Omeros Confirms Submission of Response to FDA Regarding the BLA for Narsoplimab in the Treatment of HSCT-TMA
January 19 2022 - 5:52PM
Business Wire
Omeros Corporation (Nasdaq: OMER) today confirmed that earlier
this month the company submitted to the U.S. Food and Drug
Administration (FDA) its response to the Agency’s Complete Response
Letter (CRL) for narsoplimab in the treatment of hematopoietic stem
cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
The response comprises a comprehensive briefing package drafted in
close collaboration with external clinical, regulatory and legal
experts that addresses in detail the points raised by FDA in its
CRL for narsoplimab. Omeros concurrently requested a Type A meeting
with FDA to resolve any outstanding items.
Narsoplimab is the first drug candidate submitted to FDA for
approval in HSCT-TMA. It has Breakthrough Therapy and Orphan
designations in both HSCT-TMA and IgA nephropathy.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting inflammation, immunologic diseases (e.g.,
complement-mediated diseases) and cancers. Omeros’ lead MASP-2
inhibitor narsoplimab targets the lectin pathway of complement and
is the subject of a biologics license application pending before
FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy. Narsoplimab is
also in multiple late-stage clinical development programs focused
on other complement-mediated disorders, including IgA nephropathy,
atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’
inhibitor of MASP-3, the key activator of the alternative pathway
of complement, is in a Phase 1 clinical trial. For more information
about Omeros and its programs, visit www.omeros.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, which are
subject to the “safe harbor” created by those sections for such
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“goal,” “intend,” “likely,” “look forward to,” “may,” “objective,”
“plan,” “potential,” “predict,” “project,” “should,” “slate,”
“target,” “will,” “would” and similar expressions and variations
thereof. Forward-looking statements, including expectations with
regard to interactions and communications with FDA and Omeros’
pursuit of regulatory approval for narsoplimab in HSCT-TMA, are
based on management’s beliefs and assumptions and on information
available to management only as of the date of this press release.
Omeros’ actual results could differ materially from those
anticipated in these forward-looking statements for many reasons,
including, without limitation, risks associated with product
commercialization and commercial operations, regulatory processes
and oversight, and the risks, uncertainties and other factors
described under the heading “Risk Factors” in the company’s Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on March 1, 2021. Given these risks, uncertainties and
other factors, you should not place undue reliance on these
forward-looking statements, and the company assumes no obligation
to update these forward-looking statements, whether as a result of
new information, future events or otherwise, except as required by
applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20220119006120/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
Omeros (NASDAQ:OMER)
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