Why Is Protagonist Therapeutics Stock Trading Higher On Monday?

On Monday, Protagonist Therapeutics, Inc. PTGX announced topline results from ANTHEM-UC Phase 2b study of icotrokinra (JNJ-2113) in adults with moderately to severely active ulcerative colitis (UC).

The study conducted by Protagonist’s collaboration partner, Johnson & Johnson, met its primary endpoint of clinical response in all icotrokinra dose groups evaluated.

Additionally, the study demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at Week 12.

• All three doses of once daily icotrokinra met the primary endpoint of clinical response at Week 12.
• At Week 12, patients treated with the highest dose of icotrokinra achieved a response rate of 63.5% versus 27.0% for placebo.
• 30.2% of patients treated with the highest dose of icotrokinra demonstrated clinical remission at Week 12, compared to 11.1% of patients who received placebo.
• Clinical remission and response rates continued to improve through Week 28.

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On Saturday, Johnson & Johnson JNJ released new icotrokinra data from its comprehensive Phase 3 program in adults and adolescents 12 years and older with moderate-to-severe plaque psoriasis (PsO).

Data from the Phase 3 ICONIC-LEADa study, presented at the 2025 American Academy of Dermatology Annual Meeting, show once daily icotrokinra demonstrated significant skin clearance and a favorable safety profile.

In the ICONIC-LEAD study, nearly two-thirds (65%) of patients treated with once daily icotrokinra achieved an Investigator’s Global Assessment (IGA)b score of 0/1 (clear or almost clear skin) and 50% achieved a Psoriasis Area and Severity Index (PASI)c 90 response, compared to 8% and 4% receiving placebo, respectively (P<0.001 for both endpoints) at Week 16.

Continued skin clearance improvement was reported at Week 24. Up to 74% of patients treated with icotrokinra achieved IGA 0/1 and 65% achieved PASI 90.

At Week 24, nearly half of the patients treated with icotrokinra achieved completely clear skin – 46% reached IGA 0, and 40% reached PASI 100.

Similar proportions of patients experienced adverse events (AEs) between icotrokinra (49%) and placebo groups (49%), with no new safety signals identified.

Additionally, topline results show that the Phase 3 ICONIC-ADVANCE 1&2e studies met their co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16.

Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to Bristol-Myers Squibb & Co’s BMY Sotyktu deucravacitinib in patients with moderate-to-severe plaque PsO.

Johnson & Johnson is initiating the Phase 3 ICONIC-ASCENDg study, a head-to-head study of an oral pill, icotrokinra, compared to an injectable biologic, Stelars (ustekinumab).

Price Action: PTGX stock is up 35.9% at $52.42. JNJ stock is up 0.54% at $167.59 during the premarket session at the last check Monday.

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