Allarity Therapeutics provides update on dovitinib program for renal cell carcinoma.

The Company is announcing an update on timing for its originally planned first NDA filing for dovitinib as a treatment for renal cell carcinoma (RCC). This NDA is based on non-inferiority to the approved drug sorafenib. The Company’s preparation of the application itself is progressing as scheduled, however the third-party contract manufacturer of the registration batch of the drug is experiencing delays, in part as a result of the ongoing coronavirus pandemic. A registration batch is a mandatory component of the NDA filing. Due to this reported delay, Allarity is now expecting to file the NDA in 2021. Separately, the Company remains on track to file its first pre-market approval (PMA) application with the FDA for the use of the dovitinib DRP companion diagnostic to select and treat likely responders to the drug. If regulatory authorities provide the expected PMA approval of the Dovitinib DRP and an NDA approval of dovitinib, the Company believes it can make the drug available to DRP-selected RCC patients as an effective new therapy to treat their disease. Dovitinib, originally developed by Novartis, addresses a significant unmet need for improved therapies for the treatment of RCC, and is a potential therapeutic alternative to sorafenib.