Core Viewpoint - Theravance Biopharma is hosting a virtual key opinion leader investor event to discuss the unmet medical need for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) and the potential of ampreloxetine as a treatment option [1][2][3] Company Overview - Theravance Biopharma focuses on delivering innovative medicines, including the investigational drug ampreloxetine, which is in development for treating symptomatic nOH in MSA patients [9] - The company has previously developed the FDA-approved YUPELRI (revefenacin) inhalation solution for chronic obstructive pulmonary disease (COPD) [9] Event Details - The investor event is scheduled for December 8, 2025, featuring Dr. Horacio Kaufmann from NYU Langone Health, who will discuss the medical need for nOH treatment in MSA patients and review ampreloxetine's potential [1][2] - The event will also provide an overview of the ongoing Phase 3 CYPRESS study of ampreloxetine, including strategic design choices based on positive results from the REDWOOD study [3] Drug Information - Ampreloxetine is a once-daily selective norepinephrine reuptake inhibitor, showing benefits such as increased norepinephrine levels and improved blood pressure in MSA patients [5] - The drug has received Orphan Drug Designation in the U.S. for treating symptomatic nOH in MSA patients, with plans for a New Drug Application (NDA) submission pending supportive results from the CYPRESS study [5] Study Overview - The CYPRESS study (Study 0197) is a Phase 3, multi-center, randomized withdrawal study evaluating the efficacy and durability of ampreloxetine in MSA patients with symptomatic nOH [6] - The primary endpoint is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score after 20 weeks of treatment [6] Disease Context - Multiple system atrophy (MSA) is a progressive brain disorder affecting movement and balance, with approximately 50,000 patients in the U.S., of whom 70-90% experience nOH symptoms [7] - Neurogenic orthostatic hypotension (nOH) is characterized by a significant drop in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [8]