Every 8-K that Acrivon Therapeutics, Inc. (ACRV) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ACRV and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ACRV filings page.
Acrivon Therapeutics reported second-quarter 2026 results and highlighted progress across its precision oncology pipeline built on its Generative Phosphoproteomics AP3 platform. The lead asset ACR-368 continues dosing in all-comer serous endometrial cancer arms of a registrational-intent Phase 2b trial, with a prespecified simultaneous interim analysis and data update from both arms planned for the second half of 2026 and a Phase 3 confirmatory trial targeted for the first half of 2027.
The company’s second program, ACR-2316, a WEE1/PKMYT1 inhibitor, has entered the randomized dose expansion stage of its Phase 1/2 study at 120 mg and 160 mg once-daily doses, with durable single-agent activity observed in several tumor types, including heavily pretreated lung cancers. Acrivon is also advancing an internally discovered CDK11 inhibitor program through IND-enabling studies, with an IND submission planned for the first half of 2027.
For the quarter ended June 30, 2026, Acrivon reported a net loss of $18.0 million, improved from $21.0 million a year earlier, as research and development and general and administrative expenses both declined. Cash, cash equivalents and investments totaled $90.0 million as of June 30, 2026, which the company expects to fund operations into the fourth quarter of 2027.
Acrivon Therapeutics, Inc. held its 2026 annual meeting of stockholders, where shareholders approved an Amended and Restated 2022 Equity Incentive Plan. The plan authorizes up to 8,606,723 shares of common stock for equity awards, including an increase of 3,000,000 shares approved at the meeting, and features an annual automatic share reserve increase of 5% of fully diluted shares through 2032 unless the Board sets a lower amount.
Shareholders also elected Michael Tomsicek and Charles Baum as Class I directors to serve until the 2029 annual meeting, ratified PricewaterhouseCoopers LLP as independent auditor for the fiscal year ending December 31, 2026, and approved the amended equity plan. A quorum of 31,336,993.43 shares, representing 73.21% of shares entitled to vote as of April 23, 2026, was present or represented by proxy.
Acrivon Therapeutics reported first quarter 2026 results and highlighted progress across its oncology pipeline. Net loss was $19.0 million versus $19.7 million a year earlier, with research and development expenses of $15.2 million and general and administrative expenses of $4.7 million, reflecting lower employee-related costs.
Cash, cash equivalents and investments totaled $97.7 million as of March 31, 2026, and together with $7.3 million from a subsequent equity financing are expected to fund operations into the third quarter of 2027. Clinically, the registrational intent Phase 2b trial of ACR-368 in endometrial cancer showed a confirmed overall response rate of 52% in serous patients compared with 22% in non-serous patients, with an interim analysis of serous arms planned for the second half of 2026. The ACR-2316 Phase 1/2 study is moving toward expansion after early signs of durable activity and a mainly transient neutropenia safety profile, including responses in heavily pretreated lung cancers.
Acrivon Therapeutics reported 2025 results alongside important clinical updates for its oncology pipeline. In an ongoing registrational-intent Phase 2b trial, ACR-368 showed a confirmed overall response rate of 52% in serous endometrial cancer, a high unmet-need subtype linked to a large share of endometrial cancer deaths. The company is expanding this study by adding Arm 4 to test ACR-368 monotherapy in biomarker-unselected serous patients and has completed exploratory Arm 2 using ultra low-dose gemcitabine sensitization in biomarker-negative subjects.
Early Phase 1 data for ACR-2316 showed favorable tolerability and tumor shrinkage, including in heavily pre-treated lung cancer. For the quarter and year ended December 31, 2025, net loss was $19.0 million and $77.9 million, respectively. Acrivon ended 2025 with $118.6 million in cash, cash equivalents and marketable securities, which it expects to fund operations into the second quarter of 2027.
Acrivon Therapeutics, Inc. is shifting its ACR-368 OncoSignature diagnostic testing fully in-house after completing and certifying an internally owned Clinical Laboratory Improvement Amendment (CLIA) laboratory in Watertown, Massachusetts. This new lab is intended to support development of the company’s current and future targeted therapies.
On February 25, 2026, Acrivon and Akoya Biosciences, a wholly owned subsidiary of Quanterix Corporation, entered into a Termination and Transition Agreement to mutually end their June 17, 2022 OncoSignature Companion Diagnostic Agreement. The termination involves no financial payments between the parties. Quanterix and Acrivon agreed on a transition plan so procedures, materials and know-how from Akoya’s prior ACR-368 OncoSignature work are transferred to Acrivon, while Quanterix continues clinical testing during the changeover to support Acrivon’s registrational-intent Phase 2b study. Effective immediately, Acrivon holds full development and commercialization rights to its proprietary ACR-368 OncoSignature test.
Acrivon Therapeutics described interim Phase 2b data for its CHK1/2 inhibitor ACR-368 in endometrial cancer during a company-sponsored key opinion leader panel held at the ESGO Congress. The trial uses the ACR-368 OncoSignature biomarker to prospectively select patients predicted to benefit.
In the biomarker-positive Arm 1, ACR-368 monotherapy showed an objective response rate of 39% (95% CI, 24–56) in 31 treated subjects, with disease control rate of 80.6% and 16‑week clinical benefit rate of 61.3%. Across arms, better response rates were observed in patients with ≤2 prior lines of therapy, including serous and non‑serous histologies.
Safety data showed mainly hematologic adverse events such as thrombocytopenia, anemia, leukopenia and neutropenia, with no fatal treatment-related events and a notable absence of common non‑hematologic toxicities. The study is expanding to additional U.S. and European sites, with enrollment completion for the serous all‑comer cohort targeted in Q4 2026.
Acrivon Therapeutics, Inc. reported that it hosted a corporate webcast and conference call on January 8, 2026, featuring a presentation by its leadership team and an interactive Q&A session. In connection with this event, the company posted a presentation on its investor relations website titled the January 8, 2026 Data Update. This presentation includes clinical data and program updates for the ACR-368 program as well as initial clinical data for ACR-2316.
The same January 8, 2026 Data Update has been furnished as Exhibit 99.1 to this report under a Regulation FD disclosure item, and is expressly not deemed filed for liability purposes under the Exchange Act unless later specifically incorporated by reference.
Acrivon Therapeutics reported preliminary unaudited cash, cash equivalents and investments of about $119 million as of December 31, 2025, which it currently expects will fund operations into the second quarter of 2027. This extends its financial runway as it advances multiple oncology programs.
The company highlighted updated Phase 2b data for ACR-368 in endometrial cancer, with an overall response rate of 39% in one trial arm and higher confirmed response rates in serous endometrial cancer, guiding a focus on this subgroup and expansion of Arm 3 into the EU with up to 90 subjects. Initial Phase 1 results for ACR-2316 showed tolerability and tumor shrinkage, including a confirmed partial response in endometrial cancer and unconfirmed responses in small cell and squamous non-small cell lung cancers.
Acrivon also nominated ACR-6840, a CDK11 inhibitor, as its next development candidate and outlined milestones through 2026, including Phase 2 updates and Phase 3 readiness for ACR-368, further ACR-2316 data and dose expansion, an IND submission for ACR-6840, and additional AP3-driven programs.
Acrivon Therapeutics, Inc. furnished an 8‑K announcing it issued a press release covering financial results for the quarter ended September 30, 2025, and business updates. The press release is included as Exhibit 99.1 dated November 13, 2025.
The company states that the information in Item 2.02 and Exhibit 99.1 is furnished and not deemed “filed” under Section 18 of the Exchange Act, nor incorporated by reference into other SEC filings.
Acrivon Therapeutics, Inc. furnished a corporate presentation on its website, providing an update on its business and research programs. The presentation includes new syngeneic mouse model data showing continued strong synergy between its clinical candidates ACR-368 and ACR-2316 and immune checkpoint inhibitors. After multiple rounds of tumor implantation over almost one year, the models showed complete tumor regression and evidence of immune memory, and the company further analyzed which immune cell types drive this effect. These results support the rationale for potential combinations of ACR-368 and ACR-2316 with anti-PD(L)1 agents in the front line setting. The company also updated its pipeline overview to include the all-comer ACR-368 + ULDG ARM 3 of the ongoing ACR-368-201 trial and expanded information on its Generative Phosphoproteomics AP3 platform. The presentation is attached as Exhibit 99.1.