Takeda Pharmaceutical

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. » Más en 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. » Más en de.investing.com

The FDA has approved Mimrylo (active ingredient rusfertid) from Takeda for the treatment of erythrocytosis in adults with polycythaemia vera. The decision is based on the phase‑III VERIFY study with 293 patients, in which 76.9% of treated patients showed a clinical response between weeks 20 and 32 and reduced hematocrit levels, fewer phlebotomies, and relief of fatigue were documented. Mimrylo is administered once weekly subcutaneously; common adverse events were injection‑site reactions (56%) and anemia (16%). Takeda holds the exclusive global development and commercialization rights and does not expect an impact on consolidated guidance for the fiscal year. » Más en de.investing.com