regulatory
confidence high
sentiment negative
materiality 0.85
Keros halts entire Phase 2 PAH trial (all doses, placebo) on pericardial effusion safety
Keros Therapeutics, Inc.
- Voluntary halt of all dosing in TROPOS trial, including 1.5 mg/kg and placebo arms, due to new pericardial effusion adverse events.
- Previously halted 3.0 mg/kg and 4.5 mg/kg arms on Dec 12, 2024; now entire study terminated early.
- Patients to be monitored through end-of-trial visits; investigators and FDA notified.
- Company still expects to present topline data from all treatment arms in Q2 2025.
- CEO Jasbir Seehra cited patient safety as top priority; working with FDA and other regulators.