Upcoming FDA decision · February 28, 2027
AD109 (Oxnimbi) PDUFA date: FDA decision expected February 28, 2027
135 days to goApnimed, Inc. (APMD) (APMD) →
The FDA is expected to decide on AD109 (Oxnimbi) from Apnimed, Inc. (APMD) in Obstructive sleep apnea (OSA) by the PDUFA target action date of February 28, 2027. For Obstructive sleep apnea (OSA). NDA filing. Extracted from SEC filing: EX-99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
February 28
Target action date
NDA
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for AD109 (Oxnimbi)?
- The FDA's PDUFA target action date for AD109 (Oxnimbi) is February 28, 2027. The FDA can act before that date, and the review can be extended.
- What is AD109 (Oxnimbi) being reviewed for?
- The application under FDA review covers Obstructive sleep apnea (OSA).
- Which company is developing AD109 (Oxnimbi)?
- Apnimed, Inc. (APMD) (APMD).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).