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
Theravance Biopharma (NASDAQ: TBPH) will host a virtual key opinion leader investor event on December 8, 2025 at 10:30 AM ET to review ampreloxetine's Phase 3 clinical development program for symptomatic neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA) ahead of topline data expected in Q1 2026. The session will feature Horacio Kaufmann, MD, and company management discussing the unmet medical need in MSA, the CYPRESS Phase 3 study design informed by positive REDWOOD results, and ampreloxetine's commercial opportunity and strategy. A live Q&A will follow.
Theravance Biopharma (NASDAQ: TBPH) terrà un evento virtuale per leader di opinione nel settore investitori il 8 dicembre 2025 alle 10:30 AM ET per esaminare lo sviluppo clinico di fase 3 di ampreloxetina per l'ipotensione ortostatica neurogenica sintomatica (nOH) nell'atrofia multisistemica (MSA) in vista dei dati principali previsti nel Q1 2026. La sessione vedrà Horacio Kaufmann, MD, e il management dell'azienda discutere del bisogno medico insoddisfatto nell'MSA, del design dello studio di fase 3 CYPRESS informato dai positivi risultati REDWOOD, e delle opportunità commerciali e della strategia di ampreloxetina. Seguirà una sessione di domande e risposte dal vivo.
Theravance Biopharma (NASDAQ: TBPH) celebrará un evento virtual de líderes de opinión clave para inversores el 8 de diciembre de 2025 a las 10:30 AM ET para revisar el programa clínico de fase 3 de ampreloxetina para la hipotensión ortostática neurogénica sintomática (nOH) en la atrofia multisistémica (MSA) antes de los datos principales esperados en Q1 2026. La sesión contará con Horacio Kaufmann, MD, y la dirección de la empresa, discutiendo la necesidad médica insatisfecha en MSA, el diseño del estudio de fase 3 CYPRESS informado por resultados positivos de REDWOOD, y la oportunidad comercial y la estrategia de ampreloxetina. Seguirá una sesión de preguntas y respuestas en vivo.
Theravance Biopharma (NASDAQ: TBPH)는 2025년 12월 8일 동부 표준시 10:30 AM에 가상 주요 의견 리더 투자자 이벤트를 주최하여, 다발성 경화증(MSA)에서의 증상성 신경성 기립성 저혈압(nOH)을 위한 ampreloxetine의 3상 임상 개발 프로그램을 검토하고 Q1 2026에 예상되는 topline 데이터 발표를 앞둡니다. 이 세션에는 Horacio Kaufmann 의사와 회사 경영진이 MSA의 미충족 의료 필요성, 긍정적 REDWOOD 결과를 바탕으로 한 CYPRESS 3상 연구 설계, 그리고 ampreloxetine의 상업적 기회와 전략에 대해 논의합니다. 이후 라이브 Q&A가 진행됩니다.
Theravance Biopharma (NASDAQ: TBPH) organisera un événement virtuel avec des leaders d'opinion clés investisseurs le 8 décembre 2025 à 10h30 ET pour examiner le programme clinique de phase 3 d'ampreloxetine pour l'hypotension orthostatique neurogénétique symptomatique (nOH) dans l'atrophie multisystémique (AMS) avant les données topline prévues au Q1 2026. La session mettra en vedette Horacio Kaufmann, MD, et la direction de l'entreprise discutant du besoin médical non satisfait dans la MSA, du design de l'étude de phase 3 CYPRESS informé par les résultats positifs REDWOOD, et de l'opportunité commerciale et de la stratégie d'ampreloxetine. Une session de questions-réponses en direct suivra.
Theravance Biopharma (NASDAQ: TBPH) wird am 8. Dezember 2025 um 10:30 Uhr ET eine virtuelle Investorenveranstaltung mit führenden Meinungsbildnern veranstalten, um das Phase-3-Entwicklungsprogramm von Ampreloxetin für die symptomatische neurogenerische orthostatische Hypotonie (nOH) bei der multiplen Systematrophie (MSA) vor den erwarteten Topline-Daten im Q1 2026 zu prüfen. Die Sitzung wird Horacio Kaufmann, MD, und das Unternehmensmanagement umfassen, die den ungedeckten medizinischen Bedarf bei MSA, das CYPRESS-Phasen-3-Studien-Design, das von positiven REDWOOD-Ergebnissen beeinflusst ist, sowie die kommerzielle Chance und Strategie von Ampreloxetin diskutieren. Es folgt eine Live-Frage-und-Antwort-Runde.
Theravance Biopharma (NASDAQ: TBPH) ستعقد حدثاً افتراضياً رائداً للمؤثرين في الرأي من المستثمرين في 8 ديسمبر 2025 الساعة 10:30 صباحاً بتوقيت شرق الولايات المتحدة لاستعراض برنامج التطوير السريري للمرحلة الثالثة لـ amp‑reloxetine لعلاج انخفاض ضغط الدم العصبي الآتي من اضطراب النُّخاع العصبي النشط (nOH) في التدهور العصبي متعدد الأنظمة (MSA) قبل أن تتوقع بيانات القمة في Q1 2026. ستشارك الجلسة الدكتور هوراشيو كوفمان، ومديرو الشركة مناقشين الاحتياج الطبي غير المُلبي في MSA، وتصميم دراسة المرحلة 3 CYPRESS المستند إلى نتائج REDWOOD الإيجابية، وفرص Ampreloxetine التجارية واستراتيجيتها. ستتبعها جلسة أسئلة وأجوبة مباشرة.
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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 ~
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
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
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:
investor.relations@theravance.com
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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FAQ
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