Immunomedics, Inc. (NASDAQ: IMMU) is having a relatively strong start to the trading session this morning, and for good reason. The company announced that the FDA has accepted its Biologics License Agreement, leading to excitement among investors and sending the stock screaming for the top. Today, we’ll talk about:
- The acceptance of the Biologics License Application;
- what we’re seeing from IMMU as a result; and
- what we’ll be watching for ahead.
IMMU Announces BLA Acceptance
As mentioned above, Immunomedics is having a relatively strong start to the trading session this morning after announcing regulatory news. In a press release issued early this morning, the company announced that the United States Food and Drug Administration has accepted its Biologics License Application (BLA) for filing. The company also announced that the FDA has granted Priority Review surrounding sacituzumab govitecan for the treatment of patients with triple-negative breast cancer (mTNBC) who have previously received at least two prior lines of therapy for metastatic disease.
The IMMU said that the PDUFA target action date for the BLA is January 18,2019. If the company does achieve approval, the treatment will be the first and only ADC approved for the treatment of mTNBC. In a statement, Michael Pehl, President and CEO at IMMU, had the following to offer:
We are delighted that the FDA has accepted the sacituzumab govitecan BLA for Priority Review… We will continue to work closely with the regulatory agency as we strive to bring this potential new treatment to mTNBC patients expeditiously.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of IMMU, the news proved to be overwhelmingly positive. After all, the acceptance of the BLA further validates the company’s work with regard to sacituzumab govitecan and sets the stage for a potential approval in January. So, it’s no surprise that excited investors are pushing the stock upward in the market this morning. At the moment (9:34), IMMU is trading at $26.07 per share after a gain of $0.67 per share or 2.64% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on IMMU. In particular, we’re interested in following the story surrounding the company’s continued work to bring sacituzumab govitecan to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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