Actuate Therapeutics Inc Stock Price, News & Analysis

Actuate Therapeutics (NASDAQ:ACTU) has announced positive results from its Phase 1 trial evaluating elraglusib in pediatric patients with refractory malignancies. The study demonstrated remarkable outcomes in Ewing Sarcoma (EWS), with 2 out of 10 patients achieving complete responses and two additional patients showing stable disease.

The trial also reported a partial response in a patient with desmoplastic small-round-cell tumor (DSRCT). Based on these encouraging results, Actuate plans to advance to a Phase 2 trial in children, adolescents, and adults with relapsed/refractory EWS, expected to initiate in 2026, subject to funding.

Elraglusib, which targets glycogen synthase kinase-3 beta (GSK-3β), could potentially become a first-in-class therapy for EWS, where no approved targeted therapies currently exist.

Actuate Therapeutics (NASDAQ: ACTU) reported significant results from its Phase 2 trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) for metastatic pancreatic cancer treatment. Patients receiving at least one cycle showed improved median overall survival of 12.5 months vs 8.5 months in the control group, with a 43% reduction in death risk.

The trial demonstrated enhanced outcomes with elraglusib/GnP combination, including disease control rate of 53.4% vs 44.8% and overall response rate of 37.9% vs 29.3%. Notably, patients with liver metastases experienced a 2.5-fold increase in 1-year overall survival and 38% reduced death risk compared to control, with 13.6% survival probability at 18 months versus 0% in the control group.

Actuate Therapeutics (NASDAQ: ACTU) presented positive biomarker data from their Phase 2 trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) for first-line metastatic pancreatic cancer treatment at ASCO. The study used machine learning to analyze 40 pre-treatment plasma biomarkers, identifying 7 significant predictors of favorable survival in elraglusib-treated patients. Notably, CXCL2 emerged as a key biomarker, showing reversed survival trends compared to the control arm. High levels of CXCL2 and TRAIL, along with low levels of CCL3, IL-1α, IL-18, TGF-β, and TRAIL R3, were associated with improved overall survival. The findings suggest elraglusib's potential to enhance immune response mechanisms and its immunomodulatory effects on various immune system components.

Actuate Therapeutics (NASDAQ: ACTU) announced its inclusion in the Russell 3000® and Russell 2000® Indexes, effective June 27, 2025, following its IPO last year. The Russell 3000® Index tracks the top 3,000 U.S. public companies, while the Russell 2000® focuses on small-cap stocks. The inclusion comes after positive Phase 2 trial results for their lead candidate elraglusib in metastatic pancreatic ductal adenocarcinoma (mPDAC), which showed significant improvement in median overall survival (10.1 months vs 7.2 months, p=0.01) with a 37% reduction in death risk. Approximately $10.6 trillion in assets are benchmarked against Russell U.S. Indexes as of May 2025, making this inclusion a significant milestone for Actuate's visibility in the investment community.

Actuate Therapeutics (NASDAQ: ACTU) announced positive Phase 2 trial results for elraglusib combined with gemcitabine/nab-paclitaxel (GnP) in treating metastatic pancreatic cancer. The trial met its primary endpoint with significant survival improvements: median overall survival increased to 10.1 months vs 7.2 months (p=0.01), and 12-month survival rate doubled to 44.1% vs 22.3%. The drug showed continued benefits at 18 and 24 months, with survival rates of 19.7% vs 4.4% and 13.8% vs 0% respectively. The treatment demonstrated a favorable safety profile, with mostly Grade 1-2 adverse events, primarily including reversible visual impairments. The study also showed improved response rates (29.0% vs 21.8%) and progression-free survival (5.6 vs 5.1 months). Key opinion leaders emphasized the significance of these results, highlighting elraglusib's potential to reshape metastatic pancreatic cancer treatment through its unique immune-modulating mechanism.

Actuate Therapeutics (NASDAQ: ACTU) announced positive Phase 2 trial results for elraglusib in treating metastatic pancreatic cancer, presented at ASCO 2025. The trial met its primary endpoint, showing significant improvement in median overall survival (10.1 months vs 7.2 months) when elraglusib was combined with standard chemotherapy (GnP). The treatment reduced death risk by 37% and doubled the 1-year survival rate to 44.1% compared to 22.3% with GnP alone. The drug demonstrated a manageable safety profile with mostly Grade 1-2 adverse events. Biomarker analysis confirmed the drug's immune-modulating mechanism. Based on these promising results, Actuate plans to engage with FDA and EMA in H2 2025 to discuss registration pathway.

Actuate Therapeutics (NASDAQ: ACTU) has announced positive Phase 2 trial results for elraglusib in treating metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial, involving 286 patients, demonstrated that the combination of elraglusib with gemcitabine/nab-paclitaxel (GnP) achieved statistically significant improvements in median overall survival and 1-year survival rates compared to GnP alone. The study also showed increased Objective Response Rates and Disease Control Rates. The detailed findings will be presented at the 2025 ASCO Annual Meeting on May 31, 2025, by Dr. Devalingam Mahalingam of Northwestern University. The company will host a KOL event featuring distinguished experts to discuss the results. Elraglusib, administered at 9.3 mg/kg by IV infusion, works by inhibiting GSK-3β to potentially enhance chemotherapy activity and activate anti-tumor immunity.

Actuate Therapeutics (NASDAQ: ACTU) announced a key opinion leader (KOL) event to discuss topline Phase 2 clinical data for elraglusib in metastatic pancreatic ductal adenocarcinoma (mPDAC). The event, scheduled for May 31, 2025, will feature a fireside discussion with distinguished experts from leading medical institutions. The Phase 2 study (Actuate-1801 Part 3B) involved 286 mPDAC patients randomized 2:1 to receive either elraglusib with gemcitabine/nab-paclitaxel (GnP) or GnP alone. The trial's primary endpoint is 1-year survival rate, with median overall survival as the primary parameter. Elraglusib, administered at 9.3 mg/kg by IV infusion, works by inhibiting GSK-3β to potentially enhance chemotherapy activity and activate anti-tumor immunity.

Actuate Therapeutics (NASDAQ: ACTU) announced significant topline results from its Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial met its primary endpoints, demonstrating statistically significant improvement in overall survival and one-year survival rates compared to GnP control arm.

The elraglusib/GnP combination showed a substantial improvement in median overall survival since December 2024's analysis, with a favorable risk-benefit profile. The complete topline dataset will be presented at the ASCO Annual Meeting on May 31, 2025. The company plans to engage with US and EU regulators in H2 2025 to advance elraglusib towards NDA and registration.

This development represents the first major advance in first-line treatment survival for metastatic pancreatic cancer in over a decade.