Allarity Therapeutics (NASDAQ:ALLR) shares more than doubled after the pharmaceutical firm announced that its investigational therapy for advanced ovarian cancer, stenoparib, has received Fast Track Designation from the US Food and Drug Administration (FDA).
The FDA’s Fast Track program is designed to speed the development and review of drugs that target serious conditions and address unmet medical needs.
The designation allows for more frequent engagement with the agency and could provide eligibility for accelerated approval, priority review, and rolling review, if certain requirements are met.
Stenoparib is described as a dual PARP and WNT pathway inhibitor currently in Phase 2 clinical development.
Allarity began patient enrollment in June under a new Phase 2 trial protocol testing stenoparib in individuals with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. Several patients have already been treated, the company said.
The trial also incorporates Allarity’s DRP companion diagnostic and builds on earlier data that showed durable benefit, including some patients who have remained on therapy for more than 22 months.
“We are very pleased that the FDA has granted Fast Track designation to stenoparib,” Allarity CEO Thomas Jensen said in a statement.
“This recognition 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.”
Shares of Allarity added 117.3% at about $2.05 late morning on Tuesday.