DUBLIN - Theravance Biopharma, Inc. (NASDAQ: NASDAQ:TBPH) today revealed findings from a sub-study of Phase 3 trials of YUPELRI, underscoring its efficacy in enhancing lung function for COPD patients. The study, published in the International Journal of Chronic Obstructive Pulmonary Disease, detailed the drug's consistent and durable impact over 24 hours compared to a placebo.
YUPELRI, a once-daily nebulized long-acting muscarinic antagonist (LAMA), is the sole FDA-approved treatment of its kind for COPD maintenance. The sub-study pooled data from trials 0126 and 0127, focusing on the 175 mcg dose, which is the FDA-approved quantity.
Dr. Donald A. Mahler highlighted the comprehensive view of 24-hour bronchodilation provided by the analysis, which is crucial for clinical decision-making. Dr. Blake LeMaster emphasized the drug's rapid onset, with significant bronchodilation observed within 15 minutes of administration.
Results showed that revefenacin improved bronchodilation versus placebo, with a mean FEV1 difference of 145 mL at 15 minutes. Improvements were sustained over 24 hours, with mean differences in FEV1 AUC ranging from 205 mL to 282 mL (p
The studies involved adults with moderate-to-very-severe COPD and a significant smoking history. Participants received either revefenacin or placebo via a standard jet nebulizer over 12 weeks. The primary efficacy endpoint was the change from baseline in trough FEV1 on Day 85.
Theravance Biopharma and Viatris Inc (NASDAQ:VTRS). have collaborated on the development and commercialization of nebulized revefenacin products for COPD. The company aims to deliver medicines that significantly impact patients' lives and create value for shareholders.
This news is based on a press release statement from Theravance Biopharma.
In other recent news, Theravance Biopharma reported a minor decrease in net sales for its product Yupelri in the second quarter, totaling $54.5 million. This drop was due to changes in the brand's channel mix. Despite this, Theravance Biopharma anticipates price improvements in upcoming quarters and remains hopeful about Yupelri's long-term growth potential in the US market for COPD maintenance treatment. Additionally, the company's Ampreloxetine program experienced delays, with the last patient enrollment for the CYPRESS study now expected in mid-2025.
Theravance Biopharma also settled a patent litigation with Qilu Pharmaceutical, providing Qilu a license to produce and sell its generic version in the United States starting on April 23, 2039. Meanwhile, H.C. Wainwright maintained a Buy rating on Theravance Biopharma shares, and TD Cowen revised its outlook on the company, lowering the price target to $9. These recent developments reflect the ongoing dynamics in Theravance Biopharma's operations and market positioning.
InvestingPro Insights
As Theravance Biopharma (NASDAQ: TBPH) showcases promising results for its COPD treatment YUPELRI, it's worth examining the company's financial health and market position. According to InvestingPro data, Theravance Biopharma has a market capitalization of $421.71 million, reflecting its position in the biotechnology sector.
The company's revenue growth is noteworthy, with a 20.97% increase over the last twelve months as of Q2 2024, reaching $62.02 million. This growth aligns with the positive clinical results for YUPELRI and suggests potential for future market expansion.
However, investors should note that Theravance Biopharma is currently not profitable, with an operating income margin of -62.82% over the same period. This is not uncommon for biotech companies investing heavily in research and development, especially those with promising drug candidates like YUPELRI.
An InvestingPro Tip indicates that management has been aggressively buying back shares, which could signal confidence in the company's future prospects. Additionally, Theravance Biopharma holds more cash than debt on its balance sheet, providing financial flexibility to support ongoing clinical trials and potential commercialization efforts.
For those interested in a deeper analysis, InvestingPro offers 5 additional tips that could provide further insights into Theravance Biopharma's investment potential. These tips, along with real-time financial metrics, can help investors make more informed decisions about the company's stock in light of its recent clinical achievements.
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