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Actuate Therapeutics Inc Stock Price, News & Analysis

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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 (ACTU) delivers targeted therapies through its innovative GSK-3β inhibition platform, focusing on high-impact cancers with limited treatment options. This news hub provides investors and healthcare professionals with essential updates on clinical developments, regulatory progress, and strategic initiatives.

Access real-time information about elraglusib's clinical trials across multiple oncology indications, including pancreatic cancer and sarcoma. The page consolidates verified press releases covering trial phases, scientific collaborations, and mechanistic insights into the company's immune-oncology approach.

Key updates include progress reports on combination therapies, FDA communications, and preclinical research validating GSK-3β's role in tumor microenvironments. Content is curated to support informed analysis of the company's pipeline potential while maintaining compliance with financial disclosure standards.

Bookmark this resource for structured updates on Actuate's advancements in overcoming treatment resistance through molecular targeting. Regular visits ensure timely awareness of material developments affecting oncology research and therapeutic innovation.

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Actuate Therapeutics (NASDAQ: ACTU) announced positive Phase 2 trial results for elraglusib combined with gemcitabine/nab-paclitaxel (GnP) in treating metastatic pancreatic cancer. The trial met its primary endpoint with significant survival improvements: median overall survival increased to 10.1 months vs 7.2 months (p=0.01), and 12-month survival rate doubled to 44.1% vs 22.3%. The drug showed continued benefits at 18 and 24 months, with survival rates of 19.7% vs 4.4% and 13.8% vs 0% respectively. The treatment demonstrated a favorable safety profile, with mostly Grade 1-2 adverse events, primarily including reversible visual impairments. The study also showed improved response rates (29.0% vs 21.8%) and progression-free survival (5.6 vs 5.1 months). Key opinion leaders emphasized the significance of these results, highlighting elraglusib's potential to reshape metastatic pancreatic cancer treatment through its unique immune-modulating mechanism.
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Actuate Therapeutics (NASDAQ: ACTU) announced positive Phase 2 trial results for elraglusib in treating metastatic pancreatic cancer, presented at ASCO 2025. The trial met its primary endpoint, showing significant improvement in median overall survival (10.1 months vs 7.2 months) when elraglusib was combined with standard chemotherapy (GnP). The treatment reduced death risk by 37% and doubled the 1-year survival rate to 44.1% compared to 22.3% with GnP alone. The drug demonstrated a manageable safety profile with mostly Grade 1-2 adverse events. Biomarker analysis confirmed the drug's immune-modulating mechanism. Based on these promising results, Actuate plans to engage with FDA and EMA in H2 2025 to discuss registration pathway.
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Actuate Therapeutics (NASDAQ: ACTU) has announced positive Phase 2 trial results for elraglusib in treating metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial, involving 286 patients, demonstrated that the combination of elraglusib with gemcitabine/nab-paclitaxel (GnP) achieved statistically significant improvements in median overall survival and 1-year survival rates compared to GnP alone. The study also showed increased Objective Response Rates and Disease Control Rates. The detailed findings will be presented at the 2025 ASCO Annual Meeting on May 31, 2025, by Dr. Devalingam Mahalingam of Northwestern University. The company will host a KOL event featuring distinguished experts to discuss the results. Elraglusib, administered at 9.3 mg/kg by IV infusion, works by inhibiting GSK-3β to potentially enhance chemotherapy activity and activate anti-tumor immunity.
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Actuate Therapeutics (NASDAQ: ACTU) announced a key opinion leader (KOL) event to discuss topline Phase 2 clinical data for elraglusib in metastatic pancreatic ductal adenocarcinoma (mPDAC). The event, scheduled for May 31, 2025, will feature a fireside discussion with distinguished experts from leading medical institutions. The Phase 2 study (Actuate-1801 Part 3B) involved 286 mPDAC patients randomized 2:1 to receive either elraglusib with gemcitabine/nab-paclitaxel (GnP) or GnP alone. The trial's primary endpoint is 1-year survival rate, with median overall survival as the primary parameter. Elraglusib, administered at 9.3 mg/kg by IV infusion, works by inhibiting GSK-3β to potentially enhance chemotherapy activity and activate anti-tumor immunity.
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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.

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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.

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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of Actuate Therapeutics (ACTU)?

The current stock price of Actuate Therapeutics (ACTU) is $8.65 as of June 13, 2025.

What is the market cap of Actuate Therapeutics (ACTU)?

The market cap of Actuate Therapeutics (ACTU) is approximately 178.3M.
Actuate Therapeutics Inc

Nasdaq:ACTU

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ACTU Stock Data

178.34M
15.84M
18.69%
51.79%
0.4%
Biotechnology
Pharmaceutical Preparations
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