Actuate Therapeutics Announces Pediatric Cancer Trial Results
Actuate Therapeutics announced results from the phase 1 portion of its phase 1/2 clinical study evaluating elraglusib as a monotherapy or in combination with irinotecan, irinotecan plus temozolomide, or with cyclophosphamide plus topotecan in pediatric patients with refractory malignancies. The Actuate-1902 trial was an open-label, multicenter phase 1/2 study evaluating the safety and efficacy of elraglusib in 40 pediatric patients ages 3 - 21 with relapsed/refractory cancers, including Ewing sarcoma, neuroblastoma, Central Nervous System tumors, non-EWS sarcomas, and other refractory pediatric malignancies. Summary: Two Complete Metabolic Responses observed in patients with relapsed/refractory metastatic Ewing sarcoma and one Complete Response observed in a patient with relapsed/refractory metastatic neuroblastoma; Clinical responses and disease control observed in 15 of 40 patients with difficult-to-treat refractory pediatric cancers, including 10 of 19 patients treated with elraglusib plus cyclophosphamide/topotecan; Data support advancing clinical development of elraglusib in Ewing sarcoma and potentially neuroblastoma in 2026; Company has been granted Rare Pediatric Designations from the FDA for both indications
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Positive Study Results: Actuate Therapeutics reported favorable outcomes from a Phase II study of elraglusib combined with carboplatin or cisplatin for advanced metastatic salivary gland cancers, showing a median overall survival of 18.6 months.
Patient Demographics and Survival Rates: The study included 47% adenoid cystic carcinoma (ACC) and 53% non-ACC patients, with non-ACC patients experiencing a median overall survival of 27.8 months.
Progression-Free Survival: The median progression-free survival was 6.4 months, with only 27% of patients remaining progression-free at one year, contrasting with historical estimates for ACC and non-ACC.
Market Reaction: Following the announcement, Actuate shares increased by over 4% in pre-market trading, closing at $7.52, reflecting a 1.35% rise from the previous day.

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Public Offering Announcement: Actuate Therapeutics, Inc. has priced an underwritten public offering of 2,142,858 shares of common stock at $7.00 per share, aiming to raise approximately $15 million for working capital and corporate purposes.
Use of Proceeds: The company plans to utilize the net proceeds from the offering for general corporate needs, with the offering expected to close on September 11, 2025, pending customary closing conditions.
Company Focus: Actuate Therapeutics is a clinical-stage biopharmaceutical company developing therapies for challenging cancers, with its lead drug, elraglusib, targeting pathways that promote tumor growth and resistance to conventional treatments.
Forward-Looking Statements: The press release includes forward-looking statements regarding the offering's timing and completion, emphasizing the inherent risks and uncertainties that could affect actual results.

Analyst Ratings Updates: Top Wall Street analysts have revised their outlooks on several companies, with a focus on upgrades and new coverage initiations.
Actuate Therapeutics Coverage: B. Riley Securities analyst Mayank Mamtani initiated coverage on Actuate Therapeutics (ACTU) with a Buy rating and a price target of $20, while the stock closed at $7.98.
Gyre Therapeutics Coverage: HC Wainwright & Co. analyst Matthew Keller also initiated coverage on Gyre Therapeutics (GYRE) with a Buy rating and a price target of $18, closing at $8.18.
CareDx Coverage: William Blair analyst Andrew Brackmann started coverage on CareDx (CDNA) with a Market Perform rating, with shares closing at $12.75.

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Clinical Trial Announcement: Actuate Therapeutics has initiated a Phase 1b clinical trial at UPMC Hillman Cancer Center to evaluate the combination of elraglusib, retifanlimab, and modified FOLFIRINOX as a frontline therapy for advanced pancreatic adenocarcinoma, aiming to determine the recommended phase 2 dose and assess efficacy and safety.
Potential Benefits of Elraglusib: Previous studies have shown that elraglusib can enhance immune responses in cancer treatment, demonstrating significant improvements in overall survival rates when combined with other therapies, suggesting its potential as a novel approach in treating difficult cancers like pancreatic adenocarcinoma.




