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JNJ Seeks EU Approval for Oral Psoriasis Drug Icotrokinra
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Key Takeaways
JNJ submitted an EMA filing for icotrokinra to treat plaque psoriasis in adults and pediatric patients.
Four phase III ICONIC studies met primary and co-primary endpoints with positive results.
Treatment showed significant skin clearance and favorable safety with once-daily oral dosing.
Johnson & Johnson (JNJ - Free Report) has submitted a regulatory filing to the European Medicines Agency (EMA) to seek approval for its investigational oral peptide, icotrokinra, to treat moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 years and above.
The regulatory filing in Europe was based on data from four phase III studies, ICONIC-LEADa, ICONIC-TOTALb and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 — all part of the ICONIC clinical development program, which evaluated icotrokinra for the given indication.
All four studies met all primary and co-primary endpoints, wherein treatment with icotrokinra demonstrated significant skin clearance and a favorable safety profile with once-daily oral dosing in adults and adolescents with moderate-to-severe plaque psoriasis.
A similar filing for icotrokinra was submitted in the United States in July.
JNJ’s Price Performance
Year to date, shares of J&J have rallied 23.5% against the industry’s decline of 0.4%.
Image Source: Zacks Investment Research
JNJ's Recent Development Activities With Icotrokinra
Per management, icotrokinra has the potential to change the treatment landscape for plaque psoriasis and can position itself as the new standard in the treatment of the disease.
Icotrokinra is being jointly developed by J&J and Protagonist Therapeutics (PTGX - Free Report) under a license and collaboration agreement signed in 2017. Per the terms, J&J holds exclusive worldwide rights to develop the drug in phase II studies and beyond.
Besides plaque psoriasis, J&J and Protagonist are also exploring icotrokinra’s potential in other IL-23-mediated diseases, including psoriatic arthritis and ulcerative colitis.
Earlier this year, JNJ and PTGX reported positive results from the phase IIb ANTHEM-UC study, which evaluated icotrokinra in adults with moderately to severely active ulcerative colitis. The study met its primary endpoint of clinical response across all dose groups.
Icotrokinra is uniquely engineered to block the IL-23 receptor, a key driver of inflammation in plaque psoriasis, with potential applications in other IL-23-driven diseases.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share have moved up from $6.53 to $7.25. Earnings per share estimates for 2026 have increased from $7.07 to $7.74 during the same period. ANIP stock has soared 78.6% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share have moved up from $1.10 to $1.52. Earnings per share estimates for 2026 have increased from $1.46 to $2.12 during the same period. CRMD stock has surged 61.6% year to date.
CorMedix’s earnings beat estimates in each of the trailing four quarters, the average surprise being 34.85%.
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JNJ Seeks EU Approval for Oral Psoriasis Drug Icotrokinra
Key Takeaways
Johnson & Johnson (JNJ - Free Report) has submitted a regulatory filing to the European Medicines Agency (EMA) to seek approval for its investigational oral peptide, icotrokinra, to treat moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 years and above.
The regulatory filing in Europe was based on data from four phase III studies, ICONIC-LEADa, ICONIC-TOTALb and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 — all part of the ICONIC clinical development program, which evaluated icotrokinra for the given indication.
All four studies met all primary and co-primary endpoints, wherein treatment with icotrokinra demonstrated significant skin clearance and a favorable safety profile with once-daily oral dosing in adults and adolescents with moderate-to-severe plaque psoriasis.
A similar filing for icotrokinra was submitted in the United States in July.
JNJ’s Price Performance
Year to date, shares of J&J have rallied 23.5% against the industry’s decline of 0.4%.
Image Source: Zacks Investment Research
JNJ's Recent Development Activities With Icotrokinra
Per management, icotrokinra has the potential to change the treatment landscape for plaque psoriasis and can position itself as the new standard in the treatment of the disease.
Icotrokinra is being jointly developed by J&J and Protagonist Therapeutics (PTGX - Free Report) under a license and collaboration agreement signed in 2017. Per the terms, J&J holds exclusive worldwide rights to develop the drug in phase II studies and beyond.
Besides plaque psoriasis, J&J and Protagonist are also exploring icotrokinra’s potential in other IL-23-mediated diseases, including psoriatic arthritis and ulcerative colitis.
Earlier this year, JNJ and PTGX reported positive results from the phase IIb ANTHEM-UC study, which evaluated icotrokinra in adults with moderately to severely active ulcerative colitis. The study met its primary endpoint of clinical response across all dose groups.
Icotrokinra is uniquely engineered to block the IL-23 receptor, a key driver of inflammation in plaque psoriasis, with potential applications in other IL-23-driven diseases.
JNJ's Zacks Rank & Other Key Picks
J&J currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) and CorMedix (CRMD - Free Report) , each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share have moved up from $6.53 to $7.25. Earnings per share estimates for 2026 have increased from $7.07 to $7.74 during the same period. ANIP stock has soared 78.6% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share have moved up from $1.10 to $1.52. Earnings per share estimates for 2026 have increased from $1.46 to $2.12 during the same period. CRMD stock has surged 61.6% year to date.
CorMedix’s earnings beat estimates in each of the trailing four quarters, the average surprise being 34.85%.