Keros Therapeutics doses first patient in Phase 3 MDS trial

Published 17/07/2025, 13:06
Keros Therapeutics doses first patient in Phase 3 MDS trial

LEXINGTON, Mass. - Keros Therapeutics, Inc. (NASDAQ:KROS) has dosed the first patient in its Phase 3 RENEW clinical trial evaluating elritercept for adults with transfusion-dependent anemia in myelodysplastic syndromes (MDS), the company announced Thursday. According to InvestingPro data, Keros maintains a strong financial position with more cash than debt and a healthy current ratio of 19.29, providing substantial runway for its clinical development programs.

The milestone triggers a $10 million payment to Keros under its global license agreement with Takeda, which became effective in January 2025.

"The initiation of patient dosing in the RENEW trial marks an important next step in evaluating elritercept as a potentially differentiated therapy for patients with MDS," said Jasbir S. Seehra, Chair and Chief Executive Officer of Keros, according to the press release.

The RENEW trial is a global, randomized, double-blind, placebo-controlled study focused on adults with transfusion-dependent anemia with very low, low, and intermediate risk MDS. Its primary objective is to evaluate elritercept’s efficacy in reducing red blood cell transfusions.

Under the licensing agreement with Takeda, Keros received a $200 million upfront payment in February 2025 and remains eligible for development, commercial and sales milestones potentially exceeding $1.1 billion, plus tiered royalties on net sales.

Elritercept is an engineered ligand trap designed to treat low blood cell counts in patients with MDS and myelofibrosis. The drug comprises a modified ligand-binding domain of the TGF-β receptor fused to a portion of human antibody.

Keros Therapeutics focuses on developing therapeutics targeting dysfunctional signaling of the TGF-β family of proteins, which regulate growth and maintenance of various tissues including blood, bone, and skeletal muscle. The company’s stock, currently trading at $14.49, has shown resilience with a 33% gain over the past six months, despite broader market volatility. InvestingPro analysis reveals 11 additional investment insights and key metrics available to subscribers, including detailed financial health scores and growth projections.

In other recent news, Keros Therapeutics announced plans to return $375 million to shareholders, following a comprehensive strategic review. The company aims to enhance stockholder value while continuing to develop its lead product candidate, KER-065, for Duchenne muscular dystrophy. In a significant corporate restructuring, Keros decided to halt the development of cibotercept for pulmonary arterial hypertension after adverse events in the TROPOS trial and will reduce its workforce by approximately 45%, resulting in cost savings of about $17 million annually. Meanwhile, BofA Securities downgraded Keros Therapeutics from Buy to Neutral, lowering the price target to $18.00 due to concerns about near-term stock price appreciation and safety issues. ADAR1 Capital Management, the largest shareholder, expressed dissatisfaction with the board’s capital allocation strategy, highlighting low shareholder support for two directors. The firm demands more aggressive cost reductions and additional returns to shareholders. Keros’s board is also considering various strategic alternatives, including a potential sale, with updates expected in the coming months. Despite these challenges, Keros remains financially strong and committed to advancing its other development programs.

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