Theravance Biopharma, Inc. has announced the approval of Yupelri® (revefenacin) inhalation solution by China's National Medical Products Administration (NMPA). This marks the first once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in China. The approval triggers a one-time $7.5 million milestone payment from Viatris Inc., with further sales-based milestones of up to $37.5 million and tiered royalties of 14% to 20% on net sales in China.
As of March 31, 2025, Theravance Biopharma had $131 million in cash, and an additional $225 million was received from the recent sale of Trelegy royalties to GSK. The company also has access to 35% of U.S. Yupelri profits and up to $150 million in near-term potential Trelegy milestone payments from Royalty Pharma.
The company is nearing completion of enrollment in the open-label portion of Cypress, its registrational study of Ampreloxetine in symptomatic neurogenic orthostatic hypotension associated with multiple system atrophy. Ampreloxetine is an investigational, once-daily, selective norepinephrine reuptake inhibitor with the potential to address a significant unmet need in this rare neurological disorder.
The Cypress study (0197) is a registrational phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of Ampreloxetine in participants with multiple system atrophy and symptomatic neurogenic orthostatic hypotension after 20 weeks of treatment.
Theravance Biopharma's focus is to deliver medicines that make a difference in people's lives. The company is committed to creating and driving shareholder value. Following these announcements, the company's shares moved 0.66%, and are now trading at a price of $10.65. Check out the company's full 8-K submission here.
