MREO

LONDON, May 12, 2026 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced financial results for the first quarter ended March 31, 2026, and provided an update on recent corporate developments. “Based on extensive analysis of data across the two global Phase 3 studies of setrusumab in osteogenesis imperfecta in collaboration with our partner Ultragenyx, we believe there is basis to engage with the regulatory agencies to determine if there is a path forward in pediatric patients. These interactions have been initiated, and we plan to provide updates once we have some definitive feedback. We continue to believe that setrusumab has the potential to provide meaningful benefit for people living with OI, a condition with no FDA or EMA approved therapies,” said Denise Scots-Knight, Chief Executive Officer of Mereo. “We are engaged with potential partners for alvelestat in AATD-LD and believe alvelestat can quickly enter Phase 3 development following closing of a partnership transaction. Our other partnered program, vantictumab, is continuing to move forward with āshibio, who plan to initiate a Phase 2 trial in osteopetrosis in the second half of 2026. We continue to expect that our cash position, which totaled $36.2 million as of March 31, will provide runway into mid-2027, through several key inflection points expected during the remainder of this year.” Recent Corporate Developments and Anticipated Milestones Setrusumab (UX143) Further analyses of the data from the Orbit and Cosmic Phase 3 studies, including patient subgroups, have been completed. While neither study achieved statistical significance against the primary endpoints of reduction in annualized clinical fracture rate compared to placebo (Orbit) or bisphosphonates (Cosmic), both studies achieved high statistical significance against the key secondary endpoint of improvement in bone mineral density versus control as well as reductions in vertebral fractures and improvements in patient reported outcomes (PROs) associated with disease severity, pain / discomfort and daily activities, with these PRO improvements achieving statistical significance in the Orbit study. The safety profile of setrusumab was consistent with that observed in prior studies. Based on the Phase 3 data analysis from...

Additional data analyses from Orbit and Cosmic Phase 3 studies of setrusumab (UX143) in osteogenesis imperfecta ongoing Cash of $41.0 million as of December 31, 2025, expected to provide runway into mid-2027 LONDON, March 19, 2026 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced financial results for the full year ended December 31, 2025, and provided an update on recent corporate developments. “In collaboration with our partner Ultragenyx, we have analysed a significant part of the data from the Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta and continue to develop our understanding of the fracture data and the patient reported outcomes (PROs), especially in patients aged 2–18 years old. We believe that these data, which include pre-specified sub-groups and ad hoc analyses, may provide the basis for engagement with the regulatory agencies,” said Denise Scots-Knight, Chief Executive Officer of Mereo. “There are no FDA or EMA therapies approved specifically for OI and although bisphosphonates are used to improved bone mineral density, it remains a high unmet need. Setrusumab has demonstrated statistically significant improvements in bone mineral density as well as compelling reductions in vertebral fractures and statistically significant improvements in PROs of disease pain and daily activity in pediatric and teenage patients. We look forward to providing updates on these efforts as we progress with next steps. Alongside this, our partnering discussions around alvelestat in AATD-LD are continuing to advance on multiple fronts and our partner āshibio has indicated that it plans to initiate a Phase 2 trial of vantictumab in osteopetrosis in the second half of this year. Following our cost reductions and delays to investment in manufacturing and pre-commercial activities for setrusumab, our revised financial runway into mid-2027 enables us to potentially deliver on several key milestones during 2026.” Setrusumab (UX143) As announced on December 29, 2025, the Phase 3 Orbit and Cosmic studies of setrusumab in OI did not achieve statistical significance against the primary endpoints of reduction in annualized clinical fracture rate compared to placebo or bisphosphonates, respectively. Both studies achieved high stat...

Data from Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta on-track for around the end of 2025 Cash of $48.7 million as of September 30, 2025, expected to support operations into 2027 LONDON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced its financial results for the third quarter ended September 30, 2025, and provided recent corporate highlights. “We are rapidly approaching a major transition period in our corporate evolution, with the Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta on track to read out around the end of the year. Based on the data from prior studies, we remain confident in the potential of setrusumab to reduce fractures and improve quality of life for people with OI. We continue to invest in commercial readiness activities to ensure Mereo is well positioned for a potential launch in our European territories,” said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. “Alongside the progress of the setrusumab program, we are continuing to advance partnering discussions for alvelestat. In addition, we are excited to have retained European commercial rights in our recent partnership deal with āshibio for vantictumab, which is being investigated in autosomal dominant osteopetrosis type 2, another rare bone disease for which promising preclinical data were presented at this year’s ASBMR Annual Meeting. With $48.7 million of cash at the end of the third quarter, we remain well-capitalized to continue executing through these important milestones.” Third Quarter 2025 Highlights, Recent Developments, and Anticipated Milestones Setrusumab (UX143) for osteogenesis imperfecta (OI) The Phase 3 Orbit and Cosmic studies, led by our partner Ultragenyx, evaluating setrusumab in pediatric and young adult patients and young pediatric patients with OI, are progressing towards final analyses at which time patients will have been on therapy for at least 18 months. The data from both Orbit and Cosmic are expected around the end of 2025. The threshold for the Phase 3 Orbit final analysis is p<0.039 and the threshold for the Phase 3 Cosmic final analysis is p<0.05. Pre-commercial efforts continue in Europe where Mereo holds commercial rights. These include continuation...

Data from Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta expected around year-end 2025 Cash of $56.1 million as of June 30, 2025, expected to support operations into 2027 LONDON, Aug. 12, 2025 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced its financial results for the second quarter ended June 30, 2025, and provided recent corporate highlights. “We look forward to the final analysis for the two ongoing Phase 3 studies for setrusumab in osteogenesis imperfecta, the Phase 3 Orbit study in pediatric and young adult patients, and the Phase 3 Cosmic study in young pediatric patients, around the end of the year. We continue to be excited about the potential of setrusumab to reduce fractures and improve other functional parameters for individuals living with osteogenesis imperfecta,” said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. “In parallel with the advancement of setrusumab, we are continuing to advance partnering discussions around alvelestat, our first-in-class oral small molecule for AATD-lung disease, and to ready the program for Phase 3 initiation. Our prudent management of our cash and resources means we are well positioned through these key milestones to support our operations into 2027.” Second Quarter 2025 Highlights, Recent Developments, and Anticipated Milestones Setrusumab (UX143) for osteogenesis imperfecta (OI) The Phase 3 Orbit and Cosmic studies, led by our partner Ultragenyx, evaluating setrusumab in pediatric and young adult patients and young pediatric patients with OI, are progressing towards their final analyses around the end of 2025. The randomized, placebo-controlled Phase 3 portion of the Orbit study was evaluated by the Data Monitoring Committee at an interim analysis in July 2025 and they informed Ultragenyx that setrusumab demonstrated an acceptable safety profile and that the study should continue to the final analysis. Data from the Cosmic study were not analyzed at the interim timepoint, consistent with the statistical analysis plan. Patients will continue dosing in both the Phase 3 Orbit and Cosmic studies, with the final analyses to be conducted after patients have been on therapy for at least 18-months. The threshold for the Phase 3 Orbit final analysis is p<0...

Progress continues in Phase 3 Orbit study of setrusumab in osteogenesis imperfecta (OI) Cash of $62.5 million as of March 31, 2025, expected to fund operations into 2027 LONDON, May 13, 2025 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced its financial results for the first quarter ended March 31, 2025, and provided recent corporate highlights. “As we close out the first quarter of 2025, we continue to anticipate that this will be an important, milestone-rich year for Mereo. The Phase 3 Orbit study of setrusumab in osteogenesis imperfecta remains on track to read-out either at the second interim analysis in mid-2025 or at the final analysis in the fourth quarter. We are continuing to invest in the pre-commercial activities for setrusumab to enable a successful launch in our European territory, following potential regulatory approvals,” said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "Further, alvelestat is now Phase 3 ready and we are finalizing the trial start-up activities to support our ongoing partnering process. Along with our late-stage pipeline, we believe that continued close management of our cash balance will enable us to support our operations into 2027.” First Quarter 2025 Highlights, Recent Developments, and Anticipated Milestones Setrusumab (UX143) Continued progress in the two global Phase 3 studies led by our partner Ultragenyx: The randomized, placebo-controlled Phase 3 portion of the Orbit study (in patients aged 5 to 25 years) is progressing toward the second interim analysis (IA2) in mid-2025 or a final analysis in the fourth quarter of 2025. All patients have now been on therapy for at least 12 months, conduct of the study is going well and patient safety in the Phase 3 portion of the study is consistent with safety observed in the Phase 2. Patients in the Cosmic study (aged 2 to <7 years) are being treated with either setrusumab or intravenous bisphosphonates (IV-BP) therapy and will be evaluated in parallel with the Orbit interim analysis. If Orbit progresses to full study completion in the fourth quarter of 2025, Cosmic will also continue to a data readout, to align with the Orbit readout without spending alpha at the mid-year interim assessment. Continued pre-commercial activities in Europe to...

Orbit Phase 3 study of setrusumab in osteogenesis imperfecta progressing toward second interim analysis, expected mid-2025 Alvelestat granted Orphan Designation by the European Commission for treatment of Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD) Cash of $69.8 million as of December 31, 2024, expected to fund operations into 2027 LONDON, March 26, 2025 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced its financial results for the full year ended December 31, 2024, and provided recent corporate highlights. “2024 was a year of focused execution and strategic advancement at Mereo, driving our lead programs closer to key milestones," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "The Phase 3 Orbit study of setrusumab in osteogenesis imperfecta (OI) is set to read out at the upcoming second interim analysis mid-year or at the final analysis during the fourth quarter of 2025. This could set the stage for us, alongside our partner Ultragenyx, to file for regulatory approvals in the U.S. and EU. Our European pre-commercial activities are ongoing, where we are focused on laying the foundation for a successful and efficient commercial launch, following potential regulatory approval. On alvelestat, the recent receipt of European Orphan Designation and the Phase 3 readiness activities have been highly supportive for our ongoing partnering process. With a strong financial position, we look forward to a transformative 2025, focused on bringing life-changing therapies to patients with rare diseases.” 2024 Highlights, Recent Developments, and 2025 Anticipated Milestones Setrusumab (UX143) Continued progress in two global studies, the Phase 3 portion of Orbit (Phase 2/3) and Cosmic (Phase 3), of setrusumab in OI patients, led by our partner Ultragenyx. The Phase 3 portion of the Orbit Study is continuing to dose pediatric and young adult patients, with the second interim analysis expected mid-2025 and potential final analysis in the fourth quarter of 2025. Treatment is ongoing in the open-label Phase 3 Cosmic study evaluating setrusumab against intravenous bisphosphonate therapy in patients aged 2 to <7 years. Data from this study will be evaluated in parallel with the interim or final analysis from the Orbit st...