Theravance Biopharma to Host Virtual KOL Investor Event to Review Ampreloxetine Phase 3 Clinical Development Program, Ahead of Topline Data in Q1 2026, on December 8, 2025
DUBLIN, Nov. 20, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ:TBPH) today announced that it will host a virtual key opinion leader (KOL) investor event on Monday, December 8, 2025 at 10:30 AM ET. To register, click here.
The event will feature Horacio Kaufmann, MD (Dysautonomia Center, NYU Langone Health), who will join company management to discuss the unmet medical need for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), a chronic, debilitating condition caused by autonomic dysfunction that is present in ~80% of patients with MSA. Dr. Kaufmann will also review ampreloxetine as a potential precision therapy approach in development for nOH in patients with MSA.
In anticipation of the Phase 3 CYPRESS study topline results in the first quarter of 2026, the event will also provide an overview of the ongoing CYPRESS study of ampreloxetine, and the strategic design choices of the study, informed by the positive results observed in patients with MSA in the REDWOOD study. Additionally, Company management will summarize ampreloxetine's commercial opportunity and strategy.
A live question and answer session will follow the formal presentations.
About Horacio Kaufmann, MD
Horacio Kaufmann, MD is the director of the Dysautonomia Center at NYU Langone. He is dedicated to providing expert care to patients with autonomic disorders. Dr. Kaufmann's approach is grounded in compassion and scientific discovery, ensuring that each patient receives honest answers, hope, and access to cutting-edge clinical trials. His team is committed to transforming lives through a combination of research and medicine. Dr. Kaufmann specializes in diagnosing and treating patients with a range of autonomic disorders, including familial dysautonomia, multiple system atrophy, pure autonomic failure, amyloidosis, and congenital insensitivity to pain. His fascination with the autonomic nervous system, which functions unconsciously and is essential to maintaining every bodily function, has driven his career in neurology and translational research. Throughout his career, Dr. Kaufmann has had the privilege of collaborating with brilliant colleagues, scientists, and physicians, as well as extraordinary families. Together, they have made significant progress in understanding these rare and complex conditions. Their efforts have led to the development of clinical trial tools, pioneering new drugs, and disease-modifying genetic therapies, providing support to generations of families facing life-altering diagnoses. Dr. Kaufmann's journey into medicine began with a deep love for biology and neuroscience. As a medical student, he became captivated by the autonomic nervous system, which led him to pursue neurology. The intensity of focus and the potential for scientific discovery inspired him to dedicate his career to improving lives, one patient at a time. At NYU Langone, Dr. Kaufmann is proud to be part of a team that ensures the highest standard of comprehensive and coordinated care for patients.
About Ampreloxetine
Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the U.S., the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.
About CYPRESS (Study 0197), a Phase 3 Study
Study 0197 (NCT05696717) has completed enrollment. This is a registrational Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. The Study includes four periods: screening, open label (12-week period, participants will receive a single daily 10 mg dose of ampreloxetine), randomized withdrawal (eight-week period, double-blind, placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine), and a long-term treatment extension. Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that require standing for a short time) and item 3 (activities that require walking for a short time).
About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH)
MSA is a progressive brain disorder that affects movement and balance and disrupts the function of the autonomic nervous system. The autonomic nervous system controls body functions that are mostly involuntary. One of the most frequent autonomic symptoms associated with MSA is a sudden drop in blood pressure upon standing (nOH).1 There are approximately 50,000 MSA patients in the US2 and 70-90% of MSA patients experience nOH symptoms.3 Despite available therapies, many MSA patients remain symptomatic with nOH.4
Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a fall in systolic blood pressure of ⩾20 mm Hg or diastolic blood pressure of ⩾10 mm Hg, within 3 minutes of standing. Severely affected patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain.
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value.
For more information, please visit www.theravance.com.
THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries).
YUPELRI® is a registered trademark of Viatris Specialty LLC. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.
Forward-Looking Statements
This press release will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma, Inc. (the "Company") intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's goals, designs, strategies, plans and objectives, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, the safety, efficacy or differentiation of our investigational therapy, commercial potential and market opportunity of our investigational therapy, and expectations around the use of OHSA scores as endpoints for clinical trials. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, and general economic and market conditions. Other risks affecting the Company are in the Company's Form 10-Q filed with the SEC on November 12, 2025, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
Contact:
[email protected]
650-808-4045
1 https://medlineplus.gov/genetics/condition/multiple-system-atrophy/
2 UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K).
3 Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999).
4 Data on file. MSA Natural History Statistics, NYU September 2019.
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