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FDA regulatory action on Keros Therapeutics TROPOS trial by Q2 2025?
2
Resolution / Starting Odds
Approve continuation • 25%
Request modifications • 25%
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No action taken • 25%
FDA announcements or Keros Therapeutics regulatory filings
Story
Keros Therapeutics Halts Dosing in Phase 2 PAH Trial Due to Safety Concerns
Dec 12, 2024, 12:02 PM
Keros Therapeutics Inc. (Nasdaq: KROS) has voluntarily halted dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms of its ongoing Phase 2 TROPOS trial due to safety concerns related to pericardial effusion adverse events. The trial, which evaluates cibotercept (KER-012) in combination with background therapy for patients with pulmonary arterial hypertension (PAH), remains fully enrolled. Dosing in the 1.5 mg/kg treatment arm continues following a risk and benefit assessment by the independent Data Monitoring Committee (DMC). The company has informed investigators and regulatory authorities, including the FDA, of this decision and plans to present topline data from all treatment arms in the second quarter of 2025. Shares of Keros Therapeutics plunged following the announcement.
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