Omeros Receives Complete Response Letter from FDA for Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA
October 18 2021 - 6:30AM
Business Wire
-- Conference call today at 8:30 a.m. ET, 5:30
a.m. PT --
Omeros Corporation (Nasdaq: OMER) today announced that the
company received a Complete Response Letter (CRL) from the U.S.
Food and Drug Administration (FDA) regarding its Biologics License
Application (BLA) for narsoplimab in the treatment of hematopoietic
stem cell transplant-associated thrombotic microangiopathy
(HSCT-TMA).
Following HSCT, patients generally have complex clinical courses
and are often severely ill. HSCT-TMA increases that complexity and
worsens outcomes. In the CRL, FDA expressed difficulty in
estimating the treatment effect of narsoplimab in HSCT-TMA and
asserted that additional information will be needed to support
regulatory approval. There were no chemistry, manufacturing and
controls (CMC), safety, or non-clinical issues precluding approval
raised in the CRL.
Omeros remains confident in the efficacy and safety data for
narsoplimab in HSCT-TMA. The company worked closely with FDA on the
clinical development plan, including with respect to both the
single-arm trial to support approval and the definition of response
as the primary endpoint.
Omeros plans to request a Type A meeting as soon as possible
with FDA to discuss the CRL and determine the most expeditious path
forward for the approval of narsoplimab in the treatment of
HSCT-TMA.
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.
Conference Call Details
Omeros’ management will host a conference call to discuss
today’s announcement. The call will be held today at 8:30 a.m.
Eastern Time; 5:30 a.m. Pacific Time. To access the live conference
call via phone, please dial (844) 831-4029 from the United States
and Canada or (920) 663-6278 internationally. The participant
passcode is 9549686. A telephone replay will be available for one
week following the call and may be accessed by dialing (855)
859-2056 from the United States and Canada or (404) 537-3406
internationally. The replay passcode is 9549686.
To access the live or subsequently archived webcast of the
conference call on the internet, go to the company’s website at
https://investor.omeros.com/upcoming-events.
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 Omeros is
seeking FDA approval of narsoplimab for the treatment of
hematopoietic stem cell transplant-associated thrombotic
microangiopathy. Additional narsoplimab programs are 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.
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/20211018005335/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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