Allarity Therapeutics, Inc. (ALLR) said it is moving Stenoparib closer to pivotal-stage development as the company's Phase 3 manufacturing campaign progresses on schedule, marking a key step toward preparing the drug for a potential registrational trial in advanced ovarian cancer.
The company reported that the active pharmaceutical ingredient (API) manufacturing campaign is on track for completion no later than the third quarter of 2026, ensuring drug supply readiness ahead of a planned pivotal trial. All manufacturing-related payments have already been completed, and no additional cash outlays for manufacturing are expected.
Stenoparib is a dual PARP and WNT pathway inhibitor being developed for platinum-resistant ovarian cancer, an area of high unmet need. Allarity said the decision to advance manufacturing reflects growing confidence in the drug's potential, supported by previously reported data showing extended overall survival in heavily pretreated ovarian cancer patients.
The manufacturing work is being conducted at a European CDMO operating under FDA and EMA Good Manufacturing Practice (GMP) standards. The company noted that Phase 3-level manufacturing requires higher quality specifications than earlier-stage production, and initiating the campaign now ensures readiness for late-stage clinical development.
Allarity continues to enroll patients in its amended Phase 2 trial of Stenoparib in platinum-resistant or platinum-ineligible ovarian cancer, designed to accelerate the drug's path toward FDA approval. A separate Phase 2 study evaluating Stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) is also enrolling across U.S. Veterans Administration sites.
ALLR has traded between $0.76 and $2.35 over the past year. The stock closed Monday's trading at $1.25, down 3.85%. In pre-market trading, the stock is at $1.37, up 9.60%.
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