Trial Profile

A phase III Study of OMS906 in ''switch-over" design in PNH patients who have had an unsatisfactory response to ravulizumab

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 10 Apr 2025

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At a glance

26 Mar 2025 According to an Omeros Corporation media release, site activation has begun in Phase 3 development program evaluating zaltenibart. Company remains on track to readout data late next year, and is focused on establishing ex-U.S. partnerships for zaltenibart.
21 Mar 2025 According to an Omeros Corporation media release, Data needed for submission of the biologics licensing application (BLA) and global approval dossiers for zaltenibart in PNH remain on track for the fourth quarter of 2026.
21 Mar 2025 According to an Omeros Corporation media release, A total of 120 clinical investigative sites across 30 countries have been chosen for clinical trial participation in the zaltenibart Phase 3 program in PNH.

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