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. (NASDAQ: ACTU) is a clinical-stage biopharmaceutical company developing elraglusib, a small-molecule inhibitor of glycogen synthase kinase-3 beta (GSK-3β), for high-impact, difficult-to-treat cancers. The ACTU news feed on Stock Titan aggregates company press releases and other coverage so readers can follow how Actuate’s oncology programs evolve over time.
Recent news from Actuate emphasizes clinical data for elraglusib across multiple tumor types. The company has reported that its randomized Phase 2 Actuate-1801 Part 3B trial in first-line metastatic pancreatic ductal adenocarcinoma met its primary endpoint, with a statistically significant overall survival benefit for elraglusib plus gemcitabine/nab-paclitaxel compared with chemotherapy alone. Additional updates describe immune and genomic biomarker findings that may help explain responses and guide future studies.
News items also highlight elraglusib’s activity in other settings, including a Phase II trial in recurrent, metastatic salivary gland carcinoma and the Actuate-1902 Phase 1/2 study in refractory pediatric cancers such as Ewing sarcoma and neuroblastoma. Actuate has announced complete and partial responses, durable stable disease, and biomarker associations that support further development in these rare and challenging indications.
Beyond clinical results, ACTU news covers corporate and regulatory milestones, such as public and private financings, registration statements, and collaborations. Examples include a securities purchase agreement for common stock and warrants, an underwritten public offering of common stock, and a collaboration with Incyte Corporation and UPMC Hillman Cancer Center to evaluate elraglusib with retifanlimab and modified FOLFIRINOX in advanced pancreatic cancer.
Investors and followers of biotechnology and oncology can use the Actuate Therapeutics news page to monitor trial readouts, regulatory plans, financing transactions, and partnership updates related to the company’s GSK-3β–targeted cancer programs.
Actuate Therapeutics (NASDAQ:ACTU) reported encouraging pediatric and formulation progress for elraglusib, a selective GSK-3β inhibitor, including phase 1 pediatric responses and an oral formulation with ~51% bioavailability versus IV.
Key catalysts: pediatric complete responses supporting Ewing sarcoma and neuroblastoma development, eligibility for a Rare Pediatric Disease Priority Review Voucher, planned adult oral and RAS-combination programs, and potential PRV monetization worth $150–$205M based on recent market transactions.
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.
Actuate Therapeutics (NASDAQ: ACTU) announced a planned Phase 1/2 clinical program to evaluate an oral tablet formulation of elraglusib in advanced cancers, with Phase 1 initiation planned in 2H 2026. The Phase 1 portion will determine MTD/MAD, DLTs, PK, and preliminary anti‑tumor activity to establish a recommended dose for Phase 2 expansion. Phase 2 will evaluate elraglusib in refractory metastatic melanoma and select solid tumor and hematologic indications. Prior IV data (Phase 1, n=67; 11 CPI‑refractory melanoma) showed disease control ≥12 weeks in 5 of 10 evaluable melanoma patients, median overall survival of 9.9 months, and one ongoing complete response exceeding 6 years.
Actuate Therapeutics (NASDAQ: ACTU) reported Phase 2 randomized data showing elraglusib plus gemcitabine/nab-paclitaxel (GnP) met the primary endpoint in previously untreated metastatic pancreatic cancer. The combination reduced risk of death by 38% (HR=0.62) and improved median overall survival to 10.1 months vs 7.2 months for GnP alone (p=0.02). Twelve-month survival rose to 44.4% vs 22.3% and 24-month survival to 12.9% vs 2.6%. Safety was consistent with prior data; no new safety signals at the 9.3 mg/kg dose were identified. Biomarker analyses identified genomic and immune changes associated with benefit. Results were presented at ASCO GI on January 9, 2026.
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.