Actuate Therapeutics Submits Updated Clinical Data Package To FDA For Planned Regulatory Talks With FDA And EMA In The Coming Months

Actuate Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing treatments for difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), has announced an important update on the regulatory path for its drug candidate elraglusib in pancreatic cancer. The announcement follows the company’s recent public offering of $17.25 million, which will help fund its development plans and anticipated milestones well into the second half of 2026.

The company has amended its investigational new drug (IND) application with new clinical data from its ongoing international randomized Phase 2 trial, Actuate-1801 Part 3B. This trial evaluates elraglusib in combination with the chemotherapy drugs gemcitabine and nab-paclitaxel (GnP) compared to GnP alone for the first-line treatment of metastatic pancreatic cancer. The updated data showed a statistically significant improvement in median overall survival for patients receiving the combination therapy compared to those receiving standard treatment. 

Actuate plans to use this data to begin regulatory submissions to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) later in 2025, continuing into early 2026. The Phase 2 study remains active. There are currently 22 patients in the elraglusib plus GnP group who are either still receiving treatment or are being monitored for survival, with time on study ranging from 20 to 42 months. In contrast, only three patients remain in survival follow-up in the GnP-only group, with study times ranging from 21 to 23 months.

Actuate also emphasized additional evidence supporting elraglusib’s potential. Early data from an ongoing clinical trial led by Harvard/Massachusetts General Hospital showed significant and durable long-term responses in patients with highly metastatic disease treated with elraglusib in combination with FOLFIRINOX and losartan. Furthermore, Actuate has entered a new clinical collaboration with Incyte and the UPMC Hillman Cancer Center to study elraglusib with modified FOLFIRINOX and Incyte’s anti-PD-1 therapy retifanlimab in advanced pancreatic cancer. These efforts indicate that elraglusib could serve as a backbone therapy capable of working with different treatment regimens for this aggressive and deadly disease.

Daniel Schmitt, President and Chief Executive Officer of Actuate, stated that the recent financing provides sufficient capital to support the company’s initiatives through mid-2026 and its planned interactions with regulatory authorities. He added that the observed survival benefits, combined with elraglusib’s mechanism of action and safety profile, make it a strong candidate for use alongside chemotherapy, immunotherapy, and potentially RAS inhibitors. Schmitt emphasized the importance of expanding treatment options for pancreatic cancer patients, noting that clinicians currently have limited tools to improve patient survival and quality of life.