Immunomedics stock is taking a beating on Friday after receiving a response from the U.S. Food and Drug Administration (FDA) concerning one of its drugs.
Immunomedics (NASDAQ:IMMU) notes that it has received a Complete Response Letter from the FDA in response to its request for “accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer.”
The bad news here for Immunomedics stock is what a Complete Response Letter from the FDA means. This is what the government agency sends out to companies when it has decided that the application is not ready for approval.
Here is the response from Immunomedics President and CEO Michael Pehl to the Complete Response Letter from the FDA.
“We believe in sacituzumab govitecan’s potential to be a viable treatment option for these patients. The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated. We are going to request a meeting with the FDA as soon as possible to gain a full understanding of the Agency’s requirements and timelines for approval and we will work closely with the FDA with the goal of bringing this important medicine to patients as soon as possible.”
Despite the positive outlook on the matter from the company’s President and CEO, investors still weren’t happy with the news. This caused IMMU stock to fall by 26% as of Friday afternoon.
As of this writing, William White did not hold a position in any of the aforementioned securities.