Allarity completes stenoparib manufacturing campaign, gets key US patent and CLIA certification
The company reported second quarter 2026 results alongside a completed Phase 3-ready manufacturing run, a new patent through 2042, and in-house diagnostic testing capability.
Allarity Therapeutics said that subsequent to the second quarter, its active pharmaceutical ingredient manufacturing campaign for stenoparib was successfully completed in July 2026, ahead of the originally planned completion by the third quarter of 2026.1 The company said the campaign supports accelerating stenoparib toward FDA approval following its FDA Fast Track designation and was completed in anticipation of clinical benefit data from the ongoing Phase 2 trial in advanced ovarian cancer.1
The USPTO granted a patent covering the stenoparib-specific DRP companion diagnostic, with a term extending into April 2042.1 The patent covers methods for predicting clinical benefit from stenoparib based on gene-expression profiles derived from tumor samples, as well as methods for selecting patients most likely to benefit from stenoparib treatment.1
Allarity also obtained CLIA certification for its in-house laboratory in Hørsholm, Denmark, according to the release. The FDA requires biomarker testing used to select patients for registration trials to be performed in a CLIA-certified laboratory environment, and Allarity said it is now able for the first time to perform its DRP testing in-house in such an environment to support U.S. clinical trials, including a planned registrational trial in advanced ovarian cancer.1
On enrollment, Allarity continued its Phase 2 trial evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer,1 and separately a Phase 2 trial combining stenoparib with temozolomide for relapsed small cell lung cancer, fully funded by the U.S. Department of Veterans Affairs, continued enrolling patients across multiple VA medical centers.1
On finances, the company said cash and restricted cash totaled $26.9 million as of June 30, 2026, compared to $14.7 million a year earlier.1 CEO Thomas Jensen said the cash position provides "the financial resources to continue the important work of advancing stenoparib."1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.