Acrivon Therapeutics Inc (ACRV)

Late-Stage Breakthroughs: How 2026's Top Clinical Platforms Are Redefining Cancer TreatmentJanuary 28, 2026 2:15 PM
PR Newswire (Canada)

Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC., Jan. 28, 2026 /CNW/ -- USANewsGroup.com News Commentary – As the global oncology clinical trials market surges toward a projected $25.61 billion valuation by 2035[1], a structural rotation is favoring 'registration-ready' platforms that demonstrate exceptional efficacy and pivotal-trial alignment with 2026's evolving FDA regulatory frameworks[2]. Investors are increasingly prioritizing late-stage and newly commercial companies poised for rapid maturation as sector fundamentals strengthen. This structural shift creates a window for Oncolytics Biotech Inc. (NASDAQ: ONCY), BioNTech (NASDAQ: BNTX), MAIA Biotechnology (NYSE-A: MAIA), Acrivon Therapeutics (NASDAQ: ACRV), and ImmunityBio (NASDAQ: IBRX).







With 2026 set to be a banner year for M&A as buyers facing patent cliffs compete for a limited pool of late-stage assets[3], companies demonstrating disciplined pivotal execution and FDA alignment command asymmetric upside in an environment where executive infrastructure determines valuation floors.Oncolytics Biotech Inc. (NASDAQ: ONCY) is strengthening its operational and clinical leadership as it advances pelareorep toward multiple registration-directed programs in gastrointestinal cancers.The company recently announced the appointments of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, bringing deep expertise in late-stage oncology trial execution and regulatory strategy. McAdory joins from CG Oncology, where he served as Vice President of Clinical Operations leading late-stage development programs for oncolytic virus therapies. Wu arrives from Morphic Therapeutic, where he headed Biostatistics through the company's acquisition by Eli Lilly, and previously led statistical strategy for multiple Phase 3 oncology programs at Takeda. Both executives bring direct experience navigating complex registration trials and global regulatory interactions."John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."These appointments complete a transformative executive team buildout following Kelly's promotion to CEO last year and the addition of Chief Business Officer Andrew Aromando. They were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics also recently expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, positioning the company for accelerated clinical development across multiple indications.The company recently announced breakthrough efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat patient population.The company is also advancing pelareorep toward potential accelerated approval in anal cancer after reporting third-line data that achieved a 29% objective response rate, nearly tripling historical benchmarks in a setting with no FDA-approved treatment options. The median duration of response reached approximately 17 months.Second-line or later results were equally compelling, with pelareorep achieving a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response of 15.5 months compared to 9.5 months for standard care demonstrates pelareorep's ability to deliver durable clinical benefit in patients with limited treatment options.Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease. This regulatory milestone clears the path for initiating a pivotal study in one of oncology's most challenging therapeutic areas.CONTINUED… Read this and more news for Oncolytics Biotech at:  https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include:BioNTech (NASDAQ: BNTX) received FDA Fast Track designation for BNT113, an investigational mRNA cancer immunotherapy, for the treatment of patients with human papillomavirus type 16 positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1. The designation was granted based on preliminary safety and efficacy data from the ongoing pivotal Phase 2/3 AHEAD-MERIT clinical trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1, a cancer type with limited treatment options where patients experience median overall survival of 20.7 months under current standard of care.Head and neck squamous cell carcinoma is the seventh most common cancer type worldwide with increasing global incidence, with about one third of cases being HPV-positive and approximately 90% of oropharyngeal cancers driven by HPV16. BNT113 is designed to induce HPV16-specific anti-tumor immune responses by encoding the E6 and E7 proteins of HPV16 that are frequently found in HPV16+ solid tumors, with the FDA Fast Track designation enabling more frequent engagement with the FDA to support development and expedite regulatory review of this novel HPV-targeted chemotherapy-free treatment option.MAIA Biotechnology (NYSE-A: MAIA) advanced ateganosine into pivotal development with high probability of technical success based on exceptional efficacy data in third-line non-small cell lung cancer. The telomere-targeting agent secured FDA Fast Track designation and represents the first and only direct telomere-targeting anticancer therapy in clinical development, targeting an estimated $50+ billion global immunotherapy market."MAIA's strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks," said Vlad Vitoc, M.D., founder and CEO of MAIA. "The results clearly differentiate our novel telomere-targeting science and support the U.S. FDA's Fast Track designation granted in 2025, positioning ateganosine for potential eligibility under the Accelerated Approval and Priority Review regulatory pathways."The company advanced concurrent Phase 3 and Phase 2 expansion trials targeting potential early commercial approval within 18 to 24 months. MAIA Biotechnology received a $2.3 million NIH grant supporting U.S. patient enrollment and is advancing second-generation molecules into Phase 1 development with enhanced expected efficacy.Acrivon Therapeutics (NASDAQ: ACRV) announced positive data from its ACR-368 Phase 2b registrational-intent trial showing 39% overall response rate in endometrial cancer with 52% confirmed response rate in serous subtype patients with up to two prior lines of therapy. The company submitted EU Clinical Trial Application for Arm 3 enrollment across more than 20 European sites in four major countries, with enrollment completion expected in Q4 2026."We are pleased with tangible progress accelerating across multiple high-value opportunities," said Peter Blume-Jensen, M.D., Ph.D., CEO of Acrivon. "We are particularly excited by the observation from our ongoing ACR-368 Phase 2 trial that subjects with serous endometrial cancer with up to two prior lines of therapy are showing over 50% confirmed response rate. This provides an attractive opportunity for rapid Arm 3 enrollment without the need for a pretreatment biopsy, both in the US and more than 20 newly selected sites in major EU countries."Acrivon Therapeutics has submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 combined with anti-PD-1 therapy in frontline endometrial cancer based on strong preclinical synergy data. The company also reported initial ACR-2316 Phase 1 data showing tumor shrinkage in endometrial cancer, SCLC and squamous NSCLC, with ACR-6840 nominated as its next CDK11 inhibitor development candidate.ImmunityBio (NASDAQ: IBRX) announced that it recently held a Type B End-of-Phase meeting with the U.S. FDA regarding the Company's supplemental Biologics License Application for ANKTIVA plus Bacillus Calmette-Guérin in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors. The Company presented more than five years of follow-up data demonstrating durable disease-specific survival of approximately 96% at 36 months with median survival not yet reached even with five years of follow-up, high rates of cystectomy avoidance of 92% and 82% at one and three years respectively, and a safety profile consistent with the currently approved indication in CIS disease with or without papillary tumors."We appreciate the FDA's collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails," said Richard Adcock, President and CEO of ImmunityBio. "We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days for the Agency's review."Based on discussions with the FDA, the Agency recommended that the Company provide certain additional information for its consideration to support a potential resubmission of the sBLA initially submitted in 2025 for the papillary indication, with this additional information not contemplating the initiation or design of a new clinical trial. ImmunityBio commercially launched ANKTIVA for NMIBC CIS with or without papillary tumors in the United States and has since expanded approvals to the United Kingdom and Saudi Arabia, with conditional approval in the European Union.Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES CITED:https://www.globenewswire.com/news-release/2026/01/20/3222140/0/en/Global-Oncology-Clinical-Trials-Market-Projected-to-Reach-US-25-61-Billion-by-2035-Supported-by-Advances-in-Precision-and-Targeted-Therapies-Says-Astute-Analytica.html https://lumanity.com/perspectives/the-8-fda-regulatory-trends-shaping-2026-and-beyond/ https://www.biospace.com/business/with-biotech-back-analysts-make-their-picks-for-2026Logo: https://mma.prnewswire.com/media/2838876/5656770/USA_News_Group_Logo.jpg



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Original: Late-Stage Breakthroughs: How 2026's Top Clinical Platforms Are Redefining Cancer Treatment

$ACRV News: Acrivon Therapeutics Announces Late-Breaking Oral Presentation at Upcoming European Society of Gynecological Oncology (ESGO) Annual International Congress
Acrivon Therapeutics, Inc
Fri, January 23, 2026 at 8:11 AM EST 5 min read

Globally recognized key opinion leader Panagiotis (Panos) Konstantinopoulos, M.D., Ph.D., Dana-Farber Cancer Institute, will highlight company’s recent interim clinical data from the ongoing, registrational-intent Phase 2b study of ACR-368 in subjects with endometrial cancer

WATERTOWN, Mass., Jan. 23, 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 a presentation at the upcoming ESGO 27th Annual Congress, being held in Copenhagen, Denmark, February 26-28, 2026.

“We are very excited that Dr. Konstantinopoulos will be presenting ACR-368 clinical data at this prestigious event,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and co-founder of Acrivon. “We believe that the recent interim clinical data from our ongoing study provide a highly compelling clinical profile in a high unmet need patient population and look forward to Panos sharing the data and his insights with leading gynecological oncologists from around the world.”

The ESGO Annual Congress is one of the largest global medical conferences in gynecological oncology, and this year is expected to bring together over 3,000 attendees from over 100 countries for presentations sharing the latest developments in the field of gynecological cancer.

Presentation Details:

Title

Clinical Activity of ACR-368 in patients with endometrial carcinoma prospectively selected by OncoSignature – A Phase 2 study - ACR-368-201/GOG3082 (NCT05548296)

Presenter

Panagiotis (Panos) Konstantinopoulos, M.D., Ph.D., Velma Eisenson Endowed Chair for Clinical and Translational Research at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School

Date and Time

Friday, February 27th, 2026, 12:05 p.m. – 1:05 p.m., CET (6:05 a.m. – 7:05 a.m., EST)

Presentation Number

ESGO-2026-1321





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

$ACRV Rising fast! #BIOTECH NEWS $LLY Eli Lilly and $ACRV Acrivon Therapeutics Agreement - Eli Lilly retains a financial interest in the success of Acrivon's ACR-368 (prexasertib) through potential milestone payments and royalties, and crucially, it has a contractual right to negotiate first to reacquire the drug

$ACRV Acrivon Therapeutics (NASDAQ:ACRV) announced positive data from its ACR-368 Phase 2b trial in endometrial cancer, showing a 39% overall response rate in OncoSignature-positive patients with a 67% confirmed response rate in BM-positive patients with serous subtype. The company has expanded the trial into the European Union across more than 20 sites in Germany, Italy, France and Spain, with Arm 3 enrolling up to 90 patients with serous subtype who have received two or fewer prior lines of therapy.

"We are particularly excited by the observation from our ongoing ACR-368 Phase 2 trial that subjects with serous endometrial cancer with up to two prior lines of therapy are showing over 50% confirmed response rate," said Peter Blume-Jensen, M.D., Ph.D., CEO, President and co-founder of Acrivon Therapeutics.

The company has also submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 plus anti-PD-1 therapy in frontline endometrial cancer patients based on preclinical data showing strong synergy. Acrivon expects to complete Arm 3 enrollment in the fourth quarter of 2026, with global trial readiness for the Phase 3 study anticipated mid-2026. https://barchart.com/story/news/37041532/the-69b-precision-pivot-why-biomarker-platforms-are-igniting-a-new-oncology-gold-rush $ONCY $BCTX $CATX $GLSI

$ACRV Piper Sandler raises Acrivon Therapeutics stock price target to $8 on positive cancer data

Analyst Ratings
Published 01/09/2026, 08:59 AM https://investing.com/news/analyst-ratings/piper-sandler-raises-acrivon-therapeutics-stock-price-target-to-8-on-positive-cancer-data-93CH-4439652

$ACRV #biotech partnerships form overnight. Acrivon has reported #tumorshrinkage with ACR-368 #cancerresearch #buybacks #news expected

$ACRV and Eli Lilly

#BIOTECH NEWS (LLY) Eli Lilly and $ACRV Acrivon Therapeutics Agreement - Eli Lilly retains a financial interest in the success of Acrivon's ACR-368 (prexasertib) through potential milestone payments and royalties, and crucially, it has a contractual right to negotiate first to reacquire the drug.
Eli Lilly (LLY) is currently in a licensing agreement with Acrivon (Nasdaq: $ACRV), which includes a provision granting Lilly the first right to negotiate the reacquisition of the drug, known as prexasertib (ACR-368). An outright acquisition of Acrivon by Eli Lilly to retrieve the drug is a potential, but less direct, scenario.

Acrivon.com $ACRV #Oversold

$ACRV UPDATE: Expect volatility if the stock gaps up to 50(DMA) $2.70 consider taking partial profits. Platform Supported. Acrivon (ACRV) Clears the Bar.

Acrivon Therapeutics appears to have executed a high-wire act. The data released January 8th demonstrates their core thesis: that proteomics (AP3) can find responders where genomics failed.

The Rescue Seems to Work: The lead asset (ACR-368) showed a 39% ORR in biomarker-positive patients, tripling the standard of care.

The Pipeline Looks Real: The wholly-owned NCE (ACR-2316) showed confirmed responses and a manageable safety profile, apparently de-risking the one-drug pony fear.

Acrivon (ACRV) is a BUY. The potential patent cliff on the lead asset is still real (2030) and the validation of the discovery platform and the emergence of a viable second asset should significantly outweigh the structural risks.

The Scorecard Review
In the pre-game analysis,three specific tests were set for this readout. Here is how they performed:

Test 1: The Diagnostic Moat (ACR-368 Efficacy)
The Bar: Set to an ORR >30% in the OncoSignature Positive (BM+) group to prove the diagnostic works.

The Result: PASS.

39% ORR in the overall BM+ population.

44% ORR in BM+ patients with =2 prior lines (the target commercial population).

67% Confirmed ORR in the Serous subtype of endometrial cancer.

Take: This is the Moneyball moment. Standard chemotherapy in this setting yields ~12% response rates. Acrivon has effectively carved out a high-responder niche that generics evidently cannot easily access without replicating the diagnostic. The 67% response rate in Serous tumors (which are aggressive and hard to treat) is a potential Standard of Care defining number.

Test 2: The Crown Jewel (ACR-2316 Safety & Efficacy)
The Bar: Clean safety (no severe neutropenia) and confirmed activity to prove they can design their own drugs.

The Result: PASS.

Efficacy: Tumor shrinkage in 9 out of 20 evaluable patients at therapeutic doses (=120mg).

Responses: One Confirmed Partial Response (cPR) in Endometrial Cancer, plus unconfirmed PRs in Small Cell Lung Cancer (SCLC) and Squamous NSCLC.

Safety: Management cites favorable tolerability and successfully established dosing schedules (3-days-on/4-days-off).

Take: The response in Small Cell Lung Cancer (SCLC) is a pleasant surprise. WEE1 inhibitors typically struggle there. If the safety data holds up in the full presentation (watch for Grade 3/4 stats), this asset could alone justify the current market cap.

Test 3: The Dilution Danger (Phase 3 Design)
The Bar: Avoid an immediate, massive cash burn.

The Result: GOOD

They submitted a Phase 3 protocol for Frontline Endometrial Cancer (ACR-368 + Anti-PD-1).

“Global trial readiness expected mid-2026.”

Take: “Frontline” means a new trial. While bullish for long-term revenue,
Acrivon confirmed that they have the cash on hand but if it's a very large trial you may see a paretnership or offering closer to $5.

New Asset Alert: ACR-6840 (CDK11)
Acrivon quietly unveiled a third asset: ACR-6840, targeting CDK11.

Why it matters: CDK11 is a known synthetic lethal target for many cancers but has been notoriously hard to drug. Acrivon claims this is an AP3-derived NCE. IND is planned for Q4 2026. This adds shots on goal to the pipeline.

The Verdict
The Bull Case Now Appears Structural: You are no longer betting on a single, old drug. You may be betting on a Platform that has:

Rescued a failed drug (ACR-368).

Designed a novel active drug (ACR-2316).

Identified a third target (CDK11).

The 2030 patent cliff on ACR-368 could be a solvable problem now that the pipeline is firing especially with cash on hand.

$ACRV Price Targets from $6-$19 Cash on Hand: $119M Market Cap: 59M Cash Value $4.09 • Positive Data confirmed ✅ $ANPA $LHRC $LIY $EVTV #Bullish

$ACRV Value Disconnect - • Cash on Hand: $119M
• Market Cap: Only $58M • Trading ~50% BELOW cash value
• Positive Data confirmed
* Market is asleep at the wheel. Huge upside potential here.

Loaded up!

$ACRV Acrivon PT Raised at Piper Sandler on 'Positive Clinical Data' https://streetinsider.com/Analyst+Comments/Acrivon+Therapeutics+Inc+%28ACRV%29+PT+Raised+at+Piper+Sandler+on+Positive+Clinical+Data/25829378.html via
@Street_Insider

@Nasdaq

Peers: $BMRN $VRTX $REGN $AMGN $GILD $BIIB $EXEL $INCY $NBIX $IONS
Held by: $VTI $VXF $IWC $CHNA

$ACRV Acrivon Therapeutics stock falls after updated Phase 2b ACR-368 endometrial cancer data show a 67% confirmed ORR in biomarker-positive serous patients and initial Phase 1 ACR-2316 results show tumor shrinkage; the company also unveiled a new CDK11 candidate and reported $119M year-end cash with runway into Q2 2027.

$ACRV News out: Acrivon Therapeutics Announces Positive ACR-368 Phase 2b Endometrial Cancer Clinical Data with EU Expansion to Accelerate Enrollment, Initial ACR-2316 Clinical Data, and ACR-6840, its Next AP3-Enabled Development Candidate, Targeting CDK11

Jan 08, 2026

Electronic data capture (EDC) extract from the ongoing ACR-368 registrational-intent Phase 2b monotherapy trial in OncoSignature-positive (BM+) subjects with endometrial cancer (EC) showed 39% overall response rate (ORR) and 44% in subjects with ≤2 prior lines of therapy*

Analysis of data from all-comer subjects with serous subtype and ≤2 prior lines of therapy, a high unmet need population, showed a confirmed ORR (cORR) of 52%, and within BM+ subjects cORR was 67%, consistent with higher BM levels across serous subjects

Arm 3 is enrolling up to 90 subjects with serous subtype and ≤2 prior lines of therapy, without requirement for a tumor biopsy, for treatment with ACR-368 plus ultra-low dose gemcitabine (ULDG) as a tumor sensitizer and enrollment completion expected in fourth quarter 2026

Based on preclinical AP3 data showing strong synergy between ACR-368 and anti-PD-L1, company has submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 plus anti-PD-1 therapy in frontline EC subjects; global trial readiness expected mid-2026

Initial data from Phase 1 dose escalation (N=33) for ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, showed favorable tolerability; two weekly oral dosing regimens (160 mg QD, 3d on/4d off and 240 mg QD, 2d on/5d off) established with a bi-weekly regimen initiated

Tumor shrinkage was observed at ≥120 mg dose level in 9/20 subjects, including a confirmed PR in EC, and unconfirmed PRs in SCLC and sqNSCLC, two tumor types predicted sensitive by AP3, not previously shown sensitive to WEE1 inhibitors in development

ACR-6840, a potential first-in-class AP3-derived oral CDK11 inhibitor, nominated as next preclinical development candidate, with IND submission planned for fourth quarter 2026

Company to hold video conference call and webcast today at 8:30 a.m. ET

WATERTOWN, Mass., Jan. 08, 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 significant progress across its pipeline, including updates regarding the Phase 2 ACR-368 program, initial clinical data from the ACR-2316 Phase 1 study, and the nomination of Acrivon’s next AP3-enabled preclinical development candidate, ACR-6840, a potential first-in-class, oral CDK11 inhibitor.

“We are pleased with tangible progress accelerating across multiple high-value opportunities,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and co-founder of Acrivon. “We are particularly excited by the observation from our ongoing ACR-368 Phase 2 trial that subjects with serous endometrial cancer with up to two prior lines of therapy are showing over 50% confirmed response rate. This provides an attractive opportunity for rapid Arm 3 enrollment without the need for a pretreatment biopsy, both in the US and more than 20 newly selected sites in major EU countries, with anticipated enrollment completion in 2026. Given the high response rate we have observed, and that we intend to give all patients ULDG as a sensitizer for ACR-368, we believe the data from our ongoing study provide for a highly compelling clinical profile in this high unmet need patient population.”

“About a third of all second- and third-line endometrial cancer cases are of serous subtype and represent a challenging patient population,” said Mansoor Raza Mirza, M.D., chief medical officer of Acrivon. “Moreover, incorporating feedback from a Type B meeting in June 2025, we have recently submitted our Phase 3 confirmatory study protocol to the FDA for ACR-368 in combination with anti-PD-1 therapy in frontline endometrial cancer patients, building on the strong synergy observed preclinically between these two agents.”

“We are also very encouraged by the initial clinical data for ACR-2316, including the favorable tolerability profile and observed tumor shrinkage across multiple AP3-prioritized tumor types, including partial responses in heavily pretreated subjects with endometrial cancer, SCLC and squamous NSCLC,” continued Dr. Blume-Jensen. “Finally, we continue to demonstrate the value of our AP3 platform with the nomination from our cell cycle program of ACR-6840, a potential first-in-class CDK11 inhibitor development candidate, with IND submission expected in the fourth quarter of 2026. We believe these achievements represent transformative progress toward delivering meaningful new precision medicine treatment options for cancer patients with high unmet need.”

Additional Details

ACR-368: Potential First-in-Class CHK1 / CHK2 Inhibitor

In Arm 1 of the ACR-368 Phase 2b registrational-intent trial (monotherapy BM+ subjects), an updated interim analysis (EDC data extract as of December 4, 2025) showed a ORR of 39%*. In subjects with ≤2 prior lines of therapy (LoT), the ORR was 44%. Based on data that showed higher response rates in subjects with serous EC (also called uterine serous carcinoma) across Arm 1 and Arm 2 (ACR-368 with ULDG in BM- subjects), Arm 3 will now focus exclusively on subjects with serous cancer and ≤2 prior LoT.
Updated interim analysis of data showed a cORR of 67% in BM+ subjects (N=12) with serous EC
Interim analysis across both BM+ and BM- subjects showed a cORR of 52% (N=23) in serous subjects versus 22% (N=37) in non-serous EC subjects; all subjects in this analysis received up to two prior LoT, including chemotherapy and anti-PD-1
Consistent with the higher cORR observed across all subjects with serous EC, BM levels were overall higher in this tumor type
These results are consistent with serous tumors often being G1-S-deficient, leading to DNA damage repair stress and dependency on the G2-M checkpoint controlled by CHK1/CHK2
EU Clinical Trial Application for Arm 3 of the ongoing US multicenter, registrational-intent Phase 2b trial in serous subjects with ≤2 prior LoT and without requirement for a tumor biopsy has been submitted, with the selection of more than 20 sites across four major EU countries (Germany, Italy, France, and Spain). Initial patient enrollment in the EU is expected in the first quarter of 2026, with enrollment at previously activated US clinical sites continuing.
Arm 3 evaluates ACR-368 combined with ULDG as a sensitizer in BM-unselected subjects with serous EC who have received up to two prior LoT without requirement for a tumor biopsy
The company expects to complete enrollment in Arm 3 in the fourth quarter of 2026 (design of up to N=90 subjects, with potential for validation of clinical significance in as few as 40 subjects, including possibility of earlier interim analysis)
On November 12, 2025, after incorporating feedback from a Type B meeting held earlier in 2025 with the FDA and based on strong rationale and preclinical studies demonstrating synergy between ACR-368 and anti-PD-L1, the company submitted the proposed protocol design for the planned Phase 3 confirmatory study evaluating ACR-368 in combination with an anti-PD-1 agent in frontline advanced/recurrent pMMR EC subjects. No further feedback has been received from FDA on the protocol design.
ACR-2316: Potential First-in-Class WEE1 / PKMYT1 Inhibitor

A total of 33 patients were dosed across two weekly oral dosing schedules in the ongoing Phase 1 monotherapy dose-escalation study (EDC data extract as of December 22, 2025)
Initial clinical data from the study has successfully established two weekly oral dosing regimens of 160 mg QD on a 3d on / 4d off and 240 mg QD 2d on / 5d off weekly administration schedules, with a favorable tolerability profile with transient, mechanism-based hematological adverse events, predominantly neutropenia
A cohort aiming to establish a bi-weekly 2d on / 12d off dosing regimen has been initiated, based on projected enhanced single agent activity and to provide for further dosing flexibility in potential future combination studies
Clinical activity observed at dose level 120 mg and above, with tumor shrinkage in 9 out of 20 evaluable patients, including a confirmed PR in a subject with EC and unconfirmed partial responses in subjects with SCLC and sqNSCLC, two tumor types which have not shown sensitivity to other clinical WEE1 or PKMYT1 inhibitors currently in development:
A subject with high grade Mullerian EC (BRCA1/2 wt) enrolled at the 120 mg dose level, who had previously received prior platinum-based chemo and tamoxifen and second-line pembrolizumab-lenvatinib, had confirmed PR and was on therapy for 42 weeks
A subject with SCLC (MSS) enrolled at the established 160 mg dose level, who had previously received cisplatin/durvalumab, second-line tarlatamab and radiation therapy, achieved an unconfirmed PR (50% tumor shrinkage) at first scan (with subsequent scan showing further shrinkage (69%) of target lesion, but progression of liver metastases in non-target lesions after the date of EDC extract)
A subject with squamous NSCLC (BRCA1 mutated) enrolled at the 240 mg dose level, but reduced to 200 mg in the first cycle, had previously received platinum-based chemo with durvalumab followed by three other immune therapies. This subject achieved an unconfirmed PR (which was confirmed in a subsequent scan after the date of EDC extract)
The trial continues to focus on selected, AP3-prioritized solid tumor types
ACR-6840: Potential First-in-Class CDK11 Inhibitor

ACR-6840, a potential first-in-class CDK11 inhibitor, nominated as the next development candidate from company’s AP3-driven cell cycle program, with several promising back-up series also identified
CDK11 is a challenging but compelling target with multiple isoforms and broad cell cycle regulatory roles, including transcription regulation, pre-mRNA splicing, and mitosis. ACR-6840 was rationally designed using the AP3 platform to achieve optimal on-target pathway effects
IND submission anticipated in the fourth quarter of 2026
Anticipated Upcoming Milestones

Initiate enrollment for the ongoing Arm 3 of the ACR-368 Phase 2 trial in EU in Q1 2026
Provide additional update on Arm 1 and initial clinical data from Arm 3 of the ACR-368 Phase 2 trial in mid-2026
Achieve readiness for Phase 3 confirmatory trial for ACR-368 in combination with PD-1 therapy in mid-2026
Complete enrollment (planned N = 90 subjects) in the biopsy-independent Phase 2 Arm 3 trial for ACR-368 combined with ULDG as a sensitizer in Q4 2026
Report additional ACR-2316 Phase 1 clinical data in weekly and bi-weekly dosing regimens and transition into dose expansion in select tumor types in 1H 2026
Submit IND to FDA for ACR-6840 in Q4 2026
Initiate additional internal programs utilizing AP3 platform in 2H 2026
As of December 31, 2025, the company had preliminary, unaudited cash, cash equivalents and investments of approximately $119 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2027.

The cash, cash equivalents and investment amount is preliminary and are subject to completion of financial closing procedures. As a result, these amounts may differ materially from the amounts that will be reflected in the company’s consolidated financial statements for the quarter and year ended December 31, 2025.

The company will host an investor conference call and webcast today at 8:30 a.m. ET. The event can be accessed through a link on the Events & Presentations page within the investor section of the company’s website at https://ir.acrivon.com/news-events/events-presentations.

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

We should see a gap up tomorrow.

ACRV....................................https://stockcharts.com/sc3/ui/?s=ACRV&p=W&b=5&g=0&id=p86431144783

Got back in for 15000 shares today.. what can I say other than battered wife syndrome.

$47.5M market cap $143M stockholders' equity. 😺
Sometimes less (words, effort) is more, lol...
$ACRV AI Overview
Market Capitalization vs. Equity What's the Difference ...
A company's market capitalization (market cap) will almost always be higher than its shareholders' equity because market cap reflects investor expectations about future growth and earnings, while shareholders' equity represents the company's book value on its balance sheet. Market cap is the value investors are willing to pay for a company, considering factors like growth, while equity is the historical cost of assets and investments. A price-to-book ratio (P/B) compares these two, with a P/B above 1 indicating market value exceeds book value, and a P/B below 1 suggesting the market might be undervaluing the company.

Financials are SOUND. What have we got in the oven?
Need to do more DD on this one...your post caught my eye, thanks, 81vette.



Link > 10Q

$ACRV

Taking a 1.70 position on this oversold consolidation intradays setting up nicely

ACRV,Nice run up $ 2.67 (101%) pull back now to $1.95 ,watch for thru $2 explosion again

4 month bottom uptrend and volume now,cash for thru June 2027,only offering ever that I see was a private placement of $140m on April 9th 2024 ,was 8.2m shares at $8.50 per share!

Only 855 watchers(that’s unfound in my book) someone with 120k followers just posted ACRV as a play,could get found now and really start moving soon,relative volume is up 160Xs ,that’s a huge increase with no pr yet,some pr companies will be posting soon with this volume. It’s still 50% below the sma200, 100%+ upside before resistance at $4 then mental resistance at $5

Added 1.40 on the gap fill opening dip,awaiting a pr in coming days,minutes hopefully

Complete regression https://investorshub.advfn.com/stock-market/NASDAQ/acrivon-therapeutics-ACRV/stock-news/96772218/form-8-k-current-report

ACRV,unfound great cancer cure results(only in a filing so far)no debt,no dilution,$140m cash($4 per share) pr coming after the filing now,chart is a beautiful bottom,I bought 1.49.
Shares to short dropped 50% today.
Good skill everyone

ACRV, new 52 week low

ACRV, new 52 week low

my behind hurts... lol still great management. Maybe ill purchase more for the longrun.

Oppenheimer lowered the firm's price target on Acrivon Therapeutics to $10 from $18 and keeps an Outperform rating.

Investors might want to bet on Acrivon Therapeutics, Inc. (ACRV), as it has been recently upgraded to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.

The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.

Mar 27, 2025
https://ir.acrivon.com/financials-filings/sec-filings

What is the date on this PR?
TIA

Acrivon Therapeutics (NASDAQ: ACRV) reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical programs. The company's ACR-368 showed promising results in endometrial cancer patients, achieving a 35% confirmed overall response rate in OncoSignature-positive patients who had previously progressed on anti-PD-1 and chemotherapy.

Key clinical highlights include a 50% response rate in relapsed patients with duration of response exceeding 10 months, and 33% response rate in refractory patients. The Phase 1 trial of ACR-2316 is ahead of schedule, with initial clinical activity observed. The company has prioritized endometrial cancer development while deprioritizing ovarian and bladder cancer programs.

Financial results show a net loss of $22.8 million for Q4 2024 and $80.6 million for the full year. With $184.6 million in cash and investments as of December 31, 2024, Acrivon expects to fund operations into 2027.

Purchased 1000 shares @ 7.73

Liking this one.

“Today we present initial clinical data from our ongoing Phase 2 clinical trial which we believe highlights the power of our next generation proteomics-based AP3 precision medicine platform,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics. “For the first time, we share statistically significant prospective validation of our AP3 patient selection approach via our ACR-368 OncoSignature assay, which demonstrated the ability to effectively identify cancer patients whose tumors are likely to respond to ACR-368 monotherapy treatment. We are extremely gratified to not only confirm the ability to identify and enrich for patient responders with ovarian cancer, but also for patients with endometrial cancer, a new tumor type identified and predicted to be sensitive to ACR-368 by our AP3 platform prior to clinical trial initiation.”

“Today’s R&D event provides us an opportunity to present the compelling preclinical data of our AP3-based, rationally-designed ACR-2316 dual WEE1/PKMYT1 inhibitor,” said Kristina Masson, Ph.D., M.B.A., co-founder and executive vice president of business operations at Acrivon Therapeutics, Inc. and president and CEO of the company´s research subsidiary Acrivon AB. “We are excited to announce our accelerated timelines for IND filing, now expected in the third quarter with potential clinical study initiation now anticipated in the fourth quarter of this year. We believe this potential first-in-class asset, which is specifically designed for superior single-agent activity as demonstrated in preclinical studies against benchmark inhibitors, has the potential to address significant unmet treatment needs against a broad range of tumors in patients with limited treatment options.”

Company Provides Program and Data Highlights:

An overview of the broad, actionable scientific capabilities and clinically demonstrated deliverables of the AP3 platform
Initial ACR-368 clinical data in patients with ovarian or endometrial cancers (n=26; 10 OncoSignature-positive and 16 OncoSignature-negative) in the ongoing registrational-intent Phase 2b trial are being presented (data cut as of April 1, 2024).
A confirmed ORR (per RECIST 1.1) of 50% was observed in the prospective cohort of OncoSignature-positive patients who were efficacy-evaluable. All confirmed responders continue to be on treatment, median duration of response (DoR) has not yet been reached. Notably, endometrial cancer is a new tumor type with significant unmet medical need that was identified and predicted to be sensitive to ACR-368 by AP3 indication screening.
Initial, prospective validation of the AP3-based ACR-368 OncoSignature assay demonstrating its ability to identify ovarian and endometrial patients sensitive to ACR-368 monotherapy in the ongoing clinical trial, with clear segregation of RECIST responders in the OncoSignature-positive (50% confirmed ORR in 10 patients) versus OncoSignature-negative (0% ORR in 16 patients) arms (p-value=0.0038).
In the OncoSignature-negative arm with ovarian or endometrial cancers, encouraging signs of clinical activity were observed in response to ACR-368 with ultra-low dose gemcitabine at the recommended Phase 2 combination dose, with 8 out of 16 patients achieving stable disease.
Consistent with past trials, the ACR-368 treatment-related adverse event profile was predominantly reversible and transient with only mechanism-based, hematological adverse events.
ACR-2316, a potential first-in-class, potent WEE1/PKMYT1 inhibitor continues to advance rapidly with IND filing now expected in Q3 2024 (vs. previous guidance of Q4 2024) and the initiation of a clinical trial is anticipated in Q4 2024. ACR-2316 is uniquely designed by AP3 for superior single-agent activity and to overcome limitations of current WEE1 inhibitors and PKMYT1 inhibitors.
A preview of the AP3 Interactome, which is a proprietary, machine-learning-enabled interactive platform used to uncover actionable drug-induced pathway effects across all studies.
A live and recorded webcast of the event will be available through a link on the Events & Presentations page within the investor section of the company’s website at https://ir.acrivon.com/news-events/events-presentations. The webcast will be available for at least 30 days following the event.

ACRV update

Nope do your research

TY. is that always the read on your xxx under xx posts?

Still a buy

please elaborate on "ACRV under 10" = Its a buy under 10? TIA
vice versa xxx over xxx = short?

One day wonder

Acrivon Therapeutics Announces $130 Million Private Placement Financing

ACRV under $10