Cullinan Therapeutics (NASDAQ:CGEM) saw its stock rise 2.9% in Monday’s premarket session after announcing that the U.S. Food and Drug Administration has awarded Fast Track designation to CLN-049, its investigational treatment for relapsed or refractory acute myeloid leukemia (AML).
The Cambridge-based biotech said the designation demonstrates both the seriousness of AML and the need for additional therapeutic options, while recognizing the potential of CLN-049. Cullinan plans to share new findings from its ongoing Phase 1 study during the American Society of Hematology meeting on December 8.
“Fast Track designation underscores both the urgent need for new options in relapsed and refractory acute myeloid leukemia and the promise of CLN-049,” said Jeffrey Jones, Chief Medical Officer at Cullinan Therapeutics. “Initial results from our Phase 1 study have shown meaningful efficacy, including complete responses, reinforcing the broad potential of this FLT3-directed T cell engager in a population where effective treatment options are currently limited and fragmented.”
CLN-049 is a bispecific FLT3xCD3 T cell engager engineered to bind both mutated and wild-type FLT3, aiming to broaden its applicability across diverse AML patient groups.
The Fast Track pathway is intended to speed development and review for drugs addressing serious diseases with limited available therapies. Treatments earning the designation may also qualify for Accelerated Approval or Priority Review if certain criteria are met.