FDA Grants Fast Track Designation to Allarity Therapeutics' Stenoparib for Advanced Ovarian Cancer

Allarity Therapeutics has announced that the FDA has granted Fast Track designation to its investigational treatment, stenoparib, for advanced ovarian cancer. The designation aims to expedite drug development and review for serious conditions with unmet medical needs. This allows for more frequent interactions with the FDA and potentially accelerated approval, priority review, and rolling review if criteria are met.

Allarity Therapeutics, Inc. (NASDAQ: ALLR) has received a significant milestone in its drug development journey with the U.S. Food and Drug Administration (FDA) granting Fast Track designation to stenoparib for the treatment of advanced ovarian cancer. This designation aims to expedite the development and review process for drugs that treat serious conditions and fill unmet medical needs.

Stenoparib is a dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, designed to address the significant unmet need in advanced ovarian cancer treatment. The FDA's Fast Track designation allows for more frequent interactions with the regulatory body, potentially leading to accelerated approval, priority review, and rolling review if specific criteria are met. This recognition underscores the potential of stenoparib to improve treatment outcomes for patients with advanced ovarian cancer.

Allarity Therapeutics recently began patient enrollment under a new Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The first patient was enrolled in early June 2025, and several patients have already been dosed. The trial is designed to accelerate clinical development and builds on prior encouraging Phase 2 data showing durable clinical benefit, including patients who remain on treatment for over 22 months.

The company's DRP® companion diagnostic is also expected to play a crucial role in patient selection, enhancing the therapeutic benefit rate by screening patients before treatment. The DRP method, based on messenger RNA expression profiles from patient biopsies, has shown statistically significant predictions of clinical outcomes in numerous cancer types.

Allarity Therapeutics is committed to addressing significant unmet medical needs in cancer treatment. The company is headquartered in the U.S. with a research facility in Denmark, and is focused on developing personalized cancer treatments.

References:
[1] https://www.globenewswire.com/news-release/2025/08/26/3139198/0/en/Allarity-Therapeutics-Granted-FDA-Fast-Track-Designation-for-Stenoparib-for-the-Treatment-of-Advanced-Ovarian-Cancer.html