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Theravance Biopharma Completes Enrollment in Pivotal Phase 3 CYPRESS Study of Ampreloxetine in Patients with Symptomatic Neurogenic Orthostatic Hypotension due to Multiple System Atrophy
Prnewswire· 2025-08-25 10:00
Topline results anticipated in Q1 2026 and, if successful, planning for expedited NDA submission  If approved, ampreloxetine could address a critical unmet need as the first therapy with the potential to provide durable benefit for the 40,000 patients in the U.S. with symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) Ampreloxetine has Orphan Drug Designation in the U.S., underscoring the unmet need in symptomatic nOH due to MSADUBLIN, Aug. 25, 2025 /PRNewsw ...
Theravance Biopharma(TBPH) - 2025 Q2 - Earnings Call Transcript
2025-08-12 22:00
Financial Data and Key Metrics Changes - The company reported net sales for YUPELRI of approximately $66 million for the quarter, representing a 22% year-over-year increase, marking the highest Q2 results since launch [4][8] - Collaboration revenue grew by 31% year-over-year, driven by YUPELRI's net sales growth, leading to improved brand-level profit margins [22][24] - Non-GAAP losses improved to $4.2 million compared to $6.3 million in the prior year, excluding one-time items [25] Business Line Data and Key Metrics Changes - YUPELRI's hospital channel volume increased by 31% compared to 2024, with a long-acting nebulized market share in hospitals reaching approximately 20% [10][11] - The company completed the $225 million sale of its remaining royalty interest in Trelegy to GSK, significantly strengthening its balance sheet [4][22] - Ampreloxetine's Phase 3 Cyprus trial is nearing completion of enrollment, with expectations to report top-line data approximately six months after [5][28] Market Data and Key Metrics Changes - YUPELRI received approval in China, triggering a $7.5 million milestone payment, with plans for commercialization led by Beatrice [4][11] - GSK reported an all-time high of $1.1 billion in Trelegy sales for Q2, contributing to a year-to-date sales total of approximately $2 billion, an 8% increase year-over-year [22] Company Strategy and Development Direction - The company is focused on enhancing shareholder value through strategic reviews and disciplined capital management [6][28] - Ampreloxetine is positioned as a potential transformative therapy for patients with multiple system atrophy (MSA), with a targeted addressable population of approximately 40,000 patients in the U.S. [21][28] - The company aims to maintain a strong financial position while preparing for the upcoming data readout from the Cyprus study [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the $250 million sales threshold for YUPELRI, which would trigger a $25 million milestone payment [9][10] - The company anticipates a stronger second half of the year compared to previous expectations, creating a solid financial foundation as it approaches the Cyprus data readout [26][28] - Management highlighted the importance of the upcoming Cyprus trial results, which could redefine the standard of care for patients with MSA [28] Other Important Information - The company ended the quarter with approximately $340 million in cash and no debt, indicating strong cash management [6][25] - The company is preparing for NDA readiness in parallel with the Cyprus study, with modules already in advanced stages of drafting [19] Q&A Session Summary Question: What contributed to the improved pull-through for YUPELRI this quarter? - Management attributed the improved pull-through to the shift of volume to specialty pharmacy, which enhances patient support and fulfillment [32][35] Question: What is the outlook for YUPELRI in China and the enrollment trends for Cyprus? - Management noted that Beatrice will lead the commercialization in China, and the enrollment profile for Cyprus is expected to be similar to previous studies [41][42] Question: How will pricing for Ampreloxetine be determined? - Management indicated that while it is early to finalize pricing, analysis of recent rare neuro drug launches suggests an average price around $380,000 per year [47] Question: What are the expectations for SG&A increases associated with Ampreloxetine? - Management expects SG&A to remain stable through the second half of the year, with potential increases post-data readout if results are positive [54][56]
Theravance Biopharma to Present New Ampreloxetine Analyses in Neurogenic Orthostatic Hypotension (nOH) at the 77th Annual Meeting of the American Academy of Neurology
Prnewswire· 2025-03-27 10:00
Core Insights - Theravance Biopharma is presenting new analyses of the Phase 3 program for ampreloxetine at the upcoming AAN Meeting, highlighting its selective pharmacodynamic profile [1][2] - The ongoing CYPRESS Study 197 aims to confirm the efficacy of ampreloxetine in treating neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][4] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a once-daily norepinephrine reuptake inhibitor for symptomatic nOH in MSA patients [3][9] - The company has received Orphan Drug Designation for ampreloxetine in the U.S. and plans to file a New Drug Application (NDA) if ongoing studies yield positive results [3] Clinical Study Details - The CYPRESS Study 197 is a multi-center, randomized withdrawal study evaluating the efficacy of ampreloxetine after 20 weeks of treatment, with a primary endpoint of change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [4] - Previous studies (Study 169 and Study 170) indicated that while Study 169 did not meet its primary endpoint, a subgroup analysis suggested significant benefits for MSA patients, showing a 72% reduction in treatment failure odds with ampreloxetine [5][6] Disease Context - Multiple system atrophy (MSA) is a progressive disorder affecting movement and autonomic functions, with approximately 50,000 patients in the U.S., and 70-90% experiencing nOH symptoms [7][8] - Neurogenic orthostatic hypotension (nOH) is characterized by significant drops in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [8]