Welcome to our dedicated page for Allarity news (Ticker: ALLR), a resource for investors and traders seeking the latest updates and insights on Allarity stock.
Allarity Therapeutics, Inc. develops personalized cancer treatments as a clinical-stage biopharmaceutical company focused on stenoparib (2X-121), a dual PARP and WNT pathway inhibitor, and its DRP® companion diagnostic technology. The company’s updates center on Phase 2 oncology development, advanced ovarian cancer, clinical and scientific data presentations, companion-diagnostic intellectual property, FDA Fast Track status, and potential use of stenoparib in additional tumor settings.
Recurring news also covers operating and financial results, financing activity that supports clinical programs, research collaborations, and governance matters for the Nasdaq-listed company.
Allarity Therapeutics, Inc. (Nasdaq: ALLR) announced it is not in compliance with Nasdaq Listing Rule 5250(c)(1), due to the late filing of its Annual Report on Form 10-K for the fiscal year ended December 31, 2021. The notification does not immediately affect the listing of the Company's common stock. Allarity has 60 days to submit a compliance plan, with a potential extension of up to 180 days if accepted. The Company aims to file its Form 10-K by June 19, 2022, to eliminate the need for a formal compliance plan.
Allarity Therapeutics has requested a Type C meeting with the FDA to discuss the next steps for dovitinib, after the agency issued Refusal to File letters for its NDA and PMA applications. The Company aims to clarify the requirements for resubmission and anticipates a new clinical trial may be necessary. Allarity plans to provide updates on the meeting outcomes and further advancements for dovitinib and its DRP-Dovitinib companion diagnostic by the end of Q3 2022. CEO Steve Carchedi remains confident in dovitinib's potential as a treatment for cancer patients.
Allarity Therapeutics, Inc. announced that the FDA issued Refusal to File letters for their new drug application (NDA) for dovitinib and the companion diagnostic DRP®-Dovitinib. The FDA cited insufficient clinical trial data to conclude efficacy for the metastatic renal cell carcinoma treatment. Allarity plans to seek FDA guidance and likely conduct a new clinical trial to address the issues raised. Despite this setback, Allarity's CEO remains confident in dovitinib's potential as a treatment option.
Allarity Therapeutics (Nasdaq: ALLR) has entered into licensing agreements with Oncoheroes Biosciences for the development of dovitinib and stenoparib in pediatric cancers. Oncoheroes will fund and advance clinical trials, while Allarity will provide support and supply drug inventory. Allarity submitted a new drug application (NDA) for dovitinib in renal cell carcinoma (RCC), alongside the Dovitinib-DRP® companion diagnostic. The company is also evaluating stenoparib for advanced ovarian cancer. Financial terms of the agreements remain undisclosed.