Nuvation Bio: taletrectinib NDA Priority Review, $250M financing, Q4 net loss $49.4M

Nuvation Bio Inc.

FDA accepted NDA for taletrectinib with Priority Review; PDUFA goal date June 23, 2025 for advanced ROS1+ NSCLC.
Secured up to $250M non-dilutive financings from Sagard: $150M royalty interest plus $50M debt upon FDA approval.
Q4 net loss $49.4M ($0.15/sh) vs $13.8M ($0.06) in Q4 2023; R&D and SG&A rose due to AnHeart acquisition.
China NMPA approved taletrectinib Jan 2025 (Innovent commercializing); Nippon Kayaku submitted MAA in Japan.
Launched U.S. Expanded Access Program for taletrectinib in February 2025.

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