Welcome to our dedicated page for Mereo Biopharma news (Ticker: MREO), a resource for investors and traders seeking the latest updates and insights on Mereo Biopharma stock.
Mereo BioPharma Group plc (NASDAQ: MREO) is a clinical-stage biopharmaceutical company whose news flow centers on rare disease drug development, regulatory interactions, and partnering activity. The company regularly issues updates on its lead programs, setrusumab for osteogenesis imperfecta (OI) and alvelestat for alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), as well as on its collaborations for assets such as vantictumab, navicixizumab and leflutrozole.
Investors following MREO news can expect detailed announcements on clinical trial progress and results. For setrusumab, Mereo and its partner Ultragenyx have reported on Phase 3 Orbit and Cosmic studies in OI, including interim decisions by a Data Monitoring Committee, final analysis plans, and top-line outcomes showing statistically significant improvements in bone mineral density despite not meeting primary fracture endpoints. News items also cover ongoing data analyses to determine potential regulatory paths and program next steps.
For alvelestat, company updates describe regulatory milestones such as Orphan Designation from the European Commission and the FDA, Fast Track designation from the FDA for AATD-LD, and alignment with regulators on the design of a planned single global Phase 3 pivotal study. Releases also discuss partnering discussions for Phase 3 development and commercialization.
Additional MREO coverage includes quarterly and annual financial results, cash runway guidance, licensing agreements like the out-licensing of vantictumab to āshibio, and conference participation, including presentations at major healthcare investor conferences. This news page allows readers to track how clinical data, regulatory designations, partnerships, and capital position evolve over time for Mereo BioPharma’s rare disease and oncology pipeline.
Mereo BioPharma (NASDAQ: MREO) reported Phase 3 updates for setrusumab (UX143) in osteogenesis imperfecta and progress on alvelestat (MPH-966) for AATD-LD, plus revised cash guidance. As of Dec 31, 2025, cash and equivalents were approximately $41 million, expected to fund operations to mid-2027. Orbit and Cosmic Phase 3 studies did not meet their primary fracture reduction endpoints, but both achieved statistically significant improvements in bone mineral density as a key secondary endpoint. Further analyses and potential regulator interactions are ongoing. Alvelestat Phase 3 is planned as a single global trial (~220 patients, 18 months), and vantictumab was out-licensed with a Phase 2 start planned in 2H 2026.
Mereo BioPharma (NASDAQ: MREO) announced Phase 3 results for setrusumab (UX143) in Osteogenesis Imperfecta on Dec 29, 2025. Both Phase 3 studies, ORBIT and COSMIC, failed to meet their primary endpoint of reducing annualized clinical fracture rate versus placebo or bisphosphonates. Both studies did achieve their secondary endpoints: statistically significant improvements in bone mineral density (BMD). No change in the safety profile was observed. The company reported a $48.7M cash balance at end-Q3 2025 and announced immediate reductions in pre-commercial and manufacturing activities while pursuing further data analyses and partnering for alvelestat.
Mereo (NASDAQ: MREO) reported Q3 2025 results and corporate highlights on Nov 10, 2025. Key near-term catalysts include Phase 3 Orbit and Cosmic setrusumab readouts expected around the end of 2025 (Orbit final analysis threshold p<0.039; Cosmic p<0.05).
Financials: cash $48.7M as of Sep 30, 2025, expected to fund operations into 2027; Q3 R&D expense rose to $4.3M (vs $3.2M prior year); G&A was $6.0M; net loss was $7.0M in Q3 2025.
Corporate items: ongoing alvelestat partnering discussions, retained European commercial rights for vantictumab, and continued pre-commercial work in Europe for setrusumab.
āshibio has entered into an exclusive licensing agreement with Mereo BioPharma (NASDAQ: MREO) for vantictumab, targeting the treatment of autosomal dominant osteopetrosis type 2 (ADO2), a rare bone disorder affecting 1 in 20,000 births.
Vantictumab, a monoclonal antibody that inhibits Wnt signaling pathways by binding to frizzled receptors, has shown promising safety and biomarker data in previous oncology trials. The drug will be developed for ADO2, a genetic disorder caused by CLCN7 gene mutation that results in dense, brittle bones and various complications.
Under the agreement, āshibio gains development and commercialization rights globally, except in Europe, where Mereo retains commercial rights. Preclinical data will be presented at the ASBMR annual meeting in September 2025.
Mereo BioPharma (NASDAQ: MREO) has reported its Q2 2025 financial results and provided corporate updates. The company maintains a strong financial position with $56.1 million in cash as of June 30, 2025, expected to fund operations into 2027. Key highlights include the progression of two Phase 3 studies for setrusumab in osteogenesis imperfecta, with final analyses expected around year-end 2025.
Financial results show R&D expenses increased to $5.4 million in Q2 2025 from $4.9 million in Q2 2024, while G&A expenses decreased to $5.5 million from $7.9 million. The company reported a net loss of $14.6 million for Q2 2025, compared to $12.3 million in Q2 2024. The Orbit study's Data Monitoring Committee confirmed setrusumab's acceptable safety profile, allowing the study to proceed to final analysis.
Mereo BioPharma (NASDAQ: MREO) reported its full year 2024 financial results and corporate updates. The company's Phase 3 Orbit study of setrusumab in osteogenesis imperfecta is advancing toward a second interim analysis expected mid-2025. Alvelestat received European Commission Orphan Designation for Alpha-1 Antitrypsin Deficiency-associated Lung Disease treatment.
Financial highlights include cash position of $69.8 million as of December 31, 2024, expected to fund operations into 2027. R&D expenses increased to $20.9 million from $17.4 million in 2023, while general and administrative expenses rose to $26.4 million from $18.4 million. The company reported a net loss of $43.3 million for 2024, compared to $29.5 million in 2023.
Two global studies are progressing: the Phase 3 Orbit study and Cosmic study, evaluating setrusumab in OI patients. Pre-commercial activities are ongoing in Europe, with scientific advice obtained from GBA in Germany and NICE in the U.K.
Mereo BioPharma Group (NASDAQ: MREO), a clinical-stage biopharmaceutical company specializing in rare diseases, has announced its participation in the Leerink Partners Global Healthcare Conference.
The company's CEO, Dr. Denise Scots-Knight, will engage in a fireside chat scheduled for March 12, 2025, at 8:40 am ET / 1:40 pm GMT.
Investors and interested parties can access the live audio webcast through the Investors section at www.mereobiopharma.com/investors. A replay of the presentation will remain available on the company's website for two weeks after the event.
Mereo BioPharma (NASDAQ: MREO) provided updates on its lead clinical programs. The Phase 3 Orbit Study of setrusumab for Osteogenesis Imperfecta (OI) is progressing toward a second interim analysis expected in mid-2025, with potential final analysis in Q4 2025. The Cosmic study, evaluating setrusumab against bisphosphonate therapy in younger patients, continues in parallel.
Alvelestat, their treatment for alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), received a positive opinion from EMA's Committee for Orphan Medicinal Products, with final European Commission decision expected in Q1 2025. The drug previously received FDA Orphan Drug and Fast Track Designations.
The company confirmed its current cash position will fund operations into 2027, supporting key development milestones through 2025.
Mereo BioPharma Group (NASDAQ: MREO) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's CEO, Dr. Denise Scots-Knight, is scheduled to present on Thursday, January 16, 2025, at 8:15am PT / 04:15pm GMT.
The presentation will be accessible through a live audio webcast via the Investors section of Mereo's website at www.mereobiopharma.com/investors. For those unable to attend live, an archived version of the webcast will remain available on the company's website for a two-week period following the event.
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