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Allarity Therapeutics Granted FDA Fast Track Designation for Stenoparib for the Treatment of Advanced Ovarian Cancer

Allarity Therapeutics (ALLR) | August 26, 2025

By Victor Perez

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Allarity Therapeutics received Fast Track designation from the FDA for stenoparib in treating advanced ovarian cancer.

Stenoparib is a dual PARP and WNT pathway inhibitor showing promise in improving treatment outcomes.

The Phase 2 clinical trial protocol for stenoparib in ovarian cancer has already enrolled patients showing durable clinical benefit.

FDA Fast Track Designation

Enables expedited review and potential accelerated approval for stenoparib in advanced ovarian cancer.

Stenoparib's Unique Action

Inhibits PARP and blocks WNT pathway activation, offering potential therapeutic benefits in various cancer types.

DRP Companion Diagnostic

Utilizes gene expression signatures to enhance therapeutic benefit rate by selecting patients likely to respond to stenoparib.

  • Stenoparib's Fast Track designation accelerates the drug development and review process for advanced ovarian cancer treatment.
  • The enrollment in the Phase 2 trial and prior encouraging data indicate stenoparib's potential to address the significant unmet medical need in ovarian cancer treatment.

Allarity Therapeutics' FDA Fast Track designation for stenoparib marks a significant step towards improving treatment outcomes in advanced ovarian cancer. The company's dedication to personalized cancer treatments using innovative technologies like the DRP Companion Diagnostic shows promise for addressing unmet medical needs in cancer care.