ALLR - Allarity to focus on combination studies for cancer after FDA feedback

Clinical-stage biotech Allarity Therapeutics ( NASDAQ: ALLR ) announced on Tuesday that its board decided to reprioritize the company’s pipeline strategy towards the advancement of combination therapies and move away from the development of monotherapies.  Allarity ( ALLR ) shares added ~11% in reaction in the pre-market.

The decision follows the feedback, Allarity ( ALLR ) received from the FDA in 2Q 2022 via a Type C meeting in which the regulators requested the company to conduct a new dosing study for its kidney cancer therapy dovitinib before starting any Phase 3 study.

A new dosing study would delay the start and completion of the late stage for dovitinib in metastatic renal cell carcinoma ((mRCC)) and raise its stakes as a single agent in the development for the highly competitive third line option for the indication, Allarity ( ALLR ) said.

“In view of those delays and increased costs/risks, the Company has determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable or in the best interests of its shareholders,” the company added.

Read: In April, Allarity ( ALLR ) disclosed the company was not in compliance with Nasdaq listing rules due to delay in its 10-K filing.

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