Takeda Pharmaceutical Co Ltd TAK
Takeda Pharmaceutical Co Ltd (NYSE: TAK) is a GI/hepatology drug developer. Its lead program, ENTYVIO (vedolizumab), is in Phase 3 for Ulcerative colitis and Crohn's disease (IBD). Its next catalyst on record is zasocitinib (TAK-279): FDA PDUFA target action date (NDA under Priority Review) (Q1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: zasocitinib (TAK-279) — FDA PDUFA target action date (NDA under Priority Review) (Q1 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ENTYVIO (vedolizumab) | UC, Crohn's disease; pediatric sBLA under FDA review | antibody | Approved |
| ADZYNMA (recombinant ADAMTS13) | congenital TTP | protein/peptide | Approved |
| VYVANSE (lisdexamfetamine) | ADHD | small molecule | Approved |
| zasocitinib (TAK-279) | moderate-to-severe plaque psoriasis | small molecule | Phase 3 |
| oveporexton (TAK-861) | narcolepsy type 1 | unclear | Phase 3 |
| fazirsiran (TAK-999) | alpha-1 antitrypsin deficiency-associated liver disease | RNA (siRNA/ASO/mRNA) | Phase 3 |
| mezagitamab (TAK-079) | IgA nephropathy; immune thrombocytopenia | antibody | Phase 1 |
Recent results and decisions
- Sep 14, 2026accepted FDA accepted Takeda's NDA for zasocitinib in plaque psoriasis under Priority Review; PDUFA target action date in Q1 calendar 2027.
The Prescription Drug User Fee Act (PDUFA) target action date is in the first quarter of calendar year 2027
Filing - Sep 14, 2026accepted EMA accepted Takeda's marketing authorization application (MAA) for zasocitinib in plaque psoriasis, starting review (ex-US regulator: EMA).
The European Medicines Agency (EMA) also accepted Takeda’s new marketing authorization application (MAA) for zasocitinib, initiating the review process for the treatment of moderate-to-severe plaque psoriasis.
Filing - Aug 28, 2026approval FDA approved MIMRYLO (rusfertide) for erythrocytosis in adults with polycythemia vera, supported by VERIFY (76.9% clinical response, weeks 20-32).
Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32
Filing
5 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 GI/hepatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.