USFDAMay 7, 2026, 07:08 AM
Cullinan Zipalertinib NDA Accepted by FDA; Q1 Net Loss $49.7M
AI Summary
Cullinan Therapeutics announced its first quarter 2026 financial results and provided a corporate update, highlighting significant pipeline advancements. The U.S. FDA accepted the New Drug Application (NDA) for zipalertinib for the treatment of EGFR ex20ins NSCLC, setting a PDUFA target action date of February 27, 2027. The company also anticipates presenting initial clinical data for CLN-978 in SLE and RA at the EULAR 2026 Congress in June, with multi-dose data for RA expected in Q3 2026. Cullinan reported a net loss of $49.7 million for Q1 2026 and maintains a strong cash position of $393.3 million, extending its runway into 2029.
Key Highlights
- Zipalertinib NDA for EGFR ex20ins NSCLC accepted by U.S. FDA; PDUFA date Feb 27, 2027.
- Initial clinical data for CLN-978 in SLE and RA to be presented at EULAR 2026 in June.
- Multi-dose regimen data for CLN-978 in RA expected in Q3 2026.
- Cash and investments totaled $393.3 million as of March 31, 2026, providing runway into 2029.
- Net loss for Q1 2026 was $49.7 million, compared to $48.5 million in Q1 2025.
- Research and development expenses were $42.1 million for Q1 2026.
- General and administrative expenses were $11.6 million for Q1 2026.