FDA grants fast track designation for Allarity's ovarian cancer drug

TARPON SPRINGS, Fla. - Allarity Therapeutics, Inc. (NASDAQ:ALLR), a small-cap biotech company with a market capitalization of $14.45 million, announced Tuesday that the U.S. Food and Drug Administration has granted Fast Track designation to stenoparib, its investigational treatment for patients with advanced ovarian cancer. According to InvestingPro analysis, the company currently trades near its Fair Value, with a healthy current ratio of 2.31 indicating strong short-term liquidity.

The designation is designed to expedite development and review of drugs that address serious conditions and unmet medical needs. It allows for more frequent FDA interactions and potential eligibility for accelerated approval and priority review.

"This recognition underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, in a press release statement. InvestingPro data reveals the company’s financial challenges, with an EBITDA of -$17.07 million in the last twelve months. While the company maintains more cash than debt on its balance sheet, it’s currently burning through cash rapidly - one of several key insights available to InvestingPro subscribers.

Allarity recently began patient enrollment in a new Phase 2 clinical trial evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The first patient was enrolled in early June 2025, with several patients already receiving treatment.

The trial builds on previous Phase 2 data showing durable clinical benefit, including patients who have remained on treatment for over 22 months.

Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. The company notes that by inhibiting PARP and blocking WNT pathway activation, stenoparib’s mechanism shows potential for treating various cancer types.

Allarity is developing the drug alongside its Drug Response Predictor (DRP) companion diagnostic, which aims to identify patients who may benefit most from treatment based on gene expression signatures of their cancer.

The company, headquartered in the U.S. with a research facility in Denmark, secured exclusive global rights for stenoparib, which was originally developed by Eisai Co. Ltd. Trading at $0.94 per share, the stock has experienced significant volatility, declining over 81% in the past year. InvestingPro subscribers have access to over 10 additional exclusive tips and comprehensive financial metrics to better evaluate biotech investments like Allarity Therapeutics.

In other recent news, Allarity Therapeutics has seen several significant developments. Ascendiant Capital has initiated coverage on Allarity Therapeutics with a Buy rating, setting a price target of $9.00. In leadership changes, Jeffrey S. Ervin has been appointed as the new Chief Financial Officer, succeeding Alexander Epshinsky, who resigned from his position but will stay during the transition period. Ervin brings nearly two decades of executive experience, having previously served as Co-Chief Financial Officer at DayDayCook and CEO at IMAC Holdings. Additionally, Allarity Therapeutics has received patent acceptance in Australia for its Drug Response Predictor (DRP) companion diagnostic specific to stenoparib, a dual PARP and WNT pathway inhibitor. This patent acceptance includes 40 claims and is part of Allarity’s strategy to protect its DRP platform internationally. Furthermore, Jesper Høiland has been appointed to the Board of Directors, replacing Joseph Vazzano. Høiland offers over 30 years of experience in the pharmaceutical industry, including leadership roles at Novo Nordisk, Radius Health, and Ascendis Pharma.

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