Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 5:03 AM ET
AD109 (Oxnimbi) is an Apnimed, Inc. program in obstructive sleep apnea. Its PDUFA date is Feb 28, 2027, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Obstructive sleep apnea. Sponsor: Apnimed, Inc. (APMD). Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is AD109 (Oxnimbi)'s next FDA decision or readout?
AD109 (Oxnimbi)'s PDUFA date is Feb 28, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at AD109 (Oxnimbi)'s most recent FDA decision?
No FDA decision for AD109 (Oxnimbi) is in our archive yet.
What is AD109 (Oxnimbi) used for?
In our records AD109 (Oxnimbi) is under review or in development for Obstructive sleep apnea.
Who makes AD109 (Oxnimbi)?
Apnimed, Inc. (APMD).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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