Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
ACTU Catalyst Timeline
Dated clinical, regulatory and corporate events for Actuate Therapeutics, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Actuate Therapeutics, Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How ACTU actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-06-30 | elraglusib plus RAS inhibitor | Pre-clinical data readout | Pre-clinical |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 9-ING-41 Small moleculeCompletedNCT04218071 | Myelofibrosis | Phase 2 | COMPLETED | 17 | Jan 18, 2024 |
Clinical Trial Results
Readouts, endpoints and source filings for every ACTU program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| elraglusib OrphanRare Pediatric | high-risk pediatric neuroblastoma | Phase 1/2 | 2026-06-09 | Complete response in neuroblastoma patient achieved in Phase 1 study of elraglusib in refractory pediatric cancers; 60% of Th-MYCN mice treated with elraglusib plus temozolomide/irinotecan (TEMIRI)/14G2a, remained tumor-free at one year of age compared to 0% in the TEMIRI/14G2a only arm (P<0.0001)Read More | Actuate Therapeutics’ Elraglusib Selected for Evaluation in BEACON2 Trial for High-Risk Pediatric NeuroblastomaRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| SCHMITT DANIEL MDirector, Officer (President, CEO and Director) | Option | 272,056 422,237 held | $0.00 | 08/14/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in ACTU
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| PROSIGHT MANAGEMENT, LP | 0 % | 5.00 K | 885.00 |
ACTU Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How ACTU ranks across every disease it competes in
ACTU News
Actuate to Present at the H.C. Wainwright 28th Annual Global Investment Conference
Actuate Therapeutics, Inc. will present at the H.C. Wainwright 28th Annual Global Investment Conference from September 14-16, 2026, in New York City. The presentation is scheduled for September 14 at 4:00 PM ET. The company focuses on therapies for challenging cancers, with its lead drug elraglusib targeting key molecular pathways.
Read more →Actuate Announces Promising Preclinical Data Showing Synergistic Activity of Elraglusib in Combination with RAS Inhibitors Zoldonrasib and Daraxonrasib
Actuate Therapeutics announced promising preclinical data demonstrating the synergistic effects of elraglusib when combined with RAS inhibitors zoldonrasib and daraxonrasib in pancreatic cancer models. The studies, conducted in collaboration with Northwestern University and Mayo Clinic, showed enhanced tumor growth inhibition and potential for broader application in RAS-driven cancers. Further studies are planned for presentation at upcoming medical conferences.
Read more →Actuate Therapeutics’ Elraglusib Selected for Evaluation in BEACON2 Trial for High-Risk Pediatric Neuroblastoma
Actuate Therapeutics announced that elraglusib will be evaluated in the BEACON2 trial, targeting high-risk pediatric neuroblastoma. This Phase 1/2 trial will assess elraglusib in combination with dinutuximab beta and chemotherapy. The trial aims to confirm safety and establish dosing parameters, following promising results from earlier studies.
Read more →Actuate Therapeutics Announces ASCO Poster Presentations Demonstrating Compelling Clinical and Biomarker Data for Elraglusib in First-Line Metastatic Pancreatic Cancer
Actuate Therapeutics announced promising results from two studies presented at the 2026 ASCO Annual Meeting, highlighting the effectiveness of elraglusib in first-line treatment for metastatic pancreatic cancer. The data showed significant improvements in median overall survival for patients with KRAS and P53 wild-type genomics when elraglusib was used with established chemotherapy regimens like gemcitabine/Abraxane and FOLFIRINOX. The treatment was well tolerated, demonstrating a favorable safety profile. These findings suggest that elraglusib may serve as a differentiated therapy and contribute to improving outcomes in challenging cancer cases.
Read more →Actuate Therapeutics Announces FDA Clearance of IND for Oral Elraglusib and Strategic Initiatives to Advance the Elraglusib Development Program
Actuate Therapeutics has received FDA clearance for an Investigational New Drug application for its oral formulation of elraglusib, aimed at treating advanced cancers. The Phase 1/2 study will focus on patients with metastatic melanoma, NSCLC, colorectal, and pancreatic cancers, with initiation planned for the second half of 2026. The company is also exploring combination therapies with RAS inhibitors and has welcomed a new board member to enhance its strategic capabilities.
Read more →Actuate Therapeutics Announces Key Appointment of Industry Veteran to Board of Directors
Actuate Therapeutics has appointed Martin Huber, MD, as an Independent Director to its Board of Directors, effective immediately. Dr. Huber brings significant experience in oncology drug development, having previously held leadership roles at Mersana Therapeutics, Xilio Therapeutics, and TESARO. This strategic appointment is expected to strengthen Actuate's efforts in advancing their lead investigational drug, elraglusib, through various cancer indications. Elraglusib specifically targets a well-established pathway that may improve outcomes for patients with difficult-to-treat cancers.
Read more →Actuate Therapeutics Announces Nature Medicine Publication of Clinical Trial Results Showing Doubling of the Rate of Survival with Elraglusib Plus Chemotherapy in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Actuate Therapeutics announced promising results from a Phase 2 clinical trial of elraglusib combined with chemotherapy for metastatic pancreatic cancer. The study demonstrated a 40% increase in median overall survival and a one-year survival rate of 44% compared to 22% with standard treatment. The findings suggest elraglusib's potential as a first-line therapy, especially in high-risk patient groups.
Read more →Actuate Therapeutics Launches Strategic Research Initiative to Combine Elraglusib with RAS Inhibitors
Actuate Therapeutics has launched a strategic research initiative to evaluate the combination of its GSK-3β inhibitor elraglusib with RAS-targeted therapies. This initiative aims to enhance treatment efficacy for difficult-to-treat cancers, particularly pancreatic cancer. Initial preclinical results are anticipated in the second half of 2026, with the potential to improve clinical outcomes in RAS-driven cancers.
Read more →Actuate Therapeutics to Present at The Citizens Life Sciences Conference
Actuate Therapeutics, a clinical-stage biopharmaceutical company, will present at the Citizens Life Sciences Conference on March 10, 2026. CEO Dan Schmitt will discuss the company's focus on therapies for difficult-to-treat cancers, particularly their lead drug, elraglusib. The presentation will be available via webcast, and the management team will hold one-on-one meetings with attendees.
Read more →Actuate Therapeutics to Present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference
Actuate Therapeutics will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026. CEO Dan Schmitt will discuss the company's focus on therapies for challenging cancers, particularly their lead drug, elraglusib. The presentation will be available via webcast, and one-on-one meetings with investors are scheduled during the event.
Read more →Actuate Therapeutics Announces Plans to Expand Clinical Pipeline, Advancing Elraglusib Tablet into a Phase 1/2 Clinical Program in Refractory Cancers
Actuate Therapeutics announced plans to initiate a Phase 1/2 clinical program for elraglusib, an oral tablet aimed at treating refractory cancers. The Phase 1 trial will focus on determining the maximum tolerated dose and assessing preliminary anti-tumor activity. The Phase 2 portion will target specific indications, including refractory melanoma, building on previous encouraging results. The company aims to explore additional cancer indications with this formulation.
Read more →Actuate Therapeutics Reports Positive Follow-Up Data from its Randomized Controlled Phase 2 Trial Demonstrating Extended Long-Term Overall Survival Benefit with Elraglusib Plus Chemotherapy for Metastatic Pancreatic Cancer in Oral Presentation at ASCO GI 2026
Actuate Therapeutics has reported promising follow-up data from its Phase 2 trial of elraglusib combined with chemotherapy for metastatic pancreatic cancer. The study indicates that this combination may significantly improve overall survival compared to standard chemotherapy alone. The findings were presented at the ASCO GI 2026, highlighting the potential of elraglusib in addressing the high unmet medical need in this patient population.
Read more →Actuate Therapeutics Announces Positive Patient Outcomes from Phase 1 Trial in Difficult-to-Treat Refractory Pediatric Cancers
Actuate Therapeutics announced positive outcomes from its Phase 1 trial of elraglusib in pediatric cancers, showcasing significant clinical responses in patients with refractory Ewing sarcoma and neuroblastoma. Specifically, two complete metabolic responses and one complete response were observed among the participants. The results support the potential of elraglusib, both as a monotherapy and in combination therapies, leading to further clinical development plans scheduled for 2026. The company has also received Rare Pediatric Designations from the FDA for these indications.
Read more →Actuate Therapeutics Phase 2 Metastatic Pancreatic Cancer Data Selected for Oral and Poster Presentation at ASCO GI 2026
Actuate Therapeutics announced that data from its Phase 2 study of elraglusib in metastatic pancreatic cancer will be presented at the ASCO GI Cancers Symposium in January 2026. The study investigates elraglusib in combination with gemcitabine/nab-paclitaxel, a first-line chemotherapy regimen. This acknowledgment at a prestigious conference highlights the importance and potential of the treatment in addressing a critical health issue. Additionally, Actuate aims to explore mutational analyses and biomarkers associated with treatment outcomes.
Read more →Actuate Therapeutics Announces Publication of Positive Phase II Clinical Data for Elraglusib Combined with Platinum Chemotherapy and Sequential Immunotherapy in Recurrent, Metastatic Salivary Gland Carcinoma
Actuate Therapeutics has published positive Phase II clinical data for elraglusib, a GSK-3β inhibitor, combined with platinum chemotherapy in patients with recurrent, metastatic salivary gland carcinoma. The study showed a median overall survival of 18.6 months and identified nuclear GSK-3β expression as a potential biomarker for treatment response. These findings could pave the way for future clinical studies in this challenging cancer type.
Read more →Actuate Therapeutics Provides FDA with Updated Clinical Data Package to Support Planned Regulatory Interactions with FDA and EMA Over the Coming Months
Actuate Therapeutics has updated its IND application with new clinical data supporting elraglusib for metastatic pancreatic cancer. The Phase 2 trial demonstrated significant improvements in overall survival with elraglusib combined with chemotherapy. The company is preparing for regulatory submissions to the FDA and EMA, bolstered by a recent financing round. However, challenges remain regarding regulatory approval and potential side effects.
Read more →Actuate Therapeutics Announces Closing of $17.25 Million Public Offering of Common Stock, Including Full Exercise of Over-Allotment Option
Actuate Therapeutics has successfully closed a $17.25 million public offering of common stock, including the full exercise of an over-allotment option. The offering consisted of 2,464,286 shares priced at $7.00 each. The proceeds will be used for working capital and general corporate purposes. Lucid Capital Markets acted as the sole book-running manager for the offering.
Read more →Actuate Therapeutics Announces Pricing of $15.0 Million Public Offering of Common Stock
Actuate Therapeutics has announced the pricing of a public offering of 2,142,858 shares at $7.00 per share, aiming to raise approximately $15 million. The offering is set to close on September 11, 2025, and will be used for working capital and corporate purposes. Lucid Capital Markets is the sole book-running manager for this offering.
Read more →Actuate Therapeutics Announces Proposed Public Offering of Common Stock
Actuate Therapeutics, Inc. has announced a proposed public offering of its common stock to raise funds for working capital and corporate purposes. The offering is underwritten and includes a 30-day option for underwriters to purchase additional shares. The company is focused on developing therapies for challenging cancers, but the offering's completion is subject to market conditions.
Read more →