IND application amended with updated OS data from Ph 2 Actuate-1801 Part 3B trial of elraglusib + GnP versus GnP alone in 1L metastatic pancreatic cancer
“We are confident that our recently completed financing provides sufficient capital to support our corporate initiatives into the second half of 2026, and well through our upcoming anticipated interactions with the FDA and EMA. We have already updated the clinical data package on file with the FDA, and during the remainder of this year and into the first quarter of 2026, we expect to gain clarity on elraglusib’s regulatory path forward for the first-line treatment of metastatic PDAC,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “The survival benefit we’ve observed with elraglusib to date is compelling, and both its mechanism of action and safety profile support combination with chemotherapy, immunotherapy and potentially RAS inhibitors, increasing elraglusib’s potential as a backbone therapy, specifically in pancreatic cancers, where clinicians have limited options to extend and improve the lives of patients.”
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