Regeneron Pharmaceuticals (NASDAQ:REGN) said Monday that partner Hansoh Pharmaceutical Group Company Limited reported positive results from a Phase 3 clinical trial evaluating olatorepatide in Chinese patients with obesity or who are overweight. The announcement comes as the $78 billion biotechnology company trades near its 52-week high, with shares up 59% from their lowest level over the past year and gaining 37% in the last six months.
The randomized, double-blind, placebo-controlled study enrolled 604 adult participants across 33 clinical sites in mainland China. The trial compared once-weekly doses of olatorepatide with placebo over a 48-week period, testing three treatment groups receiving 5 mg, 10 mg, or 15 mg doses alongside a placebo group.
The study achieved its co-primary endpoints, showing that patients receiving olatorepatide experienced statistically significant reductions in body weight compared with placebo. A significantly higher percentage of participants in the treatment groups also achieved at least 5% weight loss by week 48.
According to the company, patients treated with olatorepatide achieved mean weight reductions of up to 19% from baseline after 48 weeks. Additional analyses indicated that as many as 97% of participants reached at least 5% weight loss by the end of the study period.
The trial also reported relatively low rates of gastrointestinal side effects and treatment discontinuation compared with other published Phase 3 studies involving dual incretin therapies. The average rate of nausea was below 10%, while vomiting occurred in fewer than 5% of participants on average.
Olatorepatide is a dual GLP-1/GIP receptor agonist. Under a strategic licensing agreement with Hansoh, Regeneron holds exclusive rights for clinical development and commercialization outside mainland China, Hong Kong, and Macau.
Regeneron said its global Phase 3 registrational program for the therapy is expected to begin later this year, and more detailed data from the study will be presented at an upcoming medical conference.
The safety and effectiveness of olatorepatide have not yet been reviewed by any regulatory authority.
Other recent developments
Regeneron has also seen several notable updates in recent weeks. Guggenheim raised its price target for the company to $975 while maintaining a Buy rating, citing continued strong sales growth for Dupixent, which increased 26% year over year to $17.8 billion.
Barclays recently initiated coverage on Regeneron with an Overweight rating, highlighting the growth potential of Dupixent and forecasting that the company’s broader portfolio will help offset pressures related to its Eylea franchise.
Meanwhile, RBC Capital lifted its price target to $765 while maintaining a Sector Perform rating following encouraging data from a melanoma study involving fianlimab and Libtayo.
In addition, the U.S. Food and Drug Administration has accepted Regeneron’s Biologics License Application for priority review of garetosmab, a potential treatment for fibrodysplasia ossificans progressiva. A regulatory decision is expected by August 2026.
Regeneron is also preparing to present Phase 3 clinical data on new allergy antibody treatments at an upcoming scientific conference, where the therapies have shown promising results in reducing allergy symptoms.