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LEVI & KORSINSKY, LLP: BONE MINERAL DENSITY CLAIMS CHALLENGED IN MEREO BIOPHARMA SECURITIES ACTION
Prnewswire· 2026-03-18 13:05
Core Viewpoint - A securities class action has been filed against Mereo BioPharma Group plc, focusing on allegations regarding the correlation between bone mineral density (BMD) improvements and fracture reduction in patients with osteogenesis imperfecta (OI) [1][2]. Group 1: Allegations and Claims - The lawsuit claims that Mereo BioPharma's management misrepresented the efficacy of setrusumab, asserting that its ability to increase BMD would lead to reduced fracture rates, while omitting critical data that lacked control group comparisons [3]. - The complaint highlights that management was aware of significant challenges in Phase 3 trials, suggesting that the Phase 2 results could not adequately differentiate setrusumab's effects from improvements due to standard care or placebo effects [4]. Group 2: Industry Context and Investor Concerns - The fundamental issue for investors is whether improvements in BMD can be considered a reliable surrogate endpoint for fracture reduction, as the company consistently reported BMD improvements that did not meet market expectations for clinically meaningful fracture reduction [4]. - The lawsuit also notes that the COSMIC study comparing setrusumab to bisphosphonates did not achieve statistical significance, raising further concerns about the drug's efficacy [6].