regulatory
confidence high
sentiment negative
materiality 0.85
Keros halts two high-dose arms of Phase 2 PAH trial after pericardial effusion
Keros Therapeutics, Inc.
- Voluntarily halted dosing in 3.0 mg/kg and 4.5 mg/kg cibotercept arms in ongoing TROPOS trial.
- Decision based on unanticipated pericardial effusion adverse events; safety review triggered.
- 1.5 mg/kg treatment arm continues dosing after DMC and internal risk-benefit assessment.
- Topline data from all treatment arms still expected in Q2 2025; FDA and other regulators notified.
- CEO Jasbir Seehra stated patient safety is top priority; Company investigating findings.