The FDA granted Orphan Drug Designation to Cullinan Therapeutics’ CLN-049 for relapsed/refractory AML. CLN-049 is in Phase 1 studies and had already received Fast Track designation.
Ultrasensitive testing of tumor DNA in blood and urine may identify muscle-invasive bladder cancer patients who can safely forgo radical cystectomy, with 69% achieving 3-year bladder-intact survival after systemic therapy.
Faron Pharmaceuticals announces acceptance of bexmarilimab Phase I/II data for poster presentation at BSH 2026, while launching a new Phase II BEAM-X study evaluating the drug in AML patients post-stem cell transplantation.
A Phase II trial led by WVU Cancer Institute reports the first-ever use of subcutaneous blinatumomab in CD19-positive mixed phenotype acute leukemia, with the first patient achieving complete remission after one cycle.
Faron Pharmaceuticals announces Phase II BEAM-X trial evaluating bexmarilimab plus azacitidine in MRD-positive AML patients after stem cell transplantation. The Nordic AML Group-led trial will enroll 24 patients with first results expected 12-15 months after enrollment begins in Q3 2026.
