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

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. » More on de.investing.com

The FDA has approved Orzeyful (Oveporexton) from Takeda for the treatment of narcolepsy type 1 in adults. Orzeyful is an oral orexin receptor-2 agonist; the approval is based on two phase‑III studies (FirstLight, RadiantLight) showing significant improvements in daytime sleepiness, cataplexy and quality of life. Common adverse effects were insomnia, increased urination and increased salivation; the drug is contraindicated with strong CYP3A inhibitors. The DEA is still reviewing the controlled-substance scheduling; once that process is complete, dispensing will be via specialty pharmacies. Takeda does not expect a material impact on consolidated financial guidance for the fiscal year ending 31.03.2027. » More on de.investing.com