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CHICAGO and FORT WORTH, Texas - Actuate Therapeutics, Inc. (NASDAQ: ACTU), a clinical-stage biopharmaceutical company valued at $193 million, announced today that its drug elraglusib, when combined with chemotherapy, has met primary endpoints in a Phase 2 trial for treating metastatic pancreatic ductal adenocarcinoma (mPDAC). The company’s stock has shown remarkable momentum, gaining nearly 8% in the past week and 24% year-to-date, according to InvestingPro data. The study showed a statistically significant improvement in overall survival for patients treated with the elraglusib and gemcitabine/nab-paclitaxel (GnP) combination compared to those receiving GnP alone.
The trial, known as Actuate-1801 Part 3B, enrolled 286 patients who had not received prior systemic treatment for their metastatic disease. The primary measure of success was median overall survival, with secondary endpoints including disease control rate, objective response rate, progression-free survival, and adverse events. While the company maintains an excellent financial health score of 4.38 according to InvestingPro, analysts project continued losses this year, with forecasted EPS of -$1.38. Get access to 6 more exclusive InvestingPro Tips and comprehensive financial analysis to make informed investment decisions.
Daniel Schmitt, President & CEO of Actuate, highlighted the importance of these findings, stating that the results indicate a significant step forward in the treatment of a cancer type that has seen little advancement in over a decade. The favorable risk-benefit profile of the elraglusib/GnP combination also suggests potential for changing the standard of care in mPDAC.
The topline data from this trial will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) on May 31, 2025. Following these promising results, Actuate plans to engage with U.S. and EU regulators in the second half of the year to discuss the drug’s advancement toward a New Drug Application (NDA) and registration.
Elraglusib is a novel inhibitor of glycogen synthase kinase-3 beta (GSK-3β), which is believed to play a role in tumor growth and chemotherapy resistance. By inhibiting this enzyme, elraglusib may enhance chemotherapy effectiveness and activate anti-tumor immunity.
The announcement is based on a press release statement from Actuate Therapeutics. The company aims to bring elraglusib to commercialization as quickly as possible, given the significant improvement in survival observed in the combination arm of the study.
In other recent news, Actuate Therapeutics has announced the completion of patient enrollment for its Phase 2 trial of elraglusib in combination with FOLFIRINOX and losartan, targeting untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The study, led by Dr. Colin Weekes at Massachusetts General Hospital, enrolled 56 patients and aims to evaluate the drug combination’s safety, tolerability, and progression-free survival. Initial data presented at a conference indicated early evidence of increased clinical activity. Additionally, Craig-Hallum has initiated coverage on Actuate Therapeutics with a Buy rating and a price target of $21, citing optimism about elraglusib’s potential to improve survival outcomes in mPDAC. Analysts at Craig-Hallum are encouraged by interim data showing significant improvements in survival when elraglusib is combined with standard treatments. Actuate has also scheduled its first Annual Meeting of Stockholders for May 22, 2025, with March 25 set as the record date for determining eligible voters. The company has outlined procedures for stockholders to submit proposals or nominations for the meeting.
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