Apnimed, Inc. (Nasdaq: APMD) reported its financial results for the second quarter ended June 30, 2026, and announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for AD109.
The investigational drug candidate, proposed to be named Oxnimbi, is intended for the treatment of adults with obstructive sleep apnea (OSA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027. If approved, Oxnimbi is designed to be the first oral pharmacologic therapy targeting the neuromuscular root cause of upper airway collapse.
Regarding financial performance, Apnimed reported cash and cash equivalents of approximately $172.8 million as of June 30, 2026. The company also completed an upsized initial public offering of 13.8 million shares at a price of $16.00 per share, generating gross proceeds of $220.8 million.
For the three months ended June 30, 2026, the company reported net income of $125.9 million, compared to a net loss of $69.5 million in the same period in 2025. This increase was attributed to gains on the reversal of a deposit liability and the sale of an equity method investment, alongside a decrease in research and development expenses.
- Research and development expenses decreased by $6.1 million, or 38%, to $9.9 million, primarily due to the completion of clinical trials for AD109 in 2025.
- General and administrative expenses increased by $7.3 million, or greater than 100%, to $12.7 million, driven by legal services, infrastructure costs for commercial readiness, and increased headcount.
In addition to the FDA acceptance, Apnimed highlighted recent corporate milestones, including the completion of a strategic monetization of its interest in Shionogi-Apnimed Sleep Science, which generated $100 million in upfront proceeds. The company’s common stock began trading on the Nasdaq Global Select Market on July 31, 2026.
