Apnimed's OSA drug NDA accepted by FDA, PDUFA date set for February 2027

Apnimed announced on September 8, 2026 that the FDA accepted for review the New Drug Application for AD109, proposed proprietary name Oxnimbi, for treatment of adults with obstructive sleep apnea, with a PDUFA target action date of February 28, 2027.¹

Oxnimbi combines aroxybutynin, described as a novel antimuscarinic, with atomoxetine, a selective norepinephrine reuptake inhibitor.¹ The drug has completed two Phase 3 trials covering mild, moderate and severe OSA.¹ The company also said it presented pooled data from the SynAIRgy and LunAIRo Phase 3 trials at ATS 2026 and SLEEP 2026¹ and published two peer-reviewed papers on Oxnimbi, including Phase 3 SynAIRgy results in the American Journal of Respiratory and Critical Care Medicine and a mechanistic review in the American Journal of Respiratory Cell and Molecular Biology.¹

On the corporate side, Apnimed said it appointed Kevin Lind as Chief Executive Officer, Michael Kelly as Chief Financial Officer and Steven Spector as Chief Legal Officer and Head of Corporate Affairs as part of a planned leadership transition.¹ The company also disclosed two financing moves: an upsized IPO that raised $220.8 million in gross proceeds and a senior secured credit facility of up to $150 million provided by funds managed by HealthCare Royalty Partners.¹ Separately, Apnimed said it monetized its interest in Shionogi-Apnimed Sleep Science for $100 million upfront, with potential additional milestone and royalty payments.¹ Its stock began trading on the Nasdaq Global Select Market under "APMD" on July 31, 2026.¹

Financially, Apnimed held about $172.8 million in cash and cash equivalents as of June 30, 2026,¹ before the IPO proceeds were added. The company posted net income of $125.9 million for the quarter, versus a net loss of $69.5 million in the same period last year,¹ driven largely by one-time gains tied to the Shionogi transaction and debt reversal rather than operating results.