Actuate Therapeutics, Inc. develops oncology therapies centered on elraglusib, a small-molecule inhibitor of glycogen synthase kinase-3 beta (GSK-3β) for difficult-to-treat cancers. Company news commonly covers clinical data in metastatic pancreatic ductal adenocarcinoma, development of intravenous and oral tablet formulations, FDA clearance of an IND for oral elraglusib, and research combinations with RAS-targeted therapies.
Updates also include scientific publications, conference presentations, and governance changes as Actuate advances elraglusib across cancer indications including pancreatic cancer, melanoma, colorectal cancer, and sarcoma.
Actuate Therapeutics (ACTU) will deliver a corporate presentation at the H.C. Wainwright 28th Annual Global Investment Conference in New York City on Monday, September 14, 2026, at 4:00 PM ET.
The company’s management will also be available for one-on-one meetings during the September 14–16, 2026 event, and a webcast of the presentation will be accessible via the Investor section of Actuate’s website.
Actuate Therapeutics (ACTU) reported new preclinical data showing that its GSK‑3β inhibitor elraglusib has synergistic activity with two RAS‑targeted agents, zoldonrasib (G12D‑selective) and daraxonrasib (multi‑selective), in pancreatic ductal adenocarcinoma (PDAC) models.
In murine KPC and human patient‑derived xenograft pancreatic cancer cell lines, adding elraglusib to zoldonrasib reduced tumor‑cell growth beyond zoldonrasib alone across all models tested. Elraglusib combined with daraxonrasib also showed enhanced anti‑cancer activity versus either agent alone, suggesting elraglusib’s effect extends across distinct RAS inhibitors.
In FOLFIRINOX‑resistant murine and human PDAC models, elraglusib plus zoldonrasib produced greater reductions in tumor‑cell viability than single agents. Additional preclinical and planned clinical combination studies are ongoing, with results to be presented at future medical conferences.
Actuate Therapeutics (NASDAQ: ACTU) announced that its GSK-3β inhibitor elraglusib was selected for evaluation in the European BEACON2 multi-arm, multi-stage Phase 1/2 trial for relapsed and refractory pediatric neuroblastoma. The regimen combines elraglusib with dinutuximab beta plus chemotherapy and includes an initial dose-confirmation cohort of up to 20 patients, with potential expansion to a randomized stage enrolling about 75 patients.
Rationale includes preclinical data where 60% of Th-MYCN mice receiving elraglusib plus TEMIRI/14G2a remained tumor-free at one year versus 0% for TEMIRI/14G2a alone, a complete bone marrow response in a heavily pretreated neuroblastoma patient, and FDA Rare Pediatric Disease designation for neuroblastoma.
Actuate Therapeutics (NASDAQ: ACTU) reported Phase 2 clinical and biomarker data for elraglusib in first-line metastatic pancreatic cancer at ASCO 2026.
Elraglusib plus gemcitabine/nab-paclitaxel improved median overall survival in several wild-type genomic subgroups and in landmark analyses, while elraglusib plus FOLFIRINOX showed longer survival and was generally well tolerated.
Actuate Therapeutics (NASDAQ: ACTU) announced FDA clearance of an IND for a Phase 1/2 trial of oral elraglusib in advanced solid tumors, with initiation planned for 2H 2026. The company is transitioning from IV to oral dosing, supported by Phase 2 mPDAC data showing exposure–outcome correlation and overall survival improvement. Actuate obtained EMA guidance for a potential single registration study and plans further regulatory interactions on an oral tablet design. Preclinical combination work with RAS inhibitors is ongoing, with data updates expected mid‑2026. Industry veteran Martin Huber, MD, has joined the board.
Actuate Therapeutics (NASDAQ: ACTU) announced the appointment of Martin Huber, MD, as an Independent Director effective May 6, 2026. Dr. Huber brings oncology drug development, regulatory strategy, and commercialization experience, including leadership at Mersana and contributions to approvals for multiple oncology medicines.
The appointment is presented as strengthening governance as Actuate advances elraglusib toward registration studies and potential commercialization across difficult-to-treat cancer indications, with specific mention of recent metastatic pancreatic cancer results.
Actuate Therapeutics (NASDAQ: ACTU) reported Nature Medicine publication of randomized Phase 2 results showing elraglusib plus gemcitabine/nab-paclitaxel improved median overall survival to 10.1 months versus 7.2 months with chemotherapy alone (HR 0.62; p=0.01).
One-year survival doubled to 44.1% vs 22.3%; exploratory biomarker data showed 7–40X increases in tumor-infiltrating cytotoxic immune cells. Safety was generally manageable; most common ≥Grade 3 events included neutropenia, anemia, and fatigue.
Actuate Therapeutics (NASDAQ: ACTU) launched an expanded research initiative to evaluate elraglusib, a selective GSK-3β inhibitor, in combination with emerging RAS-targeted therapies.
Key points: elraglusib has been given to >500 patients, is in a Phase 2 metastatic pancreatic cancer trial, and initial combination data are expected in Q2 2026 with additional preclinical results in 2H 2026.
Actuate Therapeutics (NASDAQ: ACTU) announced that Dan Schmitt, President & CEO, will present at the Citizens Life Sciences Conference in Miami Beach on March 10, 2026 at 8:25 a.m. ET. The presentation will be webcast and available live under "Events" in Investors at the company website.
A replay will be available on Actuate's website for 30 days after the presentation, and management will hold one-on-one meetings with registered attendees.
Actuate Therapeutics (NASDAQ: ACTU) announced that President & CEO Dan Schmitt will present at the Oppenheimer 36th Annual Healthcare Life Sciences conference on February 26, 2026 at 9:20 a.m. ET.
The presentation will be webcast and posted under Events in the Investors section of the company website, and a replay will be available on the company website for 30 days following the presentation. Management will hold one-on-one investor meetings at the conference.