Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
BAXFENDY (baxdrostat) was approved by the FDA on May 15, 2026 to treat hypertension in combination with other antihypertensive drugs, the 15th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Daily close, T-120 (12/1/25) through T+5. Run-up high $209.48 on 2/18/26, low $179.64 on 12/16/25 (T-120 to T-1). FDA decision 5/18/26. Historical price action, not a forecast.
FDA record of the action: the FDA approved on May 15, 2026, per NDA 219878 ORIG-1 (FDA letter). The sponsor announced it on May 18, 2026. 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.
Specialist biotech funds holding AZN, 13F for the quarter ended June 30, 2026
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was BAXFENDY (baxdrostat) approved by the FDA?
Yes. The FDA approved the application for BAXFENDY (baxdrostat) on May 15, 2026, per the FDA's own record. The company announced it on May 18, 2026. The primary source is linked on this page.
Which company is behind BAXFENDY (baxdrostat)?
BAXFENDY (baxdrostat) is an AstraZeneca PLC (AZN) program. The FDA decision came on May 15, 2026; the FDA's own record of the decision is linked on this page.
How did AZN stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), AZN moved -0.2%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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