Immunomedics Inc. (NASDAQ: IMMU) shares made a handy gain on Thursday after the company announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for its breast cancer treatment.
The BLA is seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease, as a complete class 2 response. The Prescription Drug User Fee Act (PDUFA) target action date of the resubmitted BLA is June 2, 2020.
Previously, the FDA awarded sacituzumab govitecan both Fast Track and Breakthrough Therapy Designations.
Triple-negative breast cancer is an aggressive disease with an annual incidence estimated to be about 40,000 people, roughly 15% of all breast cancer types, in the United States alone.
Dr. Behzad Aghazadeh, executive chair of Immunomedics, commented:
We are pleased that the FDA has accepted our resubmission, which was a top priority for us in 2019. We look forward to working closely with the FDA to facilitate their review of our BLA to enable us to bring this potentially transformational treatment to patients affected by mTNBC.
Shares of Immunomedics were last seen up about 7% at $21.88, in a 52-week range of $11.55 to $22.22. The consensus price target is $26.36.