Core Viewpoint - Theravance Biopharma is set to present its clinical development program for ampreloxetine, a potential treatment for neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), at the upcoming International Symposium on the Autonomic Nervous System [1][2]. Company Presentations - The company will have one platform presentation and three poster presentations at the symposium, focusing on the efficacy and methodologies related to ampreloxetine [1][2]. - The platform presentation will highlight results from the REDWOOD trial, showcasing durable symptomatic benefits of ampreloxetine in MSA patients [2]. - The three poster presentations will cover topics such as the impact of ampreloxetine on supine hypertension, retention strategies in rare disease clinical trials, and enrollment strategies in a Phase III trial for MSA-related nOH [2]. About Ampreloxetine - Ampreloxetine is an investigational, once-daily norepinephrine reuptake inhibitor aimed at treating symptomatic nOH in MSA patients [2][8]. - The treatment has shown an increase in norepinephrine levels and a favorable impact on blood pressure, with no worsening of supine hypertension reported [2]. - The company has received Orphan Drug Designation for ampreloxetine in the U.S. and plans to file a New Drug Application (NDA) if the ongoing Phase 3 CYPRESS study yields positive results [2]. Phase 3 Studies - The CYPRESS study is a registrational Phase 3 trial evaluating the efficacy and durability of ampreloxetine in MSA patients with symptomatic nOH after 20 weeks of treatment [3]. - The primary endpoint is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [3]. - The REDWOOD study previously indicated that the benefits of ampreloxetine were particularly significant in MSA patients, with a 72% reduction in the odds of treatment failure compared to placebo [5]. Disease Context - Multiple system atrophy (MSA) is a progressive brain disorder affecting movement and balance, with approximately 50,000 patients in the U.S. [6]. - 70-90% of MSA patients experience symptomatic nOH, which is characterized by a significant drop in blood pressure upon standing [6][7]. - Neurogenic orthostatic hypotension (nOH) can lead to debilitating symptoms, including dizziness and fainting, severely impacting patients' quality of life [7].

Core Insights - Theravance Biopharma, Inc. will report its Q3 2025 financial results and provide a business update on November 10, 2025, after market close [1] - A conference call and webcast will be held on the same day at 5:00 pm EST [2] Company Overview - Theravance Biopharma focuses on delivering impactful medicines, leveraging decades of expertise [3] - The company has developed YUPELRI (revefenacin), an FDA-approved inhalation solution for chronic obstructive pulmonary disease (COPD) [3] - Ampreloxetine, a late-stage investigational drug, is being developed for neurogenic orthostatic hypotension in patients with Multiple System Atrophy, potentially becoming a first-in-class therapy [3]