Actuate announces corporate update on regulatory path for elraglusib

Actuate Therapeutics (ACTU) announced a corporate update on the regulatory path for elraglusib in pancreatic cancer and anticipated milestones enabled by the recent $17.25M public offering. Actuate has amended its investigational new drug application with updated clinical data from its international randomized Phase 2 trial in first-line treatment of metastatic pancreatic cancer, which showed a statistically significant improvement in median overall survival with the combination arm of elraglusib plus gemcitabine/nab-paclitaxel versus GnP alone. These data are intended to support planned regulatory submissions with the U.S. Food and Drug Administration and the European Medicines Agency beginning later this year and continuing into early 2026. The 1801-3B Phase 2 study is currently ongoing, with 22 patients in the elraglusib plus GnP arm either in active treatment or survival follow-up, ranging from 20 to 42 months in time on study, while only 3 patients remain in survival follow-up in the GnP arm, with time on study ranging from 21 to 23 months. These results of elraglusib in combination with GnP, combined with early data demonstrating significant and durable long term responses in patients with highly metastatic disease treated with the combination of elraglusib/FOLFIRINOX/losartan in the ongoing clinical trial in patients with mPDAC led by Havard/MGH, plus the new clinical collaboration with Incyte and UPMC Hillman Cancer Center in patients with advanced pancreatic cancer using the combination of modified FOLFIRINOX and Incyte’s anti-PD-1 retifanlimab, further strengthen the case for elraglusib as a back-bone therapy that can be combined with different regimens used to treat this highly aggressive and deadly disease.