- Immunomedics (NASDAQ:IMMU) has received a Complete Response Letter (CRL) from the FDA for its BLA seeking accelerated approval for 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.
- The Company will host a conference call today at 8:00 am ET to discuss the rejection.
- Shares, currently halted, will resume trading at 9:10 am ET.
- Update: Shares are down 35% premarket.