ORZEYFUL (oveporexton), an oral orexin receptor 2 agonist taken twice daily, approved for narcolepsy type 1 in adults (Aug 5 2026).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (2/6/26) through T+0. Run-up high $18.8 on 2/23/26, low $15.03 on 6/3/26 (T-120 to T-1). FDA decision 8/5/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-08-05
OutcomeApproved
Drug / candidateORZEYFUL (oveporexton)
IndicationNarcolepsy type 1 in adults
CompanyTakeda Pharmaceutical Company Limited
Market-cap tierLarge
120-day run-up (T-120→T-1)-3.6%
Cohort decision-day move (history)1.0% median (n=834)
A traditional approval, granted with Breakthrough Therapy designation and Priority Review, and the 30th novel drug approval of 2026. One practical caveat that matters for timing: the FDA has recommended the product for scheduling, and it cannot lawfully be marketed until the DEA issues its scheduling decision, so approval and availability are not the same date here.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Yes. The FDA approved the application for ORZEYFUL (oveporexton) on August 5, 2026. The primary source is linked on this page.
Which company is behind ORZEYFUL (oveporexton)?
ORZEYFUL (oveporexton) is a Takeda Pharmaceutical Company Limited (TAK) program. The FDA decision came on August 5, 2026; the company's own announcement is linked on this page.
How did TAK stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), TAK moved -3.6%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.
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