Yupelri (revefenacin) / Viatris, Zymeworks - LARVOL DELTA

Zymeworks Completes Acquisition of Theravance Biopharma (Zymeworks Press Release) - "With the completion of the transaction, Theravance Biopharma is now part of Zymeworks, further advancing Zymeworks’ strategy to build a diversified revenue-generating biotechnology company, combining innovative R&D with growing commercial and royalty-based cash flows."

M&A • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease

Operational Highlights (PRNewswire) - "YUPELRI Collaboration Revenue increased 11% year-over-year, from $18.7 million to $20.7 million, driven by continued Net Sales growth and improved operating leverage...Q2 2026 TRELEGY net sales, reported by GSK, of approximately $1.0 billion; high confidence in achieving the $100 million 2026 milestone payment."

Sales • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

Safety, Efficacy, and Feasibility of Nebulized Long-Acting Bronchodilators vs Short-Acting Bronchodilators in Hospitalized Patients With Acute Exacerbations of COPD: A Phase IV, Randomized, Parallel-Group Clinical Trial. (PubMed, CHEST Pulm) - "There were no serious adverse events or treatment failures in either group. Our findings indicate that in nonventilated hospitalized patients with exacerbations of COPD, the institution of nebulized formoterol/revefenacin in combination within 24 to 36 hours of hospital admission provided convenient dosing and required fewer drug doses to achieve comparable efficacy and safety with the standard short-acting nebulized albuterol/ipratropium combination."

Journal • P4 data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD (clinicaltrials.gov) - P4 | N=60 | Completed | Sponsor: University of Tennessee Graduate School of Medicine | Recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD) (clinicaltrials.gov) - P4 | N=280 | Not yet recruiting | Sponsor: University of Tennessee Graduate School of Medicine

New P4 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Zymeworks to Acquire Theravance Biopharma, Inc. (GlobeNewswire) - "This acquisition, when closed, provides Zymeworks with access to a 35% U.S. net profit share in YUPELRI, the only approved nebulized LAMA for the maintenance treatment of COPD...Settlements have been reached with all YUPELRI generic filers for an April 2039 licensed launch date for their versions of the product, or earlier depending on certain circumstances...Theravance Biopharma remains eligible to receive an additional $125 million in commercial milestone payments from Viatri...Theravance Biopharma is expected to receive $100 million in commercial milestone payments from Royalty Pharma in Q1 2027 related to global net sales of TRELEGY ELLIPTA by GSK....Theravance Biopharma is eligible to receive up to ~20% royalty on net sales of VIBATIV from Cumberland."

Financing • M&A • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease

Global pharmaceutical leader Lupin Limited…announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Revefenacin Inhalation Solution, 175 mcg/3 mL Unit-Dose Vials (PRNewswire) - "Lupin's Revefenacin Inhalation Solution, 175 mcg/3 mL is bioequivalent to Mylan's Yupelri Inhalation Solution and indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)."

ANDA • Chronic Obstructive Pulmonary Disease • Immunology

Development of a novel voltammetric method for revefenacin determination using modified electrodes in pharmaceutical and biological matrices. (PubMed, BMC Chem) - "Under optimal experimental conditions, the analytical results showed direct relationship responses in the range of 0.19-2.0 µg mL-1 and a low limit of detection (LOD) of 0.04 µg mL-1 and limit of quantification (LOQ) of 0.13 µg mL-1. Our investigation reveals the outstanding applicability of the suggested sensor in quality control laboratories to achieve the fast determination for REV across various sample types (pure form, dosage form, biological samples)."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Exacerbation Outcomes With Revefenacin in COPD Patients With Cardiovascular Risk or History: Exploratory Analyses From Study 0128 (ATS 2026) - No abstract available

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Earlier Onset of Bronchodilation With Revefenacin: New Analyses From Phase 3 COPD Trials (ATS 2026) - No abstract available

New P3 trial • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Evaluation of Revefenacin Use in Hospitalized Patients with Chronic Obstructive Pulmonary Disease (ASHP 2025) - No abstract available

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

YUPELRI (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long-acting muscarinic antagonist) bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) (PRNewswire) - "Achieved all-time high U.S. net sales of $71.4 million in Q3 2025, increasing 15% year-over-year (YoY) (Q3 2025 vs Q3 2024) driven by customer demand growth of 6% YoY (Q3 2025 vs Q3 2024) and improved net pricing due to favorable channel mix; Approximately $54 million required in Q4 2025 to trigger $25 million milestone for the achievement of $250 million of net sales in 2025; Increased doses pulled through the hospital channel by 29% YoY (Q3 2025 vs Q3 2024), reflecting another quarter of strong momentum."

Sales • Chronic Obstructive Pulmonary Disease • Immunology

ADHERENCE TO REVEFENACIN ASSOCIATED WITH REDUCTIONS IN EXACERBATIONS AND HEALTH CARE COSTS FOLLOWING A COPD-RELATED HOSPITALIZATION (CHEST 2025) - "Moderate exacerbations were defined as an outpatient COPD visit accompanied by a filled prescription for a course of theophylline, aminophylline, or an oral corticosteroid or oral antibiotic within 7 days of the outpatient visit. Patients with COPD who were hospitalized, prescribed nebulized revefenacin post-discharge, and adhered to their medication demonstrated statistically significant reductions in both exacerbations and healthcare costs compared to patients who did not adhere to prescribed revefenacin. CLINICAL IMPLICATIONS: Results demonstrate that revefenacin can be effective in reducing COPD exacerbations and the associated costs, though adherence to medication remains critical."

Adherence • Clinical • HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • Squamous Cell Carcinoma

EXACERBATION RATES IN COPD PATIENTS: A RETROSPECTIVE ANALYSIS OF THE NEBULIZED ONCE DAILY LONG-ACTING MUSCARINIC ANTAGONIST REVEFENACIN IN A 52-WEEK SAFETY STUDY (CHEST 2025) - " This retrospective data analysis evaluated exacerbation rates in a 52-week, randomized, open-label Phase 3 safety trial comparing revefenacin (175 and 88 mcg) with tiotropium HandiHaler® in patients with moderate-to-severe COPD. In this retrospective analysis, exacerbations over 52 weeks are reported for COPD patients treated with revefenacin or tiotropium. These findings suggest that once-daily revefenacin provides a viable long-term exacerbation control, offering an alternative nebulized LAMA option for COPD patients. CLINICAL IMPLICATIONS: Once-daily revefenacin provides a long term exacerbation profile at least as effective as tiotropium based upon this retrospective analysis over 52 weeks."

Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Theravance Biopharma to Present New Analyses Highlighting YUPELRI (revefenacin) Outcomes in COPD at the 2025 CHEST Annual Meeting (PRNewswire) - "A retrospective cohort study of claims data demonstrated that following hospital discharge, patients adherent to YUPELRI experienced significantly fewer, and less severe, exacerbations and had significantly lower healthcare costs than non-adherent patients....Post-hoc analyses of a Phase 3 safety study showed that patients taking YUPELRI had significantly lower incidence of moderate-to-severe acute exacerbations, and overall, less severe exacerbations, than patients taking tiotropium."

P3 data • Retrospective data • Chronic Obstructive Pulmonary Disease

Comparison of nebulized long-acting muscarinic antagonist (LAMA) revefenacin to short acting muscarinic antagonist (SAMA) ipratropium in COPD patients with acute respiratory failure requiring mechanical ventilation (ERS 2025) - "Nebulized revefenacin once daily in mechanically ventilated COPD patients in ARF is a feasible alternative to SAMA and reduces resource utilization for bronchodilator delivery. Ventilatory mechanics show potentially greater benefit of revefenacin than ipratropium on airway resistance."

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Stepwise Management of Status Asthmaticus Refractory to Initial Therapy: A Case Report. (PubMed, Cureus) - "First, the patient was treated with inhaled beta-2 agonist (albuterol) and corticosteroids (prednisone, dexamethasone, and methylprednisolone). The patient did not improve with these treatments and was given the anticholinergic agent ipratropium bromide in an attempt to increase bronchodilation. Nebulized racemic epinephrine was then added to the patient to optimize maximum bronchodilation and vasoconstriction in an attempt to reduce airway edema and inflammation. To reduce ventilator peak airway pressures through sedation and paralytics, rocuronium and cisatracurium (Nimbex) were administered. Ketamine was added as a sedative and bronchodilator. Propofol and midazolam (Versed) were used to sedate the patient for mechanical ventilation. After the acute episode, maintenance therapy included inhaled corticosteroids (budesonide), a long-acting beta-2 agonist (arformoterol), a long-acting muscarinic antagonist (revefenacin), and montelukast (a leukotriene receptor..."

Journal • Anesthesia • Asthma • Cardiovascular • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

RARICO: Revefenacin in Acute Respiratory Insufficiency in COPD (clinicaltrials.gov) - P2 | N=21 | Completed | Sponsor: University of California, Los Angeles | Recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Jan 2025 | Trial primary completion date: Apr 2025 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Theravance Biopharma, Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update (PRNewswire) - "Achieved total U.S. net sales of $66.3 million in Q2 2025, increasing 22% year-over-year (Q2 2025 vs Q2 2024)....Net sales benefited from continued improvement to net pricing and a one-time favorable adjustment to net price....Earned $7.5 million milestone payment from Viatris in Q2 2025 for YUPELRI approval in China."

Commercial • Chronic Obstructive Pulmonary Disease

Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators (clinicaltrials.gov) - P4 | N=72 | Recruiting | Sponsor: University of Tennessee Graduate School of Medicine

New P4 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Quantification and Aerodynamic Particle Size Distribution of Revefenacin Aerosol With UHPLC-MS/MS. (PubMed, J Sep Sci) - "These findings indicate that the aerodynamic properties of revefenacin aerosol remain stable over prolonged nebulization. This study establishes a reliable analytical method for revefenacin aerosol quantification and provides valuable insights into its aerodynamic characteristics, supporting its further application in chronic obstructive pulmonary disease treatment."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Theravance Biopharma Announces Approval of YUPELRI (revefenacin) by China’s NMPA Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.) (PRNewswire) - "Theravance Biopharma, Inc....announced that Viatris Inc. ('Viatris'), has secured regulatory approval from China's National Medical Products Administration (NMPA) for YUPELRI (revefenacin) inhalation solution, the first once–daily nebulized long–acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) in China...This approval triggers a one-time $7.5 million milestone from Viatris to Theravance Biopharma, which is expected to be received in Q3 2025. Theravance Biopharma is also eligible for further sales-based milestones of up to $37.5 million and tiered royalties of 14% to 20% on net sales in China. Viatris is responsible for all aspects of development and commercialization of YUPELRI in China."

China approval • Chronic Obstructive Pulmonary Disease

Differences in Demographic and Clinical Profiles Among Patients Adherent Vs. Non-Adherent to Revefenacin Following a COPD-Related Hospitalization (ISPOR 2025) - "Demographic and clinical differences were observed between patients adherent vs. non-adherent to revefenacin post COPD hospitalization. This is the first real world study observing adherence on revefenacin prescribed after a recent COPD hospitalization, and highlights potential age, racial and socioeconomic disparities that present opportunities to improve medication adherence."

Clinical • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Diabetes • Heart Failure • Immunology • Metabolic Disorders • Mood Disorders • Psychiatry • Respiratory Diseases

Theravance Biopharma, Inc. Reports First Quarter 2025 Financial Results and Provides Corporate Update (PRNewswire) - "YUPELRI (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long-acting muscarinic antagonist) bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD): Achieved total US net sales of $58.3 million in Q1 2025, increasing 6% year-over-year (Q1 2025 vs Q1 2024)....TRELEGY Update: GSK posted first quarter 2025 global net sales of $854 million (up 14% from $749 million reported in the first quarter of 2024): FY 2025 global net sales of ~$3.41 billion (representing minus 1% growth vs. 2024) required to trigger $50M milestone from Royalty Pharma."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease

Development of a novel stability-indicating UHPLC method for revefenacin quality control and impurity identification using 2D-LC-HRMS. (PubMed, J Pharm Biomed Anal) - "The results demonstrate that this method is suitable for Rev quality control. The novel stability-indicating UHPLC method developed for quantifying Rev DPs offers a reliable approach for quality assurance."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases