Core Viewpoint - Novo Nordisk has submitted a supplemental marketing application to the FDA for a higher dose of semaglutide injection (7.2 mg) aimed at chronic weight management, with expectations for regulatory decisions in various regions, including the EU by Q1 2026 [1][2]. Group 1: Application Details - The application includes results from the STEP UP trial, a 72-week phase 3 study that assessed the efficacy and safety of semaglutide 7.2 mg against placebo and semaglutide 2.4 mg in 1,407 adults with obesity [3]. - Patients with diabetes were excluded from the trial [3]. Group 2: Trial Results - Participants treated with semaglutide 7.2 mg experienced an average weight loss of 20.7% after 72 weeks, compared to 17.5% for semaglutide 2.4 mg and 2.4% for placebo, starting from a mean baseline weight of 249 pounds [4]. - 33.2% of patients on semaglutide 7.2 mg achieved a weight loss of 25% or more, compared to 16.7% for semaglutide 2.4 mg and 0.0% for placebo [4]. Group 3: Additional Findings - When including participants who discontinued, those on semaglutide 7.2 mg achieved an 18.7% weight loss, while semaglutide 2.4 mg and placebo resulted in 15.6% and 3.9% weight loss, respectively [5]. - 90.7% of participants on semaglutide 7.2 mg achieved at least a 5% reduction in body weight, compared to 89.9% for semaglutide 2.4 mg and 36.8% for placebo [5]. - 31.2% of those receiving semaglutide 7.2 mg achieved a weight loss of 25% or more, compared to 15.3% for semaglutide 2.4 mg and 0.0% for placebo [6]. Group 4: Market Reaction - Following the news, Novo Nordisk shares rose by 3.77%, reaching $48.83 at the time of publication [6].

Core Viewpoint - A class action lawsuit has been initiated against Novo Nordisk A/S, alleging that the company made false or misleading statements regarding its CagriSema obesity treatment during the class period from November 2, 2022, to December 19, 2024, leading to significant investor losses [1][3]. Summary by Sections Class Action Details - Investors who purchased Novo Nordisk securities during the specified class period can file a lead plaintiff motion by March 25, 2025 [1]. - The Portnoy Law Firm is offering complimentary case evaluations to affected investors [2]. Allegations Against Novo Nordisk - The lawsuit claims that Novo Nordisk misrepresented the reliability of projected success for the Phase 3 CagriSema obesity study, "REDEFINE-1," and did not adequately discuss dosage tolerability [5]. - The company’s claims that CagriSema would achieve at least 25% weight loss in the REDEFINE-1 study were deemed unrealistic [5]. - The flexible protocol of the study limited its ability to provide meaningful weight loss data, suggesting potential issues with dosage tolerability or a rushed patient selection process [5]. Impact on Stock Price - Following the release of results from the REDEFINE-1 trial on December 20, 2024, Novo Nordisk's stock price experienced a nearly 18% drop, indicating a significant market reaction to the disclosed information [3].