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- Celularity (NASDAQ:CELU) gains 12.1% premarket after announcing that the FDA has granted Fast Track Designation for its non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001, in development for the treatment of acute myeloid leukemia (AML).
- Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
- “We believe that the unique properties of our cell source, including the ability to proliferate and maintain activity, could be the key to improving response rates and durability for patients," said Robert Hariri, M.D., Ph.D., Founder, Chairperson and CEO of Celularity.
- Last month, FDA cleared CELU's IND for CYNK-101 + chemotherapy for gastric and gastroesophageal cancer.