Omeros Gets FDA Orphan-Drug Designation for OMS906 in PNH
July 29 2022 - 09:25AM
Dow Jones News
By Colin Kellaher
Omeros Corp. on Friday said the U.S. Food and Drug
Administration granted orphan-drug designation to OMS906 for the
treatment of the rare blood disease paroxysmal nocturnal
hemoglobinuria, or PNH.
The Seattle biopharmaceutical company said it recently completed
a Phase 1 trial of OMS906 in healthy subjects and expects to begin
enrollment this summer in a study assessing OMS906 in PNH patients
who have had an unsatisfactory response to the C5 inhibitor
ravulizumab.
The FDA's orphan-drug program gives special status to drugs and
biologics for diseases and disorders that affect fewer than 200,000
people in the U.S. and provides for an extended marketing
exclusivity period against competition.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 29, 2022 09:10 ET (13:10 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
Omeros (NASDAQ:OMER)
Historical Stock Chart
From Feb 2024 to Mar 2024
Omeros (NASDAQ:OMER)
Historical Stock Chart
From Mar 2023 to Mar 2024