Omeros: FDA Found Deficiencies in Review of Biologics License Application for Narsoplimab
October 01 2021 - 9:56AM
Dow Jones News
By Michael Dabaie
Omeros Corp. said the U.S. Food and Drug Administration
identified deficiencies that preclude discussion of labeling and
post-marketing requirements/commitments for narsoplimab in
hematopoietic stem cell transplant-associated thrombotic microangat
this time.
The stock fell 32% to $9.35 in premarket trade.
Omeros said it was notified by the administration as part of
FDA's ongoing review of the company's biologics license application
for narsoplimab. The FDA stated the notification doesn't reflect a
final decision on the information under review, Omeros said.
The FDA didn't provide specific details of the deficiencies in
its notification. In a meeting held Sept. 30, the FDA expressed its
intention to work with Omeros to resolve any issues as
expeditiously as possible, Omeros said. However, the company said
it doesn't currently expect any such resolution by the Oct. 17
target action date under the Prescription Drug User Fee Act.
Omeros said it is evaluating potential next steps as it awaits
additional information. The company said it plans to obtain FDA
approval for narsoplimab in HSCT-TMA, a frequently lethal
complication of HSCT for which there is no FDA-approved treatment,
as quickly as possible.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
October 01, 2021 09:41 ET (13:41 GMT)
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