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Theravance Biopharma Announces Approval of YUPELRI® (revefenacin) by China's NMPA
Prnewswire· 2025-06-26 10:00
YUPELRI approved by China's NMPA as the first once-daily nebulized LAMA for maintenance treatment of COPD Approval triggers $7.5 million milestone payment from Viatris, with eligibility to receive further sales milestones and tiered royalties on net sales in China Theravance Biopharma incurs no commercial costs in China; Viatris is responsible for the launch and commercializationDUBLIN, June 26, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today a ...
Theravance Biopharma Announces Ampreloxetine Presentations at the International MSA Congress
Prnewswire· 2025-05-09 16:00
DUBLIN, May 9, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced presentation of analyses of its previous Phase 3 program evaluating ampreloxetine, an investigational medicine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) at the International MSA Congress, taking place May 9-11 in Boston, Massachusetts.A subgroup analysis selected as a platform presentation focused on patients with Multiple System Atrophy (MSA ...
Theravance Biopharma to Report First Quarter 2025 Financial Results on May 8, 2025
Prnewswire· 2025-04-24 10:00
DUBLIN , April 24, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will report its first quarter 2025 financial results and provide a business update after market close on Thursday, May 8, 2025. An accompanying conference call and simultaneous webcast will be hosted at 5:00 pm EDT (2:00 pm PDT/10:00 pm IST) that day.Conference Call InformationTo participate in the live call by telephone, please dial (800) 715-9871 from the US or (646) 307-1963 for international callers, using the Conference I ...
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]