Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
BREZTRI AEROSPHERE was approved by the FDA on April 27, 2026 for asthma.
AstraZeneca PLC, BREZTRI AEROSPHERE · Asthma.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (11/11/25) through T+5. Run-up high $209.48 on 2/18/26, low $162.3 on 11/13/25 (T-120 to T-1). FDA decision 4/28/26. Historical price action, not a forecast.
Drug / candidateBREZTRI AEROSPHERE (budesonide/glycopyrrolat
CompanyAstraZeneca PLC
120-day run-up (T-120→T-1)+14.7%
FDA record of the action: the FDA approved on April 27, 2026, per NDA 212122 SUPPL-9 (FDA letter). The sponsor announced it on April 28, 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 BREZTRI AEROSPHERE approved by the FDA?
Yes. The FDA approved the application for BREZTRI AEROSPHERE on April 27, 2026, per the FDA's own record. The company announced it on April 28, 2026. The primary source is linked on this page.
Which company is behind BREZTRI AEROSPHERE?
BREZTRI AEROSPHERE is an AstraZeneca PLC (AZN) program. The FDA decision came on April 27, 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 +14.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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