Apnimed files for IPO

CAMBRIDGE, Mass. – Apnimed has filed for an initial public offering (IPO) with the U.S. Securities and Exchange Commission (SEC) as it awaits approval from the U.S. Food & Drug Administration for Oxnimbi, an oral treatment for obstructive sleep apnea (OSA).

In its Form S-1, the company acknowledges positive airway pressure (PAP) as the current standard of care for OSA, but notes many patients refuse or discontinue the treatment due to issues such as discomfort, pressure intolerance and lifestyle disruption, resulting in persistently low compliance.

“We believe a novel, oral and convenient treatment option that targets the underlying cause of OSA is well positioned to address significant unmet need,” the company states. “A pharmacological option could unlock latent demand for treatment and expand overall awareness, screening, diagnosis and treatment of OSA. Therefore, we designed Oxnimbi as an oral, once-daily, rapid-onset therapy to improve upper airway muscle activity during sleep, a crucial underlying cause of all OSA. If approved, we believe Oxnimbi has the potential to become a standard of care for the treatment of OSA.”

Apnimed says Oxnimbi, AD109, is designed to target the neuromuscular defect of OSA by improving upper airway muscle activity to help maintain airway patency and prevent airway collapse during sleep.

Based on the results from two registrational trials, Apnimed submitted a New Drug Application (NDA) with the FDA in April 2026. The registrational trials were Phase 3, randomized, double-blind, placebo-controlled, parallel-arm trials in adults with mild to severe OSA. Together, they enrolled approximately 1,300 patients, representing one of the largest and most diverse cohorts ever studied in an OSA pharmacologic trial, the company says. LunAIRo was conducted in the United States and SynAIRgy was conducted in the United States and Canada.

The trials found apnea hypopnea index (AHI) was reduced from baseline by 55.6% in SynAIRgy and 46.8% in LunAIRp, and hypoxic burden (HB) decreased by 60.5% and 5 8.2%, respectively, at week 26.

Earlier this year, Apnimed also entered into a secured senior credit facility for up to $150 million with funds managed by HealthCare Royalty Partners (HCRx).