The US FDA Sets PDUFA Date of Apr 9, 2027 for Elevar’s Resubmitted Rivoceranib + Camrelizumab NDA in 1L uHCC

Shots: The US FDA has assigned a PDUFA target action date of Apr 9, 2027, for Elevar Therapeutics’ resubmitted NDA of rivoceranib + Hengrui Pharma’s resubmitted BLA of camrelizumab as 1L systemic therapy for unresectable or metastatic HCC Applications will be reviewed under an integrated process; the Oct 9, 2026, resubmissions respond to the FDA’s Jul 2026 Complete Response Letter Filing is based on P-III (CARES-310), where camrelizumab + rivoceranib achieved mOS of 23.8mos. vs 15.2mos. with sorafenib (HR 0.64; 95% CI: 0.52–0.79; p<0.0001); both agents remain investigational in the US Ref: Elevar Therapeutics  |   Image: Elevar Therapeutics  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post The US FDA Sets PDUFA Date of Apr 9, 2027 for Elevar’s Resubmitted Rivoceranib + Camrelizumab NDA in 1L uHCC appeared first on PharmaShots.