CYDY - Immunomedics Gets Early FDA Approval - Path To Profitability Still Treacherous
Immunonmedics (NASDAQ: IMMU) received regulatory approval from the FDA for Trodelvy (sacituzumab govitecan) for the treatment of metastatic Triple-Negative Breast Cancer (mTNBC) for patients that have had at least 2 prior therapies. The PDUFA date was June 2nd so this action is much earlier than expected. The company's journey to approval has not been easy. Over a year ago they received a Complete Response Letter ((CRL)) citing the Chemistry, Manufacturing and Control issues. Recently IMMU's confirmatory ASCENT study was stopped early by the Data Safety Monitoring Committee (DSMC) after it validated the safety of IMMU's