Keros Therapeutics, Inc. (KROS) shares ended the last trading session 9.8% higher at $15.19. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 11.1% loss over the past four weeks.The stock price gain can be attributed to investor optimism regarding the potential of Keros’ pipeline candidate, KER-065, being developed for treating neuromuscular disorders, with an initial focus on Duchenne muscular dystrophy in a phase ...

LEXINGTON, Mass., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that, as part of its previously announced $375 million capital return program, it has commenced a cash tender o ...

Core Points - Keros Therapeutics has entered into agreements to repurchase all shares held by ADAR1 Capital Management and Pontifax Venture Capital for approximately $181 million at a price of $17.75 per share, as part of a $375 million capital return program [1][4] - The company plans to commence a tender offer to repurchase up to $194 million of additional shares at the same price of $17.75 per share, expected to start by the end of October 2025 [3][4] - Keros intends to distribute 25% of any net cash proceeds from its global license agreement with Takeda Pharmaceuticals to stockholders by December 31, 2028 [2] Financial Details - The total purchase price for the repurchase of shares from ADAR1 and Pontifax is approximately $181 million, funded from existing cash and cash equivalents [1] - The planned tender offer will also be funded from the company's existing cash and cash equivalents [3] Management and Strategic Outlook - The capital return program reflects Keros' confidence in its outlook and the prospects for its key clinical program, KER-065, which is targeted for a Phase 2 clinical trial in patients with Duchenne muscular dystrophy in Q1 2026 [4] - The negotiation and approval of the repurchase transactions were overseen by a Capital Return Committee composed entirely of independent directors, ensuring a focus on enhancing long-term stockholder value [4]

Core Viewpoint - Keros Therapeutics has received Orphan Drug designation from the FDA for KER-065, aimed at treating Duchenne muscular dystrophy (DMD), highlighting the significant unmet medical need in this area [1][2]. Company Overview - Keros Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting disorders linked to dysfunctional signaling of the TGF-ß protein family [5]. - The company is recognized for its expertise in the TGF-ß family of proteins, which are crucial for the growth, repair, and maintenance of various tissues, including blood, bone, skeletal muscle, adipose, and heart tissue [5]. Product Information - KER-065 is a novel ligand trap designed to inhibit the biological effects of myostatin and activin A, promoting skeletal muscle regeneration, increasing muscle size and strength, reducing body fat, and enhancing bone strength [3]. - The product is initially focused on treating DMD, a severe condition characterized by muscle degeneration due to the lack of functional dystrophin protein [4]. Disease Context - Duchenne muscular dystrophy (DMD) is the most common form of muscular dystrophy, leading to muscle degeneration and premature death, affecting approximately one in every 3,500 male births worldwide [4]. - The absence of dystrophin results in increased susceptibility of muscle cells to damage, progressive muscle cell death, and replacement with fibrotic and fatty tissue, ultimately causing loss of muscle strength and function [4]. Regulatory Milestone - The Orphan Drug designation provides Keros with several benefits, including tax credits for clinical testing, waivers or reductions in FDA application fees, and seven years of market exclusivity upon approval [2].

Core Viewpoint - Keros Therapeutics is discontinuing the development of cibotercept to focus on its key clinical program, KER-065, which is aimed at treating Duchenne muscular dystrophy (DMD) [1][2][4] Strategic Realignment - The company will cease all internal development activities related to cibotercept following the termination of its development in pulmonary arterial hypertension (PAH) due to safety and efficacy data from the TROPOS Phase 2 clinical trial [2] - Keros is reallocating resources to enhance the development of KER-065, which has shown promising results in initial clinical trials [1][4] Leadership Changes - Keros announced several transitions in its Board of Directors and leadership to support its streamlined operational structure [3][5] - Jasbir S. Seehra, Ph.D., will take on the additional role of President while stepping down as Chair of the Board, with Jean-Jacques Bienaimé appointed as the new Chair [5] - Christopher Rovaldi will leave the company, and Lorena Lerner, Ph.D., will be promoted to Chief Scientific Officer [5] Clinical Development Plans - Keros plans to initiate a Phase 2 clinical trial for KER-065 in patients with DMD in the first quarter of 2026, pending positive regulatory interactions [4] - The company has reported initial topline results from the Phase 1 clinical trial of KER-065, achieving key objectives related to safety, tolerability, pharmacokinetics, and pharmacodynamics [4] Financial Results - Keros has released its financial results for the second quarter ended June 30, 2025, which can be accessed on its website [6]

Core Insights - Keros Therapeutics, Inc. reported a net loss of $30.7 million for Q2 2025, a decrease from a net loss of $45.3 million in Q2 2024, primarily due to revenue from a license agreement with Takeda Pharmaceuticals [3][4] - The company is focusing on advancing its pipeline, particularly KER-065, which is set to enter a Phase 2 clinical trial for Duchenne muscular dystrophy in Q1 2026 [2][6] - Keros' cash and cash equivalents increased to $690.2 million as of June 30, 2025, compared to $559.9 million at the end of 2024, allowing for operational funding into the first half of 2028 [5][12] Financial Performance - Total revenue for Q2 2025 was $18.2 million, compared to $37,000 in Q2 2024, with a significant portion attributed to service and other revenue [10] - Research and development expenses rose to $43.5 million in Q2 2025 from $40.5 million in Q2 2024, reflecting increased R&D efforts [4][10] - General and administrative expenses increased to $14.5 million in Q2 2025 from $10.0 million in Q2 2024, mainly due to higher external expenses [4][10] Balance Sheet Highlights - Keros' total assets as of June 30, 2025, were $757.2 million, up from $615.9 million at the end of 2024 [12][13] - The company reported total liabilities of $50.4 million as of June 30, 2025, compared to $44.3 million at the end of 2024 [12][13] - Stockholders' equity increased to $706.7 million as of June 30, 2025, from $571.6 million at the end of 2024, driven by a reduction in accumulated deficit [13]

Core Points - Keros Therapeutics announced the dosing of the first patient in the Phase 3 RENEW clinical trial for elritercept, which triggers a $10 million milestone payment from Takeda under their global license agreement [1][2] - The global license agreement with Takeda, effective January 16, 2025, includes a $200 million upfront cash payment and potential milestones exceeding $1.1 billion, along with tiered royalties on net sales [2] Company Overview - Keros Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapeutics for disorders linked to dysfunctional signaling of the TGF-ß protein family [5] - The company is recognized for its understanding of TGF-ß proteins, which regulate growth and maintenance of various tissues, and is developing protein therapeutics aimed at providing disease-modifying benefits [5] - Keros' lead product candidate, KER-065, targets neuromuscular diseases, while elritercept (KER-050) is focused on treating cytopenias, including anemia and thrombocytopenia in patients with myelodysplastic syndromes and myelofibrosis [5] Clinical Trial Details - The Phase 3 RENEW clinical trial is a global, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy of elritercept in reducing red blood cell transfusions in adults with transfusion-dependent anemia and varying risk levels of MDS [3]

Core Viewpoint - Keros Therapeutics has decided to discontinue the development of cibotercept for pulmonary arterial hypertension (PAH) following safety concerns and will undergo corporate restructuring to align with strategic priorities [1][3][5]. TROPOS Trial Results - The TROPOS trial was a Phase 2 clinical trial evaluating cibotercept in combination with background therapy for PAH, which was halted due to observed adverse events, specifically pericardial effusions [2][7]. - The company voluntarily stopped dosing in all treatment arms of the trial after safety reviews indicated new adverse events [2]. Corporate Restructuring - Keros plans to reduce its workforce by approximately 45%, resulting in a total of 85 full-time employees, which is expected to yield annualized cost savings of about $17 million [5][6]. - The restructuring is aimed at aligning operations with ongoing development programs and maximizing stockholder value [6]. Future Development Strategy - The company will evaluate the potential development of cibotercept for other indications after completing a strategic alternative review process [4][6]. - Keros is also exploring various strategic alternatives, including potential sale or business combinations, continued investment in its pipeline, and returning excess capital to stockholders [6]. Company Overview - Keros Therapeutics focuses on developing therapeutics targeting disorders linked to dysfunctional signaling of the TGF-ß family of proteins, with lead candidates including KER-065 for neuromuscular diseases and elritercept for cytopenias [8].