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FDA Grants Priority Review to Zasocitinib for Psoriasis
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Fusion42 · 16 September 2026 · Fusion42 review
The FDA has granted priority review to zasocitinib, an oral TYK2 inhibitor, for moderate-to-severe plaque psoriasis in adults, with a regulatory decision expected in Q1 2027. The approval bid is supported by two large phase 3 trials showing superior efficacy over apremilast and placebo, with no new safety concerns.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 14 Sep 2026 and 16 Sep 2026.
◆ ◆ The Wire takeaway
You face a new oral alternative to injectable biologics that is moving fast toward US approval. This shifts competitive pressure on psoriasis treatments and opens market access for patient-friendly options without injectables.
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2 sources · first reported 14 Sep 2026 · latest 16 Sep 2026
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