On Friday, shares of Immunomedics (IMMU) closed up by over 20% after the company announced that it was given Breakthrough Therapy Designation for a Breast Cancer drug. The company’s drug is known as sacituzumab govitecan, or IMMU-132. More specifically the company is developing for a type of breast cancer known as Triple-negative Breast Cancer — TNBC. 

Triple-negative breast cancer is a type of breast cancer that occurs because it doesn’t express a particular type of gene. Such genes that are excluded in TNBC are: 

  • Estrogen Receptor
  • Progesterone Receptor
  • HER2/NEU
  • In order for patients to quality for this trial and be able to take this drug they have to meet one requirement. That requirement is that they had to have failed at least two other prior therapies with metastatic disease in order to be eligible to receive the drug. 

    It was not an easy task to obtain Breakthrough Therapy Designation from the FDA, and the company had to submit phase 2 trial data in which patients failed a median of 5 prior therapies before entering the study. Breakthrough Therapy Designation gives priority review to the drug in question. That means instead of a company having to wait 10 to 12 months for a drug review they only need wait 3 to 4 months after NDA submission. 

    IMMU-132 is not a one hit wonder drug either. It is currently being tested in other advanced cancers such as: Non-small cell lung cancer, small-cell lung cancer, and urothelial cancers. This scope of multiple clinical trials provides for a reduced investment risk profile. This is because there are multiple shots on goal to get the product right and reduce investor risk. 

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