Will the FDA approve Apnimed's AD109 (Oxnimbi) for treatment of adults with obstructive sleep apnea by March 14, 2027?
deadline 2027-03-14
confidence medium
tier 2 evidence
87%PolySignal estimate
Resolution criterion
Yes if the FDA approves AD109 for the indication stated above (Drugs@FDA entry, FDA announcement or Apnimed press release) no later than March 14, 2027. A complete response letter, an extension of the PDUFA date or the absence of a decision by then counts as no. An accelerated or conditional approval counts as an approval; a later label update does not change the outcome.
Verified starting state
As of October 13, 2026: according to the Apnimed filing of September 8, 2026, the FDA has set a PDUFA target action date of February 28, 2027. Source: https://www.sec.gov/Archives/edgar/data/1745648/000119312526385355/apmd-ex99_1.htm
What pushes it up
- FDA has set a PDUFA target action date of Feb 28 2027, well before the Mar 14 2027 deadline [tier 1]
- Fierce Biotech reports AD109 is on the FDA’s desk, confirming active review [tier 2]
What pushes it down
- FDA could issue a complete response letter or extend the PDUFA date, which happens in a minority of cases [tier 3]
- No official approval announcement has been made yet [tier 1]
What would move this number most
Whether the FDA will issue a complete response letter or extend the PDUFA target date beyond Feb 28 2027
How this number is built
| Deadline | 2027-03-14 |
| Base rate | 87% |
| Best evidence | tier 2 · 1 article(s) used |
| Independent runs | 83 · 90 (spread 7 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-13 13:45 |
| Model | openai/gpt-oss-120b (Groq) |
Sources consulted