$TAK · TAKEDA PHARMACEUTICAL CO LTD
Takeda announced the FDA accepted its New Drug Application for zasocitinib (TAK-279) under Priority Review for moderate-to-severe plaque psoriasis. The PDUFA target action date is Q1 2027. The filing is supported by Phase 3 LATITUDE data across nearly 3,000 patients showing ~70% sPGA 0/1 at week 16 and superiority across all 44 ranked secondary endpoints versus placebo and apremilast. The EMA has also accepted the MAA for European review.
- FDA accepted the NDA for zasocitinib under Priority Review with a PDUFA target action date in Q1 2027.
- Phase 3 LATITUDE trials showed ~70% of patients achieved clear or almost clear skin (sPGA 0/1) at week 16.
- Zasocitinib demonstrated superiority vs placebo and apremilast across all 44 ranked secondary endpoints in both pivotal studies.
- The EMA also accepted Takeda's MAA for zasocitinib, initiating the European review process.
- Takeda stated the NDA filing has no significant impact on the FY ending March 31, 2027 consolidated financial forecast.
Extended-hours trading shows TAK at $18.51, up +1.37% vs the regular close of $18.26, indicating a modest positive reaction to the Priority Review acceptance.
Zasocitinib represents a potential blockbuster oral therapy in the large psoriasis market, with Phase 3 data suggesting best-in-class efficacy that could challenge Bristol Myers Squibb's Sotyktu.
The oral TYK2 inhibitor class is a growing segment in the psoriasis market, with Bristol Myers Squibb's Sotyktu (deucravacitinib) as the first approved. Zasocitinib's 1-million-fold selectivity for TYK2 over JAK1/2/3 could differentiate it on safety.
Zasocitinib remains investigational and has not been approved by any regulatory authority; clinical success does not guarantee commercial success. Competitive pressures exist from other oral TYK2 inhibitors and biologics in the psoriasis market.
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