Rhythm Pharmaceuticals Inc., a global commercial-stage biopharmaceutical company, has announced significant progress in its regulatory review process. The company remains on track to submit a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) and a Type II variation request to the European Medicines Agency for its drug, setmelanotide, targeted at treating patients with acquired hypothalamic obesity. This follows the successful achievement of the primary endpoint in a pivotal Phase 3 trial, which demonstrated a -19.8% placebo-adjusted BMI reduction in 120 patients. Additionally, Rhythm Pharmaceuticals is anticipated to complete enrollment in a Phase 3 trial substudy investigating the use of setmelanotide in congenital hypothalamic obesity by the second half of 2025.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.