Keros Therapeutics Earns $20 Million Milestone Payment From Takeda After First Patient Dosed In Phase 3 ELRiSE MDS Trial

Keros Therapeutics, Inc., a clinical-stage biopharmaceutical company developing treatments for diseases linked to dysfunctional transforming growth factor-beta (TGF-β) signaling, has announced that it will receive a $20 million development milestone payment from its partner, Takeda. The payment was triggered after the first patient was dosed in the Phase 3 ELRiSE MDS clinical trial evaluating elritercept.

The ELRiSE MDS study is a multicenter, open-label, randomized Phase 3 trial designed to compare the efficacy and safety of elritercept with epoetin alfa for the treatment of anemia in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS). The trial marks an important step in the continued clinical development of elritercept for patients with limited treatment options.

Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros Therapeutics, said the company is pleased to see the continued advancement of the elritercept program. He added that the encouraging results from the Phase 2 study, which demonstrated positive clinical signals in patients with very low-, low-, and intermediate-risk MDS, including both those with and without ring sideroblasts, support the therapy's continued development in the Phase 3 setting.

Under the global licensing agreement that became effective on January 16, 2025, Takeda holds the rights to develop, manufacture, and commercialize elritercept worldwide, excluding mainland China, Hong Kong, and Macau. As part of the agreement, Keros received an upfront payment of $200 million in February 2025 and remains eligible to receive more than $1.1 billion in additional development, commercial, and sales milestone payments, along with tiered royalties based on future net sales.

Keros also announced that it plans to distribute 25% of the net cash proceeds from the $20 million milestone payment to its stockholders after the payment is received, reflecting the company's commitment to returning value to shareholders while continuing to advance its clinical pipeline.