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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.
Mereo BioPharma Group plc (NASDAQ: MREO) has successfully closed its public offering of 39,675,000 American Depositary Shares (ADSs) at $2.90 each. This includes 5,175,000 ADSs from underwriters' options, yielding gross proceeds of $115.1 million. The offering utilized a shelf registration statement, effective since October 21, 2020. Mereo focuses on developing therapeutics for oncology and rare diseases, with multiple product candidates in clinical stages.
Mereo BioPharma Group plc (NASDAQ: MREO) announced the pricing of a public offering of 34.5 million American Depositary Shares (ADSs) at $2.90 each, aiming for gross proceeds of $100.1 million. The offering, fully underwritten by SVB Leerink and others, includes a 30-day option for underwriters to purchase an additional 5.175 million ADSs. The transaction is expected to close on February 12, 2021, pending customary conditions. The funds will support Mereo's clinical development efforts in oncology and rare diseases.
Mereo BioPharma Group plc (NASDAQ: MREO) announced plans for an underwritten public offering of American Depositary Shares (ADSs), subject to market conditions. The company aims to use the net proceeds for ongoing clinical development of its product candidates and for general corporate purposes. Additionally, underwriters have a 30-day option to purchase up to 15% more ADSs. The offering follows a shelf registration statement declared effective by the SEC in October 2020. SVB Leerink serves as the sole book-running manager, with BTIG and Needham & Company as co-lead managers.
Mereo BioPharma Group (MREO) has entered a collaboration with Ultragenyx Pharmaceutical for the development of setrusumab, a monoclonal antibody for osteogenesis imperfecta (OI). Mereo will retain commercial rights in Europe, while Ultragenyx will lead global development and commercialization in other regions. Mereo will receive $50 million upfront and could earn up to $254 million in milestone payments. Setrusumab aims to be the first approved therapy for OI, which affects thousands without existing treatment options. The partnership is expected to focus on pediatric development starting in 2021.
Mereo BioPharma Group plc (NASDAQ: MREO) announced the cancellation of its Ordinary Shares trading on AIM, effective December 18, 2020. The last trading day on AIM will be December 17, 2020. Mereo will continue to list its American Depositary Shares (ADSs) on Nasdaq. Additionally, the company issued warrants to Silicon Valley Bank and Kreos Capital, allowing them to subscribe for 621,954 ordinary shares at $0.4144 per share. Mereo has also repaid a loan to the Lenders in full.
Mereo BioPharma Group plc (NASDAQ: MREO) announced the appointment of Dr. Suba Krishnan as Senior Vice President of Clinical Development, effective December 7, 2020. Dr. Krishnan brings over 20 years of experience in immuno-oncology, previously serving as Global Program Head at Genmab. Mereo's CEO, Dr. Denise Scots-Knight, expressed confidence in Dr. Krishnan's expertise aiding the advancement of their lead candidate, etigilimab. Mereo is progressing late-stage clinical trials for etigilimab and other therapeutic candidates in oncology and rare diseases.
Mereo BioPharma Group plc (NASDAQ: MREO) will host a virtual R&D day on November 24, 2020, to discuss its key pipeline programs. The event will focus on etigilimab (Anti-TIGIT) for solid tumors and alvelestat for alpha-1 antitrypsin deficiency and COVID-19 respiratory disease. Key opinion leaders from renowned institutions will present insights into the etigilimab development program. A live audio webcast will be available on the company’s website and an archived replay will follow. This initiative aims to enhance stakeholder understanding of Mereo's innovative therapeutic developments.
Mereo BioPharma Group, a clinical stage biopharmaceutical company, announced that CEO Dr. Denise Scots-Knight will present at the Stifel 2020 Virtual Healthcare Conference on November 16, 2020, at 11:20 am ET. Investors can access a live audio webcast via the company’s website, with an archived version available for two weeks after the event. Mereo focuses on oncology and rare diseases, with products like etigilimab and setrusumab currently in various clinical trials. Forward-looking statements in the announcement caution investors about potential risks and uncertainties.
Mereo BioPharma Group plc (NASDAQ: MREO) announces the appointment of Christine Fox as Chief Financial Officer and Heidi Petersen as Senior Vice President of Regulatory Affairs. Fox, a CPA with over 18 years of experience, replaces interim CFO Michael Wyzga, while Petersen brings 25 years of regulatory expertise in biopharmaceuticals. Their appointments come as Mereo anticipates significant milestones in its pipeline, including a Phase 1b/2 study for its anti-TIGIT antibody, etigilimab, set to begin soon. Both bring valuable skills to strengthen Mereo's leadership.
Mereo BioPharma Group plc (NASDAQ: MREO) announced FDA clearance for its IND application to initiate a Phase 1b/2 study of etigilimab, a novel anti-TIGIT monoclonal antibody, in Q4 2020. The study will evaluate etigilimab with anti-PD-1 in 100 patients across various tumor types. Results from prior studies indicated no dose-limiting toxicities, with some patients achieving partial responses. Mereo plans a virtual R&D day in November 2020 to discuss the etigilimab program and its rare disease pipeline.
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