Overview
- Two pivotal studies met co-primary goals (PASI 75 and sPGA 0/1) at week 16 and all 44 ranked secondary endpoints, showing superiority over placebo and Amgen’s Otezla.
- More than half of patients achieved clear or almost clear skin by week 16 and about 30% reached complete clearance, with responses continuing to improve through week 24.
- The once-daily TYK2 inhibitor was generally well tolerated; common side effects included respiratory tract infections, colds/nasopharyngitis, and acne.
- The molecule was identified with help from AI at Nimbus Therapeutics and was acquired by Takeda for $4 billion upfront, with additional milestone potential.
- Takeda is running a head-to-head study against Bristol Myers Squibb’s Sotyktu and trials in psoriatic arthritis and IBD, and it projects peak annual sales of $3–6 billion if approved.