly-owned clinical laboratory in Watertown, Massachusetts, expected to be fully operational in H1 2026. The facility will support patient testing and internal development of companion diagnostics.

The in-house CLIA lab aims to accelerate AP3-driven biomarker discovery, streamline co-regulatory workflows, and improve speed and cost-efficiency for precision medicine programs and potential partner collaborations.

Key Figures

Lab operational timing: first half of 2026

1 metrics

Lab operational timing first half of 2026 Expected timing for CLIA-certified lab to become fully operational

Market Reality Check

Price: $1.61 Vol: Volume 418,388 is below 2...

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$1.61 Last Close

Volume Volume 418,388 is below 20-day average 852,957 (relative volume 0.49). low

Technical Shares at 1.615, trading below 200-day MA of 1.69 and 73.44% under the 52-week high.

Peers on Argus

Peers show mixed moves: PSTV up 0.14%, TELO up 2.68%, RADX down 2.24%, RENB up 1...

1 Up 1 Down

Peers show mixed moves: PSTV up 0.14%, TELO up 2.68%, RADX down 2.24%, RENB up 19.33%. Momentum scanner flags one peer up and one down, indicating stock-specific dynamics rather than a unified biotech sector move.

Historical Context

5 past events · Latest: Jan 23 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 23	Conference presentation	Positive	+1.0%	Late-breaking oral ESGO presentation of interim ACR-368 Phase 2b data.
Jan 08	Clinical data update	Positive	-34.6%	Positive ACR-368 Phase 2b and ACR-2316 data plus ACR-6840 pipeline update.
Jan 06	Webcast announcement	Neutral	+31.4%	Planned January data update webcast for ACR-368 and ACR-2316 programs.
Dec 17	Webcast preview	Neutral	-4.5%	Update that January 2026 webcast will cover multiple AP3-driven programs.
Dec 17	Clinical plans	Neutral	-4.5%	Announcement of upcoming ACR-368 and ACR-2316 clinical updates and Phase 3 plans.

Pattern Detected

Recent clinical and data-related announcements have produced mixed reactions, with one major positive update selling off sharply while others saw modest gains.

Recent Company History

Over the past few months, Acrivon has focused on advancing its AP3-enabled oncology pipeline. Key updates included positive Phase 2b ACR-368 endometrial cancer data and pipeline progress for ACR-2316 and ACR-6840 on Jan 8, 2026, which coincided with a -34.58% move. Earlier and subsequent clinical update announcements in Dec 2025 and the webcast news in early January showed smaller, mixed price reactions. Against this backdrop, the new CLIA-certified internal lab enhances operational control supporting these same programs and future companion diagnostics.

Market Pulse Summary

This announcement highlights Acrivon’s completion of a CLIA-certified, wholly owned lab expected to ...

Analysis

This announcement highlights Acrivon’s completion of a CLIA-certified, wholly owned lab expected to be fully operational in the first half of 2026. The facility is intended to support biomarker identification, companion diagnostics, and streamlined co-regulatory pathways for its precision oncology programs. In recent months, the company has paired such infrastructure moves with significant ACR-368 and ACR-2316 data updates. Investors may watch how quickly the lab is integrated into ongoing trials and partnerships, and how it impacts development speed and costs.

Key Terms

clinical laboratory improvement amendment, clia, companion diagnostics, biomarkers, +2 more

6 terms

clinical laboratory improvement amendment regulatory

"completion and certification of its internal, wholly-owned and operated Clinical Laboratory Improvement Amendment (CLIA) certified laboratory"

A federal regulatory program that sets standards and requires certification for medical testing laboratories to ensure test accuracy and reliability; often called CLIA. Investors care because labs, diagnostic companies, and any business that markets medical tests must meet these rules to sell or report results, much like a vehicle needing a safety inspection before it can be legally driven. Compliance affects a lab’s ability to operate, generate revenue, and avoid fines or reputational harm.

clia regulatory

"This state-of-the-art facility has received CLIA certification from the state of Massachusetts"

CLIA stands for the Clinical Laboratory Improvement Amendments, a U.S. federal program that sets quality and safety standards for laboratories that test human samples. For investors, a CLIA certification is like a safety inspection or license for a lab — it signals that test results are produced under accepted quality controls, affects a lab’s ability to sell or bill certain tests, and therefore influences a company’s regulatory risk, market access, and credibility.

companion diagnostics medical

"develop companion diagnostics Laboratory provides significant operational and strategic benefits"

A companion diagnostic is a medical test used alongside a specific drug or therapy to identify which patients are likely to benefit from it or may face safety risks. Think of it as a tailored matchmaker that tells doctors whether a particular treatment is a good fit for an individual. For investors, these tests matter because they can shape a drug’s approved use, speed and cost of development, patient uptake, reimbursement, and the commercial value of both the therapy and the diagnostic.

biomarkers medical

"full control over the identification of predictive biomarkers, the development of companion diagnostics"

Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

co-regulatory approvals regulatory

"streamlining of potential co-regulatory approvals and co-commercialization of therapeutic and diagnostic products"

Co-regulatory approvals occur when more than one authority or a mix of government regulators and industry overseers must sign off before a product or activity can proceed. For investors this matters because it can lengthen or complicate the path to market — like needing permission from several landlords before renovating a building — which affects launch timing, compliance costs and the certainty of future revenues.

precision medicines medical

"clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary"

Precision medicines are treatments designed to work for specific groups of patients identified by genetic, biological, or lifestyle characteristics, rather than a one-size-fits-all drug. They matter to investors because these therapies can be more effective and command premium pricing in smaller, well-defined markets—offering higher potential returns if successful but also concentrated development and regulatory risk, like betting on a tailored suit that fits only certain people.

AI-generated analysis. Not financial advice.

Wholly-owned laboratory has received CLIA certification from Massachusetts with full license to conduct patient testing and develop companion diagnostics

Laboratory provides significant operational and strategic benefits for internal and future partnered assets

WATERTOWN, Mass., Feb. 18, 2026 (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 the completion and certification of its internal, wholly-owned and operated Clinical Laboratory Improvement Amendment (CLIA) certified laboratory, located on premises in Watertown.

This state-of-the-art facility has received CLIA certification from the state of Massachusetts and is expected to become fully operational during the first half of 2026. The CLIA certification signifies that the lab operates in accordance with CLIA regulations, which are federal standards applicable to all U.S. facilities testing human specimens for health assessment, diagnosis, prevention, or treatment of diseases and ensures high standards for accuracy and reliability in laboratory testing.

"We are excited to bring our cutting-edge CLIA lab online, expanding our targeted therapeutics development capabilities,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and co-founder of Acrivon. "Complementing our distinctive AP3-driven biomarker discovery technology, our internal CLIA lab enables us to translate these discoveries and deploy proprietary companion diagnostics for our therapeutics with minimal dependency on outside partners."

By bringing CLIA operations in-house, the company gains enhanced capabilities to support the development of its current and future targeted therapeutic agents. This includes full control over the identification of predictive biomarkers, the development of companion diagnostics, indication finding, and the streamlining of potential co-regulatory approvals and co-commercialization of therapeutic and diagnostic products. Additionally, the lab is expected to increase speed and cost-efficiency in precision medicine drug development. The lab will also be leveraged for business development and potential partnering opportunities for internally developed assets, externally partnered programs, or in-licensed therapies. The company has staffed the lab with an experienced team of professionals who understand the opportunities and complexities associated with running a world-class CLIA lab.

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 2 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 weekly dosing regimens established. Initial data has shown a favorable tolerability profile limited to transient, mechanism-based hematological adverse events, predominantly neutropenia and initial clinical activity across AP3-selected solid tumor types, including PRs in endometrial cancer, as well as SCLC and sqNSCLC, two tumor types which have not shown sensitivity to other clinical WEE1 or PKMYT1 inhibitors currently in development. In addition, the company is advancing ACR-6840, an internally discovered development candidate targeting CDK11.

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

What did Acrivon (ACRV) announce about its new CLIA laboratory on February 18, 2026?

Acrivon announced completion and Massachusetts CLIA certification of a wholly-owned lab, expected operational in H1 2026. According to Acrivon, the facility will conduct patient testing and support development of proprietary companion diagnostics to advance its precision medicine programs.

How will the new Acrivon CLIA lab affect ACRV's biomarker and companion diagnostic development?

The CLIA lab enables Acrivon to bring biomarker identification and companion diagnostic development in-house, reducing outside dependency. According to Acrivon, this should streamline co-regulatory processes and speed translation from AP3 discoveries to clinical-grade tests.

When will Acrivon's CLIA-certified laboratory become fully operational and what services will it provide?

The lab is expected to be fully operational during the first half of 2026 and will conduct patient testing and develop companion diagnostics. According to Acrivon, it will support internal and partnered assets and offer capabilities for business development and partnerships.

Will Acrivon's CLIA lab be used for partnered programs and external collaborations?

Yes. Acrivon intends to leverage the CLIA lab for internal assets and potential partnered or in-licensed programs. According to Acrivon, the facility is designed to support co-commercialization and business development opportunities with external collaborators.

What operational benefits does Acrivon claim the CLIA lab will deliver for ACRV shareholders?

Acrivon says the CLIA lab will increase speed and cost-efficiency in precision medicine development and provide full control over predictive biomarkers. According to Acrivon, these capabilities aim to de-risk translational steps and support regulatory and commercial coordination for its therapies.