Oveporexton (TAK-861-2001) was approved by the FDA on August 5, 2026 for narcolepsy type 1 (NT1), the 30th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Verified against: FDA action day August 5, 2026 (NDA 220860 ORIG-1) · Announcement August 5, 2026 (sponsor announcement) · Goal date none sourced.
ORZEYFUL (oveporexton), an oral orexin receptor 2 agonist taken twice daily, approved for narcolepsy type 1 in adults (Aug 5 2026).
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.
Primary source: FDA press announcement, August 5, 2026
FDA record of the action: the FDA approved on August 5, 2026, per NDA 220860 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for ORZEYFUL (oveporexton) on August 5, 2026, per the FDA's own record. The primary source is linked on this page.
ORZEYFUL (oveporexton) is a Takeda Pharmaceutical Company Limited (TAK) program. The FDA decision came on August 5, 2026; the FDA's own record of the decision is linked on this page.
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.