Omeros Announces Extension of FDA Review Period for Narsoplimab in HSCT-TMA
20 May 2021 - 10:45PM
Business Wire
-- PDUFA Date is October 17, 2021--
Omeros Corporation (Nasdaq: OMER), a commercial-stage
biopharmaceutical company committed to discovering, developing and
commercializing small-molecule and protein therapeutics for
large-market as well as orphan indications targeting inflammation,
immunologic diseases (e.g., complement-mediated diseases and
cancers) and central nervous system disorders, today reported that
the U.S. Food and Drug Administration (FDA) will require additional
time to review the Biologics License Application (BLA) for
narsoplimab for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA). The
new Prescription Drug User Fee Act (PDUFA) target action date is
October 17, 2021.
As part of the ongoing BLA Priority Review, Omeros recently
submitted a response to an FDA information request. FDA has
classified the response as a major amendment, which requires
additional time to review.
“We’re pleased with our ongoing interactions with FDA on the
narsoplimab BLA,” said Gregory A. Demopulos, M.D., chairman and
chief executive officer of Omeros. “Omeros views the information
provided in response to FDA’s information request as further
supporting the application, and we look forward to making
narsoplimab available to HSCT-TMA patients and their physicians as
soon as possible.”
The first drug submitted to FDA for approval in HSCT-TMA,
narsoplimab has Breakthrough Therapy and Orphan designations in
both HSCT-TMA and IgA nephropathy. The BLA for narsoplimab in
HSCT-TMA was accepted for filing in January 2021 under FDA’s
Priority Review program.
About Omeros Corporation
Omeros is a commercial-stage 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) and central nervous
system disorders. Its commercial product OMIDRIA® (phenylephrine
and ketorolac intraocular solution) 1%/0.3% continues to gain
market share in cataract surgery. Omeros’ lead MASP-2 inhibitor
narsoplimab targets the lectin pathway of complement and is the
subject of a biologics license application under priority review by
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, and the company’s
PDE7 inhibitor program OMS527, targeting addiction and movement
disorders, has successfully completed a Phase 1 trial. Omeros’
pipeline holds a diverse group of preclinical programs including a
proprietary-asset-enabled antibody-generating technology and a
proprietary GPCR platform through which it controls 54 GPCR drug
targets and their corresponding compounds. One of these novel
targets, GPR174, modulates a new cancer immunity axis recently
discovered by Omeros, and the company is advancing GPR174-targeting
antibodies and small-molecule inhibitors. 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 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 (SEC) 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/20210520005392/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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