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.ACR-368 DataIn Arm 1 of the ACR-368 Phase 2b registrational-intent trial in endometrial cancer, an updated interim analysis showed an overall response rate (ORR) of 39%. In subjects with over two prior lines of therapy, the ORR was 44%.Based on data that showed higher response rates in subjects with serous endometrial cancer (also called uterine s ...

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Acrivon Therapeutics Conference Call Summary Company Overview - **Company**: Acrivon Therapeutics (NasdaqGM:ACRV) - **Focus**: Development of precision oncology therapies utilizing the AP3 generative phosphoproteomics platform Key Industry Insights - **Industry**: Oncology, specifically targeting endometrial cancer and other solid tumors - **Market Need**: Significant unmet need in treating relapsed serous endometrial cancer, which accounts for approximately 40% of all endometrial cancer deaths, translating to about 20,000 deaths annually in the U.S. and EU combined [15][16] Core Points and Arguments 1. **AP3 Platform**: Acrivon's AP3 platform allows for unbiased identification and quantification of drug effects on disease-causing signaling pathways, enhancing drug discovery and development [4][5] 2. **Pipeline Overview**: The pipeline includes: - ACR368: A potent selective CHK1/2 inhibitor with promising clinical data - ACR2316: A dual WEE1/PKMYT1 inhibitor designed to overcome resistance mechanisms - ACR6840: A new candidate targeting CDK11, with potential first-in-class status [6][29] 3. **Clinical Data for ACR368**: - Overall response rate of 39% in biomarker-positive endometrial cancer patients treated with ACR368 monotherapy [11] - Disease control rate of over 80% in the same population [11] - Notable response rates of 67% in serous tumors, indicating a strong potential for this subgroup [13] 4. **Regulatory Pathway**: A phase 3 confirmatory trial protocol for ACR368 has been submitted to the FDA, aiming to improve progression-free and overall survival in advanced endometrial cancer [18][20] 5. **Combination Therapy Potential**: ACR368 shows strong synergy with anti-PD-L1 therapies, which may enhance treatment efficacy [9][34] 6. **Safety Profile**: ACR368 has a favorable tolerability profile, primarily associated with transient hematological adverse events, with no significant non-hematological adverse events reported [9][40] Additional Important Insights - **Market Opportunity**: The prevalence of relapsed serous endometrial cancer is estimated at 55,000-60,000 patients, with a significant portion progressing to second-line therapy, highlighting the potential market for ACR368 [15][16] - **Emerging Candidates**: ACR6840 is positioned as a potential first-in-class agent targeting CDK11, with promising preclinical anti-tumor activity and a planned IND submission in Q4 2026 [29][31] - **Dosing Regimens**: ACR2316 has established two-weekly oral dosing regimens, showing activity in heavily pretreated patients with aggressive cancers like small cell lung cancer and squamous non-small cell lung cancer [34][35] Conclusion Acrivon Therapeutics is advancing its innovative oncology pipeline with a focus on precision medicine, particularly in addressing the unmet needs in endometrial cancer. The promising clinical data for ACR368 and the strategic regulatory submissions position the company favorably within the oncology landscape.

ACR-368 - In OncoSignature-positive endometrial cancer subjects, the Objective Response Rate (ORR) with ACR-368 single agent is 39% (n=31)[31] - In subjects with ≤ 2 prior lines of therapy, the ORR in BM+ subjects is 44% (n=25) and in BM- subjects is 26% (n=35) with ACR-368 single agent and ACR-368 + ULDG combo, respectively[34] - In BM+ subjects with ≤ 2 prior lines, the ORR in serous carcinosarcoma is 67% (n=12)[37] - In biomarker-unselected subjects with ≤ 2 prior lines, the ORR in serous subjects is 52% (n=23) and in non-serous subjects is 22% (n=37)[40] - In serous subjects with ≤ 2 prior lines, the Disease Control Rate (DCR) is 92% and Clinical Benefit Rate (CBR) at 16 weeks is 83% in Arm 1 (BM+), while in Arm 2 (BM-) the DCR is 55% and CBR at 16 weeks is 45%[43] - Serous endometrial cancer accounts for approximately 40% of all endometrial cancer deaths, equating to roughly 20,000 deaths per year in the US and EU[46, 52] ACR-2316 - In the Phase 1 dose escalation study, clinical activity was observed at dose level 120 mg and above, with tumor shrinkage in 9 out of 20 evaluable patients[74] - A total of 33 patients were dosed across two weekly dosing schedules in the ongoing Phase 1 monotherapy dose-escalation study[68, 74] - In the Phase 1 study, 79% of the subjects were White, 9% were Black/African American, 3% were Asian, 3% were Native Hawaiian/Pacific Islander, and 6% were Unknown/Other[69] Financials - As of December 31, 2025, Acrivon has approximately $119 million in cash and investments, projecting a runway into Q2 2027[96]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 08, 2026 480 Arsenal Way Suite 100 Watertown, Massachusetts 02472 (Address of Principal Executive Offices) (Zip Code) Delaware 001-41551 82-5125532 (Commission File Number) (IRS Employer Identification No.) Registrant's Telephone Number, Including Area Code: (617) 207-8979 Acrivon Thera ...

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 s ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Has Humacyte, Inc. (HUMA) been one of those stocks this year? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Humacyte, Inc. is a member of our Medical group, which includes 933 different companies and currently sits at #8 in the Zacks Sector Rank. The Zacks Sector Rank considers 16 differe ...

WATERTOWN, Mass., Jan. 06, 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, ...

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]

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]