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(NASDAQ:IMMU) (“Immunomedics” or the “Company”), a science-based and innovation-focused biopharmaceutical company committed to the development and worldwide commercialization of its unique and proprietary antibody-drug conjugate (ADC) platform, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) 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. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of mTNBC.
“The treatment of TNBC clearly represents an area of high unmet medical need and there are currently only very limited treatment options for mTNBC patients,” said Michael Pehl, President and Chief Executive Officer. “Further, the BLA submission of sacituzumab govitecan represents a significant milestone for Immunomedics on our path to unlock the future promise of our unique ADC platform for patients and healthcare professionals. We greatly thank the patients that participated in our trials along with their caregivers, and look forward to working closely with the FDA.”
The filing is based on Phase 1/2 data of sacituzumab govitecan in mTNBC.
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 anticipated filing timeline for the BLA, 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.
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Investors:Dr. Chau ChengSenior Director, Investor Relations & Corporate Secretary(973) 605-8200, extension email@example.com