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 Group (NASDAQ: MREO) announced a R&D update call on October 31, 2022, at 8:00 am ET, focusing on the alvelestat program for alpha-1-antitrypsin deficiency (AATD). This follows the Fast Track Designation received from the FDA on October 17, 2022. The call will include insights and a Q&A session featuring experts like Prof. Robert Stockley and Prof. Robert Sandhaus. Interested parties can register via a link provided, and the event will be accessible on Mereo's investor website.
Mereo BioPharma Group plc (NASDAQ: MREO) announced a shareholder meeting on November 18, 2022, to vote on resolutions proposed by Rubric Capital Management, which seeks to remove five incumbent directors. Mereo’s board has urged shareholders to vote against these resolutions, arguing that Rubric's nominees are underqualified and that their proposals could disrupt Mereo's strategy for developing potential life-changing therapies for rare diseases. Mereo emphasizes its commitment to maximizing shareholder value and executing its strategic plan.
Rubric Capital Management, an investment advisor owning approximately 14% of Mereo BioPharma Group plc (NASDAQ: MREO), commends the company for streamlining operations to extend its cash runway by two years. However, Mereo burnt approximately £9 million in cash in Q2, which is deemed unsustainable. Rubric emphasizes the need for active corporate governance and shareholder alignment to unlock further value, urging support for its slate of director nominees ahead of the general meeting.
Mereo BioPharma Group plc (NASDAQ: MREO) announced a revised operational plan aimed at enhancing its capital efficiency while prioritizing its promising programs. The company plans to reduce its workforce by up to 40% and cut other costs significantly, extending its cash runway into 2026. Mereo is focusing on its lead programs, including setrusumab for osteogenesis imperfecta and alvelestat, which recently received Fast Track designation from the FDA. The updated plan is designed to maximize shareholder value while retaining essential resources for ongoing projects.
Mereo BioPharma announced that the FDA has granted Fast Track designation for its investigational drug, alvelestat, aimed at treating AATD-associated lung disease. This designation recognizes alvelestat’s potential in addressing significant unmet medical needs. Mereo plans to discuss the design of a pivotal registration study in an upcoming End-of-Phase 2 meeting with the FDA. The company also reported positive data from the ASTRAEUS Phase 2 study and is studying alvelestat for other related conditions. An R&D update is scheduled for October 31, 2022.
Mereo BioPharma (NASDAQ: MREO) announced that Rubric Capital Management has rejected a settlement proposal and heightened its proxy campaign to take control of Mereo's Board. Mereo urges shareholders to dismiss Rubric's resolutions that aim to replace a majority of independent directors, claiming such actions would undermine the Board's expertise and strategic direction. Despite Rubric's efforts, including a nomination for five directors, Mereo's Board maintains its qualified composition is essential for maximizing shareholder value through ongoing clinical programs, particularly setrusumab and alvelestat.
Rubric Capital Management LP, owning about 14% of Mereo BioPharma Group (NASDAQ: MREO), has issued an open letter criticizing Mereo's Board for rejecting its request for a special shareholders' meeting. Rubric claims the Board is employing entrenchment tactics to avoid shareholder scrutiny. In response, Rubric has expanded its proposed slate of director nominees to five, emphasizing the need for enhanced financial and strategic expertise on the Board to maximize shareholder value.
Mereo BioPharma Group plc (NASDAQ: MREO) announced that its proposal to resolve issues with Rubric Capital Management LP was rejected. Mereo offered to appoint a Rubric principal and another director to its Board, but Rubric demanded four Board seats instead. Mereo expressed disappointment at Rubric's refusal to negotiate, highlighting that this move would lead to a costly proxy contest for Mereo and its shareholders. Additionally, Mereo declared Rubric's notice for a General Meeting invalid, citing non-compliance with the Companies Act 2006.
Rubric Capital Management, owning 14% of Mereo BioPharma (NASDAQ: MREO), has submitted a revised requisition for a shareholder meeting, criticizing Mereo's governance and misleading communications. Rubric's open letter alleges that Mereo's Board is obstructing shareholder rights and lacks a credible plan to enhance shareholder value. The firm has nominated four candidates for Board positions and urges Mereo to allow shareholders to vote on these proposals. Rubric asserts that the Board's actions waste shareholder capital and ignore the need for a strategic overhaul.
Mereo BioPharma Group plc (NASDAQ: MREO) announced promising clinical data from the ACTIVATE Phase 1b/2 study evaluating etigilimab, an anti-TIGIT antibody, combined with nivolumab for treating advanced solid tumors. The study observed continued clinical benefits, particularly in PD-L1 negative or low subjects, with significant complete responses in cervical cancer and other tumor types. Biomarker analysis indicates the potential of PVR, CD226, and TIGIT as predictive markers for patient enrichment. The trial is currently paused for further enrollment, with 30 patients remaining on study.
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