Rivoceranib + camrelizumab
FDA PDUFA Target Action Date · Elevar Therapeutics, Inc.
Thursday, July 23, 2026
Complete Response Letter
Complete Response Letter Note: EXPLICIT company-stated CRL — not inferred from absence of approval. FDA acted 13 days EARLY, on 2026-07-10, ahead of the 2026-07-23 PDUFA target action date, which is why an approval-window scan found nothing. FDA acted 2026-07-10 (target was 2026-07-23). Source: https://elevartx.com/2026/07/10/elevar-crl-july-2/
Drug Information
- Drug Name
- Rivoceranib + camrelizumab (CT.gov)
- Application Type
- NDA
- Indication
- Unresectable hepatocellular carcinoma (1L systemic)
- Approved As
- Rivoceranib + camrelizumab
Filing Details
- Company
- Elevar Therapeutics, Inc.
- SEC CIK
- Source
- GlobeNewswire →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-05-18. Report an issue