Protagonist Therapeutics Advances Key Drug Candidate with European Regulatory Submission

Protagonist Therapeutics US74366E1029

Protagonist Therapeutics Inc. saw its shares close at $58.86 on Friday, registering a decline of 1.37%, despite a significant corporate development. On the same day, Johnson & Johnson submitted a marketing authorization application to the European Medicines Agency (EMA) for icotrokinra, an oral treatment for moderate-to-severe plaque psoriasis.

This European filing represents the second major regulatory step for the drug candidate, following a submission to the U.S. Food and Drug Administration (FDA) that was completed in July. Both applications are supported by a robust clinical data package derived from four separate Phase 3 trials within the ICONIC development program. The studies successfully met all primary and co-primary endpoints, demonstrating that the once-daily oral therapy offers significant skin clearance and is well-tolerated by patients.