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 United Kingdom-based biopharmaceutical company dedicated to developing innovative therapeutics for rare and specialty diseases. The company's primary focus is on acquiring and advancing mid-stage development programs from larger pharmaceutical firms, aiming to transform patient quality of life and improve human health. Mereo's strategy includes optimizing the commercial value of its programs through strategic partnerships or, for select opportunities, by commercializing products independently.
Mereo has a robust pipeline of late-stage clinical product candidates, particularly in rare disease areas. The company's flagship candidates include setrusumab for Osteogenesis Imperfecta (OI) and alvelestat for severe Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD). Setrusumab, developed in partnership with Ultragenyx Pharmaceutical Inc., has shown promising results in reducing the annualized fracture rate by 67% in OI patients. The Phase 2/3 Orbit study continues to enroll patients, aiming for regulatory approvals from both the FDA and EMA.
Alvelestat, another key candidate, has demonstrated significant effects in clinical trials, including the ATALANTa study. The data supports its use for AATD-LD, and the company is aligning with both the FDA and EMA on Phase 3 study designs, targeting a broader patient population. Mereo is actively seeking partners for further development and commercialization of alvelestat.
Additionally, Mereo is advancing its oncology pipeline with candidates such as etigilimab (anti-TIGIT) and navicixizumab. Etigilimab is in a Phase 1b/2 trial for recurrent/advanced solid tumors, while navicixizumab has completed a Phase 1 study and is under a global licensing agreement with OncXerna Therapeutics Inc.
Financially, Mereo reported cash and short-term deposits of £51.2 million as of September 30, 2023, with a cash runway extending into 2026. The company has also recently entered into a global license agreement with ReproNovo SA for leflutrozole, a non-steroidal aromatase inhibitor.
Mereo BioPharma's commitment to rare disease therapeutics positions it as a significant player in the biopharmaceutical landscape, with ongoing advancements in its clinical programs and strategic partnerships shaping its path forward.
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.
Mereo BioPharma Group (NASDAQ: MREO) has announced its participation in the Jefferies London Healthcare Conference. Dr. Denise Scots-Knight, CEO, will engage in a Fireside Chat on Tuesday, November 19, 2024, at 10:30am ET / 03:30pm GMT. The presentation will be accessible via live audio webcast through the Investors section of Mereo's website, with a replay available for two weeks after the event.
Mereo BioPharma reported Q3 2024 financial results with cash position of $80.5 million, expected to fund operations into 2027. The company's setrusumab received Breakthrough Therapy designation from FDA for osteogenesis imperfecta treatment. Q3 net loss increased to $15.0 million from $6.5 million in Q3 2023, primarily due to foreign exchange losses. R&D expenses decreased 12% to $3.2 million, while G&A expenses increased 9% to $6.2 million. The company continues to advance setrusumab's Phase 3 program with partner Ultragenyx and expects alvelestat to be Phase 3-ready by end of 2024.
Mereo BioPharma Group (NASDAQ: MREO), a clinical-stage biopharmaceutical company specializing in rare diseases, has announced its participation in the 2024 Cantor Global Healthcare Conference. Dr. Denise Scots-Knight, CEO of Mereo, will engage in a Fireside Chat on Wednesday, September 18, 2024, at 10:55am ET / 03:55pm BST.
Interested parties can access a live audio webcast of the event through the Investors section of Mereo's website at www.mereobiopharma.com/investors. For those unable to attend live, an archived replay of the webcast will be available on the company's website for two weeks following the event, providing an opportunity for stakeholders to stay informed about Mereo's latest developments and insights in the rare disease sector.
Mereo BioPharma (NASDAQ: MREO) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- Cash position of $87.4 million as of June 30, 2024, expected to fund operations into 2027
- Phase 3 Orbit and Cosmic studies of setrusumab in OI fully enrolled
- New long-term Phase 2 data showed continued 67% reduction in fracture rates after 14 months of setrusumab treatment
- R&D expenses increased to $4.9 million, up 33% year-over-year
- Net loss of $12.3 million for Q2 2024, compared to $1.8 million in Q2 2023
The company continues to make progress on setrusumab for OI and alvelestat for AATD, with multiple potential value inflection points ahead.
Mereo BioPharma Group plc (NASDAQ: MREO), a clinical-stage biopharma firm focused on rare diseases, has announced a $50 million underwritten offering of 12,531,300 American Depositary Shares (ADS). Each ADS is priced at $3.99, representing five ordinary shares. The offering is set to close on June 17, 2024. Net proceeds will fund the setrusumab program and other corporate purposes. Investors include Frazier Life Sciences, Deerfield Management, and Perceptive Advisors, alongside existing shareholders like Rubric Capital Management and Janus Henderson Investors. Jefferies, Leerink Partners, and Cantor are managing the offering.
Mereo BioPharma (NASDAQ: MREO), a clinical-stage biopharmaceutical company specializing in rare diseases, announced that CEO Dr. Denise Scots-Knight will participate in a Fireside Chat at the Jefferies Global Healthcare Conference. The event is scheduled for June 6, 2024, at 11:00am ET / 04:00pm BST. A live webcast will be available on Mereo's investor website, with a replay accessible for two weeks post-event.
Mereo BioPharma reported its Q1 2024 financial results, showing cash and cash equivalents of $48.7 million. The company expects to fund operations into 2026. Key updates include the completion of enrollment in the Orbit and Cosmic studies for setrusumab in osteogenesis imperfecta by partner Ultragenyx, and ongoing pre-launch activities in Europe. Mereo also announced progress in partnering discussions and research for alvelestat and etigilimab. Financial highlights included a 25% decrease in R&D expenses, a 8% reduction in general and administrative expenses, and a net loss of $9.0 million, compared to $12.1 million in Q1 2023. The company remains focused on advancing its clinical programs and engaging with partners for future developments.