Zasocitinib

During this year’s American Academy of Dermatology annual meeting in Denver, companies like Sanofi , Biogen and Tanabe Pharma presented data for their respective candidates. But there were other pharma companies that stood out with results from their previously toplined trials: 📊 Takeda’s Phase 3 plaque psoriasis data: Zasocitinib, which Takeda acquired for $4 billion in its 2022 deal with Nimbus Therapeutics, appears more efficacious than Bristol Myers Squibb’s similar drug Sotyktu (cross-trial caveats notwithstanding). In its two Phase 3 studies, zasocitinib saw 76% and 71% of patients, respectively, achieve skin clearance of at least 75% after 16 weeks. In the two studies Sotyktu used for its plaque psoriasis approval, the Bristol Myers drug helped 58.3% and 53% of patients reach the same level of skin clearance. Both zasocitinib and Sotyktu are oral, once-a-day TYK2 inhibitors. Takeda previously toplined the Phase 3 data in December and says it’s on track to file for FDA approval by March 31, 2027. Also notable were two secondary endpoints looking at 90% and 100% skin clearance after 16 weeks. Takeda said across the two studies, 61.3% and 51.9% of patients saw 90% skin clearance, while 33.4% and 25.2% of patients saw their psoriasis completely clear up. Takeda pitted zasocitinib directly against Amgen’s Otezla and placebo, with zasocitinib reaching statistically significant improvements against both comparator arms. 💊 Alumis also gets a plaque psoriasis win: Aiming to also compete with Sotyktu, Alumis revealed its own full Phase 3 data for an oral TYK2 drug. After 16 weeks, envudeucitinib saw 76.5% and 70.4% of patients, respectively, reach skin clearance of at least 75% . Those figures numerically stack up against Takeda’s reported data for zasocitinib (again, cross-trial caveats notwithstanding) and were statistically superior to placebo and Otezla. Secondary endpoints also fell in similar ranges. In Alumis’ two Phase 3 studies, 59.9% and 53.1% of patients reached skin clearance of 90%, while 29.4% and 27.7% of those who took envudeucitinib achieved full clearance of their psoriasis. Both endpoints were measured after 16 weeks of treatment. Alumis toplined the data in January and plans to file for FDA approval in the second half of 2026. 📊 Roivant touts autoimmune drug ahead of PDUFA: Roivant said the candidate it licensed from Pfizer showed “rapid and statistically significant reductions in itch,” and parallel improvements in skin-related quality of life in a Phase 3 trial for dermatomyositis. Roivant and its subsidiary Priovant announced last year that brepocitinib met its primary endpoint and all nine secondary endpoints. Leerink analysts said this weekend that the additional analyses, including itch reduction, “support our positive outlook on its commercial prospects.” The FDA is expected to make an approval decision in the third quarter of this year. 💊 Incyte unveils JAK1 extension data: Incyte said its drug povorcitinib for hidradenitis suppurativa showed “durable responses” in a 42-week extension period across two Phase 3 studies. Up to 71.4% of patients achieved HiSCR50, a key clinical endpoint that measures the improvement of patients’ skin condition from baseline. Stifel analysts noted that those responses mark a continued improvement from Week 24 data previously reported last year. “We look forward to advancing our regulatory applications in the US and Europe,” Incyte’s president and global head of R&D Pablo Cagnoni said.

iStock, designer491 AbbVie’s Skyrizi appears to have stronger efficacy than Johnson & Johnson’s newly approved pill Icotyde, as well as a less frequent dosing schedule that patients could prefer, according to analysts at BMO Capital Markets. AbbVie is ready to face off against the newest kid on the immunology block: Johnson & Johnson and Protagonist Therapeutics’ peptide pill Icotyde. The FDA gave the greenlight to Icotyde earlier this month, marking the first oral targeted therapy that blocks the IL-23 receptor and completely clears the skin of patients with plaque psoriasis. This puts the drug’s sponsors in direct competition with immuno stalwart AbbVie, which owns Skyrizi, a biologic therapy that also targets the IL-23 cascade. First approved in April 2019 for moderate to severe plaque psoriasis, Skyrizi has since become a cornerstone of AbbVie’s portfolio, growing into a $17.562 billion franchise in 2025 to help the pharma gracefully ride out the patent cliff of its mega-blockbuster Humira. The therapeutic antibody has also picked up several other indications, including Crohn’s disease and ulcerative colitis. Skyrizi was the industry’s fifth top-selling drug last year. Earnings Keytruda Hangs On to Best Seller Crown as GLP-1s Gain Ground Merck’s Keytruda will soon lose exclusivity, just as weight-loss giants Eli Lilly and Novo Nordisk press in with their blockbuster GLP-1s. March 4, 2026 · 9 min read · Tristan Manalac Read more “While Icotyde is expected to take share, Skyrizi is likely to remain a value driver for AbbVie across I&I,” analysts at BMO Capital Markets wrote in a note to investors on Friday afternoon after catching up with AbbVie management to clear up competitive concerns following Icotyde’s approval. “AbbVie does not underestimate competitive threats,” the note continued, “but is confident in the strength of Skyrizi.” Key to AbbVie’s confidence is the drug’s superior efficacy. At 16 weeks in the Phase 3 UltIMMa-1 and UltIMMa-2 studies, 70% to 73% of patients treated with Skyrizi saw a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores, a key tool used to assess disease severity, as compared with placebo. At the same follow-up, 36% to 49% saw a 100% PASI improvement, BMO added, meaning the complete resolution of lesions. In contrast, Icotyde achieved a 46% placebo-adjusted PASI-90 at 16 weeks in the late-stage ICONIC-LEAD trial, while roughly 27% achieved PASI-100, BMO reported. (In the absence of a direct head-to-head study, cross-trial comparisons are inconclusive.) Aside from an efficacy edge, Icotyde’s oral availability and daily dosing schedule could also work against it, the analysts continued. “Frequently dosed orals often bring adherence challenges with risk of reduced real-world efficacy,” they explained, noting that skipped doses could lower the drug’s therapeutic benefit. In turn, “providers and patients may favor longer-acting/durable therapies like Skyrizi,” which is administered subcutaneously every three months. Approvals J&J Wins FDA Nod for First Targeted Oral Anti-IL-23 Therapy for Plaque Psoriasis Icotyde, co-developed by Johnson & Johnson and Protagonist Therapeutics, is backed by data from the Phase 3 ICONIC program, which, among other advantages, showed significant superiority over Bristol Myers Squibb’s Sotyktu. March 18, 2026 · 2 min read · Tristan Manalac Read more Despite these key advantages for Skyrizi, “we remain positive on the commercial opportunity presented by Icotyde as the first and only oral IL-23 on the market,” BMO stated in its Friday note. J&J and Protagonist are also proposing Icotyde for psoriasis more broadly, an “already large” market that could unlock billions in opportunity for the drug. Peak psoriasis sales for the pill could hit $3.2 billion in 2040, the firm forecasted. Another plaque psoriasis player is Takeda, though the pharma is far behind AbbVie and J&J, with its TYK2 inhibitor zasocitinib still in Phase 3 development. Data from a pair of late-stage studies, presented Saturday at the American Academy of Dermatology Annual Meeting, showed that daily doses of zasocitinib induced clear or almost clear skin in 69.2% to 71.4% of patients, as compared with 10.7% to 12.6% of placebo comparators and 29.7% to 32.1% of those on Amgen’s Otezla. PASI-90 was likewise significantly higher in the zasocitinib arms versus placebo and Otezla. Takeda plans to zasocitinib’s approval during its fiscal year 2026, which starts on April 1.