NasdaqGS:CGEMBiotechs
Cullinan Therapeutics (CGEM): Assessing Valuation Following FDA Submission for Zipalertinib Accelerated Approval
Cullinan Therapeutics has started a rolling submission with the FDA for accelerated approval of zipalertinib, its experimental drug for advanced non-small cell lung cancer with EGFR exon 20 insertion mutations. This regulatory step follows positive results from the Phase 1/2 REZILIENT1 trial and builds on the drug’s prior Breakthrough Therapy Designation.
See our latest analysis for Cullinan Therapeutics.
The momentum around Cullinan Therapeutics has turned noticeably positive this month,...