Apnimed files for IPO as FDA reviews Oxnimbi NDA for sleep apnea

Apnimed, Inc. filed an S-1 registration statement with the SEC on July 10, 2026 for an initial public offering of common stock, seeking to list on Nasdaq under the symbol "APMD." The filing covers Apnimed's initial public offering, and the company has applied to list its common stock on The Nasdaq Global Market under the symbol "APMD."¹

The company's sole clinical candidate is AD109, which it plans to brand as Oxnimbi. AD109 pairs a novel anti-muscarinic compound with a selective norepinephrine reuptake inhibitor, designed as a fixed-dose oral treatment for obstructive sleep apnea.¹ Based on two registrational trials, Apnimed submitted a New Drug Application for Oxnimbi to the FDA in April 2026.¹ Those trials, called LunAIRo and SynAIRgy, were Phase 3, randomized, double-blind, placebo-controlled studies that together enrolled approximately 1,300 patients with mild to severe OSA.¹

Oxnimbi met its primary endpoint and several secondary endpoints in both trials; under the treatment policy estimand, mean apnea hypopnea index reductions at week 26 were 44.1% in SynAIRgy and 33.7% in LunAIRo, versus 17.6% and 7.3% with placebo.¹

However, the filing discloses regulatory uncertainty. During a pre-NDA meeting, the FDA raised questions about how clinically meaningful certain endpoint results were, including the primary endpoint, and noted limitations in the patient-reported outcome data.¹ Regulators said the company may need to provide further analysis to justify that the results reflect a clinically meaningful benefit for OSA patients.¹ Apnimed said it addressed this feedback in its submission but acknowledged the FDA could reach a different conclusion, which could affect timing or outcome.

Financially, the company reported net losses of $128.2 million and $111.3 million for 2025 and 2024, respectively, and had an accumulated deficit of $329.6 million as of March 31, 2026.¹ Share pricing and offering size were not yet disclosed.