Obstructive Sleep Apnea (OSA)

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Nyxoah Announces Preliminary Results for the Second Quarter of 2025
Globenewswire· 2025-08-11 05:00
Core Viewpoint - Nyxoah has reported preliminary financial results for Q2 2025, indicating significant growth and successful commercial proof of concept in Germany, with plans to expand into the U.S. market following FDA approval of its Genio system [1][3]. Financial Results - Revenue for Q2 2025 is anticipated to be approximately €1.3 million, representing a 73% increase compared to Q2 2024 [4]. - Operating expenses for Q2 2025 are expected to be around €20.7 million, a 50% increase from Q2 2024 [4]. - Cash, cash equivalents, and financial assets are projected to be approximately €43.0 million as of June 30, 2025 [4]. Business Updates - The Genio system has received FDA approval for a subset of adult patients with moderate to severe Obstructive Sleep Apnea (OSA), specifically those with an Apnea-Hypopnea Index (AHI) between 15 and 65 [4][6]. - The company plans to close patient enrollment in its ACCCESS clinical trial, which aims to assess the safety and efficacy of Genio therapy for patients suffering from Complete Concentric Collapse (CCC) [4]. - Nyxoah has reorganized its global R&D function, transitioning ongoing activities from Israel to the U.S. and Belgium [4]. Legal Matters - Inspire Medical Systems, Inc. has filed a lawsuit against Nyxoah in the U.S. for alleged patent infringement, and the company intends to vigorously defend itself [4].
Incannex Healthcare Inc. Expands IHL-42X Clinical Advisory Board with Appointments of Four Industry and Academic Leaders to Advance Obstructive Sleep Apnea (OSA) Program
Globenewswire· 2025-06-03 11:30
Core Insights - Incannex Healthcare Inc. has appointed four experts to its IHL-42X Obstructive Sleep Apnea Clinical Advisory Board, enhancing its capabilities in developing treatments for obstructive sleep apnea (OSA) [1][2][4] - The company is preparing to announce Phase 2 topline data for IHL-42X in July 2025 and will initiate a Phase 3 U.S. study later in the year [1][8] - IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide, designed to target the underlying pathophysiology of OSA [7][10] Company Overview - Incannex is focused on developing combination medicines targeting chronic conditions, including OSA, rheumatoid arthritis, and generalized anxiety disorder [10] - The company is advancing three clinical-stage product candidates, with IHL-42X being the lead program [10] - Incannex aims to address critical gaps in care for conditions that have limited or no approved pharmaceutical treatments [10] Clinical Advisory Board - The newly appointed members include: - Scott A. Sands, Ph.D., an expert in respiratory physiology and engineering [1][5] - Ali Azarbarzin, Ph.D., focusing on the physiological consequences of sleep apnea [2][5] - Lora J. McGill, M.D., FAAN, a neurologist with extensive experience in clinical trials [3][5] - Nancy Collop, M.D., a recognized leader in sleep medicine [4][5] IHL-42X Development - IHL-42X is currently in the RePOSA Phase 2/3 clinical trial, expected to enroll over 560 patients globally [7][8] - Previous trials indicated that IHL-42X reduced the Apnea-Hypopnea Index (AHI) by an average of 51% at the lowest dose [8][9] - The treatment targets two key physiological pathways associated with OSA, potentially benefiting a broader range of patients, including those not classified as obese [9]
Mineralys Therapeutics to Host KOL Call to Discuss Clinical Data from Launch-HTN and Advance-HTN Pivotal Trials Tuesday, April 1, 2025, at 8:00 AM ET
Newsfilter· 2025-03-25 12:00
Core Insights - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases related to dysregulated aldosterone [1][3] - The company will host a conference call featuring Dr. Luke Laffin from the Cleveland Clinic to discuss results from the Advance-HTN and Launch-HTN clinical trials, highlighting the unmet medical needs in uncontrolled and resistant hypertension [1] Company Overview - Mineralys Therapeutics is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [3] - The company's lead product candidate, lorundrostat, is an orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions influenced by dysregulated aldosterone [3] Upcoming Events - A conference call and webinar will take place on April 1st at 8:00 a.m. ET, where a live webcast will also be available on the company's Investor Relations page [2]