Announcement • Jul 14
American Academy of Orthopaedic Surgeons Launches New Pain Management Resource Center in Partnership with Curonix LLC Pacira Biosciences, Inc., Vertex Pharmaceuticals, and Viatris American Academy of Orthopaedic Surgeons launched a new Pain Management Resource Center, an online destination designed to help orthopaedic surgeons and patients make more informed decisions about pain care before, during and after treatment as a first step of a new comprehensive pain initiative. The new Resource Center brings together centralized access to practical tools, clinical guidance and education tailored specifically to musculoskeletal care. The new online pain management resource supports decision-making across the full continuum of orthopaedic care not just postoperative recovery by offering targeted resources for both clinicians and patients. For patients and caregivers, the Pain Management Resource Center offers visual guides to help explain pain, recovery and treatment options at a glance, tools to support conversations with care teams about medications, recovery plans and next steps, and practical information on nutrition, recovery strategies and opioid safety. For orthopaedic surgeons and care teams, resources include perioperative pain management strategies tailored to orthopaedic procedures, topic-based pathways that guide clinicians to relevant learning and practical content for common pain management challenges, and access to CME opportunities through the AAOS learning environment. By bringing these resources together in one location, AAOS aims to support more consistent, patient-centered approaches to pain management while helping clinicians stay current with emerging evidence and best practices. The Pain Management Resource Center was developed in partnership with founding partners Curonix LLC, Pacira BioSciences Inc., Vertex Pharmaceuticals and Viatris. Announcement • Jul 01
Viatris Inc. to Report Q2, 2026 Results on Aug 06, 2026 Viatris Inc. announced that they will report Q2, 2026 results at 9:30 AM, US Eastern Standard Time on Aug 06, 2026 Announcement • Jun 29
Viatris Announces Positive Top-Line Results from Phase 3 Study of Vr-205 in Japanese Adults with Primary Immunoglobulin A Nephropathy Viatris Inc. announced positive top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 (targeted-release budesonide formulation) (Nefecon®) in Japanese adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of developing end-stage renal disease. The Phase 3 clinical trial was a multicenter, interventional, open-label study designed to evaluate the efficacy and safety of 16 mg of VR-205 in Japanese adult patients with primary IgAN. Patients were treated for nine months, followed by a three-month follow-up period. The study achieved its primary endpoint, with VR-205 demonstrating a 33.75% reduction in geometric mean urine protein-to-creatinine ratio (UPCR) at 9 months compared to baseline [95% CI: -45.27 to -19.80; p < 0.001]. These results were statistically significant and clinically meaningful, and were consistent with those observed in the global Phase 3 program for the product. In addition to a statistically significant and clinically meaningful reduction in UPCR at 6 and 12 months, VR-205 demonstrated a significant improvement in estimated glomerular filtration rate (eGFR) and reductions in serum creatinine and urine albumin-to-creatinine ratio (UACR) at 9 months compared to baseline. The overall therapeutic benefit of VR-205 was further supported by improvements in microhematuria and a sustained proteinuria reduction. No study participants progressed to dialysis, kidney transplant or severe renal impairment (eGFR =15 mL/min per 1.73 m2) by the end of the study. VR-205 was generally well tolerated over the nine-month treatment period, with a safety profile consistent with the known safety profile of targeted-release budesonide in non-Japanese patients. Viatris is targeting submission of a New Drug Application in Japan by the end of 2026. In 2022, Calliditas Therapeutics AB and Viatris Pharmaceuticals Japan Inc., a subsidiary of Viatris Inc., entered into an exclusive license agreement to obtain marketing authorization and to commercialize VR-205 for the treatment of primary IgAN in Japan. It is currently a specialty drug approved and marketed as Tarpeyo® in the U.S. and as Kinpeygo® in Europe. The Phase 3 trial was a multicenter, interventional, open-label study conducted in Japan to evaluate the efficacy and safety of oral VR-205 (targeted-release budesonide formulation) for the treatment of primary IgA nephropathy in Japanese adult patients at risk of developing end-stage renal disease. The study enrolled a total of 39 participants who were treated with 16 mg of VR-205 daily (four capsules) over a nine-month treatment period. Following completion of treatment, participants entered a three-month follow-up period including a two-week dose tapered to 8 mg of VR-205 (two capsules) daily at the start of the follow-up period. IgAN is a progressive, immune-mediated kidney disease and the most common primary glomerulonephritis worldwide. Japan reports the highest incidence rates globally, at 39 to 45 cases per million population per year, with peak age at diagnosis between 30 and 39 years. In Japan, adult-onset IgAN is reported to progress to end-stage renal disease (dialysis or transplantation) in approximately 15-20% of patients within 10 years. Most patients reaching end-stage renal disease face decades of dialysis. The total national cost of maintenance hemodialysis in Japan is approximately JPY 1.5 trillion per year. Chronic glomerulonephritis (with IgAN as a leading underlying cause) accounts for 23.4% of Japan's more than 340,000 dialysis patients. Despite this burden, therapies that target the underlying immunological drivers of IgAN to preserve long-term kidney function have remained limited, and a clear need persists for disease-modifying treatment options. Announcement • May 19
Viatris Inc. Receives FDA Acceptance For New Drug Application For Fast-Acting Meloxicam For Moderate-To-Severe Acute Pain Viatris Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain. The FDA has assigned a PDUFA goal date of Dec. 27, 2026. Acute pain affects more than 80 million individuals in the United States each year, where opioids remain a commonly used treatment option. The NDA is supported by data from the Phase 3 program which was presented at PAINWeek 2025. The Phase 3 program consisted of two randomized, double-blind, placebo-(double-dummy) and active-controlled trials – one following herniorrhaphy surgery (NCT06215859) and one following bunionectomy surgery (NCT06215820). Both Phase 3 trials evaluated the efficacy and safety of fast-acting meloxicam versus placebo and included an opioid arm (tramadol 50mg q6h) to confirm the sensitivity of the pain model. The primary endpoint in both trials was defined by the Sum of Pain Intensity Difference (SPID) based on the Numeric Rating Scale measured over 0-48 hours (SPID0-48h) versus placebo. Both trials evaluated the reduction in opioid usage that was defined by number of mean doses of opioid rescue medication and proportion of opioid-free patients over the combined in- and out-patient treatment phases. In both studies, fast-acting meloxicam met primary and secondary endpoints and demonstrated a safety profile consistent with the well-characterized safety profile of this mechanism of action. Viatris is pursuing several value-added medicines, including fast-acting meloxicam, to drive high value products through life cycle optimization including new formulations, delivery technologies and indications. Post-operative herniorrhaphy and bunionectomy patients aged 18 or older who experienced moderate-to-severe acute pain following surgery were eligible to participate in the trials, NCT06215859 and NCT06215820, respectively. 579 herniorrhaphy subjects and 410 bunionectomy subjects were randomized and received doses of either MR-107A-02, tramadol or placebo during the inpatient phase (0-48h). During the outpatient phase, subjects continued to receive the study drug. Subjects randomized to receive tramadol during the inpatient phase received placebo in the outpatient phase. Fast-acting meloxicam (MR-107A-02) is an investigational, novel fast-acting oral formulation of meloxicam being developed by Viatris for the treatment of moderate-to-severe acute pain. Meloxicam is a non-steroidal anti-inflammatory drug (NSAID), and this formulation was designed to enable more rapid dissolution and absorption than currently approved oral meloxicam products. Viatris has reported positive results from two pivotal Phase 3 studies of MR-107A-02 in acute post-surgical pain models following bunionectomy and herniorrhaphy. MR-107A-02 has been submitted to the U.S. Food and Drug Administration for review under the 505(b)(2) regulatory pathway and has not been approved by any regulatory authority. Announcement • May 09
Viatris Inc. Reaffirms Earnings Guidance for the Fiscal Year 2026 Viatris Inc. reaffirmed earnings guidance for the fiscal year 2026. For the year, the company expected total revenues to be in the range of $14,450 million to $14,950 million, Midpoint of $14,700 million. 
