Biotech Stock Intel
Catalyst CalendarPDUFA CalendarMover SignalsCompany Screener
Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
AboutMethodologyTermsPrivacy
Biotech Stock Intel
Catalyst CalendarPDUFA CalendarMover SignalsCompany Screener
Home/Stocks/TAK/Catalyst
ApprovedUpdate

Oveporexton (Orexin Agonist)

Narcolepsy Type 1

TAKTakeda
Expected catalystTBA

Catalyst overview

Event details

Drug or asset
Oveporexton (Orexin Agonist)
Development stage
Approved
Event type
Update
Indication
Narcolepsy Type 1

Research summary

What is being tracked?

This catalyst tracks a Approved update for Oveporexton (Orexin Agonist) in Narcolepsy Type 1. The expected timing is based on the latest available company guidance and may change.

Development notes

05/10/26:- Priority Review granted. Approval expected in FY2026-2027. U.S. launch planned in H2 2026. 06/15/26:- FirstLight and RadiantLight Phase 3 secondary endpoint results presented. PDUFA goal date is Q3 2026. 08/05/26:- FDA approved ORZEYFUL for adult NT1; DEA scheduling expected within 90 days.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

More from TAK

Related pipeline programs

PDUFA

Entyvio/Vedolizumab (Vedolizumab) (Integrin Inhibitor)

Moderate-To-Severe Crohn's Disease (Pediatric, Ages 2+)

View company pipeline
PDUFA

Rusfertide (Hepcidin Mimetic)

Polycythemia Vera

View company pipeline

Company

Takeda

TAK · NYSE
Industry
Biotechnology
Pipeline assets
5
View TAK research

BioPharma Pro

Track every date change

Watchlists, source history and catalyst alerts will be available with Pro.

Start free

Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
AboutMethodologyTermsPrivacy