FDA Grants Fast Track Designation to Keros Therapeutics for MDS Treatment

Keros Therapeutics, Inc. has just announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for their lead product candidate, Ker-050 (elritercept), for the treatment of anemia in adult patients with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS).

This designation underscores the need for novel treatment options for people living with lower-risk MDS. Keros Therapeutics, Inc. is now looking forward to working closely with the FDA to design a phase 3 clinical trial evaluating Ker-050 in lower-risk MDS in the first half of this year.

Ker-050 is an engineered ligand trap being developed for the treatment of low blood cell counts, including anemia and thrombocytopenia, in patients with MDS and myelofibrosis. Keros Therapeutics, Inc. is focused on developing and commercializing novel therapeutics to treat patients with disorders linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins.

The company’s second product candidate, Ker-012, is being developed for the treatment of pulmonary arterial hypertension and cardiovascular disorders. Additionally, their third product candidate, Ker-065, is being developed for the treatment of obesity and neuromuscular diseases.

Fast track designation from the FDA is a process designed to facilitate the development and expedite the review of investigational treatments that demonstrate the 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, as well as a rolling submission of the marketing application. Product candidates with fast track designation may also be eligible for priority review and accelerated approval.

The market has reacted to these announcements by moving the company's shares -2.4% to a price of $66.05. Check out the company's full 8-K submission here.

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