$TAK

Takeda Pharmaceutical (TAK) announced FDA priority review for zasocitinib, a treatment for moderate-to-severe plaque psoriasis, with a target action date in Q1 2027. The application includes Phase 3 studies showing significant skin clearance compared to placebo. The company also reported positive results from a head-to-head study against deucravacitinib, highlighting potential differentiation. Approval and commercial access will determine revenue potential.

Global investment in longevity biotech reached $18.4bn in 2025, up from $4.7bn in 2024, with $12.1bn invested in 2026, according to Longevity.Technology. The report predicts a $617bn market by 2045, with gerotherapeutic drugs approved by 2035. Big Pharma companies like Eli Lilly, Takeda, and Novo Nordisk are investing in the sector.

Takeda Pharmaceutical's (TAK) Chief Transformation Officer sold 34,535 shares on 2026-09-14, continuing a year-long insider selling trend. The company's shares trade at $18.54, with a market cap of $59.72 billion. GuruFocus values the stock at $14.16, indicating it is significantly overvalued. Some institutional investors have increased holdings despite insider sales.

Duprey Lauren Rusckowski (Chief Transformation Officer) sold 34,535 shares of TAKEDA PHARMACEUTICAL CO LTD (TAK) at $18.54 ($0.64M total) on 2026-09-14.

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.

Andy Plump, Takeda's R&D chief, will retire in June 2027. He led a major overhaul of the company's R&D, focusing on external collaborations and key therapeutic areas. Takeda's CEO praised his work, noting a robust late-stage pipeline and upcoming launches. Plump was instrumental in the $62 billion Shire acquisition and established a US R&D hub.

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.