This section highlights FDA-related milestones and regulatory updates for drugs developed by Keros Therapeutics (KROS).
Over the past two years, Keros Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
KER-012, KER-050, and KER-065. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
KER-012 - FDA Regulatory Timeline and Events
KER-012 is a drug developed by Keros Therapeutics for the following indication: Healthy Volunteers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KER-012
- Announced Date:
- May 29, 2025
- Indication:
- Healthy Volunteers
Announcement
Keros Therapeutics, Inc. announced topline data from the TROPOS trial, a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension ("PAH"), and provided a corporate update.
AI Summary
Keros Therapeutics, Inc. announced topline data from the TROPOS trial, a global Phase 2 study testing cibotercept (KER-012) combined with background therapy in patients with pulmonary arterial hypertension (PAH). The trial was designed as a randomized, double-blind, placebo-controlled study, but safety concerns, including pericardial effusions observed at higher dose levels, led to the early termination of all treatment arms. After reviewing all the safety and efficacy results, the company decided to completely discontinue the development of cibotercept for PAH.
Alongside the trial update, Keros provided a corporate update, revealing a strategic restructuring that includes reducing its workforce by approximately 45%. This move aims to align the company’s operations with its ongoing development priorities and is expected to result in annual cost savings of around $17 million. The company remains focused on its other pipeline programs as it reviews further strategic alternatives.
Read Announcement- Drug:
- KER-012
- Announced Date:
- January 15, 2025
- Indication:
- Healthy Volunteers
Announcement
Keros Therapeutics, Inc. announced that it has voluntarily halted all dosing in the TROPOS trial, a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension ("PAH"), including the 1.5 mg/kg and placebo treatment arms, based on the ongoing safety review due to new observations of pericardial effusion adverse events.
AI Summary
Keros Therapeutics, Inc. announced they have voluntarily stopped all dosing in the Phase 2 TROPOS trial of cibotercept (KER-012) for patients with pulmonary arterial hypertension (PAH). The decision affects both the 1.5 mg/kg dose and placebo treatment arms. This action was taken during an ongoing safety review after new observations of pericardial effusion adverse events were noted. Patient safety remains the company’s top priority, according to their statement.
The TROPOS trial was designed to evaluate the impact of cibotercept in combination with background therapy on pulmonary hemodynamics and exercise capacity in PAH patients. Keros has informed the U.S. Food and Drug Administration and other regulatory authorities about this decision. Although the trial is being terminated early, patients will continue to be monitored through end-of-trial visits, and topline data from all treatment arms is still expected to be presented in the second quarter of 2025.
Read Announcement- Drug:
- KER-012
- Announced Date:
- December 12, 2024
- Indication:
- Healthy Volunteers
Announcement
Keros Therapeutics, Inc. announced that it has voluntarily halted dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms in the ongoing TROPOS trial, a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension ("PAH"), based on a safety review due to the unanticipated observation of pericardial effusion adverse events in the trial.
AI Summary
Keros Therapeutics, Inc. announced it has voluntarily stopped dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms in its ongoing TROPOS Phase 2 trial of cibotercept for pulmonary arterial hypertension (PAH). This decision follows a safety review after unexpected pericardial effusion adverse events were observed. The company’s CEO, Jasbir S. Seehra, emphasized that patient safety is the top priority and that Keros is working to understand the unanticipated findings better.
The independent Data Monitoring Committee recommended halting these doses, while dosing continues in the 1.5 mg/kg arm after a benefit-risk assessment. Keros has notified the FDA and other regulatory agencies and will keep collecting safety and efficacy data, with topline results planned for the second quarter of 2025.
Read Announcement- Drug:
- KER-012
- Announced Date:
- September 3, 2024
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 - 2025
- Indication:
- Healthy Volunteers
Announcement
Keros announced that it will present topline data in the second quarter of 2025.
AI Summary
Keros Therapeutics, Inc. announced that it has successfully closed screening for its global Phase 2 TROPOS trial, which is evaluating cibotercept as a treatment for pulmonary arterial hypertension (PAH) in combination with background therapy. With enrollment expected to complete by the end of September, the company is on track to present topline data in the second quarter of 2025. This accelerated timeline is a result of high demand and robust enrollment in the study. The TROPOS trial is designed to assess the impact of cibotercept on pulmonary hemodynamics and exercise capacity compared to placebo. Keros is optimistic that the forthcoming data will support the potential of cibotercept in offering a new treatment option for patients with PAH. The company also expressed its gratitude to the investigators, research staff, and participating patients for their commitment to this important clinical research effort.
Read Announcement- Drug:
- KER-012
- Announced Date:
- September 3, 2024
- Indication:
- Healthy Volunteers
Announcement
Keros Therapeutics, Inc. announced that the Company has closed screening for the TROPOS trial, a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension ("PAH").
AI Summary
Keros Therapeutics announced that screening for its TROPOS trial has officially closed. The TROPOS trial is a global, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating cibotercept (KER-012) when used with existing background therapy in patients with pulmonary arterial hypertension (PAH). This step is crucial for the company as it demonstrates significant patient enrollment progress, garnering a faster-than-expected pace in the trial’s setup.
Keros expects to complete enrollment by the end of September, and early topline data is projected for the second quarter of 2025. Company leaders expressed gratitude to the trial investigators, research staff, and the patients who took part. They believe that the accelerated enrollment could lead to earlier data readouts and bring them one step closer to offering a new, differentiated treatment option for PAH patients.
Read Announcement- Drug:
- KER-012
- Announced Date:
- September 3, 2024
- Estimated Event Date Range:
- September 1, 2024 - September 30, 2024
- Target Action Date:
- September 1, 2024
- Indication:
- Healthy Volunteers
Announcement
Keros announced that it expects to complete enrollment by the end of September
AI Summary
Keros Therapeutics, Inc. recently announced an important update about its TROPOS Phase 2 clinical trial for cibotercept (KER-012) in patients with pulmonary arterial hypertension (PAH). The company has closed screening for the trial and expects to complete enrollment by the end of September 2024. This fast progress in recruitment has positioned the study to move ahead swiftly, with topline data expected in the second quarter of 2025.
The TROPOS trial is designed to assess cibotercept when used alongside standard PAH therapy, focusing on its effects on pulmonary hemodynamics and exercise capacity. Keros emphasized that the strong demand and efficiency in enrolling patients highlight the team’s commitment, potentially bringing a new and differentiated treatment option closer to patients living with PAH.
Read Announcement
KER-050 - FDA Regulatory Timeline and Events
KER-050 is a drug developed by Keros Therapeutics for the following indication: Myelodysplastic Syndromes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KER-050
- Announced Date:
- December 9, 2024
- Indication:
- Myelodysplastic Syndromes
Announcement
Keros Therapeutics, Inc. announced that it presented additional data from its two ongoing Phase 2 clinical trials of elritercept (KER-050), one in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes ("MDS") and one in patients with myelofibrosis ("MF"), at the 66th American Society of Hematology Annual Meeting and Exposition ("ASH"), held in person in San Diego, California and virtually from December 7-10, 2024.
AI Summary
Keros Therapeutics, Inc. recently presented new data at the 66th American Society of Hematology Annual Meeting and Exposition, held in San Diego and virtually, regarding its ongoing Phase 2 clinical trials of elritercept (KER-050). The company shared encouraging results from two separate trials—one in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS) and another in patients with myelofibrosis (MF). In the MDS trial, elritercept demonstrated durable transfusion independence, with a median response duration of 134.1 weeks, and led to improvements in patient-reported fatigue scores. For MF patients, the treatment showed promise by reducing spleen volume and enhancing overall symptom scores, suggesting potential benefits in ameliorating ineffective hematopoiesis and addressing cytopenias. These findings support further clinical development of elritercept and pave the way for an upcoming Phase 3 trial.
Read Announcement- Drug:
- KER-050
- Announced Date:
- June 17, 2024
- Indication:
- Myelodysplastic Syndromes
Announcement
Keros Therapeutics, Inc. announced that it presented additional data from its two ongoing Phase 2 clinical trials of elritercept (KER-050), one in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes ("MDS") and one in patients with myelofibrosis ("MF"), at the 29th Annual Hybrid Congress of the European Hematology Association ("EHA"), held in person in Madrid, Spain and virtually from June 13 through 16, 2024.
AI Summary
Keros Therapeutics, Inc. recently shared additional Phase 2 clinical trial data for its lead candidate, elritercept (KER‑050), at the 29th Annual Hybrid Congress of the European Hematology Association in Madrid and online. One trial involved patients with very low-, low-, or intermediate‑risk myelodysplastic syndromes (MDS), where elritercept showed durable transfusion independence—even in those with a high transfusion burden—and led to significant improvements in fatigue scores. A second ongoing trial in patients with myelofibrosis (MF) demonstrated that elritercept not only improved blood cell production and addressed cytopenias, but also showed broader benefits. These included reductions in spleen volume and improvements in overall symptom scores, highlighting the drug’s potential to positively impact quality of life. The encouraging results support the continued development of elritercept for treating these blood disorders.
Read Announcement
KER-065 - FDA Regulatory Timeline and Events
KER-065 is a drug developed by Keros Therapeutics for the following indication: 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.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KER-065
- Announced Date:
- March 31, 2025
- Indication:
- 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
Announcement
Keros Therapeutics,announced initial topline results from the Phase 1 clinical trial of KER-065 in healthy volunteers.
AI Summary
Keros Therapeutics announced positive initial topline results from its Phase 1 clinical trial of KER-065 in healthy volunteers. The study met key objectives by evaluating the drug’s safety, tolerability, pharmacokinetics, and pharmacodynamics during the multiple ascending dose treatment period through Day 85.
Results showed that KER-065 was generally well-tolerated with no major safety issues, serious adverse events, or dose-limiting toxicities. The trial also provided evidence of activin inhibition, indicated by changes in bone biomarkers and improvements in body composition, such as increased bone density and muscle mass along with reduced fat mass. These findings support the drug’s potential in treating Duchenne muscular dystrophy and other neuromuscular disorders.
Based on these encouraging results, Keros plans to discuss with regulators and advance KER-065 into a Phase 2 clinical trial in early 2026.
Read Announcement
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