Welcome to our dedicated page for Actuate Therapeutics news (Ticker: ACTU), a resource for investors and traders seeking the latest updates and insights on Actuate Therapeutics stock.
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 (NASDAQ: ACTU) reported Phase 1 results from the Actuate-1902 study of elraglusib in 40 pediatric patients (ages 3–21) with relapsed/refractory cancers on Jan 6, 2026. Clinical responses or disease control were observed in 15 of 40 patients, including 10 of 19 treated with elraglusib plus cyclophosphamide/topotecan.
Notable outcomes include two Complete Metabolic Responses (CMRs) in relapsed/refractory Ewing sarcoma, one Complete Response (CR) in metastatic neuroblastoma, a 60% tumor reduction in a lung lesion, and additional partial responses and prolonged stable disease. The company received Rare Pediatric Designations from FDA for Ewing sarcoma and neuroblastoma and plans to advance development in 2026.
Actuate Therapeutics (NASDAQ: ACTU) announced that Phase 2 data for elraglusib in metastatic pancreatic cancer were selected for an oral and a poster presentation at the ASCO GI Cancers Symposium, Jan 8–10, 2026 in San Francisco.
The oral presentation (Abstract 653) reports results from the randomized Phase 2 1801 Part 3B study of elraglusib plus gemcitabine/nab-paclitaxel (GnP) versus GnP in previously untreated metastatic pancreatic ductal adenocarcinoma and is scheduled for Jan 9, 2026 at 4:15 PM PST (Rapid Oral Abstract Session B).
The poster (Abstract 761, Board L5) covers mutational analysis and potential biomarkers from the same study and is scheduled for Jan 9, 2026 during Poster Session B; first authors are Devalingam Mahalingam, MD, PhD (oral) and Andrey Ugolkov, MD, PhD (poster).
Actuate Therapeutics (NASDAQ: ACTU) published Phase II data (NCT05010629) reporting elraglusib combined with platinum chemotherapy ± sequential pembrolizumab in 32 patients with recurrent, metastatic salivary gland carcinoma.
Key results: median overall survival (OS) 18.6 months (95% CI 9.7–29.4), median progression-free survival (PFS) 6.4 months (95% CI 2.3–8.8), 40% alive at 2 years, and non-ACC median OS 27.8 months. Nuclear GSK-3β expression was markedly higher in responders (50% vs. 2%) and associated with longer PFS. Three partial responses occurred (all non-ACC); median duration of response was 6.9 months. The regimen was tolerable with 6% discontinuation due to toxicity and no treatment-related deaths.
Actuate Therapeutics (NASDAQ: ACTU) has updated its IND application with the FDA, including new clinical data from its Phase 2 trial of elraglusib in first-line metastatic pancreatic cancer treatment. The trial demonstrated statistically significant improvement in median overall survival when combining elraglusib with gemcitabine/nab-paclitaxel (GnP) versus GnP alone.
The ongoing Phase 2 study shows promising durability, with 22 patients in the combination arm remaining active for 20-42 months, compared to only 3 patients in the control arm at 21-23 months. The company plans regulatory submissions to FDA and EMA through early 2026, supported by its recent $17.25 million public offering which extends its runway through H2 2026.
Actuate Therapeutics (NASDAQ: ACTU), a clinical-stage biopharmaceutical company focused on cancer therapies, has successfully closed a $17.25 million public offering of common stock. The offering included 2,464,286 shares at $7.00 per share, with the full exercise of the over-allotment option adding 321,428 shares.
The company plans to use the net proceeds of $15.62 million for working capital and general corporate purposes. Lucid Capital Markets served as the sole book-running manager, while Titan Partners Group acted as financial advisor for the offering.
Actuate Therapeutics (NASDAQ: ACTU), a clinical-stage biopharmaceutical company focused on cancer therapies through GSK-3β inhibition, has announced the pricing of its public offering of 2,142,858 shares at $7.00 per share.
The offering, expected to close on September 11, 2025, aims to raise $15.0 million in gross proceeds. The company has granted underwriters a 30-day option to purchase up to 321,428 additional shares. Lucid Capital Markets is serving as the sole book-running manager, with Titan Partners Group acting as financial advisor.
The proceeds will be used for working capital and general corporate purposes. The offering is being made pursuant to an effective shelf registration statement on Form S-3.
Actuate Therapeutics (NASDAQ: ACTU), a clinical-stage biopharmaceutical company developing cancer therapies through GSK-3β inhibition, has announced a proposed public offering of common stock. The company plans to grant underwriters a 30-day option to purchase an additional 15% of shares at the public offering price, less underwriting discounts.
The offering, managed by Lucid Capital Markets as sole book-running manager, will be conducted under an effective S-3 shelf registration. Proceeds will be used for working capital and general corporate purposes. The completion and terms of the offering are subject to market conditions.
Actuate Therapeutics (NASDAQ: ACTU) has announced the initiation of a Phase 1b trial studying the combination of its drug elraglusib with Incyte's PD-1 inhibitor retifanlimab and mFOLFIRINOX as a frontline therapy for advanced pancreatic cancer. The trial, named RiLEY (NCT06896188), will be conducted at UPMC Hillman Cancer Center.
The study will initially enroll up to 12 patients with advanced pancreatic adenocarcinoma, with potential for expansion based on interim results. In a recent Phase 2 study, elraglusib combined with gemcitabine/nab-paclitaxel showed promising results, including a 37% reduction in death risk and doubled 12-month survival rate in metastatic pancreatic cancer patients.
The collaboration between Actuate, UPMC Hillman Cancer Center, and Incyte aims to explore synergistic opportunities in treatment-naïve patients, building on elraglusib's demonstrated immune-modulating properties.
Actuate Therapeutics (NASDAQ:ACTU) has announced positive results from its Phase 1 trial evaluating elraglusib in pediatric patients with refractory malignancies. The study demonstrated remarkable outcomes in Ewing Sarcoma (EWS), with 2 out of 10 patients achieving complete responses and two additional patients showing stable disease.
The trial also reported a partial response in a patient with desmoplastic small-round-cell tumor (DSRCT). Based on these encouraging results, Actuate plans to advance to a Phase 2 trial in children, adolescents, and adults with relapsed/refractory EWS, expected to initiate in 2026, subject to funding.
Elraglusib, which targets glycogen synthase kinase-3 beta (GSK-3β), could potentially become a first-in-class therapy for EWS, where no approved targeted therapies currently exist.
Actuate Therapeutics (NASDAQ: ACTU) reported significant results from its Phase 2 trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) for metastatic pancreatic cancer treatment. Patients receiving at least one cycle showed improved median overall survival of 12.5 months vs 8.5 months in the control group, with a 43% reduction in death risk.
The trial demonstrated enhanced outcomes with elraglusib/GnP combination, including disease control rate of 53.4% vs 44.8% and overall response rate of 37.9% vs 29.3%. Notably, patients with liver metastases experienced a 2.5-fold increase in 1-year overall survival and 38% reduced death risk compared to control, with 13.6% survival probability at 18 months versus 0% in the control group.