Ready to de­clare a de­fin­i­tive come­back in two months, Im­munomedics stops PhI­II ear­ly, re­cruits new CEO

More than a year ago, hit by a sur­prise com­plete re­sponse let­ter from the FDA, Im­munomedics bid its then-CEO, Michael Pehl, adieu and be­gan a 15-month quest to re­solve the man­u­fac­tur­ing is­sues cit­ed in the CRL and seek a new leader — all the while mov­ing for­ward with a Phase III study on its lead drug for metasta­t­ic triple-neg­a­tive breast can­cer.

To­day the biotech said their stars are fi­nal­ly align­ing. Not on­ly is No­var­tis On­col­o­gy vet Harout Se­mer­jian com­ing on board as CEO to steer what they be­lieve will be a smooth sail to a new PDU­FA date in June, Im­munomedics has al­so been in­formed that their late-stage tri­al can be stopped ear­ly due to “com­pelling ev­i­dence of ef­fi­ca­cy.”

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