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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.
The bispecific antibodies for cancer market is projected to grow by USD 400.72 million from 2022 to 2027, with a CAGR of 8.82%, driven by an increasing incidence of cancer and the advantages these antibodies hold over traditional monoclonal antibodies. North America is expected to account for 38% of this growth, especially due to favorable reimbursement schemes. Key trends include an increase in strategic alliances and advancements in bispecific antibody generation platforms, while challenges such as high drug costs and late diagnoses impact market growth.
Glyscend Therapeutics announced the appointment of Michael Wyzga to its Board of Directors, enhancing its leadership in the biotechnology space. Wyzga, with over 20 years of experience in life sciences, previously held senior positions at Radius Health and Genzyme Corporation. His expertise is expected to be crucial as Glyscend advances its lead product, GLY-200, through clinical trials for Type 2 diabetes and obesity. Wyzga expressed enthusiasm about the company’s promising Phase 1 trial results for GLY-200, which utilizes a unique gut-targeted approach. The company is focused on developing innovative polymer therapies for metabolic disorders.
Mereo BioPharma Group plc (NASDAQ: MREO) released its financial results for the year ended December 31, 2022, reporting a net loss of £34.2 million compared to a net profit of £12.7 million in 2021. The company maintains £68.2 million in cash resources, sufficient to fund operations into 2026. Key developments include positive data from the Phase 2 ASTRAEUS study of alvelestat for severe alpha-1-antitrypsin deficiency and completion of enrollment for the Phase 2 Orbit study of setrusumab in osteogenesis imperfecta. Mereo has received Fast Track Designation from the FDA and anticipates further data in mid-2023.
Mereo BioPharma announced a clear path forward for its alvelestat program following positive regulatory feedback from the FDA and EMA. The company plans a single global Phase 3 study evaluating alvelestat at a 240 mg dose against placebo for alpha-1-antitrypsin deficiency-related lung disease (AATD-LD) over 12-18 months. The study's independent primary endpoints will include a patient-reported outcome and lung density via CT scan. Notably, no additional confirmatory study is required for full marketing approval in both the U.S. and EU. The conference call today at 8:30 AM ET will provide further details.
Mereo BioPharma Group (NASDAQ: MREO) has announced that CEO Dr. Denise Scots-Knight will participate in a fireside chat at the SVB Securities Global Biopharma Conference on February 15, 2023, at 01:00 PM GMT / 08:00 AM ET. The event will be accessible via a live audio webcast on the company's website, with an archived replay available for two weeks post-event.
Mereo is focused on developing therapeutics for rare diseases, with two main candidates: setrusumab for osteogenesis imperfecta and alvelestat for severe Alpha-1 antitrypsin deficiency. The company aims to advance its drug pipeline with strategic partnerships and clinical studies.
Mereo BioPharma Group plc (NASDAQ: MREO) announced that CEO Dr. Denise Scots-Knight will participate in a fireside chat at the Jefferies London Healthcare Conference on November 15, 2022, at 12:55pm GMT / 07:55am ET. The event will include a live audio webcast available on the company's Investors page. Mereo focuses on innovative therapeutics for rare diseases and oncology, holding two rare disease candidates and two oncology candidates in clinical development, with significant partnerships and potential milestone payments totaling over $500 million.
Mereo BioPharma Group (NASDAQ: MREO) has received a notification from Nasdaq regarding its failure to maintain a minimum bid price of $1.00 for 30 consecutive business days. The company has until May 1, 2023, to regain compliance. If compliance is not achieved, an additional 180-day grace period may be requested. Despite the notification, Mereo's American Depositary Shares will continue trading as usual. The company monitors its ADS price closely, and the notification does not affect its ongoing business operations.
Mereo BioPharma Group plc (NASDAQ: MREO) announced the appointment of four new directors to its Board, following a cooperation agreement with its largest shareholder, Rubric Capital Management. The new directors include Dr. Annalisa Jenkins, Dr. Daniel Shames, Mr. Marc Yoskowitz, and Mr. Justin Roberts, replacing outgoing members. Rubric has also withdrawn its requisition notice for a General Meeting, indicating a standstill until Mereo’s 2024 Annual General Meeting. The Company aims to improve shareholder value by focusing on its rare disease programs, particularly setrusumab and alvelestat.
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.
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