Takeda Pharmaceutical (TAK) Gets Priority Review. Can Zasocitinib Win in Psoriasis?

Takeda's NDA for zasocitinib (TAK-279) in moderate-to-severe plaque psoriasis accepted by the FDA under Priority Review. Phase 3 data showed 70% of patients achieved clear or almost clear skin at week 16. A decision is expected in Q1 2027, with no financial impact on FY2027 forecast.

The FDA approved 13 drugs in August 2026, including Moderna's mFLUSIVA ($149.56/dose) for influenza prevention, Takeda's Orezyful for narcolepsy, Replimune's Tudriqev ($450,000/course) for melanoma, Bristol-Myers Squibb's Zenbexus ($29,500/28-day cycle) for multiple myeloma, Lantheus' Tauklarify for Alzheimer's diagnosis, and Regeneron's Pasatru for FOP. Each drug showed positive clinical trial results.

Takeda's oveporexton (ORZEYFUL) showed significant improvements in narcolepsy type 1 (NT1) symptoms and quality of life in Phase 3 studies, according to data published in the New England Journal of Medicine. The drug, approved in the U.S., China, and Japan, is the first orexin agonist designed to treat the underlying cause of NT1. It demonstrated clinically meaningful improvements in wakefulness, sleepiness, cataplexy, and disease severity, with a generally well-tolerated safety profile. Takeda

King’s College Hospital enrolled the first patient in a phase 3 trial (TAK-226-3001) comparing elritercept (TAK-226) with epoetin alfa for treating anemia in lower-risk myelodysplastic syndromes (MDS). The global study aims to enroll 300 patients, with King’s College as one of 2 UK sites. Elritercept, licensed by Takeda from Keros Therapeutics, is designed to promote red blood cell production. The trial evaluates its efficacy in reducing transfusion needs and improving patient quality of life.

Ionis (IONS) and Milestone (MIST) gained FDA approvals for neurology and cardiology drugs. Biogen (BIIB) and AstraZeneca (AZN) also received regulatory nods for Alzheimer's and cancer treatments. Novavax (NVAX) secured global approvals for its COVID-19 vaccine. TScan (TCRX) and Novartis (NVS) announced job cuts. Novartis (NVS) and HUTCHMED (HCM) struck deals worth up to $3.2B and $1.295B respectively.

In August 2026, the FDA approved Oveporexton (Takeda) for narcolepsy, a first-in-class drug restoring orexin signaling. It also cleared Roche's Elecsys Phospho-Tau test (with Eli Lilly) for Alzheimer's assessment and C2N Diagnostics' PrecivityAD2 for younger adults. REGENXBIO's Hunter syndrome therapy was put on hold, while Cellenkos' ALS therapy received Fast Track designation. Lantheus' Tauklarify, a tau-targeted imaging agent, was approved for AD evaluation.