Takeda Pharmaceutical

The FDA accepted Takeda's new drug application for zasocitinib under priority review with a target action date in Q1 2027 for adults with moderate-to-severe plaque psoriasis. Phase 3 trials showed strong efficacy (around 70% achieving clear or almost clear skin at week 16 versus ~11% for placebo) and statistical superiority to deucravacitinib on complete skin clearance. Approval, label restrictions, tolerability signals and payer access will determine commercial uptake and real-world revenue potential. » More on finance.yahoo.com

Takeda outlines a two-stage strategy emphasizing heavy pipeline investment and imminent launches (Horizon One), followed by a growth phase (Horizon Two). ORZEYFUL, the orexin agonist for narcolepsy type 1, received FDA approval and is awaiting DEA scheduling ahead of a planned US launch later this year. The selective TYK2 inhibitor zasocitinib has a PDUFA date of 13 March 2027 and is cited with peak sales potential of $3–6 billion for psoriasis/psoriatic arthritis; additional data on inflammatory bowel disease are expected by the end of fiscal 2024. R&D chief Andy Plump is retiring, Julie Kim is expected to shape future strategy; a more detailed update is scheduled for the capital markets day on 11 December in Tokyo. » More on de.investing.com

The FDA has accepted Takeda’s New Drug Application for Zasocitinib (TAK-279) to treat moderate-to-severe plaque psoriasis for priority review; the PDUFA target date is Q1 2027. The EMA has also accepted the marketing application. The submission is supported by two phase III trials in which around 70% of patients achieved nearly clear skin after 16 weeks; key endpoints were met and no new safety signals emerged. Takeda does not expect the submission to have a material impact on consolidated financial guidance for the fiscal year ending 31 March 2027. » More on de.investing.com