Keros Therapeutics, Inc. has announced the initiation of the Phase 3 Renew clinical trial of elritercept in adults with transfusion-dependent anemia with very low, low, or intermediate risk myelodysplastic syndromes ("MDS"). This marks a significant milestone for the company, as the dosing of the first patient triggered a $10 million milestone payment under the global license agreement with Takeda.
Under the terms of the global license agreement with Takeda, which became effective on January 16, 2025, Keros received a $200 million upfront cash payment in February 2025. Additionally, the company is eligible to receive development, commercial, and sales milestones with the potential to exceed $1.1 billion. Keros will also be eligible to receive tiered royalties on net sales.
The Phase 3 Renew clinical trial (NCT06499285) is a global, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy of elritercept in reducing red blood cell transfusions in adults with transfusion-dependent anemia with very low, low, and intermediate risk MDS.
Elritercept, also known as 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 a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins. The company's lead product candidate, KER-065, is being developed for the treatment of neuromuscular diseases, with an initial focus on Duchenne muscular dystrophy.
The market has reacted to these announcements by moving the company's shares 0.41% to a price of $14.55. Check out the company's full 8-K submission here.
