Home/Pipeline/Zipalertinib (CLN-081/TAS6417)

Zipalertinib (CLN-081/TAS6417)

Relapsed EGFR exon 20 insertion NSCLC

NDA SubmissionRolling NDA submission completed

Key Facts

Indication
Relapsed EGFR exon 20 insertion NSCLC
Phase
NDA Submission
Status
Rolling NDA submission completed
Company

About Cullinan Therapeutics

Cullinan Therapeutics is a public, clinical-stage biotech company driving forward a deliberate pipeline of innovative therapies in autoimmune diseases and oncology. The company's strategy centers on rigorous scientific decision-making and strategic risk-taking to accelerate promising molecules. Key near-term catalysts include initial clinical data for CLN-978 in systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) in Q2 2025, and the completion of a rolling NDA submission for zipalertinib in EGFR exon 20 insertion non-small cell lung cancer (NSCLC).

View full company profile

About Cullinan Therapeutics

Cullinan Therapeutics is a public, clinical-stage biotech company driving forward a deliberate pipeline of innovative therapies in autoimmune diseases and oncology. The company's strategy centers on rigorous scientific decision-making and strategic risk-taking to accelerate promising molecules. Key near-term catalysts include initial clinical data for CLN-978 in systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) in Q2 2025, and the completion of a rolling NDA submission for zipalertinib in EGFR exon 20 insertion non-small cell lung cancer (NSCLC).

View full company profile