Shares of Immunomedics (NASDAQ:IMMU) rose nearly 12% last month, according to data provided by S&P Global Market Intelligence. The $5 billion biopharma announced fiscal first-quarter and full-year 2018 financial results, although as a pre-commercial company, investors were more interested in the business updates provided.
The company filed a biologics license application (BLA) for its lead drug candidate, an antibody drug conjugate (ADC) called sacituzumab govitecan, which in December 2017 reported promising phase 2 data as a treatment for metastatic triple-negative breast cancer (mTNBC). The application will receive priority review from the U.S. Food and Drug Administration and has a PDUFA date scheduled for Jan. 18, 2019, which is when regulators will decide the drug's commercial fate.
It's a good start, but Immunomedics thinks the market opportunity for the drug could be pretty large. The BLA up for review asks regulators to consider using sacituzumab govitecan as a treatment for mTNBC patients who've failed to respond to at least two prior therapies. But the drug is also being investigated as a potential first-line treatment, meaning the first drug a patient would receive after diagnosis, in combination with a drug from AstraZeneca. Then there's another combination regimen being investigated with Clovis Oncology. And another for patients who have failed to respond to a checkpoint inhibitor drug. That doesn't even include the company's plans to evaluate the drug's ability to treat other solid tumor cancers.
The company is well on its way to transitioning into a commercial-stage operation. A recent $300 million capital raise will help should sacituzumab govitecan receive U.S. FDA approval in early 2019, and there's plenty of momentum building in the clinic. While investors shouldn't get too carried away with this biopharma stock considering its $5 billion valuation prices in a lot of success, it may be one to keep an eye on.