Allarity Therapeutics' Ovarian Cancer Therapy Receives FDA Fast Track Designation, Shares Soar

Allarity Therapeutics' shares more than doubled after its ovarian cancer therapy, stenoparib, received Fast Track Designation from the FDA. The designation allows for faster development and review of the drug, which targets advanced ovarian cancer and addresses unmet medical needs. Stenoparib is a dual PARP and WNT pathway inhibitor in Phase 2 clinical development. The FDA's Fast Track program aims to speed up the development and review of drugs for serious conditions.

Allarity Therapeutics, Inc. (NASDAQ:ALLR) saw its shares more than double on Tuesday following the U.S. Food and Drug Administration (FDA) granting Fast Track Designation to its investigational treatment, stenoparib, for advanced ovarian cancer. The designation, which aims to expedite the development and review of drugs targeting serious conditions with unmet medical needs, has significantly boosted investor confidence in the company's pipeline.

Stenoparib is a dual PARP and WNT pathway inhibitor currently in Phase 2 clinical development. The FDA's Fast Track program allows for more frequent engagement with the regulatory agency and could provide eligibility for accelerated approval, priority review, or rolling submissions if certain conditions are met. This designation underscores the significant unmet need in treating advanced ovarian cancer and reflects the potential of stenoparib to improve treatment outcomes.

The company's CEO, Thomas Jensen, expressed his satisfaction with the FDA's recognition, stating, "This 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. The trial began enrollment in June 2025 and incorporates the company's DRP® companion diagnostic, which uses gene-expression profiles to identify patients most likely to respond to specific therapies. This trial builds on earlier Phase 2 data showing durable benefit, with some patients remaining on therapy for more than 22 months.

Shares of Allarity Therapeutics added 117.3% at about $2.05 late morning on Tuesday, reflecting investor optimism about the potential of stenoparib and the company's efforts to advance personalized cancer treatments.

References:
[1] https://investorshub.advfn.com/market-news/article/15279/allarity-therapeutics-wins-fda-fast-track-designation-for-ovarian-cancer-drug-candidate-stenoparib
[2] https://www.proactiveinvestors.com/companies/news/1077335