(RTTNews) - Shares of Immunomedics Inc. (IMMU) are declining 11% in Friday's morning trade.
Immunomedics' shares are currently trading at $9.48, down $1.17 or 10.99%, on the Nasdaq, on a higher-than average volume of 3.7 million shares.
There have been rumors in the air of a delay in upgrading a facility at Samsung Biologics, which was to produce commercial-scale quantities of the humanized antibody used in antibody-drug conjugate sacituzumab govitecan (IMMU-132).
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer.
Meanwhile, reports also suggest that the delay is due to Immunomedics not receiving approval from FDA for its sacituzumab govitecan.
Sacituzumab govitecan is the company's lead drug candidate. The drug is in development for metastatic triple-negative breast cancer (mTNBC) advanced urothelial cancer (UC) and metastatic non-small cell lung cancer.
In January of this year, the FDA refused to approve Sacituzumab govitecan proposed for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior treatments due to issues related to Chemistry, Manufacturing and Control matters. The company has resubmitted the application, which is currently under FDA review with an action date of June 2.