Omeros Says FDA Needs More Information to Support Regulatory Approval for Narsoplimab
October 18 2021 - 7:12AM
Dow Jones News
By Dave Sebastian
Omeros Corp. said the U.S. Food and Drug Administration, in a
complete response letter for a biologics license application,
expressed the need for more information for the regulatory approval
of narsoplimab in the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy.
The biopharmaceutical company on Monday said the FDA expressed
difficulty in estimating narsoplimab's treatment effect. It said
the letter didn't raise chemistry, manufacturing and controls,
safety or non-clinical issues precluding approval.
The company said it plans to ask for a type A meeting with the
FDA as soon as possible.
Omeros said its management will host a conference call Monday at
8:30 a.m. eastern time about the development.
Write to Dave Sebastian at dave.sebastian@wsj.com
(END) Dow Jones Newswires
October 18, 2021 06:57 ET (10:57 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Omeros (NASDAQ:OMER)
Historical Stock Chart
From Aug 2024 to Sep 2024
Omeros (NASDAQ:OMER)
Historical Stock Chart
From Sep 2023 to Sep 2024