Derek Archila

Philip Nadeau

Raghuram Selvaraju

Seamus Fernandez

Tazeen Ahmad

Joseph Stringer

Whitney Ijem

Jonathan Wolleben

Leland Gershell

Michael Ulz

Paul Matteis

Corinne Jenkins

Corinne Johnson

Dae Gon Ha

Dennis Ding

Jeff Hung

Jon Wolleben

Yuchen Ding

- Rhythm Pharmaceuticals is preparing for the potential launch of **IMCIVREE (setmelanotide)** for acquired hypothalamic obesity (aHO), with a **PDUFA goal date of December 20, 2025**.  **[1649904_2155969:0]** **[1649904_2155969:13]** 
- Phase 3 trial results for setmelanotide in aHO demonstrated **significant BMI reduction**, with **80%** of patients achieving a **5% BMI reduction** at 52 weeks compared to 10% for placebo, and a **statistically significant reduction in hunger score**.  **[1649904_2155969:7]** 
- The company identifies a **significant global market opportunity** for aHO, with estimated prevalence of **~10,000** in the U.S. and Europe, and **5,000-8,000** in Japan, and has established commercial teams and strategies for launch.  **[1649904_2155969:10]** **[1649904_2155969:12]** 
- Rhythm's pipeline also includes **bivamelagon**, which achieved positive Phase 2 results and is anticipated to begin Phase 3 in 2026, and **RM-718**, currently in Phase 1, aiming to extend the MC4R franchise.  **[1649904_2155969:13]**

Rhythm Pharmaceuticals Provides Update on Commercial Readiness for Acquired Hypothalamic Obesity

- According to a transcript published on **September 24, 2025**, Rhythm Pharmaceuticals discussed its commercial readiness for setmelanotide in Acquired Hypothalamic Obesity (HO), anticipating a **PDUFA date of December 20, 2023**, for which it saw a **"truly transformative opportunity"** due to the unmet medical need.  **[1649904_2155975_1]** **[1649904_2155975_3]** 
- The company highlighted strong clinical data for setmelanotide, including a **19.8% placebo-adjusted BMI reduction** in the phase 3 trial, with **80% of patients losing 5% or more** of BMI.  **[1649904_2155975_3]** **[1649904_2155975_5]** 
- Rhythm Pharmaceuticals estimated the HO patient population to be **5,000 to 10,000** and, in preparation for the potential launch, had expanded its sales force from **16 to 43**.  **[1649904_2155975_1]** **[1649904_2155975_27]** 
- Market research indicated that **all surveyed endocrinologists would prescribe** setmelanotide for HO, and payers were expected to update coverage policies within **3 to 12 months post-approval**.  **[1649904_2155975_25]** **[1649904_2155975_26]**

Rhythm Pharmaceuticals Discusses Commercial Readiness for Setmelanotide in Acquired Hypothalamic Obesity

- Rhythm Pharmaceuticals anticipates launching IMCIVREE for Hypothalamic Obesity (HO) **early next year**, targeting a patient population estimated between **5,000 and 10,000**.  **[1649904_tx_380329_3]** **[1649904_tx_380329_4]**  The launch is expected to be more **gradual** than Prader-Willi Syndrome (PWS) but potentially quicker than Bardet-Biedl Syndrome (BBS) initially.  **[1649904_tx_380329_3]** 
- The company is revisiting Prader-Willi Syndrome (PWS) with setmelanotide, conducting an open-label study with higher doses (up to **5 mg**).  **[1649904_tx_380329_7]**  The primary goal for PWS treatment is **5% weight loss**.  **[1649904_tx_380329_7]** **[1649904_tx_380329_8]** 
- Rhythm's next-generation pipeline includes **bivamelagon** (oral), which will advance to Phase 3 for HO, and **RM-718** (weekly), also in development for HO, with the intent to develop both.  **[1649904_tx_380329_10]** 
- The company highlighted that its U.S. formulation patents for IMCIVREE extend through **2034**, providing a strong market position.  **[1649904_tx_380329_1]**

Rhythm Pharmaceuticals Provides Update on IMCIVREE Launch and Pipeline Development

RHYTHM PHARMACEUTICALS (RYTM)