APMD PDUFA Date: AD109

Name: AD109 FDA decision
Start: 2027-02-28
End: 2027-02-28

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

FDA decision (PDUFA) target Feb 28, 2027 · Apnimed, Inc. · Obstructive sleep apnea

Source: Apnimed 8-K 2026-09-08 (EX-99.1, Q2 2026 results). “Food and Drug Administration (FDA) Accepted the NDA for AD109, with a proposed proprietary name Oxnimbi, and assigned a PDUFA target action date of February 28, 2027”

Key facts

FDA PDUFA target date2027-02-28

Drug / candidateAD109 (Oxnimbi)

IndicationObstructive sleep apnea

CompanyApnimed, Inc.

Market-cap tierSmall

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FAQ

When is the APMD PDUFA date?

The FDA PDUFA target date for APMD (Apnimed, Inc.) is 2027-02-28 for AD109 (Oxnimbi). Dates are company/FDA-sourced and can slip. Verify against primary filings.

What is APMD's drug AD109?

AD109 (Oxnimbi) is Apnimed, Inc.'s candidate under FDA review for Obstructive sleep apnea.