NasdaqGS:CGEMBiotechs
Will FDA-Backed Registrational Phase 2 for CLN-049 Redefine Cullinan Therapeutics' (CGEM) Narrative?
Cullinan Therapeutics reported that it previously received positive feedback from the U.S. FDA following an End-of-Phase 1 meeting for CLN-049, clearing the way for a potentially registrational Phase 2 trial in relapsed/refractory acute myeloid leukemia and additional combination studies in previously untreated patients.
The FDA’s alignment on a seamless Phase 2 design and CLN-049’s Fast Track and Orphan Drug designations together underscore the program’s regulatory momentum in a...