Oxnimbi (aroxybutynin/atomoxetine) / Apnimed, Royalty - LARVOL DELTA

7130: Clinical Overview of an Investigational Oral Tablet for OSA (CHEST 2026) - "Description Through an interactive format using clinical profiles, faculty will explore the heterogeneity of obstructive sleep apnea and the importance of multidimensional assessment beyond AHI. Our faculty panel will discuss and present emerging clinical evidence from an investigational oral tablet, AD109, in the context of evolving OSA research."

Clinical • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Apnimed…filed an S-1 registration statement with the SEC on July 27, 2026, seeking to raise approximately USD 150 million in an IPO on the Nasdaq Global Market (AllSci Corp) - "The offering comprises 10 million shares of common stock at an assumed midpoint price of USD 15.00 per share, generating estimated net proceeds of USD 134.6 million before exercise of an overallotment option covering 1.5 million additional shares, which would lift net proceeds to approximately USD 155.5 million....Apnimed intends to use approximately USD 228.8 million in combined IPO proceeds and existing cash to fund the FDA regulatory approval process and, if approved, the commercial launch of AD109 (Oxnimbi) for obstructive sleep apnea, with remaining proceeds directed to research and development and general corporate purposes."

Financing • Obstructive Sleep Apnea

Apnimed, Inc…announced that the U.S. Food and Drug Administration ('FDA') has accepted for review the New Drug Application ('NDA') filing of AD109 (aroxybutynin 2.3 mg/atomoxetine 75 mg) for the treatment of adults with obstructive sleep apnea (PRNewswire) - "The FDA has assigned a Prescription Drug User Fee Act ('PDUFA') target action date of February 28, 2027...The NDA submission is supported by data from Apnimed's Phase 3 clinical program, including the SynAIRgy and LunAIRo randomized, double-blind, placebo-controlled trials evaluating AD109 in adults with mild, moderate, and severe OSA."

FDA filing • PDUFA • Obstructive Sleep Apnea

Content validity and clinically meaningful change on patient-reported outcome measures for use in obstructive sleep apnea. (PubMed, Sleep Med) - P3 | "These results confirm the content validity of all the PROMs in individuals with OSA. A one-point change on PROMs represents a clinically meaningful improvement from the patient's perspective."

Journal • Fatigue • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Aroxybutynin and atomoxetine (AD109) for obstructive sleep apnea: a randomized phase 3 trial (SynAIRgy). (PubMed, Am J Respir Crit Care Med) - P3 | "AD109 significantly improved airway obstruction and oxygenation at 26 weeks across a broad range of patients unable to use PAP, suggesting that AD109 could become a potential treatment option for patients with OSA."

Clinical • Journal • P3 data • CNS Disorders • Fatigue • Insomnia • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder • Xerostomia

Mechanisms of upper airway muscle control in sleep reveal therapeutic targets for obstructive sleep apnea. (PubMed, Am J Respir Cell Mol Biol) - "We focus on AD109, an investigational oral therapy combining a norepinephrine reuptake inhibitor (atomoxetine) with an antimuscarinic agent (aroxybutynin), designed to counteract sleep-related withdrawal of excitatory noradrenergic drive and rapid eye movement (REM)-related muscarinic inhibition at the hypoglossal motor nucleus...Symptomatic patients also experienced improvements in fatigue, sleepiness, and snoring versus placebo. Together, these findings support neuromuscular dysfunction as a tractable therapeutic target in OSA and highlight the potential of pharmacologic strategies to address both the physiological consequences of intermittent hypoxia and patient-relevant outcomes across a broad and heterogeneous OSA population."

Journal • Cardiovascular • Fatigue • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Apnimed Secures Up to $150 Million in Debt Financing with HealthCare Royalty Partners to Support Planned AD109 Commercial Launch (PRNewswire) - "Under the terms of the agreement, Apnimed will receive $50 million at closing. An additional $50 million tranche will become available upon FDA approval of AD109, and the company may access a third $50 million tranche upon achievement of a pre-specified sales milestone, subject to customary closing conditions...Apnimed previously reported positive results from the pivotal SynAIRgy and LunAIRo Phase 3 trials for AD109, which will support the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration, expected later this quarter."

FDA filing • Financing • Obstructive Sleep Apnea

AD109 Significantly Reduces Snoring in Patients With Obstructive Sleep Apnea (ATS 2026) - No abstract available

Clinical • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Estimated Reduction in Cardiovascular Risk Associated With Hypoxic Burden Improvement With AD109 in the LunAIRo and SynAIRgy Phase 3 Studies for Obstructive Sleep Apnea (ATS 2026) - No abstract available

P3 data • Cardiovascular • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea: A Pooled Analysis of the SynAIRgy and LunAIRo Phase 3 Trials (ATS 2026) - No abstract available

Late-breaking abstract • P3 data • Retrospective data • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

7131: Dawn of a New Era: Targeting the Neuromuscular Root Cause of OSA With Oral Pharmacotherapy (CHEST 2025) - "Join Dr. Patrick J Strollo, Jr as he highlights the unmet needs of people living with OSA and provide a clinical update on AD109, an investigational oral tablet targeting the neuromuscular root cause of OSA."

Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Aroxybutynin and atomoxetine (AD109) for the treatment of obstructive sleep apnea: Rationale, design and baseline characteristics of the phase 3 clinical trials. (PubMed, Contemp Clin Trials Commun) - P3 | "Key secondary outcomes include changes from baseline in oxygen desaturation index with 3% desaturation, hypoxic burden based on 4% desaturation, Patient Reported Outcome Measurement Information System (PROMIS)-Fatigue, and proportion of participants with ≥50% reduction in AHI4 at Week 26. LunAIRo and SynAIRgy are fully enrolled, large Phase 3 clinical trials designed to confirm and extend our understanding of the safety and efficacy of AD109, a combination oral drug targeting the underlying neuromuscular dysfunction contributing to upper airway muscle collapse during sleep in adults with OSA."

Journal • P3 data • Fatigue • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Demographic and Baseline Disease Characteristics of SynAIRgy: A Phase 3 Trial of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea (WSS 2025) - P3 | "The baseline demographic characteristics of participants enrolled in SynAIRgy are representative of the general population of adults living with OSA, and the baseline AHI4 scores and symptom profiles reflect those of a typical sleep clinic referral OSA population."

P3 data • Fatigue • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo) (clinicaltrials.gov) - P3 | N=660 | Completed | Sponsor: Apnimed | Active, not recruiting ➔ Completed

Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Rationale and Design of a Phase 3 Open-label Extension Study of Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea (ATS 2025) - P3 | "This large OLE study is designed to confirm and extend the safety evidence of the phase 3 SynAIRgy and LunAIRo randomized control trials evaluating the efficacy and safety of AD109 in the treatment of OSA. We have observed substantial participation and adoption for multiple-night use of digital tools including pulse oximetry and PROs to characterize both objective and subjective OSA burden. Data collected to date supports the long-term safety of AD109"

Clinical • P3 data • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea: Participant Demographics and Baseline Disease Characteristics of the Lunairo Phase 3 Trial (ATS 2025) - P3 | "Participants randomized in LunAIRo exhibit baseline AHI4 scores across the broad spectrum of OSA disease severity. The racial and ethnic diversity along with balanced ratio of female-to-male participants is representative of the general population of people living with OSA. Similarly, the symptom profiles reflect a typical sleep clinical referral population."

P3 data • Fatigue • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Apnimed's most advanced clinical program, AD109 (PRNewswire) - "Apnimed's most advanced clinical program, AD109, also continues to progress following the conclusion of enrollment in both Phase 3 clinical trials, LunAIRo and SynAIRgy. The Company continues to anticipate the availability of top-line data from both trials in Q2 and Q3 2025, respectively."

P3 data: top line • Trial status • Obstructive Sleep Apnea

Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study) (clinicaltrials.gov) - P3 | N=646 | Completed | Sponsor: Apnimed | Active, not recruiting ➔ Completed

Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

APC-APN-201: Study That Tests AD109 in Patients Taking GLP-1 Drugs (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Apnimed | Active, not recruiting ➔ Completed

Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

APC-APN-201: Study That Tests AD109 in Patients Taking GLP-1 Drugs (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Apnimed | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2024 ➔ Dec 2024

Enrollment closed • Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

APC-APN-306: Continuation Protocol for Obstructive Sleep Apnea (OSA) (clinicaltrials.gov) - P3 | N=1280 | Enrolling by invitation | Sponsor: Apnimed | Recruiting ➔ Enrolling by invitation

Enrollment status • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Parallel-Arm Study to Compare AD109 to Placebo with Patients with OSA (SynAIRgy Study) (clinicaltrials.gov) - P3 | N=740 | Active, not recruiting | Sponsor: Apnimed | Recruiting ➔ Active, not recruiting

Enrollment closed • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Continuation Protocol for Obstructive Sleep Apnea (OSA) (clinicaltrials.gov) - P3 | N=1280 | Recruiting | Sponsor: Apnimed

New P3 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

APC-APN-201: Study That Tests AD109 in Patients Taking GLP-1 Drugs (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Apnimed | Not yet recruiting ➔ Recruiting

Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Aroxybutynin and Atomoxetine (AD109) for the Treatment of OSA: Rationale and Design of the LUNAIRO Phase 3 Randomized, Controlled Clinical Trial (ATS 2024) - "LUNAIRO is a randomized, double-blind, controlled, parallel-arm, large, 1-year Phase 3 clinical trial designed to confirm and extend evidence of the safety and efficacy in of AD109, a combination drug targeting the key mechanism of upper airway muscle relaxation during sleep in adults with OSA."

Clinical • P3 data • Fatigue • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder