The stock of Immunomedics has climbed nearly 8 percent in the past week since it was picked up in the premium research service. The stock is a good contrarian pick & the shares have a more promising future.
Immunomedics’ sacituzumab has the capacity of changing the treatment paradigm of heavily-pretreated, refractory, metastatic triple-negative breast cancer, a disease with high unmet need.
Proprietary antibody-drug conjugate of Immunomedics, sacituzumab govitecan (which connects a humanized monoclonal antibody, that targets the human trophoblast cell-surface antigen 2, with SN-38, conjugated to the antibody by a cleavable linker; patent protection till 2033) has shown outstanding response rate of 33 percent with average duration of response of 7.7 months, rise in the overall survival of 11 months in metastatic and rise in progression-free survival, greater than the SOC i.e. the PFS of 5.5 months, heavily-pretreated triple-negative breast cancer, which is a disease with poor prognosis & high unmet need, resulting on Food and Drug Administration Breakthrough therapy designation (its effectiveness is substantially higher compared to Standard Of Care therapies, with suitable safety profile) (target market is nearly 8 thousand patients in the United States & 14 thousand patients in the European Union and Japan).
According to the news release, The Food and Drug Administration issued a thorough response letter, CRL, to sacituzumab’s BLA as a 3rd line or higher heavily-pretreated triple-negative breast cancer indication in January this year, referring to the manufacturing related issues (mainly at the New Jersey-based facility where the antibody is produced). The problems related to the approvability in the CRL were wholly focused on Manufacturing, Chemistry, and Control matters and no novel clinical or preclinical data need to be generated. In combination with the Chief Executive Officer’s departure in February, the stock has declined from its peak consequently.