Apnimed, Inc. APMD
Apnimed, Inc. (Nasdaq: APMD) is a respiratory drug developer. Its lead program, AD109 (Oxnimbi), is in Phase 3 for Obstructive sleep apnea (OSA). Its next catalyst on record is AD109 (Oxnimbi): FDA PDUFA goal action date for NDA (February 28, 2027).
Upcoming catalysts
- February 28, 2027AD109 (Oxnimbi) — FDA PDUFA goal action date for NDA
the FDA has issued a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2027, although the duration of the review may vary based on various factors.
- February 2027AD109 (Oxnimbi) — PDUFA goal date
The FDA review cycle is targeted to be 10-months from our NDA submission in April 2026, and the FDA has issued a Prescription Drug User Fee Act ('PDUFA') goal date of February 28, 2027
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| AD109 (Oxnimbi) | Obstructive sleep apnea (OSA) | small molecule | Phase 3 |
Recent results and decisions
- Sep 8, 2026accepted FDA accepted the NDA for AD109 (Oxnimbi) in OSA with a PDUFA date of Feb 28, 2027 (acceptance previously announced; reported in Q2 results).
The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of February 28, 2027.
Filing
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Other phase 3 respiratory companies
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