Takeda Pharmaceutical

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

Takeda presented strong clinical results from two phase-3 studies in plaque psoriasis: about 75% of patients with scalp psoriasis treated with zasocitinib achieved clear or almost clear skin by week 16 versus 7% and 13% on placebo. In palmoplantar psoriasis roughly 70% of zasocitinib patients achieved clear or almost clear skin versus 22% and 10% on placebo; responses were maintained through week 24. Zasocitinib also showed better scalp results than apremilast (77%/74% vs. 42%/30%) and improved the Nail Psoriasis Severity Index. Common adverse events through week 24 included upper respiratory tract infections, nasopharyngitis and acne, with no new safety signals. Takeda plans regulatory filings for plaque psoriasis in this fiscal year and is conducting further studies in psoriatic arthritis, Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa. » More on de.investing.com

Takeda announced topline Phase 3 LATITUDE Atlas data showing investigational oral TYK2 inhibitor zasocitinib achieved superior PASI 100 responses at Week 16 versus deucravacitinib and met major secondary endpoints, with a favorable safety profile in a 606-patient global trial. Separately, the FDA has accepted Takeda’s supplemental BLA for intravenous ENTYVIO for children aged two and older with moderate-to-severe ulcerative colitis and Crohn’s disease, with a PDUFA target action date expected in Q1 2027. Both developments expand Takeda’s late-stage dermatology and pediatric IBD portfolios and could affect its growth outlook if regulatory reviews and commercialization proceed positively. » More on finance.yahoo.com