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 [e-mail]

(END) Dow Jones Newswires

03-14-24 0832ET