Acrivon Therapeutics

ACRV

Market cap $59M

Acrivon Therapeutics Inc. (NASDAQ: ACRV) on Thursday shared updates regarding the Phase 2 ACR-368 program and initial clinical data from the ACR-2316 Phase 1 study.

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.

Company to host conference call and webcast at 8:30 a.m. ET on Thursday, January 8, 2026 Company to host conference call and webcast at 8:30 a.m. ET on Thursday, January 8, 2026

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

Advancement of ACR-368 in registrational-intent Phase 2b trial for the treatment of patients with endometrial cancer Preparing for initial clinical data disclosure for ACR-2316 from the Phase 1 trial in AP3-prioritized solid tumor types Expanding power of Generative Phosphoproteomics AP3 supersedes conventional target-centric drug discovery, yielding differentiated compounds with desired pathway effects Cash, cash equivalents and marketable securities of $134.4 million as of September 30, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the third quarter ended September 30, 2025 and reviewed recent business highlights.

AP3 Generative AI KaiSR model globally assesses drug effects on the entire intracellular protein signaling network for optimal drug design and precision medicine development

WATERTOWN, Mass., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today announced that the company approved a grant of equity award under its 2023 Inducement Plan to one employee. The equity award was granted in the form of stock options and has a grant date of October 1, 2025.

Continued advancement of two clinical-stage assets, both with clinically demonstrated single-agent anti-tumor activity -- ACR-368 in a registrational-intent Phase 2 study in endometrial cancer and ACR-2316 in a Phase 1 study in AP3-predicted tumor types

Corporate R&D event highlighted positive ACR-368 data in endometrial cancer patients who had all received prior anti-PD-1 and platinum-based chemotherapy Confirmed overall response rate (cORR) of 35% and median duration of response (mDOR) >5.6 months (not yet reached) observed in OncoSignature-positive (BM+) patients, a majority of whom were refractory to last prior therapy, and cORR of 50% and mDOR >10 months (not yet reached) for BM+ patients who had relapsed on last prior therapy Three dose escalation cohorts completed in ACR-2316 Phase 1 trial with tumor shrinkage observed already at dose level (DL)3, below projected recommended Phase 2 dose AACR presentation of ACR-2316 revealing mechanisms underlying its superior preclinical activity with potent mitotic tumor cell death using AP3 Generative Phosphoproteomics Mansoor Raza Mirza, M.D. appointed chief medical officer; accomplished clinician with stellar track record of successfully leading registrational trials through regulatory approvals, and establishing new standards of care in gynecological oncology Cash, cash equivalents and marketable securities of $164.8 million as of March 31, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass.

Acrivon Therapeutics, Inc. (ACRV) appears to have found support after losing some value lately, as indicated by the formation of a hammer chart. In addition to this technical chart pattern, strong agreement among Wall Street analysts in revising earnings estimates higher enhances the stock's potential for a turnaround in the near term.