FDA Accepts Biologics License Application for Filing and Grants Priority Review for Sacituzumab Govitecan for the Treatment o...
July 18 2018 - 8:00AM
Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics”
or the “Company”), a leading biopharmaceutical company in the area
of antibody-drug conjugates (ADC), today announced that the U.S.
Food and Drug Administration (FDA) has accepted the Company’s
Biologics License Application (BLA) for filing and granted Priority
Review for sacituzumab govitecan for the treatment of patients with
metastatic triple-negative breast cancer (mTNBC) who previously
received at least two prior therapies for metastatic disease. The
PDUFA target action date is January 18, 2019. If approved,
sacituzumab govitecan would be the first and only ADC approved for
the treatment of mTNBC.
“We are delighted that the FDA has accepted the
sacituzumab govitecan BLA for Priority Review,” commented Michael
Pehl, President and Chief Executive Officer. “We will continue to
work closely with the regulatory agency as we strive to bring this
potential new treatment to mTNBC patients expeditiously.”
The filing is based on Phase 1/2 data of
sacituzumab govitecan in mTNBC.
About Sacituzumab
GovitecanSacituzumab govitecan, Immunomedics’ most
advanced product candidate, is a novel, first-in-class
antibody-drug conjugate (ADC). It is currently under review by the
U.S. Food and Drug Administration for accelerated approval as a
treatment of patients with metastatic triple-negative breast cancer
who previously received at least two prior therapies for metastatic
disease. If approved, sacituzumab govitecan would be the first and
only ADC approved for the treatment of metastatic triple-negative
breast cancer.
About ImmunomedicsImmunomedics
is a clinical-stage biopharmaceutical company developing monoclonal
antibody-based products for the targeted treatment of cancer and
other serious diseases. Immunomedics’ corporate objective is to
become a fully-integrated biopharmaceutical company and a leader in
the field of antibody-drug conjugates. For additional information
on the Company, please visit its website at
https://immunomedics.com/. The information on its website does not,
however, form a part of this press release.
Cautionary note regarding
forward-looking statementsThis release, in addition to
historical information, may contain forward-looking statements made
pursuant to the Private Securities Litigation Reform Act of 1995.
Such statements, including statements regarding clinical trials
(including the funding therefor, anticipated patient enrollment,
trial outcomes, timing or associated costs), regulatory
applications and related timelines, including the filing and
approval timelines for BLAs and BLA supplements, out-licensing
arrangements, forecasts of future operating results, potential
collaborations, capital raising activities, and the timing for
bringing any product candidate to market, involve significant risks
and uncertainties and actual results could differ materially from
those expressed or implied herein. Factors that could cause such
differences include, but are not limited to, the Company’s
dependence on business collaborations or availability of required
financing from capital markets, or other sources on acceptable
terms, if at all, in order to further develop our products and
finance our operations, new product development (including clinical
trials outcome and regulatory requirements/actions), the risk that
we or any of our collaborators may be unable to secure regulatory
approval of and market our drug candidates, risks associated with
the outcome of pending litigation and competitive risks to marketed
products, and the Company’s ability to repay its outstanding
indebtedness, if and when required, as well as the risks discussed
in the Company’s filings with the Securities and Exchange
Commission. The Company is not under any obligation, and the
Company expressly disclaims any obligation, to update or alter any
forward-looking statements, whether as a result of new information,
future events or otherwise.
For More Information:
For Investor Inquiries:Dr. Chau
ChengSenior Director, Investor Relations & Corporate
Secretary(973) 605-8200, extension 123ccheng@immunomedics.com
For Media
Inquiries:media@immunomedics.com
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