Allarity Therapeutics Gains FDA Fast Track for Stenoparib in Advanced Ovarian Cancer

August 26, 2025

DENVER, Colo., Aug 26, 2025 (247marketnews.com)- Allarity Therapeutics (NASDAQ:ALLR) announced a key regulatory milestone today, with the U.S. Food and Drug Administration granting Fast Track designation to stenoparib, its dual PARP and WNT pathway inhibitor, for the treatment of advanced ovarian cancer. The designation reflects recognition of both significant unmet medical need and the therapy’s potential to improve outcomes in platinum-resistant or platinum-ineligible patients.

Stenoparib is currently being evaluated in a Phase 2 trial for women with recurrent ovarian cancer. The company began enrolling patients under a revised protocol in June 2025, and multiple participants have already received dosing. The study builds on prior clinical data showing durable benefit, with some patients on treatment for more than 22 months.

CEO Thomas Jensen noted that the Fast Track status will support more frequent engagement with the FDA and may provide opportunities for accelerated or priority review.

Stenoparib’s dual mechanism targets PARP1/2 and tankyrase 1/2, inhibiting DNA repair and disrupting WNT signaling, which is increasingly implicated in cancer progression. The company is also leveraging its proprietary DRP® companion diagnostic, which uses mRNA expression to predict which patients are most likely to respond.

With Fast Track status secured and a differentiated approach in a tough-to-treat population, Allarity is positioning stenoparib as a potential game-changer in ovarian cancer therapeutics.

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