The company’s Stenoparib, an investigational treatment for patients with advanced ovarian cancer, was granted the Fast Track designation by the FDA.
Allarity Therapeutics, Inc. (ALLR) on Tuesday announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its Stenoparib. Following the announcement, shares of the company more than doubled in value by Tuesday afternoon.
Stenoparib is an investigational treatment for patients with advanced ovarian cancer. FDA’s Fast Track designation is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. It allows for more frequent interactions with the FDA throughout the drug development process and potentially provides eligibility for accelerated approval and priority review, upon meeting relevant criteria.
On Stocktwits, retail sentiment around ALLR stock jumped from ‘bearish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘extremely low’ to ‘extremely high’ levels.
A Stocktwits user expressed surprise at the rally and opined that the stock might drop to below $1 by the end of the day.
Another user stated that larger pharmaceutical companies will now be interested in the drug.
Allarity CEO Thomas Jensen said the company is pleased with the designation. “We look forward to engaging closely with the FDA as we advance this program,” he added.
US-headquartered Allarity started patient enrollment under a new mid-stage clinical trial protocol evaluating Stenoparib in advanced, recurrent, platinum-resistant, or platinum-ineligible ovarian cancer in early June 2025. Several patients have already been dosed in the study. The trial is designed to accelerate clinical development of Stenoparib. Previous mid-stage study data showed durable clinical benefit for Stenoparib.
The therapy was originally developed by Eisai Co., but Allarity secured exclusive global rights for the development and commercialization.
ALLR stock has gained 74% this year but has lost 59% over the past 12 months.
Read also: Regeneron Stock Rallies After Therapy For Autoimmune Disease Meets Late-Stage Trial Goals: Retail Thinks Stock Might Hit An All-Time Low Soon
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