Allarity Therapeutics Stock Skyrockets 95% on FDA Fast Track Designation for Stenoparib Treatment

Allarity Therapeutics stock surged 95% after receiving Fast Track designation from the FDA for stenoparib, a potential treatment for advanced ovarian cancer. The designation allows the company to speed up development and expand a Phase 2 clinical trial. Investors will note that shares have fallen 19.55% YTD and 81.01% over the past 12 months. The consensus rating is Moderate Buy with a $9 price target, representing a potential 856.12% upside.

Allarity Therapeutics, Inc. (NASDAQ: ALLR) experienced a significant surge in its stock price following the U.S. Food and Drug Administration (FDA) granting Fast Track designation to stenoparib, an investigational treatment for advanced ovarian cancer. The stock surged 95% intraday, reflecting investors' optimism about the regulatory milestone and the potential of stenoparib to address an unmet medical need.

The FDA's Fast Track designation is designed to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. This designation allows Allarity Therapeutics to engage more frequently with the FDA throughout the drug development process, potentially providing eligibility for accelerated approval, priority review, and rolling review if relevant criteria are met.

Stenoparib is a dual PARP and WNT pathway inhibitor, developed by Allarity Therapeutics in collaboration with Eisai Co. Ltd. The drug's unique mechanism of action, which combines inhibition of PARP1/2 and tankyrase 1/2, holds promise for treating various cancer types, including advanced ovarian cancer. The Fast Track designation for stenoparib is a significant regulatory milestone for Allarity Therapeutics, acknowledging both the serious nature of advanced ovarian cancer and the potential of stenoparib to address unmet needs in this patient population.

Investors will note that shares of Allarity Therapeutics have fallen 19.55% year-to-date (YTD) and 81.01% over the past 12 months. Despite the recent decline, the consensus rating is Moderate Buy with a $9 price target, representing a potential 856.12% upside. The Fast Track designation for stenoparib could significantly accelerate the company's development timeline and bring the drug to market faster if clinical data supports approval.

The designation also enables Allarity Therapeutics to expand its ongoing Phase 2 clinical trial, which began patient enrollment in June 2025. The trial is evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. Prior Phase 2 data have shown durable clinical benefit, with some patients maintaining treatment for over 22 months, suggesting potential long-term efficacy.

Allarity Therapeutics' stock surge following the FDA Fast Track designation for stenoparib underscores investor confidence in the company's ability to develop and commercialize innovative cancer treatments. The designation represents a significant regulatory advantage and could pave the way for faster access to stenoparib for patients with advanced ovarian cancer.

References:
[1] https://allarity.com/press-release/allarity-therapeutics-granted-fda-fast-track-designation-for-stenoparib-for-the-treatment-of-advanced-ovarian-cancer/
[2] https://www.marketscreener.com/news/allarity-therapeutics-granted-fda-fast-track-designation-for-stenoparib-for-the-treatment-of-advance-ce7c50d9db8af521
[3] https://www.ainvest.com/news/allarity-therapeutics-shares-surge-56-75-intraday-fda-grants-fast-track-designation-stenoparib-advanced-ovarian-cancer-2508/
[4] https://www.stocktitan.net/news/ALLR/allarity-therapeutics-granted-fda-fast-track-designation-for-rke0y4wbla6w.html