Immunomedics Receives Complete Response Letter From FDA for Sacituzumab Govitecan Biologics License Application
January 17 2019 - 8:12PM
Immunomedics, Inc.,
(NASDAQ:
IMMU) (“Immunomedics” or the “Company”), a leading
biopharmaceutical company in the area of antibody-drug conjugates
(ADC), today announced it has received a Complete Response Letter
(CRL) from the U.S. Food and Drug Administration (FDA) for the
Biologics License Application (BLA) seeking accelerated approval of
sacituzumab govitecan for the treatment of patients with metastatic
triple-negative breast cancer (mTNBC) who have received at least
two prior therapies for metastatic disease.
“We believe in sacituzumab govitecan’s potential
to be a viable treatment option for these patients,” said Michael
Pehl, President and Chief Executive Officer of Immunomedics. “The
issues related to approvability in the CRL were exclusively focused
on Chemistry, Manufacturing and Control matters and no new clinical
or preclinical data need to be generated. We are going to request a
meeting with the FDA as soon as possible to gain a full
understanding of the Agency’s requirements and timelines for
approval and we will work closely with the FDA with the goal of
bringing this important medicine to patients as soon as
possible.”
Conference CallThe Company will
host a conference call and live audio webcast tomorrow, January 18,
2019 at 8:00 am Eastern Time to discuss the CRL. To access the
conference call, please dial (877) 303-2523 or (253) 237-1755 using
the Conference ID 4978574. The conference call will be a webcast
via the Investors page on the Company’s website at
https://immunomedics.com/investors/. Approximately two hours
following the live event, a webcast replay of the conference call
will be available on the Company’s website for approximately 30
days.
About ImmunomedicsImmunomedics
is a clinical-stage biopharmaceutical company developing monoclonal
antibody-based products for the targeted treatment of cancer.
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 expectations for
the timing of the CRL resubmission, potential approval and
commercial launch of sacituzumab govitecan and the Company’s
development of sacituzumab govitecan for additional indications,
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 reliance
on third-party relationships and outsourcing arrangements (for
example in connection with manufacturing, logistics and
distribution, and sales and marketing) over which it may not always
have full control, including the failure of third parties on which
the Company is dependent to meet the Company’s business and
operational needs for investigational or commercial products and,
or to comply with the Company’s agreements or laws and regulations
that impact the Company’s business; the Company’s ability to meet
post-approval compliance obligations; imposition of significant
post-approval regulatory requirements on our product candidates,
including a requirement for a post-approval confirmatory clinical
study, or failure to maintain or obtain full regulatory approval
for the Company’s product candidates, if received, due to a failure
to satisfy post-approval regulatory requirements, such as the
submission of sufficient data from a confirmatory clinical study;
the uncertainties inherent in research and development; safety and
efficacy concerns related to the Company’s products and product
candidates; uncertainties in the rate and degree of market
acceptance of products and product candidates, if approved;
inability to create an effective direct sales and marketing
infrastructure or to partner with third parties that offer such an
infrastructure for distribution of the Company’s product
candidates, if approved; inaccuracies in the Company’s estimates of
the size of the potential markets for the Company’s product
candidates or limitations by regulators on the proposed treatment
population for the Company’s products and product candidates;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of the Company’s products and product candidates; 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
litigation to which the Company is or may become a party, including
the cost and potential reputational damage resulting from such
litigation; loss of key personnel; 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.
Investor
Contact:Dr. Chau Cheng(973)
531-9123ccheng@immunomedics.com |
Media
Contact:Lauren Wood(973)
531-9287lwood@immunomedics.com |
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