The decision had been expected on the PDUFA date of June 2nd, so the announcement took investors and analysts by surprise.
Previously, in January 2019, IMMU received a CRL (complete response letter) from the FDA on its first filing attempt seeking accelerated approval for the drug.
“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” said Michael Pehl, President and CEO of Immunomedics at the time.
Following the latest news Piper Sandler’s Joseph Catanzaro bumped his IMMU price target up from $30 to $40 and reiterated his buy rating on the stock.
Although the FDA approval includes a black box warning for neutropenia (a low level of neutrophils white blood cells) and diarrhea, Catanzaro believes that sacituzumab is now a “massively de-risked asset”- especially given the strong positive data from the recent confirmatory ASCENT trial.
Indeed, on April 7 Immunomedics announced that the independent Data Safety Monitoring Committee (DSMC) for the ASCENT trial unanimously recommended halting the trial due to compelling evidence of efficacy across multiple study endpoints.
Overall, IMMU scores a cautiously optimistic Moderate Buy analyst consensus on TipRanks with 4 recent buy ratings, 1 hold rating and 1 sell rating. The average analyst price target stands at $32 (45% upside potential). (See IMMU stock analysis on TipRanks)
Abbot Laboratories: COVID-19 Tests Will Drive Further Growth, 5-Star Analyst Raises Price Target
Oppenheimer: 3 Stocks That Are Worth a Close Look
Facebook Invests An Eye-Watering $5.7B in India’s Jio Platforms