Expired
Lead Plaintiff Deadline
Apr 6, 2026
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According to the complaint, defendants provided overwhelmingly positive statements to investors while, at the same time, disseminating materially false and misleading statements and/or concealing material adverse facts concerning the true state of the Phase 3 ORBIT and COSMIC programs; neither of which hit its primary endpoints of reducing annualized clinical fracture rate compared to the placebo or bisphosphonate control groups, respectively. On December 29, 2025, Mereo issued a press release announcing that neither the ORBIT nor the COSMIC Phase 3 studies achieved statistical significance. The press release indicated that neither study met its primary endpoint of reduction in annualized clinical fracture rate compared to placebo or bisphosphonates, respectively, despite improved bone mineral density. Following this news, the price of Mereo’s ADS declined dramatically. From a closing market price of $2.31 per share on December 26, 2025, Mereo’s ADS price fell to $0.29 per share on December 29, 2025, a decline of more than 87.7%.
In order to be eligible to join the MREO class action lawsuit, you must have incurred a loss on shares of Mereo purchased during the class period listed above.
If you suffered a loss in Mereo during the relevant time frame or pursuant to the relevant offering(s), you have until April 6, 2026 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.
A securities fraud class action has been filed against Mereo Biopharma Group Plc (NASDAQ: MREO) in the Southern District of New York, under federal securities laws. The case covers investors who bought Mereo American Depositary Shares ticker MREO on the NASDAQ between June 5, 2023 and December 26, 2025. Investors allege the company and its executives misled the market about expected results from the Phase 3 ORBIT and COSMIC studies of setrusumab for osteogenesis imperfecta, while concealing adverse facts and making material misrepresentations.
The complaint states that, contrary to those representations, the ORBIT study failed an interim statistical hurdle on July 9, 2025, and on December 29, 2025 the company announced that neither ORBIT nor COSMIC met their primary endpoints of reducing annualized clinical fracture rates (versus placebo in ORBIT and bisphosphonates in COSMIC). Shares fell sharply on both disclosures, including single-day drops of 42.52% and 87.7%.
“Most MREO shareholders never file or join the class action, which means they miss out on potential recovery funds,” said Attorney Joseph Levi.
Case Name: Dodge v. Mereo Biopharma Group Plc et al.
Case No.: 1:26-cv-988
Jurisdiction: U.S. District Court, Southern District of New York
Filed on: February 4, 2026
Mereo is a NASDAQ-listed biopharmaceutical company developing therapeutics for rare diseases (rare disease therapeutics), including setrusumab for osteogenesis imperfecta, evaluated in Phase 3 clinical trials ORBIT and COSMIC and alvelestat for Alpha-1 Antitrypsin Deficiency-associated lung disease. Its strategy is to acquire and develop clinical-stage programs with substantial prior data packages.
June 5, 2023 –December 26, 2025, inclusive.
All investors who purchased or otherwise acquired Mereo ADS during this period, inclusive, are included in the proposed class, including purchases on the NASDAQ exchange, and may be eligible to join the Mereo Biopharma Group Plc (MREO) class action lawsuit.
According to the complaint, the lawsuit targets Mereo Biopharma Group Plc, its co-founder and CEO Denise Scots-Knight, and its Chief Scientific Officer John A. Lewicki. During the class period, investors allege these defendants provided upbeat information about expected Phase 3 results for investigational setrusumab in the ORBIT and COSMIC studies while disseminating false and materially misleading statements and concealing adverse facts about the true state of those programs.
The narrative begins on June 5, 2023, when a company press release quoted Gary Gottesman, MD, describing "striking" increases in bone mineralization on DXA scans (bone mineral density) and the potential for denser, stronger bone. On July 6, 2023, Ultragenyx's Chief Medical Officer, Eric Crombez, said Phase 2 Orbit data showed increases in bone formation and bone mineral density and highlighted a comprehensive Phase 3 program designed to study clinical fracture risk reduction.
As the program advanced, the complaint alleges defendants continued to issue upbeat statements about setrusumab and its Phase 3 studies. On April 30, 2024, Crombez said interim Phase 2 Orbit results showed a rapid and clinically meaningful decrease in fractures (annualized fracture rate). At the JP Morgan Healthcare Conference on January 16, 2025, CEO Denise Scots-Knight told investors there was a "medium 67% reduction in annualized fracture rate," identifying that measure as the Phase 3 metric and primary endpoint for Orbit, while CSO John Lewicki said fractures became "very infrequent" on treatment and expressed confidence in the IA-2 analysis.
Meanwhile, the complaint alleges the ORBIT and COSMIC Phase 3 programs were not on track to reach statistical significance on their primary endpoint: reduction in annualized clinical fracture rate versus the placebo control group or a bisphosphonate comparator. Investors allege defendants concealed material adverse facts and misrepresented the viability of these trials and the underlying efficacy data.
The first break in the story came on July 9, 2025, when Mereo issued a press release stating the Phase 3 ORBIT study failed to achieve statistical significance at the second interim analysis (IA-2) on the primary endpoint and would continue toward a final analysis. In the July 9, 2025 joint press release, Ultragenyx CEO Emil D. Kakkis stated that the companies had ‘hoped to be able to stop the study early’ before the full 24-month dataset became available.
The full picture arrived on December 29, 2025. In a press release, Mereo disclosed that neither ORBIT nor COSMIC achieved statistical significance and that neither met its primary endpoint of reducing annualized clinical fracture rates versus their control groups (placebo and bisphosphonates). CEO Denise Scots-Knight acknowledged disappointment and said the company would conduct additional analyses to assess next steps, contradicting prior confidence in setrusumab's ability to reduce clinical fractures.
The market reacted in two sharp moves tied to these disclosures. After the July 9, 2025 interim failure update, Mereo's ADS (ticker MREO) fell on July 10, 2025 from a prior close of $2.94 to $1.69, a single-day stock price decline of $1.25 or 42.52%. When the company announced the complete Phase 3 failures on December 29, 2025, the stock fell from a December 26 close of $2.31 to $0.29, a decline of $2.02 or 87.7% in one day, reflecting substantial investor losses. These declines reflect investor reassessment once the alleged truth became clear.
The Court will issue its order for lead plaintiff and counsel in the weeks after submissions are due.
The Court will then consider motion for class certification.
The Court will later consider a motion to dismiss.
Disclaimer: This shareholder alert is for informational purposes only and does not constitute legal advice. Consult a qualified attorney for personalized guidance. No specific outcomes are guaranteed.
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