Immunomedics Inc. (NASDAQ: IMMU) shares more than doubled on Monday after the company provided a few updates. First, Immunomedics halted a late-stage breast cancer study early due to compelling efficacy. Also, the board of directors appointed a new chief executive officer, effective mid-April.
The company announced that its Phase 3 confirmatory Ascent study was halted as the result of compelling efficacy. This decision was based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC), during its recent routine review of the study.
Some quick background: Ascent is a Phase 3 confirmatory study designed to validate the promising safety and efficacy data of sacituzumab govitecan observed in a Phase 2 study of heavily pretreated patients with metastatic triple negative breast cancer (mTNBC). The primary endpoint for the study is progression-free survival, and secondary endpoints include overall survival and objective response rate, among others.
The U.S. Food and Drug Administration (FDA) is currently reviewing a biologics license application resubmission seeking accelerated approval of sacituzumab govitecan for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease. A PDUFA target action date is set for June 2, 2020. The FDA previously granted Breakthrough Therapy Designation for sacituzumab govitecan in this disease setting.
The board of directors also has appointed Harout Semerjian as president and CEO, as well as a member of the board, effective April 16, 2020.
Most recently, Semerjian served as executive vice president, chief commercial officer at Ipsen, where he was accountable for the worldwide commercialization and portfolio strategy across oncology, neurosciences and rare diseases, as well as leading specialty operations across Europe and International markets, overseeing 2,200 employees in over 30 countries.
Semerjian commented:
I am honored and excited to be joining Immunomedics at this critical time. The Company has a unique antibody-drug conjugate platform and I share the Board’s belief that sacituzumab govitecan has the potential to offer cancer patients a viable treatment option, as demonstrated in recent clinical studies in triple-negative breast cancer, urothelial cancer and hormone-receptor positive/HER2-negative breast cancer. I look forward to working closely with the Board and the leadership team to bring this potentially transformative drug to cancer patients worldwide.
Immunomedics stock traded up about 102% to $19.06 on Monday, ina 52-week range of $8.80 to $22.22. The consensus price target is $23.55.
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