Immunomedics Jumps Almost 30% In After-Hours On FDA Approval [Yahoo! Finance News]
IMMUNOMEDICS (IMMU)
Last immunomedics earnings: 2/27 04:00 pm
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US:NASDAQ Investor Relations:
immunomedics.com/2017/immunomedics-announces-presentations-investor-event-2017-san-antonio-breast-cancer-symposium
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Source: Yahoo! Finance News
Shares in biopharma Immunomedics IMMUThe decision had been expected on the PDUFA date of June 2ndPreviously, 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’sJoseph CatanzaroAlthough 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 hal
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