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Investing.com -- Allarity Therapeutics Inc (NASDAQ:ALLR) stock surged 120% after the FDA granted Fast Track designation to its investigational ovarian cancer treatment stenoparib.
The designation is designed to expedite development and review of drugs addressing serious conditions with unmet medical needs. For Allarity, this opens the door to more frequent FDA interactions and potential eligibility for accelerated approval, priority review, and rolling review.
"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."
The company recently began enrolling patients in a new Phase 2 clinical trial evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The first patient was enrolled in early June 2025, with several patients already receiving treatment.
This trial builds on previous Phase 2 data that showed durable clinical benefit, with some patients remaining on treatment for over 22 months. Stenoparib is described as a differentiated, dual PARP and WNT pathway inhibitor.
Allarity is focused on advancing stenoparib alongside its DRP® companion diagnostic to potentially provide new treatment options for ovarian cancer patients.
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