Baxfendy (baxdrostat)

New molecular entityPriority review

Region: 🇺🇸 US
Active substance: baxdrostat
Company: Astrazeneca Ab
Status: Approved
FDA approval: Fri 15 May 2026
Designations: New molecular entity, Priority review
Application: NDA219878
Official record: www.accessdata.fda.gov

Regulatory milestones

Mon 18 Jan 2027🇪🇺 Expected EC decisionestimate

Baxfendy (baxdrostat): expected EC decision

Estimated as CHMP opinion (2026-11-12) + 67 days, the standard Commission decision period. Not an official date. · AstraZeneca AB · source

Thu 12 Nov 2026🇪🇺 CHMP positive opinion

Baxfendy (baxdrostat): CHMP positive opinion

AstraZeneca AB · source

Fri 15 May 2026🇺🇸 FDA approval

FDA approves Baxfendy (baxdrostat), a new medicine

Astrazeneca Ab; NDA219878; New molecular entity, Priority review; tablet · source

Same substance in other markets

🇪🇺 Baxfendy Opinion · AstraZeneca AB

Follow Baxfendy

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.