Allarity Therapeutics, Inc. (NASDAQ:ALLR) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to stenoparib, its investigational treatment for advanced ovarian cancer. The company’s shares rocketed on the news, gaining around 95% in pre-market trading.
Fast Track status is intended to speed up the development and review of drugs that address serious or life-threatening conditions with unmet medical needs. The designation allows more frequent engagement with the FDA during development and may provide eligibility for accelerated approval, priority review, or rolling submissions if certain conditions are met.
“We are very pleased that the FDA has granted Fast Track designation to stenoparib,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “This recognition underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes. We look forward to engaging closely with the FDA as we advance this program.”
Allarity recently launched a new Phase 2 trial evaluating stenoparib in patients with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. Enrollment began in June 2025, with several patients already dosed. The trial is designed to accelerate clinical development of stenoparib alongside the company’s DRP® companion diagnostic, and it builds on earlier Phase 2 data showing durable benefit, including patients who have remained on therapy for more than 22 months.
About Stenoparib
Stenoparib is an oral, small-molecule inhibitor targeting both PARP1/2 and tankyrase 1/2 enzymes. Tankyrases are increasingly recognized as potential cancer targets due to their role in regulating the WNT/β-catenin signaling pathway, which is often dysregulated in tumor growth and progression. By combining PARP inhibition with WNT pathway suppression, stenoparib offers a dual-action mechanism that Allarity believes could provide therapeutic benefits across multiple cancer types, including ovarian cancer. The company holds exclusive global rights to develop and commercialize the drug, originally created by Eisai Co. Ltd. and previously known as E7449 and 2X-121.
About the DRP® Companion Diagnostic
The DRP® (Drug Response Predictor) is Allarity’s gene-expression–based platform designed to identify patients most likely to respond to specific therapies. Using messenger RNA profiles from tumor biopsies, the DRP compares sensitive versus resistant cancer cell lines and integrates clinical outcomes to generate drug-specific prediction scores. The goal is to improve therapeutic success rates by enrolling only patients with a high likelihood of response. The platform has been validated across multiple retrospective and prospective studies and is patented for a wide range of oncology drugs.
The FDA’s Fast Track recognition marks an important milestone in Allarity’s efforts to advance personalized cancer treatments. The company is positioning stenoparib, together with the DRP® diagnostic, as a potential targeted option for patients with advanced ovarian cancer who currently face limited treatment alternatives.
Allarity Therapeutics stock price
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