Apnimed, Inc. (APMD) stock: price, suppliers, customers and institutional ownership
Prices via Intrinio. Supplier and customer ties are extracted from SEC filings and carry the sentence they came from. Not investment advice.
Prices via Intrinio. Supplier and customer ties are extracted from SEC filings and carry the sentence they came from. Not investment advice.
We are a late stage clinical pharmaceutical company dedicated to the discovery, development and commercialization of novel oral therapies that address the neurobiology of sleep-related breathing diseases. Our sole clinical product candidate, AD109 (Oxnimbi), is an investigational, fixed-dose, anti-apneic neuromuscular modulator, combining a novel anti-muscarinic and a selective norepinephrine reuptake inhibitor (NRI) for the treatment of obstructive sleep apnea (OSA). Oxnimbi 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 results from two registrational trials, we submitted a New Drug Application (NDA) for Oxnimbi to the U.S. Food and Drug Administration (FDA) in April 2026, which was accepted for review by the FDA in July 2026. The registrational trials were Phase 3, randomized, double-blind, placebo-controlled, parallel-arm trials in adults with mild to severe OSA, LunAIRo and SynAIRgy, which together enrolled approximately 1,300 patients and represent one of the largest and most diverse cohorts ever studied in an OSA pharmacologic trial. LunAIRo was conducted in the United States and SynAIRgy was conducted in the United States and Canada. All previous trials of Oxnimbi were conducted in the United States. In this prospectus, we also refer to AD109 by its proposed future brand name, “Oxnimbi.” This brand name was conditionally approved by the FDA in May 2025, which was reconfirmed in June 2026, and is pending approval of the NDA in its totality. Oxnimbi met its primary endpoint and several key secondary endpoints in both Phase 3 trials, SynAIRgy and LunAIRo. Under the treatment policy estimand, mean apnea hypopnea index (AHI) reductions at week 26 (≥4% (desaturation criterion for hypopneas) were 44.1% in SynAIRgy and 33.7% in LunAIRo versus (vs) 17.6% and 7.3% with placebo, respectively (p≤0.0001). Under the on-treatment estimand, reductions were 55.6% and 46.8% from baseline (p<0.0001 vs placebo). Under the treatment policy estimand, hypoxic burden (HB), a metric associated with cardiovascular risk and all-cause mortality, was reduced by 44.7% and 37.4% from baseline (p<0.001 vs placebo), and under the on-treatment estimand by 60.5% and 58.2% (p<0.0001 vs placebo), in SynAIRgy and LunAIRo, respectively. P-values are statistical measures that help determine whether the results of a trial are significant. Typically, p-values less than 0.05, like those described here, suggest that a comparison between two groups is statistically significant. Oxnimbi was generally well-tolerated, with adverse events (AEs) predominantly mild across both trials, with no drug-related serious adverse events (SAEs) in the Oxnimbi group reported in either LunAIRo or SynAIRgy. Clinical trial results are preliminary in nature, and such results may not be replicated in subsequent clinical trials. The 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, although the duration of the review may vary based on various factors. In connection with the FDA’s review of our top-line Phase 3 data, at the pre-NDA meeting, the FDA provided feedback about the clinical meaningfulness of certain endpoint results, including the primary endpoint and the limitations of the patient-reported outcomes (PROs). The FDA indicated that additional analyses and justification may be needed to support that the data demonstrates a clinically meaningful benefit for the treatment of OSA. We submitted information in response to this feedback in our NDA submission and plan to continue to address it and related requests as part of the FDA review process. While we believe the totality of the data supports the potential clinical benefit of AD109, the FDA may have a different interpretation, including, but not limited to, whether the data represent clinically meaningful differences, which could impact the outcome or timing of the regulatory review process and, in turn, our future operating results. OSA is a serious chronic disease that can lead to severe and potentially life-threatening complications and cause debilitating symptoms. Disease severity of OSA is typically measured by the AHI, which represents the number of times per hour that the airway fully or partially collapses during sleep and is considered the standard objective measure of OSA severity in clinical practice. The AHI may be calculated using different scoring criteria, that vary based on the minimum oxygen-desaturation threshold required to classify a hypopnea. For our Phase 3 program, our primary endpoints for both trials are measured by a change from baseline in AHI, based on hypopneas defined by at least a four percent reduction in oxygen saturation (SpO2). In addition to the AHI, measures of nocturnal oxygenation, such as the sleep apnea specific HB, are increasingly recognized as important complementary metrics to characterize OSA severity. While AHI is a simple frequency metric, HB captures the depth and duration of oxygen desaturation associated with airway obstructions and has been shown in third-party epidemiologic studies to correlate closely with cardiovascular and neurocognitive consequences of OSA. HB reduction was a secondary endpoint in both of our Phase 3 trials. OSA is a highly prevalent condition, estimated to be affecting approximately 80 million people in the United States between the ages of 30-69, according to a study we commissioned from Clarivate Plc. (Clarivate). We believe many people with OSA remain undiagnosed in part due to lack of awareness, but also because they seek to avoid current treatment options that they anticipate will be uncomfortable or unacceptable. OSA generally affects middle-aged and older adults of varying ages, weights, sexes, and ethnicities but can also occur in young adults. A third party study, supported by certain company personnel and a grant from us in the community setting, estimates that more than 60% of middle-aged and older adults living with OSA are not obese. We believe Oxnimbi, if approved, can be prescribed for most adults diagnosed with mild, moderate or severe OSA, including obese and non-obese patients. In the future, we may seek approval for Oxnimbi for adolescent and child patients as well. However, our current focus is on the treatment of the adult OSA population. The current standard of care is positive airway pressure (PAP), which uses a bedside machine to deliver pressurized air via a mask to keep the airway open during use; however, despite its effectiveness, many patients refuse PAP or discontinue it due to issues such as discomfort, pressure intolerance and lifestyle disruption, resulting in persistently low patient compliance. There is no FDA approved pharmacologic therapy to treat the crucial underlying cause of OSA, neuromuscular dysfunction during sleep. Prescription drug development in the field of OSA is relatively novel, and until the approval of tirzepatide in 2024 for moderate to severe OSA in obese adults in combination with a reduced-calorie diet and increased physical activity, the FDA historically did not have well-established therapeutic endpoints for this indication. We believe the OSA market is ripe for disruption, similar to other disease markets that were transformed by the introduction of an effective oral therapy such as osteoporosis, erectile dysfunction, rheumatoid arthritis, multiple sclerosis, hepatitis C and others. We believe a novel, oral and convenient treatment option that targets the underlying cause of OSA is well positioned to address significant unmet need. 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. --- While Oxnimbi currently is our sole clinical product candidate, we are currently pursuing preclinical-stage programs focused on sleep-related breathing disorders and related comorbidities. These programs include exploratory combination-therapy approaches that remain at an early stage of development. For each of these programs, we would need to complete significant additional development activities before we would be in a position to seek regulatory approval, which may include, as applicable, completion of preclinical studies, identification and optimization of a development candidate, submission and clearance of an IND or comparable regulatory filing, initiation and completion of Phase 1, Phase 2 and Phase 3 clinical trials, development of a commercial manufacturing process, completion of chemistry, manufacturing, and controls (CMC) activities and submission of an NDA or other applicable marketing application. These programs remain at an early stage, and we may not successfully advance any of them into or through clinical development. Our principal executive offices are located in Cambridge, Massachusetts.
No institutional manager reports a position in this company. Funds disclose holdings quarterly on form 13F, and none of them names it.
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Apnimed, Inc.
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