(Nasdaq: ACTU) Runs Hot On Breaking News Early Thursday (Advancing Clinical Program)

Breaking news drops on Actuate Therapeutics, Inc. (Nasdaq: ACTU) early Thursday.

Don’t Want These Anymore? Unsubscribe Here! *Sponsored Low Float (Nasdaq: ACTU) Runs Hot On Breaking News Early Thursday (Advancing Clinical Program) July 17th Greetings Readers, Breaking news drops on Actuate Therapeutics, Inc. (Nasdaq: ACTU) early Thursday. With ACTU pushing green early, take a second to chew on this: Actuate Therapeutics Advances Clinical Program in Ewing Sarcoma After Positive Phase 1 Trial Demonstrates Complete and Partial Responses in Difficult-to-Treat Pediatric Sarcomas - Announces Completion of Phase 1 Study of Elraglusib in Pediatric Patients - Prolonged and Durable Complete Responses (CRs) Observed in Two of Ten Refractory Ewing Sarcoma Patients - Two Additional Patients Had Durable Stable Disease in Notoriously Difficult-to-Treat Cancer - Confirmed Partial Response (PR) in a patient with a desmoplastic small-round-cell tumor (DSRCT) - Company Initiating Planning of Phase 2 Trial of Elraglusib in Children, Adolescents, and Adults with Refractory/Resistant Ewing Sarcoma CHICAGO and FORT WORTH, Texas, July 17, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced the end of the Phase 1 portion of its clinical study evaluating elraglusib monotherapy or in combination with irinotecan, irinotecan plus temozolomide, or with cyclophosphamide plus topotecan in pediatric patients with refractory malignancies (Actuate-1902). Following encouraging signals of activity, particularly in treatment-refractory Ewing Sarcoma (EWS), a small round cell sarcoma that forms in soft tissue and bone, the Company will seek to advance the clinical development program towards a Phase 2 study in children, adolescents, and adults with relapsed/refractory EWS. “Refractory and resistant EWS is one of the most aggressive and underserved cancers affecting children and young adults with very low survival rates,” said Dr. Andrew Mazar, Actuate’s Scientific Co-founder and Chief Operating Officer. “To observe complete responses in this setting is highly unexpected, and these exceptional early results position elraglusib as a potential first-in-class therapy option in an indication where no approved targeted therapies currently exist.” ... “We are highly encouraged by the responses observed in refractory and resistant EWS, a disease where treatment options are extremely limited beyond frontline chemotherapy,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “With these promising clinical signals in hand, we are advancing our development plans focused on EWS by pursuing a Phase 2 trial and plan to meet with regulators to discuss potential registration path in this indication.” ... Read the full article here. Remember, ACTU is a low float profile with fewer than 7Mn shares available. That means, with the news included, that volatility potential could be significantly heightened. Make sure to take a quick moment to review my initial report below and consider (Nasdaq: ACTU) for your radar. ----- Catch yesterday's breakout star? Swinging from a low of $4.17 to a high of $11.14, my most recent breakout idea cut loose on hump day. Running approx. 167% intraday, the market definitely took notice of that low float Nasdaq idea. So, here's another one to consider for your watchlist... With A low float of fewer than 7Mn shares, analyst targets pointing to triple-digit potential upside, and an important update from a key phase 2 trial, this under-the-radar Nasdaq idea has my complete attention this Thursday. Think about turning your focus to: *Actuate Therapeutics, Inc. (Nasdaq: ACTU)* Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. Key Company Highlights (1.) Advancing a potentially class-leading GSK-3β inhibitor, elraglusib with a novel, multimodal MOA, in multiple advanced cancer Phase 2 trials. (2.) Clinical responses (CRs/PRs) and Disease Control observed across cancer histologies Extended survival and increased responses are observed in mPDAC and relapsed/refractory Ewing sarcoma. Preliminary evidence of clinical benefit has also been observed in patients with metastatic melanoma and relapsed/refractory colorectal and lung cancer (3.) Oral version of elraglusib successfully evaluated in Healthy Volunteer Phase 1. Phase 1 dose escalation study planned in advanced cancer patients (4.) Broad composition of matter IP protection and development incentives. Orphan Drug Designations for pancreatic and other cancer types; Fast Track Designation for pancreatic cancer Strategic Pipeline Growth for GSK-3β Associated Diseases Grab Sources Here: ACTU Presentation. ----- These (Nasdaq: ACTU) Potential Breakout Catalysts Require Full Attention! #1. A low float. According to info from the Yahoo website, ACTU has a fairly low float. The website reports this profile to have roughly 6.05Mn shares in its float. Why is that important? It's important on one crucial level. Volatility potential. If positive company news appears in the midway part of 2025, could this low float potential help provide a breakout spark? #2. Actuate Therapeutics Highlights Significant and Sustained Survival Benefit in Key Metastatic Pancreatic Cancer Patient Populations in Phase 2 Elraglusib Trial. “We are highly encouraged by the significant clinical benefit provided by elraglusib demonstrated in this study,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “Patients who received at least one cycle – or 4 weeks – of elraglusib showed a rapid and meaningful survival benefit, including a near doubling of the 1-year overall survival and 43% reduction in the risk of death compared to control. Separately, in the subgroup of patients with liver metastases, a population with historically poor prognosis, we observed a more than 2.5-fold improvement in 1-year OS with a 38% reduction in risk of death. These results underscore the potential of elraglusib to generate rapid and durable benefit in high-risk patients, which could be highly impactful in future development and commercial pathways.” #3. Actuate Therapeutics Reports Positive Biomarker and Machine Learning Data from Phase 2 Elraglusib Trial in First-Line Treatment of Metastatic Pancreatic Cancer at ASCO. “These results represent an important advance in our biomarker strategy,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “They support the ability to use simple, non-invasive blood-based markers to potentially identify patients more likely to benefit from elraglusib. The pre-dose biomarker signatures identified in the 1801 Part 3B study, particularly involving high CXCL2 and low TGF-β, CCL3, and IL-18, which were all associated with a survival benefit, suggests that elraglusib may exert pleiotropic immunomodulatory effects regulating cytotoxic T cells, NK cells and cells of the myeloid lineage including macrophages and neutrophils. Crosstalk between components of the immune system support the growing body of evidence that elraglusib enhances immune response mechanisms critical to its antitumor efficacy.” #4. Actuate Therapeutics Announces Inclusion in the Russell 3000® and Russell 2000® Indexes. “Inclusion in the Russell 3000® and 2000® Indexes represents a significant milestone for Actuate and reflects the company’s strong momentum since our IPO last year,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “It comes on the heels of very positive topline Phase 2 data in mPDAC, which showed that the trial met its primary endpoint, demonstrating a clinically meaningful increase in median overall survival (mOS) of 10.1 months compared to 7.2 months (p = 0.01), with a 37% reduction in the risk of death (HR = 0.63), reinforcing the therapeutic potential of our lead candidate, elraglusib. This recognition not only elevates our visibility within the in-vest-ment community but also validates our platform and strategic direction. As we advanced the development of elraglusib, we believe this is a pivotal moment that further positions Actuate for long-term growth and value creation.” #5. TipRanks is reporting two separate, strong analyst targets. Take a look: As you can see above, ACTU may have triple-digit upside potential from current levels according to these analyst targets. ----- It's official. We're kicking off coverage on Actuate Therapeutics, Inc. (Nasdaq: ACTU). Be on the lookout for updates this morning. Talk soon. Sincerely, Kai Parker StockWireNews (Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.) *StockWireNews.com (“StockWireNews” or “SWN” ) is owned by SWN Media LLC, a single member limited liability company. Data is provided from third-party sources and SWN is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile SWN brings to your attention. Any emojis used do not have a specific defined meaning, and may be used inconsistently. We do not provide personalized in-vest-ment advice, are not in-vest-ment advisors, and any profiles we mention are not suitable for all in-vest-ors. Pursuant to an agreement between SWN Media LLC and TD Media LLC, SWN Media LLC has been hired for a period beginning on 07/17/2025 and ending on 07/17/2025 to publicly disseminate information about (ACTU:US) via digital communications. Under this agreement, SWN Media LLC has been paid ten thousand USD ("Funds"). These Funds were part of the funds that TD Media LLC received from a third party who did receive the Funds directly or indirectly from the Issuer and does not own st-ock in the Issuer but the reader should assume that the clients of the third party own shares in the Issuer, which they will liquidate at or near the time you receive this communication and has the potential to hurt share prices. 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