TAKEDA PHARMACEUTICAL CO LTD (TAK) Form 6-K — Sep 14, 2026
Takeda announced that the U.S. FDA accepted its New Drug Application for zasocitinib (TAK-279), an investigational once-daily oral TYK2 inhibitor, under Priority Review for moderate-to-severe plaque psoriasis. The PDUFA target action date is in the first quarter of calendar year 2027. The filing is supported by two pivotal Phase 3 LATITUDE studies in nearly 3,000 patients in which all primary and ranked secondary endpoints were met.
Key figures
- Dosing
- 30 mg once-daily oral pill
- Phase3 countries
- 21
- Patients supporting NDA
- nearly 3,000
- LATITUDE 3001 enrollment
- 693
- LATITUDE 3002 enrollment
- 1108
- LATITUDE 3003 enrollment
- approximately 2,100
- Pdufa target action date
- Q1 calendar 2027
- Tyk2 selectivity in vitro
- more than 1-million-fold greater selectivity for TYK2 vs other JAK enzymes
- Most common adverse events
- upper respiratory tract infection 10.1%, nasopharyngitis 6.2%, acne 6.5%
- PASI75 week16 LATITUDE 3001
- 76% zasocitinib vs 12% placebo vs 37% apremilast
- PASI90 week16 LATITUDE 3001
- 61% zasocitinib vs 5% placebo vs 17% apremilast
- Global psoriasis prevalence
- 66.4 million people
- S PGA 0 1 week16 LATITUDE 3001
- 71% zasocitinib vs 11% placebo vs 32% apremilast (p<0.001)
- S PGA 0 1 week16 LATITUDE 3002
- 69% zasocitinib vs 13% placebo vs 30% apremilast (p<0.001)
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