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 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) 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.