Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Shots: The US FDA has approved Imcivree for the treatment of pts (≥4yrs.) with acquired hypothalamic obesity (HO) Approval was supported by the global P-III (TRANSCEND) trial assessing setmelanotide (n=94) vs PBO (n=48) in 142 pts with acquired HO Trial met its 1EP with a 18.4% PBO-adjusted reduction in BMI, showing -15.8% vs +2.6% mean…

ByRidhi Rastogi2 days ago

NEWS

Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity

Shots: The P-III (TRANSCEND) trial (N=120) assessed setmelanotide (n=81: 33 adults & 48 pediatric) vs PBO (n= 39) for acquired hypothalamic obesity in 49 adults & 71 pediatric pts; additional arm of 12 Japanese pts is ongoing, with topline data expected by Q1’26. FDA & EMA filings to be completed by Q3’25 Trial met its…

ByRidhi RastogiApril 8, 2025

INSIGHTS+

Know Your Investor: Perceptive Advisors (March’25 Edition)

Shots: The March edition highlights Perceptive Advisors, a New York-based investment firm specializing in public and private investments within the healthcare and life sciences sectors In 2024, Perceptive Advisors invested approximately $5.81B in 44 companies through six funding rounds, including private and debt financing For the complete report, reach out to us at connect@pharmashots.com With…

ByPrince GiriMarch 20, 2025

INSIGHTS+

PharmaShots’ Key Highlights of Second Quarter 2023

Shots: The second quarter of 2023 highlights multiple clinical trial results, approvals, and numerous deals. There are major alliances in this quarter which include Merck acquired Prometheus for ~$10.8B and Astellas entered into a definitive agreement to acquire Iveric Bio for ~$5.9B The second quarter of the year also showcases multiple approvals of the therapies…

BySenior EditorJuly 3, 2023

Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity

Know Your Investor: Perceptive Advisors (March’25 Edition)

PharmaShots’ Key Highlights of Second Quarter 2023

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