NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces a class action lawsuit on behalf of purchasers of American Depositary Shares ("ADS†) of Mereo BioPharma Group plc (NASDAQ: MREO) between June 5, 2023, and December 26, 2025. Mereo describes itself as a "biopharmaceutical company focused on the development of therapeutics for rare diseases.†For more information, submit a form, email attorney Phillip Kim, or give us a call at 866-767-3653. The Allegations: Ro. ...

ATLANTA, Feb. 05, 2026 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Mereo BioPharma Group plc (“Mereo” or the “Company”) (NASDAQ: MREO). The lawsuit alleges that Defendants issued false and misleading statements and/or failed to disclose material adverse facts, including allegations that Defendants concealed and misrepresented facts regarding setrusumab’s ability to achieve statistical significance for the primary endpoints in both the ORBIT and COSMIC studies. If you purcha ...

Core Viewpoint - A class action lawsuit has been filed against Mereo BioPharma Group plc due to misleading statements regarding the Phase 3 ORBIT and COSMIC programs, which failed to meet their primary endpoints [1][2]. Group 1: Lawsuit Details - The lawsuit, Megan Dodge v. Mereo BioPharma Group plc, was initiated in the United States District Court for the Southern District of New York for investors who purchased American Depositary Shares (ADS) between June 5, 2023, and December 26, 2025 [1]. - Investors are encouraged to participate in the lawsuit before the April 6, 2026 deadline to potentially recover losses [5]. Group 2: Study Results - Mereo announced on December 29, 2025, that neither the ORBIT nor the COSMIC Phase 3 studies achieved statistical significance, failing to meet the primary endpoint of reducing annualized clinical fracture rates compared to placebo or bisphosphonates [3]. - Despite improvements in bone mineral density, the studies did not yield the expected results, leading to significant investor concerns [2][3]. Group 3: Market Reaction - Following the announcement of the study results, Mereo's ADS price plummeted from $2.31 per share on December 26, 2025, to $0.29 per share on December 29, 2025, marking a decline of over 87.7% [4].

Core Viewpoint - A class action lawsuit has been filed against Mereo BioPharma Group plc, alleging that the company misled investors regarding the results of its Phase 3 studies for the drug setrusumab, which is intended for treating Osteogenesis Imperfecta [1][2]. Group 1: Allegations and Misleading Information - The lawsuit claims that Mereo BioPharma provided investors with overly optimistic statements about the expected outcomes of the Phase 3 ORBIT and COSMIC studies, asserting confidence in setrusumab's ability to reduce annualized fracture rates [2]. - It is alleged that while making these positive statements, Mereo concealed material adverse facts about the studies, which ultimately did not meet their primary endpoints of reducing annualized clinical fracture rates compared to placebo or bisphosphonate control groups [2][3]. Group 2: Impact on Stock Price - Following the announcement on December 29, 2025, that neither the ORBIT nor COSMIC studies met their primary endpoints, Mereo's American Depository Shares (ADS) plummeted from $2.31 per share to $0.29 per share, marking a decline of over 87.7% [3]. Group 3: Class Action Participation - Shareholders of Mereo BioPharma may be eligible to participate in the class action lawsuit, with options to serve as lead plaintiff or remain an absent class member [4].

NEW YORK, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Mereo BioPharma Group plc (“Mereo” or the “Company”) (NASDAQ: MREO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Mereo and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] During pre- ...

Group 1 - Holzer & Holzer, LLC is investigating Mereo BioPharma Group plc for potential compliance issues with federal securities laws following the announcement of Phase 3 study results for setrusumab, which did not achieve statistical significance against primary endpoints [1] - The Phase 3 Orbit and Cosmic studies for setrusumab (UX143) in Osteogenesis Imperfecta revealed that neither study met the primary endpoints of reducing annualized clinical fracture rates compared to placebo or bisphosphonates [1] - Following the announcement of the study results, Mereo's stock price experienced a decline [1]

Core Viewpoint - Mereo BioPharma Group plc is under investigation for potential violations of federal securities laws following disappointing clinical trial results that led to a significant drop in stock price [1][2]. Group 1: Company Performance - On December 29, 2025, Mereo BioPharma announced results from its Phase 3 ORBIT and COSMIC studies for setrusumab (UX143) in Osteogenesis Imperfecta (OI), reporting that neither study achieved its primary efficacy endpoint of reducing the annualized clinical fracture rate compared to placebo [2]. - Following the announcement, Mereo's stock price plummeted over 89%, opening at $0.25 per share [2]. Group 2: Legal Investigation - Levi & Korsinsky has commenced an investigation into Mereo BioPharma Group plc regarding potential violations of federal securities laws, inviting investors who suffered losses to explore recovery options [1][3].

Core Viewpoint - Mereo BioPharma Group plc is under investigation for potential violations of federal securities laws following disappointing clinical trial results that led to a significant drop in stock price [1][2]. Group 1: Company Overview - Mereo BioPharma Group plc announced results from its Phase 3 ORBIT and COSMIC studies for setrusumab (UX143) in Osteogenesis Imperfecta (OI) on December 29, 2025 [2]. - The studies did not achieve their primary efficacy endpoint of reducing the annualized clinical fracture rate compared to placebo [2]. Group 2: Stock Performance - Following the announcement of the clinical trial results, Mereo's stock price plummeted over 89%, opening at $0.25 per share [2]. Group 3: Legal Investigation - Levi & Korsinsky has commenced an investigation into Mereo BioPharma Group plc concerning potential violations of federal securities laws, inviting affected investors to explore recovery options [1][3].

Company Overview - Mereo is a rare disease company focused on developing treatments for conditions such as osteogenesis imperfecta (OI) [1][2] - The company has three clinical programs, with two of them being in late-stage development [2] Patient Impact - The presentation highlighted the personal stories of patients like Martin, who has Type 3 OI and has been on bisphosphonate treatment since he was six months old, experiencing hundreds of fractures [2] - The impact of OI on patients' lives is significant, but individuals like Martin are managing to pursue their education and careers despite the challenges [2]

Summary of Mereo Biopharma Group FY Conference Call Company Overview - **Company**: Mereo Biopharma Group (NasdaqCM:MREO) - **Industry**: Rare disease biopharmaceuticals - **Focus**: Development of therapies for rare diseases, specifically osteogenesis imperfecta (OI), alpha-1 antitrypsin deficiency, and osteoporosis Core Points and Arguments Clinical Programs - Mereo has three clinical programs: - **Setrusumab** for osteogenesis imperfecta (OI) - Phase 3 results reported with partner Ultragenyx - **Alvelestat** for alpha-1 antitrypsin deficiency - Phase 3-ready, endpoints agreed with FDA and EMA - **Vantictumab** for osteoporosis - Phase 2 study planned for the second half of the year [3][5][20] Financial Position - Mereo reported approximately **$41 million** in cash at the end of 2025, providing a runway into mid-2027 [5] Setrusumab Data - Two Phase 3 studies (Orbit and Cosmic) did not meet primary endpoints, but showed: - Robust changes in bone mineral density (BMD) - Statistically significant improvements in pain and daily activities for OI patients [7][19] - In the Cosmic study, a **21% reduction** in annualized fracture rate (AFR) compared to bisphosphonates was observed, although not statistically significant [17] - A **59% reduction** in vertebral fractures was noted in setrusumab-treated patients compared to bisphosphonate-treated patients [17] - The placebo arm showed a **50% reduction** in AFR, complicating the ability to demonstrate a difference [14] Patient Impact - Pain is the primary symptom affecting OI patients, and setrusumab treatment resulted in statistically significant reductions in pain scores [15][32] - Anecdotal evidence suggests improved mobility and quality of life for patients on setrusumab, with reports of children engaging in activities they previously could not [35] Future Plans - Mereo is conducting further data analyses to prepare for potential regulatory discussions regarding setrusumab [19][41] - Plans for additional data presentations later in the year, including analyses correlating AFR and BMD in OI patients [39] Alvelestat and Vantictumab - Alvelestat is focused on severe patients with the PIZZ genotype, with a study design involving **220 patients** over 18 months [20] - Vantictumab is set to enter the clinic in the second half of the year, with previous studies indicating increased osteoclastic activity [22] Important but Overlooked Content - The significance of BMD changes in the context of OI, where patients often start with very low Z-scores, making any improvement clinically meaningful [28] - The potential for a placebo effect in the studies, as many patients reported feeling better, which may have influenced the outcomes [35] - The ongoing collection of data from patients who transitioned from bisphosphonates to setrusumab, which may provide insights into long-term efficacy [40] This summary encapsulates the key points from the Mereo Biopharma Group FY Conference Call, highlighting the company's focus on rare diseases, the status of its clinical programs, financial position, and future plans.