Biopharma Transcript

Apnimed, Inc. APMD

Nasdaq · Phase 3 · respiratory · small molecule · EDGAR · Updated Oct 24, 2026

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): PDUFA goal date for NDA review (February 2027).

Upcoming catalysts

  1. February 2027
    AD109 (Oxnimbi) — PDUFA goal date for NDA reviewThe 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

ProgramIndicationModalityStage
AD109 (Oxnimbi)Obstructive Sleep Apnea (OSA)small moleculePhase 3

Recent results and decisions

  1. Sep 8, 2026
    accepted 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
  2. Sep 8, 2026
    n/a Apnimed completed an upsized initial public offering for gross proceeds of $220.8 million.Completed its upsized initial public offering for gross proceeds of $220.8 million and its common stock began trading on the Nasdaq Global Select Market Filing
  3. Sep 8, 2026
    n/a Apnimed completed the strategic monetization of its interest in Shionogi-Apnimed Sleep Science, generating $100 million in upfront proceeds.Completed the strategic monetization of the Company's interest in Shionogi-Apnimed Sleep Science, generating $100 million in upfront proceeds, with the potential for additional milestone and royalty payments Filing

1 more on record.

For subscribers

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