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.
Kyowa Kirin and Kura Oncology started a Japanese Phase II registrational study of ziftomenib in adults with relapsed or refractory NPM1-mutated AML. Kyowa Kirin plans to seek regulatory approval in Japan after the trial.
Omeros reported initial nonhuman primate data for OncotoX-AML in acute myeloid leukemia. One treatment course reduced myeloid progenitor cells by up to 99% and was well tolerated.
Cogent Biosciences is preparing parallel FDA submissions for bezuclastinib across three indications following positive pivotal trial results, with potential launches beginning in late 2026 and full commercialization expected by early 2027.
