Cullinan Therapeutics (NASDAQ:CGEM) initiated an FDA New Drug Application for first-line zipalertinib plus chemotherapy after REZILIENT3 showed a 6.0-month median progression-free survival improvement.
Cullinan Therapeutics (NASDAQ:CGEM), Taiho Oncology, and Taiho Pharmaceutical announced that the global Phase 3 REZILIENT3 trial of zipalertinib plus platinum-based chemotherapy met its primary endpoint of progression-free survival in previously untreated patients with EGFR exon 20 insertion non-small cell lung cancer.
Cullinan Therapeutics (NASDAQ:CGEM) reported encouraging initial clinical data and outlined expanded development pathways for its portfolio of dual-targeting T-cell engagers, marking an expansion for the oncology-focused biotech into the autoimmune space.
Cullinan Therapeutics (NYSE:CGEM) received Orphan Drug Designation from the Food and Drug Administration (FDA) for its lead investigational oncology asset, CLN-049, accelerating the regulatory pathway for the treatment of high-risk acute myeloid leukemia (AML).
