Theravance Biopharma Announces Approval of YUPELRI® (revefenacin) by China's NMPA

Core Viewpoint - Theravance Biopharma announces that Viatris has received regulatory approval in China for YUPELRI® (revefenacin), marking it as the first once-daily nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in the country [1][7] Financial Impact - The approval triggers a one-time milestone payment of $7.5 million from Viatris to Theravance Biopharma, expected in Q3 2025 [2] - Theravance Biopharma is also eligible for additional sales-based milestones of up to $37.5 million and tiered royalties ranging from 14% to 20% on net sales in China [2] - The company reported a financial position that includes $131 million in cash as of March 31, 2025, and an additional $225 million from the recent sale of TRELEGY royalties to GSK [3] Product Development - Theravance Biopharma is nearing completion of enrollment in the open label portion of CYPRESS, a registrational study for ampreloxetine, which targets symptomatic neurogenic orthostatic hypotension associated with multiple system atrophy [3] - Ampreloxetine has shown potential benefits in increasing norepinephrine levels and improving blood pressure without worsening supine hypertension in MSA patients [4] Study Details - The CYPRESS study (Study 0197) is a Phase 3, multi-center, randomized withdrawal study evaluating the efficacy and durability of ampreloxetine after 20 weeks of treatment [5] - The primary endpoint of the study is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [5] Company Overview - Theravance Biopharma focuses on delivering innovative medicines, with YUPELRI® approved for COPD maintenance treatment and ampreloxetine in late-stage development for symptomatic neurogenic orthostatic hypotension [6][8]