Sunharbo (asundexian) FDA approval: Nov 9, 2026

Sunharbo (asundexian) was approved by the FDA on November 9, 2026 for secondary stroke prevention, the 48th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.

Verified against: FDA action day November 9, 2026 (FDA press announcement) · Announcement November 9, 2026 (FDA press announcement) · Goal date none sourced.

The FDA approved Sunharbo (asundexian) 50 mg tablets on November 9, 2026, the first factor XIa inhibitor, for use with antiplatelet therapy to reduce the risk of stroke in adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack.

Run-up into the decision (T-120 → T+2)

Key facts

Bayer did not publicly state a PDUFA goal date (the FDA granted Priority Review in May 2026), so this page states no early or late margin. Per the FDA: OCEANIC-STROKE enrolled 12,327 adults; Sunharbo reduced the risk of ischemic stroke by 26% versus placebo over a median 14.2 months; major bleeding was similar overall but higher in patients over 75 and in the first 90 days. Sunharbo is not approved for stroke prevention in atrial fibrillation.

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, November 9, 2026

FDA record of the action: the FDA approved on November 9, 2026, per FDA press announcement, November 9, 2026 (FDA notice). 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.