Actuate Therapeutics Stock Rises After Updating FDA Application For Lead Investigational Drug In Treating Pancreatic Cancer

2025-09-22 03:16:10

(MENAFN- AsiaNet News)

Actuate Therapeutics, Inc. (ACTU) announced on Monday that it has amended its application to the U.S. Food and Drug Administration (FDA) for its lead investigational drug Elraglusib in the treatment of pancreatic cancer.

The company stated that it has amended the investigational new drug (IND) application with updated clinical data from its ongoing international mid-stage trial of the drug in the first-line treatment of metastatic pancreatic cancer. The study showed a statistically significant improvement in median overall survival with the combination arm of Elraglusib plus Gemcitabine/nab-paclitaxel (GnP) versus GnP alone, in addition to a 37% reduction in the risk of death.

The data is intended to support planned regulatory submissions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) beginning later this year and continuing into early 2026, the company said. It also added that the data strengthens the case for Elraglusib as a back-bone therapy that can be combined with different regimens used to treat pancreatic cancer.

The company is currently studying Elraglusib in pancreatic cancer with three ongoing trials in combination with current standards of care and novel immunotherapies.

ACTU shares traded 6% higher at the time of writing. On Stocktwits, retail sentiment around ACTU jumped from 'bearish' to 'neutral' territory over the past 24 hours, while message volume stayed at 'normal' levels.

ACTU's Sentiment Meter and Message Volume as of 11:15 a.m. ET on Sept. 22, 2025 | Source: Stocktwits

Actuate also stated that its recent $17.25 million public offering provides an extended runway into the second half of 2026.

“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 CEO Daniel Schmitt.

ACTU stock is down by 11% this year but up by 6% over the past 12 months.

Read also: Tesla Stock Rallies After Piper Sandler Hikes Price Target – More Details Inside

For updates and corrections, email newsroom[at]stocktwits[dot]com.

MENAFN22092025007385015968ID1110095964

Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.