No box warning set to leave Bristol’s Sotyktu in the black

The US approval of Bristol Myers Squibb’s Tyk2 inhibitor deucravacitinib, now branded Sotyktu, will almost certainly put pressure on the rival oral psoriasis product Otezla given Sotyktu's better-than-expected label. There had been concerns that, with Tyk2 a member of the Jak family, the FDA might have taken an ultra-cautious view on safety; however, the much-feared black box warning and onerous testing requirements did not emerge, and many are predicting that Sotyktu could dominate the oral market for new psoriasis patients soon after its September launch, notwithstanding its $75,000 list price. The wider significance of Sotyktu’s approval is the potential shift towards more efficacious oral psoriasis options and the validation of Tyk2 as a target. Other Tyk2 inhibitors waiting in the wings include Nimbus’s NDI-034858 and Ventyx’s VTX958; the latter's stock soared 69% today. Privately held Nimbus, which today raised $125m, has the next most-advanced Tyk2 inhibitor, in phase 2, but has previously reported issues with neutropenia, lipid abnormalities and CPK elevation. Meanwhile, developers of other oral psoriasis options outside Tyk2, such as Dice Therapeutics and Immunic, saw their stock sink.