NEWARK, Calif. - Protagonist Therapeutics Inc. (NASDAQ:PTGX) presented one-year Phase 3 data for ICOTYDE (icotrokinra) at the 2026 American Academy of Dermatology Annual Meeting on Friday, according to a company press release.
The data from the ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies showed results for the oral treatment in patients with moderate-to-severe plaque psoriasis. ICOTYDE is an oral peptide designed to block the IL-23 receptor.
In the ICONIC-ADVANCE studies, rates of PASI 100, which measures complete skin clearance, increased from Week 24 to Week 52 in patients taking ICOTYDE. Patients who switched from placebo to ICOTYDE at Week 16 achieved similar rates of complete skin clearance by Week 52 as those treated continuously for 52 weeks. No new safety signals were identified through Week 52.
In the ICONIC-LEAD study involving adolescents, nearly 60% of patients treated with ICOTYDE achieved completely clear skin at one year, and 86% achieved PASI 90. Of those achieving PASI 90, 92% maintained that response from Week 24 to Week 52.The positive clinical data has contributed to PTGX's strong market performance, with shares delivering a 102% return over the past year and currently trading near their 52-week high of $105.69.
ICOTYDE is approved in the U.S. for treating moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older weighing at least 40 kg. The treatment is taken once daily.
The drug was jointly discovered by Protagonist and Johnson & Johnson scientists. Under a 2017 license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company, Johnson & Johnson is responsible for commercial activities for ICOTYDE.
Protagonist is eligible to receive 6-10% tiered royalties on worldwide net sales and additional regulatory and sales milestone payments of up to $580 million. The approval of ICOTYDE triggered a $50 million milestone payment to Protagonist.
Despite the promising pipeline, InvestingPro analysis suggests the stock is currently overvalued relative to its Fair Value estimate.
ICOTYDE is currently in Phase 3 studies for psoriatic arthritis, ulcerative colitis, and Crohn's disease.
In other recent news, Protagonist Therapeutics has seen significant developments following the FDA approval of its drug, Icotyde (icotrokinra), for the treatment of moderate-to-severe plaque psoriasis. This approval, which came earlier than expected, has led several analyst firms to adjust their price targets for the company. Clear Street increased its price target to $104 while maintaining a Buy rating, citing the FDA approval as a key factor. Barclays also raised its price target to $119 and maintained an Overweight rating, noting that the approval was ahead of their expectations. Jefferies followed suit, raising its price target to $121 and maintaining a Buy rating, describing Icotyde as a first-in-class and only-in-class oral IL23R peptide. Additionally, Truist Securities reiterated a Buy rating with a $110 price target, highlighting the regulatory approval as a pivotal moment for Protagonist Therapeutics as it transitions to a commercial company. The drug, developed in partnership with Johnson & Johnson, will be commercialized under a collaboration agreement established in 2017.