Immunomedics, Inc. IMMU shares were plunging Friday following an adverse regulatory development.
What Happened
Immunomedics announced Thursday after the market close the FDA issued a complete response letter for its BLA for sactuzumab govitecan, its investigational candidate for metastatic triple-negative breast cancer, or TNBC, in patients who have previously received at least two prior therapies.
"We believe in sacituzumab govitecan's potential to be a viable treatment option for these patients," CEO Michael Pehl said in a statement.
The issues outlined by the FDA relate to chemistry, manufacturing and control, and the agency has not required new clinical or pre-clinical data, the company said.
Why It's Important
Sacituzumab govitecan is Immunomedics' lead antibody drug conjugate. The candidate has a Breakthrough Therapy Designation from the FDA for TNBC and was reviewed under the accelerated approval pathway.
The approval, which was initially expected to come through Jan. 18, will now be delayed.
The setback follows a failed licensing and collaboration deal for sacituzumab govitecan with Seattle Genetics, Inc. SGE way back in May 2017.
In December, it was revealed that Immunomedics was taken to task by the FDA for a number of violations, including a data breach at its New Jersey manufacturing facility.
What's Next
Immunomedics said it plans to request a meeting with the FDA to get a full understanding of its requirements and timelines for approval.
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