Welcome to our dedicated page for Keros Therapeutics news (Ticker: KROS), a resource for investors and traders seeking the latest updates and insights on Keros Therapeutics stock.
Overview of Keros Therapeutics, Inc.
Keros Therapeutics, Inc. is a clinical‐stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel protein therapeutics. Focused on targeting dysfunctional signaling within the transforming growth factor-beta (TGF-β) family, Keros leverages deep scientific expertise to address critical unmet medical needs in hematological, pulmonary, and cardiovascular disorders.
Scientific Rationale and Core Expertise
At the heart of Keros’ approach is a detailed understanding of the TGF-β pathway, a master regulator involved in the growth, repair, and maintenance of numerous tissues including blood, bone, skeletal muscle, adipose, and heart tissue. This scientific insight has allowed the company to develop engineered ligand traps and other innovative therapeutic modalities to interfere with aberrant TGF-β signaling. By precisely modulating these pathways, Keros aims to ameliorate disease states characterized by ineffective hematopoiesis, musculoskeletal degeneration, and compromised cardiovascular function.
Product Candidates and Development Programs
Keros Therapeutics has built a diversified pipeline, with each candidate targeting specific disorders associated with TGF-β dysregulation:
- Elritercept (KER-050): This protein therapeutic is engineered to treat cytopenias. It is designed to address low blood cell counts, including anemia and thrombocytopenia, in patients with conditions such as myelodysplastic syndromes (MDS) and myelofibrosis.
- Cibotercept (KER-012): Focusing on pulmonary arterial hypertension (PAH) and broader cardiovascular disorders, cibotercept aims to modulate signaling pathways pertinent to smooth muscle hypertrophy and fibrosis. Its development includes extensive Phase 2 clinical trials with rigorous safety and efficacy evaluations.
- KER-065: This candidate is geared toward the treatment of neuromuscular diseases and obesity-related conditions. Early clinical studies and preclinical support underline its potential for addressing disorders associated with structural and functional deficits in muscle tissue.
Clinical Programs and Regulatory Focus
The company’s ongoing clinical trials are designed to rigorously evaluate the safety, tolerability, and pharmacological profile of its product candidates. Keros employs open-label, multi-dose study designs in strategically challenging patient populations—such as those with treatment-resistant cytopenias or complex cardiovascular disorders—to gather robust data. This structured approach to clinical evaluation reinforces the company’s commitment to scientific integrity, and its transparent methodologies help establish a benchmark for expertise and accountability in biopharmaceutical development.
Strategic Partnerships and Collaborative Endeavors
Keros Therapeutics enhances its research and commercial potential through strategic alliances and licensing agreements with established industry partners. These collaborations enable the company to leverage external expertise in large-scale manufacturing, regulatory navigation, and global commercialization. By aligning with partners who share its commitment to scientific excellence, Keros strengthens its operational capacity and maximizes the impact of its innovative therapeutic platforms.
Market Position and Competitive Landscape
Operating within a highly specialized niche of biotherapeutics, Keros positions itself within the competitive landscape by emphasizing its deep understanding of TGF-β biology. Unlike many generic development programs, Keros’ initiatives are underscored by detailed mechanistic research and a targeted approach to disorders with significant unmet clinical need. This specificity not only differentiates its product candidates from competitors but also builds a strong case for their potential to provide meaningful, disease-modifying benefits.
Commitment to Excellence and Transparency
Every stage of Keros’ development process is executed with a commitment to rigorous research, patient safety, and transparent communication. Detailed safety reviews, independent data monitoring, and consistent updates on clinical progress underpin the company’s reputation as a trusted and authoritative source. By thoroughly documenting both preclinical and clinical outcomes, Keros ensures that its stakeholders—ranging from healthcare professionals to investors—can access clear, reliable, and unbiased information about its operations and scientific progress.
Conclusion
In summary, Keros Therapeutics, Inc. is a multifaceted clinical-stage biopharmaceutical organization that integrates cutting-edge science with a strategic, data-driven approach to drug development. Through its focused initiatives targeting TGF-β signaling, the company addresses critical needs in patients suffering from hematological, pulmonary, and cardiovascular disorders. With an expansive pipeline, rigorous clinical methodologies, and strategic industry collaborations, Keros exemplifies a commitment to innovation, transparency, and clinical excellence. This comprehensive framework not only defines its market position but also reinforces its credibility as a pioneer in the development of novel therapeutic solutions.
Keros Therapeutics (Nasdaq: KROS), a clinical-stage biopharmaceutical company specializing in TGF-ß family protein signaling disorders, has announced its upcoming participation in two major healthcare conferences.
The company's Chair and CEO, Jasbir S. Seehra, Ph.D., will present at:
- The TD Cowen 45th Annual Healthcare Conference on March 3, 2025, at 9:50 a.m. ET
- The Leerink Partners Global Healthcare Conference on March 10, 2025, at 1:40 p.m. ET
Both presentations will be in a fireside chat format, with archived replays available on the Keros website's Investor section for 90 days post-event.
Keros Therapeutics (NASDAQ: KROS) reported its Q4 and full-year 2024 financial results, highlighting a net loss of $46.0M for Q4 and $187.4M for the full year. The company's revenue increased to $3.0M in Q4 and $3.6M for 2024, primarily due to a milestone achievement under the Hansoh license agreement.
Research and development expenses rose to $173.6M for 2024, up from $135.3M in 2023, reflecting increased pipeline development activities. The company's cash position was significantly strengthened by a $200M upfront payment from Takeda Pharmaceuticals through an exclusive license agreement for elritercept development.
With cash and cash equivalents of $559.9M as of December 31, 2024, plus the Takeda payment, Keros expects to fund operations into 2029. The company anticipates reporting initial Phase 1 data for KER-065 in healthy volunteers in Q1 2025 and data from the Phase 2 TROPOS trial evaluating cibotercept in pulmonary arterial hypertension patients.
Keros Therapeutics (NASDAQ: KROS), a clinical-stage biopharmaceutical company specializing in TGF-ß family protein signaling disorders, has announced its upcoming participation in the Guggenheim SMID Cap Biotech Conference. The company's Chair and CEO, Jasbir S. Seehra, Ph.D., will engage in a fireside chat presentation on Thursday, February 6, 2025, at 10:00 a.m. Eastern time.
The presentation will be accessible through a live audio webcast at the provided link, and an archived version will remain available on the Keros website's Investor section for up to 90 days after the event. This presentation represents an opportunity for investors and interested parties to gain insights into the company's developments and strategies.
Keros Therapeutics (Nasdaq: KROS) announced the effectiveness of its global development and commercialization license agreement with Takeda (TSE:4502/NYSE:TAK) for elritercept, effective January 16, 2025. The agreement, initially announced on December 3, 2024, was finalized following the expiration of the Hart-Scott Rodino Antitrust Improvements Act waiting period. As part of the agreement, Takeda will make an upfront payment of $200.0 million to Keros, a clinical-stage biopharmaceutical company focused on developing therapeutics for disorders linked to dysfunctional TGF-ß family protein signaling.
Keros Therapeutics (NASDAQ: KROS) has announced the complete halt of dosing in its Phase 2 TROPOS trial of cibotercept (KER-012) for pulmonary arterial hypertension (PAH) due to new observations of pericardial effusion adverse events. This decision extends to all treatment arms, including the 1.5 mg/kg and placebo groups, following a previous halt of the 3.0 mg/kg and 4.5 mg/kg treatment arms announced on December 12, 2024.
The company has notified investigators and regulatory authorities, including the FDA, about the early termination of the trial. Patients will be monitored through end-of-trial visits. Despite the setback, Keros maintains its timeline to present topline data from all treatment arms in the second quarter of 2025.
Keros Therapeutics (NASDAQ: KROS) has announced the voluntary halt of dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms of its Phase 2 TROPOS trial, which studies cibotercept (KER-012) for pulmonary arterial hypertension (PAH). This decision follows the unanticipated observation of pericardial effusion adverse events.
The 1.5 mg/kg treatment arm continues following a risk-benefit assessment by the independent Data Monitoring Committee and Keros team. The trial is fully enrolled, and the company maintains its timeline to present topline data from all treatment arms in Q2 2025. The FDA and other regulatory authorities have been notified of these developments.
Keros Therapeutics (KROS) presented data from two ongoing Phase 2 clinical trials of elritercept at the 66th ASH Annual Meeting. The first trial in lower-risk myelodysplastic syndromes (MDS) showed that 55.2% of patients achieved overall erythroid response, with a median transfusion independence duration of 134.1 weeks. Of high transfusion burden patients, 31.4% achieved transfusion independence for at least eight weeks.
The second trial in myelofibrosis (MF) demonstrated that 82.8% of non-transfusion dependent patients showed increased hemoglobin levels, while 63.4% of transfusion-dependent patients showed reduced transfusion burden. Additionally, 40% of patients showed reduced spleen volume, and 66.7% experienced reduced disease symptoms at week 24.
Elritercept was generally well-tolerated in both trials, with most adverse events being mild to moderate.
Keros Therapeutics (NASDAQ: KROS) has entered into an exclusive global license agreement with Takeda for elritercept, a drug currently in Phase 2 clinical trials for myelodysplastic syndrome (MDS) and myelofibrosis (MF). Under the agreement, Takeda will obtain exclusive rights to develop, manufacture, and commercialize elritercept worldwide, except for mainland China, Hong Kong, and Macau. Keros will receive a $200 million upfront payment and is eligible for additional milestone payments potentially exceeding $1.1 billion, plus tiered royalties on net sales. The deal is expected to extend Keros' operational runway into Q4 2028.
Takeda has entered into an exclusive licensing agreement with Keros Therapeutics for elritercept, a late-stage activin inhibitor designed to treat anemia in hematologic cancers. The agreement grants Takeda exclusive global rights outside mainland China, Hong Kong, and Macau. Elritercept targets myelodysplastic syndromes (MDS) and myelofibrosis (MF), and has received FDA Fast Track designation for MDS treatment. The drug has shown promising clinical activity in early studies. Takeda will pay $200 million upfront, plus potential milestone payments and royalties. Two Phase 2 trials are ongoing, with a Phase 3 RENEW trial for MDS patients starting soon.
Keros Therapeutics (Nasdaq: KROS), a clinical-stage biopharmaceutical company specializing in TGF-ß family protein signaling disorders, has announced its participation in two upcoming healthcare conferences. The company's CEO, Jasbir S. Seehra, Ph.D., will present at the Piper Sandler 36th Annual Healthcare Conference on December 3, 2024, at 10:30 a.m. ET, and the 7th Annual Evercore HealthCONx Conference on December 4, 2024, at 3:00 p.m. ET. Both presentations will be in a fireside chat format, with archived replays available on the Keros website for 90 days after each event.
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