Immunomedics Inc. (NASDAQ: IMMU) shares were crushed on Friday after the firm received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). Usually, CRLs can spell disaster for a firm, and it takes a long time, as well as positive results, to fix this issue.
Specifically, the FDA issued a CRL for Immunomedics’ Biologics License Application (BLA) 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.
For some quick background: Immunomedics develops monoclonal antibody-based products for the targeted treatment of cancer. Also, sacituzumab govitecan is a key part of this firm’s pipeline.
Prior to the reaction from shareholders, this company had a market cap of $3.4 billion. Now its market cap is closer to $2.3 billion. While this reaction isn’t affecting the cash holdings of the firm, it will make it more difficult for Immunomedics to progress.
Michael Pehl, president and CEO of Immunomedics, commented:
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.
Shares of Immunomedics were last seen down 33% at $12.11, with a 52-week range of $12.86 to $27.33. The stock has a consensus analyst price target of $37.38.