Shares of pharmaceutical company MacroGenics (NASDAQ: MGNX) have jumped premarket on Thursday after the company said that the US Food and Drug Administration (FDA) has approved its breast cancer drug MARGENZA.
MacroGenics said that the drug has been approved in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer patients who have received two or more prior anti-HER2 regimes.
MARGENZA is the first product approved from MacroGenics’ pipeline with the approval based on safety and efficacy results from the company’s pivotal Phase 3 SOPHIA trial.
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“The approval of MARGENZA is an exciting milestone for MacroGenics and, more importantly, it brings a new treatment option to metastatic breast cancer patients,” commented Scott Koenig President and CEO of MacroGenics.
The product is set to launch in March 2021 with Koenig saying: “As we prepare for our first commercial launch and look forward to being able to deliver MARGENZA to patients, we continue to focus on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer with eight product candidates currently in clinical development.”
MacroGenics shares are up 12.26% premarket following the news, trading at $27.75.