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DUBLIN - China’s National Medical Products Administration (NMPA) has approved YUPELRI (revefenacin) inhalation solution as the first once-daily nebulized long-acting muscarinic antagonist for maintenance treatment of chronic obstructive pulmonary disease, Theravance Biopharma, Inc. (NASDAQ:TBPH) announced Thursday. The company, currently valued at $530 million, has shown strong momentum with a 12% gain year-to-date, according to InvestingPro data.
The approval triggers a $7.5 million milestone payment to Theravance from Viatris Inc., which is expected in the third quarter of 2025. Theravance is also eligible to receive additional sales-based milestones of up to $37.5 million and tiered royalties of 14% to 20% on net sales in China.
Under the agreement, Viatris will handle all development and commercialization responsibilities for YUPELRI in China, with Theravance incurring no commercial costs in the market.
Theravance reported $131 million in cash as of March 31, 2025, and recently received $225 million from the sale of TRELEGY royalties to GSK. The company also earns 35% of U.S. YUPELRI profits and may receive up to $150 million in potential near-term TRELEGY milestone payments from Royalty Pharma.
The company is currently completing enrollment in the open-label portion of its CYPRESS study, which is evaluating ampreloxetine for symptomatic neurogenic orthostatic hypotension associated with multiple system atrophy.
YUPELRI was previously approved in the United States for the maintenance treatment of patients with COPD.
This article is based on a press release statement from Theravance Biopharma.
In other recent news, Theravance Biopharma reported its first-quarter 2025 earnings, revealing an earnings per share (EPS) of -$0.27, which did not meet analysts’ expectations of -$0.22. However, the company achieved a revenue of $15.4 million, slightly surpassing the forecast of $15.14 million, marking a 6% year-over-year increase. Theravance Biopharma also announced a settlement with Eugia Pharma Specialities, resolving patent litigation over the drug YUPELRI, allowing Eugia to market a generic version in the U.S. starting April 23, 2039. Meanwhile, BTIG analysts maintained their Buy rating on Theravance Biopharma, with a price target of $24.00, following the company’s sale of future royalties on Trelegy net sales to GlaxoSmithKline for $225 million. The firm still has the potential to earn up to $150 million in commercial milestones related to Trelegy global net sales. The ongoing CYPRESS trial is expected to conclude enrollment by late summer 2025, with data disclosure anticipated in the first half of 2026. Theravance Biopharma ended the quarter with $131 million in cash and no debt, providing financial flexibility for future initiatives.
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