Omeros Schedules Webcast to Present Final Efficacy Results from Narsoplimab BLA for the Treatment of HSCT-TMA
15 October 2020 - 11:00PM
Business Wire
-- Efficacy Results Surpass Those from
Preliminary Analysis Previously Reported --
Omeros Corporation (Nasdaq: OMER) today announced that the final
results of its pivotal trial of narsoplimab in the treatment of
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA) will be presented in a webcast on
Thursday, October 22, 2020 at 8:30 a.m. ET by Miguel Perales, M.D,
Chief of the Adult Bone Marrow Transplant Service at Memorial Sloan
Kettering Cancer Center, and Alessandro Rambaldi, MD, Professor,
Department of Oncology and Hematology-Oncology at the University of
Milan and Head of the Hematology and Bone Marrow Transplant Unit at
ASST Papa Giovanni XXIII in Bergamo, Italy.
The data to be presented are from the final analyses included in
the narsoplimab Biologics Licensing Application (BLA) being
submitted to the U.S. Food and Drug Administration (FDA) for the
treatment of HSCT-TMA. The primary efficacy endpoint of complete
response rate, as well as the secondary endpoints of 100-day and
median overall survival, were updated based on additional data
collected to provide detailed patient narratives as requested by
FDA during initial discussions regarding pivotal study design and
endpoints. These updated data and analyses form the basis of
regulatory review and product labeling. The BLA also includes data
from the HSCT-TMA compassionate-use program, which are highly
consistent with the clinical trial data. The safety profile
observed in the final data set remains consistent with data
previously presented.
To make the final data from the BLA first accessible to all
members of the public at next week’s webcast discussion by Drs.
Perales and Rambaldi, rather than only to registered conference
participants attending today’s 4th Complement-based Drug
Development Summit, the presentation that Dr. Whitaker was
previously scheduled to give at today’s Summit has been replaced
with a presentation by Jason Cummings, Ph.D., Associate Director of
Research, on Omeros’ OMS906 MASP-3 inhibitor program today at 8:30
a.m. EDT.
Webcast Details
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 7876969. Please dial
in approximately 10 minutes prior to the start of the call.
To access the live or subsequently archived webcast and
presentation materials on the internet, click here or go to the
company’s website at www.omeros.com and select “Events” under the
Investors section of the website.
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, complement-mediated diseases, disorders of
the central nervous system and immune-related diseases, including
cancers. In addition to its commercial product OMIDRIA
(phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros
has multiple late-stage clinical development programs focused on
complement-mediated disorders, including COVID-19, and substance
abuse. A rolling biologics license application for narsoplimab, the
company’s lead MASP-2 inhibitor, in hematopoietic stem cell
transplant-associated thrombotic microangiopathy is being completed
for submission to the U.S. FDA. Omeros also has a diverse group of
preclinical programs including GPR174, a novel target in
immuno-oncology that modulates a new cancer immunity axis recently
discovered by Omeros. Small-molecule inhibitors of GPR174 are part
of Omeros’ proprietary G protein-coupled receptor (GPCR) platform
through which it controls 54 new GPCR drug targets and their
corresponding compounds. The company also exclusively possesses a
novel antibody-generating platform.
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,” “can,” “could,” “estimate,”
“expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “on
track,” “plan,” “potential,” “predict,” “project,” “prospects,”
“scheduled,” “should,” “slated,” “targeting,” “will,” “would” and
similar expressions and variations thereof. Forward-looking
statements, including statements regarding anticipated regulatory
submissions, the timing and results of ongoing or anticipated
clinical trials, and the therapeutic application of Omeros’
investigational product, 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,
availability and timing of data from clinical trials and the
results of such trials, unproven preclinical and clinical
development activities, regulatory oversight, intellectual property
claims, competitive developments, litigation, and the risks,
uncertainties and other factors described under the heading “Risk
Factors” in the company’s Annual Report on Form 10-K for the year
ended December 31, 2019, filed with the Securities and Exchange
Commission (SEC) on March 2, 2020, as supplemented by its Quarterly
Report on Form 10-Q filed with the SEC on August 10, 2020 and
subsequent filings with the SEC. 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
any new information, future events or otherwise, except as required
by applicable law.
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Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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