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Is Humacyte, Inc. (HUMA) Outperforming Other Medical Stocks This Year?
ZACKS· 2026-01-07 15:41
Group 1 - Humacyte, Inc. (HUMA) has gained approximately 12.4% year-to-date, outperforming the average gain of 7.6% for Medical stocks [4] - The Zacks Rank for Humacyte, Inc. is currently 2 (Buy), indicating a positive outlook based on earnings estimates and revisions [3] - The consensus estimate for Humacyte's full-year earnings has increased by 15.9% over the past quarter, reflecting improved analyst sentiment [3] Group 2 - Humacyte, Inc. is part of the Medical - Biomedical and Genetics industry, which has an average gain of 18.6% this year, indicating that HUMA is slightly underperforming its industry [5] - Acrivon Therapeutics, Inc. (ACRV), another Medical stock, has outperformed the sector with a return of 24.9% year-to-date [4] - The Medical - Drugs industry, to which Acrivon belongs, has gained 3.1% this year and is ranked 90 among 141 stocks [6]
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 via Webcast
Globenewswire· 2026-01-06 12:30
Core Viewpoint - Acrivon Therapeutics is set to provide clinical data for its lead programs ACR-368 and ACR-2316 on January 8, 2026, highlighting advancements in precision medicine through its proprietary platform [1][4][7] Group 1: Company Overview - Acrivon Therapeutics is a clinical stage biotechnology company focused on discovering and developing precision medicines using its Generative Phosphoproteomics AP3 platform [3] - The AP3 platform enables unbiased interpretation and quantification of drug-regulated pathway activity levels in intact cells, generating terabytes of data for actionable insights [3] - Acrivon aims to overcome traditional drug discovery limitations by rapidly designing differentiated compounds and advancing them into clinical development [3] Group 2: Clinical Programs - ACR-368, a selective small molecule inhibitor targeting CHK1 and CHK2, is currently in a Phase 2b trial for endometrial cancer and has received Fast Track designation from the FDA [4] - The ACR-2316 program, a WEE1/PKMYT1 inhibitor, is in Phase 1 trials, with initial clinical activity and dose proportionality observed in early cohorts [5][7] - Upcoming updates will include interim clinical data from the ACR-368 study and initial data from the ACR-2316 study, along with a new preclinical development candidate [7]
UPDATE -- 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 via Webcast
Globenewswire· 2025-12-17 14:34
Core Insights - Acrivon Therapeutics is a clinical stage biotechnology company focused on precision medicine through its proprietary Generative Phosphoproteomics AP3 platform, which enables the interpretation and quantification of drug-regulated effects in intact cells [2][3] Company Overview - Acrivon Therapeutics utilizes its Generative Phosphoproteomics AP3 platform to develop precision medicines, allowing for unbiased interpretation of compound-specific pathway activity levels, generating terabytes of data for actionable insights [2] - The AP3 platform includes tools such as the AP3 Data Portal, AP3 Kinase Substrate Relationship Predictor, and AP3 Interactome, which enhance drug discovery beyond traditional methods [2] Clinical Programs - Acrivon's lead program, ACR-368 (prexasertib), is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a Phase 2b trial for endometrial cancer, with Fast Track designation from the FDA [3] - ACR-368 has also received Breakthrough Device designation for its OncoSignature assay to identify suitable patients for treatment [3] - The second clinical asset, ACR-2316, is a WEE1/PKMYT1 inhibitor showing promising early clinical activity and safety in a Phase 1 trial, with initial tumor shrinkage observed [4][6] Upcoming Updates - Acrivon plans to provide updates on ACR-368 and ACR-2316 clinical data through a conference call and webcast in January 2026, including interim data from the Phase 2b study and the Phase 1 study of ACR-2316 [1][6]
UPDATE -- 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 via Webcast
Globenewswire· 2025-12-17 14:34
Core Insights - Acrivon Therapeutics is a clinical stage biotechnology company focused on precision medicine through its proprietary Generative Phosphoproteomics AP3 platform, which enables the interpretation and quantification of drug-regulated effects in intact cells [2][3] Company Overview - Acrivon Therapeutics utilizes its Generative Phosphoproteomics AP3 platform to develop precision medicines, providing rapid and actionable insights from terabytes of proprietary data [2] - The platform includes tools such as the AP3 Data Portal, AP3 Kinase Substrate Relationship Predictor, and AP3 Interactome, allowing for advanced drug discovery beyond traditional methods [2] Clinical Programs - The lead program, ACR-368 (prexasertib), is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a Phase 2b trial for endometrial cancer, with Fast Track designation from the FDA [3] - ACR-2316, a second clinical stage asset, is a potent WEE1/PKMYT1 inhibitor showing promising early clinical activity and safety in a Phase 1 trial, with initial tumor shrinkage observed [4][6] Upcoming Updates - Acrivon plans to provide updates on ACR-368 and ACR-2316 clinical data via a conference call and webcast in January 2026, including interim data from ongoing trials and new preclinical candidates [1][6]
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
Globenewswire· 2025-12-17 12:30
Core Insights - Acrivon Therapeutics is a clinical stage biotechnology company focused on precision medicine through its proprietary Generative Phosphoproteomics AP3 platform, which enables the interpretation and quantification of drug-regulated effects in intact cells [2][3] Company Overview - Acrivon utilizes its Generative Phosphoproteomics AP3 platform to develop precision medicines, allowing for unbiased interpretation of compound-specific pathway activity levels, generating terabytes of data for actionable insights [2] - The platform includes tools such as the AP3 Data Portal, AP3 Kinase Substrate Relationship Predictor, and AP3 Interactome, which enhance drug discovery beyond traditional methods [2] Clinical Programs - Acrivon's lead program, ACR-368 (prexasertib), is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a Phase 2b trial for endometrial cancer, with Fast Track designation from the FDA [3] - ACR-2316, a second clinical stage asset, is a selective WEE1/PKMYT1 inhibitor showing promising preclinical results and is currently in a Phase 1 trial with initial clinical activity observed [4] Upcoming Updates - Acrivon plans to provide updates on ACR-368 and ACR-2316 clinical data in January 2026, including interim data from the Phase 2b study and initial results from the Phase 1 study of ACR-2316 [6]
H.C. Wainwright Initiates Coverage on Acrivon Therapeutics (ACRV) With “Buy” Rating and $19 PT
Yahoo Finance· 2025-11-29 06:26
Core Viewpoint - Acrivon Therapeutics, Inc. (NASDAQ:ACRV) is highlighted as a promising investment opportunity due to its strong recent performance and significant upside potential, particularly driven by advancements in its clinical pipeline [1]. Group 1: Analyst Coverage and Price Target - H.C. Wainwright initiated coverage on Acrivon Therapeutics with a "Buy" rating and a price target of $19, reflecting a positive outlook based on the company's pipeline developments, especially the ACR-368 Phase 2b trial [2]. - The inclusion of a third cohort in the ACR-368 trial is expected to enhance enrollment and overall response rates, particularly for patients with less prior treatment, thereby improving market positioning [2]. Group 2: Financial Performance - In Q3 2025, Acrivon reported a net loss of $18.2 million, an improvement from a loss of $22.4 million in the same quarter the previous year [3]. - R&D expenses decreased from $18.9 million to $13.6 million, indicating a strategic focus on endometrial cancer [3]. - The company ended the quarter with cash reserves of $134.4 million, which is projected to fund operations into Q2 2027 [3]. Group 3: Company Overview - Acrivon Therapeutics is a clinical-stage biopharmaceutical company that develops precision medicines utilizing its Generative Phosphoproteomics AP3 platform to create targeted treatments [4].
Acrivon Therapeutics(ACRV) - 2025 Q3 - Quarterly Report
2025-11-13 21:17
Oncology Pipeline - Acrivon Therapeutics is focused on oncology, advancing its pipeline of preclinical and clinical-stage small molecule inhibitors, including ACR-368 and ACR-2316[100]. - ACR-368 is in a potentially registrational Phase 2B trial for endometrial cancer, with initial data showing a confirmed overall response rate (ORR) of 35% and a disease control rate (DCR) of 80% among 20 biomarker-positive patients[105]. - The company reported that 80% of biomarker-positive patients demonstrated tumor shrinkage, indicating significant anti-tumor activity in aggressive, refractory tumors[105]. - ACR-368 received Fast Track designation from the FDA for endometrial cancer and the OncoSignature test received Breakthrough Device Designation, reflecting its potential for effective treatment[102]. - ACR-2316, a selective WEE1/PKMYT1 inhibitor, is currently in Phase 1 trials, with initial clinical activity observed and a clinical data update expected in the second half of 2025[108]. - The company plans to continue exploring drug combinations and has initiated a Phase 2 trial of ACR-368 with ultra low-dose gemcitabine in endometrial cancer patients[106]. Financial Performance - Acrivon has incurred net losses of $58.9 million and $57.7 million for the nine months ended September 30, 2025, and 2024, respectively, with an accumulated deficit of $255.9 million as of September 30, 2025[113]. - The company raised $123.8 million in net proceeds from a PIPE transaction in April 2024, selling 8,235,000 shares at $8.50 per share[112]. - Research and development expenses for Q3 2025 were $13.6 million, a decrease of $5.2 million from $18.9 million in Q3 2024[137]. - The company reported a net loss of $18.2 million for Q3 2025, an improvement of $4.2 million compared to a net loss of $22.4 million in Q3 2024[135]. - Total operating expenses for the nine months ended September 30, 2025, were $63.998 million, a slight decrease of $0.247 million from $64.245 million in the same period of 2024[139]. - Interest income for Q3 2025 was $1.5 million, down from $2.7 million in Q3 2024, reflecting a decrease of $1.2 million[138]. - Total other income, net for the nine months ended September 30, 2025, was $5.1 million, compared to $6.5 million for the same period in 2024, a decrease of $1.4 million[143]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $48.4 million, slightly increasing from $48.3 million in the same period of 2024[146]. - Net cash provided by investing activities was $44.6 million for the nine months ended September 30, 2025, resulting from $114.5 million in proceeds from maturities of investments[148]. - Net cash used in financing activities was $0.6 million for the nine months ended September 30, 2025, primarily due to tax withholding payments[150]. Research and Development - Acrivon is leveraging its proprietary AP3 platform for drug discovery and optimization, which has enabled rapid advancement of its drug candidates[109]. - The company anticipates a substantial increase in research and development expenses as it continues the development of ACR-368 and ACR-2316[126]. - Research and development expenses for the nine months ended September 30, 2025, were $45.2 million, a decrease of $0.1 million from $45.4 million in the same period of 2024[142]. - ACR-368 direct research and development expenses for Q3 2025 were $3.985 million, down from $11.098 million in Q3 2024, a decrease of $7.113 million[136]. - The company experienced a $6.5 million net decrease in costs due to fewer scheduled milestones in the current period[147]. - A $3.8 million net increase in costs was related to the clinical trial of ACR-2316, initiated in Q3 2024[147]. Future Outlook - Acrivon anticipates significant ongoing expenses related to clinical development and commercialization efforts, necessitating additional funding to support its growth strategy[115]. - The company expects to incur significant expenses and operating losses as it advances drug candidates through clinical development and seeks regulatory approval[153]. - The company anticipates that existing cash will fund operations into the second quarter of 2027, based on current assumptions[152]. - The company may require additional capital for in-licenses or acquisitions of other drug candidates in the future[153]. - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $134.4 million, expected to fund operations into Q2 2027[118]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates below $700 million[164].
Acrivon Therapeutics(ACRV) - 2025 Q3 - Quarterly Results
2025-11-13 21:10
Financial Performance - Acrivon Therapeutics reported a net loss of $18.2 million for Q3 2025, an improvement from a net loss of $22.4 million in Q3 2024, representing a 18.8% reduction in losses[6] - Total operating expenses for Q3 2025 were $19.7 million, down from $25.1 million in Q3 2024, indicating a 21.5% decrease[16] Research and Development - Research and development expenses decreased to $13.6 million in Q3 2025 from $18.9 million in Q3 2024, reflecting a 28% reduction due to fewer scheduled milestones and a focus on endometrial cancer[9] - The ongoing Phase 2b trial of ACR-368 for endometrial cancer is designed to evaluate its efficacy in patients who have received prior treatments, with enrollment and dosing ongoing[7] - Initial clinical activity for ACR-2316 has been observed, with tumor shrinkage and confirmed partial responses across several solid tumor types during the Phase 1 trial[7] - Acrivon plans to report initial clinical data from the Phase 1 study of ACR-2316 in the second half of 2025[8] - The company is advancing a new potential first-in-class cell cycle drug discovery program towards candidate nomination in 2025[8] Regulatory and Clinical Designations - ACR-368 has received Fast Track designation from the FDA for its potential as a monotherapy in endometrial cancer patients[12] Financial Position - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $134.4 million, expected to fund operations into Q2 2027[10] Data Presentation and Innovation - The company presented data at the AACR-NCI-EORTC conference demonstrating the predictive capabilities of its AP3 platform in drug design and pathway activity assessment[5]
Acrivon Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights
Globenewswire· 2025-11-13 21:10
Core Insights - Acrivon Therapeutics is advancing its clinical pipeline, particularly focusing on ACR-368 for endometrial cancer, with a registrational-intent Phase 2b trial aimed at addressing unmet medical needs in relapsed patients [2][5] - The company is also preparing to disclose initial clinical data for ACR-2316 from its Phase 1 trial, which targets solid tumor types prioritized by its AP3 platform [1][2] - Acrivon's proprietary Generative Phosphoproteomics AP3 platform is enhancing drug discovery by enabling the design of differentiated compounds with desired pathway effects [1][6] Recent Highlights - ACR-368 is a CHK1 and CHK2 inhibitor currently in a multicenter Phase 2b trial for recurrent high-grade endometrial cancer [3][5] - ACR-2316, a WEE1/PKMYT1 inhibitor, has shown promising preclinical data, demonstrating tumor regression in xenograft models [4][5] - The AP3 platform's generative AI model, KaiSR, has been presented at conferences, showcasing its ability to predict pathway activity and support rational drug design [6] Financial Overview - For Q3 2025, Acrivon reported a net loss of $18.2 million, an improvement from a net loss of $22.4 million in Q3 2024 [8] - Research and development expenses decreased to $13.6 million in Q3 2025 from $18.9 million in the same period in 2024, reflecting a focus on endometrial cancer [9] - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $134.4 million, expected to fund operations into Q2 2027 [10] Upcoming Milestones - Acrivon plans to provide updates on the registrational-intent trial for ACR-368 and report initial clinical data for ACR-2316 in the second half of 2025 [13][14] - The company is also advancing a new potential first-in-class cell cycle drug discovery program towards candidate nomination in 2025 [13]
Analysts Predict Up to 550% Rally for These 2 ‘Strong Buy’ Penny Stocks
Yahoo Finance· 2025-11-02 10:05
Company Overview - Acrivon Therapeutics is a clinical-stage biotech company focused on precision oncology, utilizing its proprietary Generative Phosphoproteomics AP3 platform to identify which patients are most likely to benefit from specific therapies [2][4] - The company has advanced two drug candidates into human clinical trials, with ACR-368 being its lead program [1][8] Drug Candidates - ACR-368 is a selective CHK1/CHK2 inhibitor currently in a registrational-intent Phase 2b trial for recurrent, high-grade endometrial cancer, showing encouraging early clinical readouts, particularly in OncoSignature-positive patients [1][7] - ACR-2316 is a dual WEE1/PKMYT1 inhibitor undergoing a Phase 1 monotherapy dose-escalation study, with preclinical data indicating strong single-agent activity and an ongoing confirmed partial response in a patient with endometrial cancer [8][10] Regulatory Designations - ACR-368 has received FDA Fast Track designation as a monotherapy for ovarian and endometrial cancer, while its companion diagnostic, OncoSignature, has been granted Breakthrough Device status [7][10] Market Potential - ACR-2316's positive emerging profile could potentially add approximately $150 million in market capitalization, with analysts noting its best-in-class potential due to its dual-targeting approach [10][11] - Acrivon’s stock, currently trading at $1.99, has a price target of $13, indicating a potential upside of 553% [9][12] Analyst Sentiment - The broader analyst consensus for Acrivon is a Strong Buy, with 6 Buy ratings and an average price target of $11.75, suggesting a potential upside of 490% over the next year [12]