Keros Gets FDA Fast-Track Designation for Lead Drug KER-050
By Colin Kellaher
Keros Therapeutics has received U.S. Food and Drug Administration fast-track designation for KER-050, its lead product candidate, for certain patients with the blood disorder anemia.
The Lexington, Mass., clinical-stage biopharmaceutical company said the designation covers KER-050 for the treatment of anemia in adults with very low-, low-, or intermediate-risk myelodysplastic syndromes.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
Keros said it plans to work closely with the FDA on the design of a Phase 3 study evaluating KER-050 in lower-risk myelodysplastic syndromes in the first half of the year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 14, 2024 08:32 ET (12:32 GMT)
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