Alumis’s genomic research guided its development of envudeucitinib, a TYK2 inhibitor that some analysts now view as best in class. The Phase 3 results that will support a planned FDA submission in plaque psoriasis are scheduled for presentation this weekend during the American Academy of Dermatology annual meeting in Denver.
FDA approval of Icotyde covers the treatment of adults and adolescents with moderate-to-severe plaque psoriasis. This once-daily pill, developed by partners Johnson & Johnson and Protagonist Therapeutics, offers an easier dosing option compared to injectables and is projected to become a blockbuster seller across several immunological indications.
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Takeda said more than half of plaque psoriasis patients treated with zasocitinib achieved clear or almost clear skin in two Phase 3 studies. Regulatory submissions for the TYK2 inhibitor are planned for 2026 and clinical trials are ongoing in other indications.
By acquiring Dermavant, Organon gets Vtama, a drug approved for treating plaque psoriasis. An FDA decision for the topical cream in atopic dermatitis is expected by the end of 2024.
Ventyx Biosciences is stopping work on its lead drug candidate in plaque psoriasis and psoriatic arthritis. Despite achieving the goals of its Phase 2 test in psoriasis, the results are short of those achieved by big pharmaceutical companies with molecules that address the same target.
FDA approval of UCB’s Bimzelx gives the Belgian drugmaker a contender in the crowded plaque psoriasis therapies market. In the rare disease generalized myasthenia gravis, the agency approved Zilbrysq, a UCB drug with advantages over two blockbuster AstraZeneca drugs addressing the same target.
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Johnson & Johnson’s oral psoriasis drug met the goals of a mid-stage clinical study, and the pharma giant now plans to advance the twice-daily pill to Phase 3 testing. J&J is one of several biopharmaceutical companies developing pill alternatives to biologic drugs that are injected or infused.
Eli Lilly’s acquisition of Dice Therapeutics comes eight months after the biotech reported positive data from a Phase 1 study in psoriasis. Dice develops oral small molecule drugs intended to offer alternatives to biologic drugs that are injected or infused.
Takeda Pharmaceutical drug TAK-279 achieved the main goal of a mid-stage clinical trial in plaque psoriasis, setting the stage for Phase 3. The Japanese pharmaceutical giant sees the small molecule as complementary to its top-selling product, the blockbuster inflammatory bowel disorder drug Entyvio, and competitive against Bristol Myers Squibb's Sotyktu.
The FDA approved Arcutis Biotherapeutics drug Zoryve, a topical treatment for plaque psoriasis. With the decision, the company will proceed with a pricing strategy it believes will speed up insurance coverage and patient adoption of the new treatment for the chronic inflammatory skin disorder.
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.