Keros Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation for KER-050 (elritercept) for the treatment of anemia in adult patients with very low-, low-, or intermediate-risk myelodysplastic syndromes. Fast Track is a process designed by the FDA to facilitate the development and expedite the review of investigational treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA to discuss the product candidate's development plan in addition to a rolling submission of the marketing application.

Product candidates with Fast Track designation may also be eligible for priority review and accelerated approval. About KER-050: KER-050, is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-ss receptor known as activin receptor type IIA that is fused to the portion of the human antibody known as the Fc domain. KER-050 is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with MDS and in patients with myelofibrosis.