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) announced significant topline results from its Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial met its primary endpoints, demonstrating statistically significant improvement in overall survival and one-year survival rates compared to GnP control arm.
The elraglusib/GnP combination showed a substantial improvement in median overall survival since December 2024's analysis, with a favorable risk-benefit profile. The complete topline dataset will be presented at the ASCO Annual Meeting on May 31, 2025. The company plans to engage with US and EU regulators in H2 2025 to advance elraglusib towards NDA and registration.
This development represents the first major advance in first-line treatment survival for metastatic pancreatic cancer in over a decade.Actuate Therapeutics (NASDAQ: ACTU), a clinical-stage biopharmaceutical company, has announced its participation in the upcoming Citizens Life Sciences Conference 2025. The event will take place on May 7-8 in New York, NY.
Daniel Schmitt, President & CEO of Actuate, will deliver a presentation on Thursday, May 8, 2025, at 12:30 PM ET. The company, which specializes in developing treatments for difficult-to-treat cancers through GSK-3β inhibition, will make the presentation webcast available in their Investor section.
The management team will also conduct one-on-one meetings with investors during the conference. Interested investors should coordinate with their Citizens JMP representatives to schedule meetings.
Actuate Therapeutics (NASDAQ: ACTU) has announced that topline data from its Phase 2 study of elraglusib will be presented at the 2025 ASCO Annual Meeting. The presentation will focus on results from the Actuate-1801 Part 3B trial, which evaluated elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC).
The oral presentation, scheduled for May 31, 2025, at 3:00 PM CDT, will be part of the Gastrointestinal Cancer session at the conference taking place in Chicago from May 30 to June 3. The study represents a significant milestone in the company's development of therapies targeting GSK-3β inhibition for difficult-to-treat cancers.
Actuate Therapeutics (NASDAQ: ACTU) will present significant data on their cancer drug elraglusib at the AACR Annual Meeting 2025 in Chicago from April 25-30. The presentation focuses on elraglusib's effectiveness in treating advanced salivary gland carcinoma when combined with chemotherapy and immunotherapy.
The first poster presentation (CT212) on April 29 will showcase elraglusib's performance as a GSK-3β inhibitor in advanced salivary cancers. Dr. Glenn Hanna from Dana Farber Cancer Institute reported encouraging response rates in non-Adenoid Cystic Carcinoma patients with nuclear GSK-3β overexpression.
Additionally, researchers from Brown University's Legorreta Cancer Center will present findings on April 28 demonstrating elraglusib's synergistic effects when combined with Jazz Pharmaceuticals' investigational compounds ONC206 and ONC212 for solid cancer treatment.
Lantern Pharma (NASDAQ: LTRN) reported its Q4 and full-year 2024 results, highlighting significant progress in its AI-driven oncology drug development programs. The HARMONIC™ trial for LP-300 showed an impressive 86% clinical benefit rate and 43% objective response rate in never-smoker NSCLC patients, with expansion in Japan and Taiwan. LP-184 received two FDA Fast Track Designations for Glioblastoma and Triple Negative Breast Cancer, plus three Rare Pediatric Disease Designations.
The company's RADR® AI platform surpassed 100 billion oncology-specific data points in 2024. Financial results showed cash position of $24.0 million as of December 31, 2024. Q4 net loss was $5.9 million ($0.54 per share), compared to $4.2 million ($0.39 per share) in Q4 2023. Full-year 2024 net loss per share was $1.93 versus $1.47 in 2023.
Actuate Therapeutics (NASDAQ: ACTU) announced the completion of patient enrollment in its Phase 2 trial of elraglusib combined with FOLFIRINOX and losartan for untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial, led by Dr. Colin Weekes at Massachusetts General Hospital and supported by the Lustgarten Foundation, enrolled 56 treatment-naïve mPDAC patients. Initial data presented at the AACR Special Conference in September 2024 showed early evidence of enhanced clinical activity. The primary objectives are to assess safety, tolerability, and progression-free survival. Final results are expected in 2026.
CEO Daniel Schmitt highlighted the milestone and noted the potential of elraglusib, citing interim Phase 2 data showing statistically significant improvements in 1-year and median overall survival when combined with gemcitabine/nab-paclitaxel (GnP). The trial involves additional sites, including The University of Colorado and the University of Washington’s Fred Hutchinson Cancer Center. Dr. Weekes expressed optimism about the trial's potential to improve treatment options for mPDAC patients.
Actuate Therapeutics (NASDAQ: ACTU), a clinical-stage biopharmaceutical company specializing in cancer therapies through GSK-3β inhibition, has announced its participation in two major investor conferences in February 2025.
The company's President & CEO, Daniel Schmitt, will attend the BIO CEO & Investor Conference on February 10, 2025, in New York, participating in the 'IPO Class of 2024 Panel' and offering one-on-one meetings with registered attendees.
Additionally, Actuate will be present at the B. Riley Precision Oncology & Radiopharma Conference on February 28, 2025, also in New York, where management will participate in a fireside chat and hold one-on-one meetings arranged through B. Riley representatives.
Actuate Therapeutics (NASDAQ: ACTU) has received European Medicines Agency (EMA) Orphan Medicinal Product Designation for elraglusib in treating pancreatic ductal adenocarcinoma (PDAC). This designation follows a similar FDA Orphan Drug Designation and recent positive interim Phase 2 trial results.
The interim analysis of the Phase 2 trial showed that elraglusib, combined with gemcitabine/nab-paclitaxel (GnP), demonstrated statistically significant improvements in both 1-year survival rate (p=0.002) and median overall survival (hazard ratio 0.63, p=0.016) compared to GnP alone in metastatic PDAC patients.
The EMA designation, granted for conditions affecting fewer than 2 in 10,000 EU residents, provides benefits including potential 10-year market exclusivity, reduced regulatory fees, and centralized EU approval process. The company expects to report topline Phase 2 data in first half of 2025.