Arcus Biosciences, Inc. has regained ownership of casdatifan, a potential treatment for clear cell renal cell carcinoma (ccRCC), after Gilead’s time-limited exclusive option rights to casdatifan expired.

In addition, Arcus has announced the pricing of a $150 million common stock offering, which is subject to customary closing conditions and includes participation from new and existing institutional healthcare investors and Gilead. The financing is expected to fund Arcus through the anticipated data readout for PEAK-1, the Phase 3 trial for casdatifan in the immuno-oncology (IO)-experienced ccRCC setting.

With this financing and its development and regulatory expertise, Arcus aims to rapidly advance casdatifan and maintain the momentum for this program.

“We are thrilled to retain ownership of casdatifan, which has the potential to address a significant unmet need for patients with an estimated $5 billion market opportunity. Owning the rights to casdatifan represents a transformational change for Arcus, providing us with significant future strategic optionality,” said Terry Rosen, Ph.D., CEO of Arcus. “Data just presented in an oral presentation at the ASCO GU conference demonstrated casdatifan’s potential to be the best-in-class HIF-2a inhibitor in what appears to be a two-horse race. We anticipate that every patient with ccRCC will receive a HIF-2a inhibitor, and our development plan is designed to position casdatifan as the HIF-2a inhibitor of choice. This includes the initiation of our Phase 3 PEAK-1 study in the IO-experienced setting, and our clinical collaboration with AstraZeneca with the eVOLVE study, which will combine casdatifan with their anti-PD-1/CTLA-4 bispecific in the IO-naive setting.”