Rhythm Pharma Hits Record High On Unexpected Obesity-Tied Win

Rhythm Pharmaceuticals said Thursday said it would send it would send its leading drug into registrational testing for Prader-Willi.

Investors Business Daily • Dec 11, 2025

Rhythm Pharma Strikes Chord As Early PWS Trial Results Show Promise

Rhythm Pharmaceuticals Inc. (NASDAQ: RYTM) stock is higher on Thursday, after the company shared preliminary results from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).

Benzinga • Dec 11, 2025

Rhythm Pharmaceuticals, Inc. (RYTM) Discusses Preliminary Phase II Data of Setmelanotide in Prader-Willi Syndrome and Next Steps Transcript

Rhythm Pharmaceuticals, Inc. (RYTM) Discusses Preliminary Phase II Data of Setmelanotide in Prader-Willi Syndrome and Next Steps Transcript

Seeking Alpha • Dec 11, 2025

Rhythm Pharmaceuticals Announces Preliminary Data from Exploratory Phase 2 Trial that showed Setmelanotide Demonstrated Positive Efficacy Signal in Prader-Willi Syndrome

-- BMI and hyperphagia reductions have been observed in patients with PWS treated with setmelanotide at Month 3 (n=8) and Month 6 (n=5); 17 of 18 enrolled patients remain on therapy -- -- Promising results supportive of Phase 3, registrational trial of setmelanotide in PWS --

GlobeNewsWire • Dec 11, 2025

Rhythm: PWS Signal, HO Speed Bump, And The Case For A Rare-Obesity Blockbuster

Rhythm Pharmaceuticals, Inc. remains a compelling rare-disease obesity platform, with a maintained Buy rating driven by progress in HO, PWS, and oral MC4R agonists. PWS Phase 2 data for IMCIVREE show early efficacy in BMI and hyperphagia reduction, though limited by small sample size and responder heterogeneity. RYTM's HO sNDA PDUFA was delayed to March 2026 for additional FDA analysis, but I remain optimistic on approval with some risk to pediatric labeling.

Seeking Alpha • Dec 11, 2025

Rhythm Pharmaceuticals to Announce Preliminary Data from Exploratory Phase 2 Trial Evaluating Setmelanotide in Prader-Willi Syndrome

BOSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast on Thursday, December 11 at 8:00 a.m. ET to disclose preliminary data from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).

GlobeNewsWire • Dec 10, 2025

Rhythm: Maintaining Strong Buy On Acquired Hypothalamic Obesity Drug Progress

Rhythm Pharmaceuticals, Inc. maintaining a Strong Buy rating, driven by IMCIVREE's growth and multiple late-stage expansion opportunities in rare genetic obesity indications. RYTM's IMCIVREE awaits FDA label expansion for acquired hypothalamic obesity, with the PDUFA date extended to March 20, 2026, after a major filed amendment. Upcoming Q4 2025 phase 2 data for IMCIVREE in Prader-Willi Syndrome and positive Bivamelagon results for acquired hypothalamic obesity offer additional catalysts and shots on goal.

Seeking Alpha • Nov 25, 2025

Rhythm Pharmaceuticals Announces Presentation of Four Datasets at ObesityWeek® 2025

– Phase 3 TRANSCEND trial data showed setmelanotide achieved significant BMI reductions in patients with acquired hypothalamic obesity on concomitant treatment with GLP-1 therapy – – Analysis of data from Phase 3 TRANSCEND trial show clinically meaningful changes in cardiometabolic parameters in patients with acquired hypothalamic obesity treated with setmelanotide for 52 weeks – BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that Rhythm and its partners delivered four Rhythm data presentations at ObesityWeek® 2025, held last week in Atlanta, GA. “Acquired hypothalamic obesity is a severe and complex disease that profoundly impacts the lives of patients and families, affecting not only body weight and hunger, but also causing severe implications for daily functioning,” said Christian Roth, M.D.

GlobeNewsWire • Nov 10, 2025

Rythm Pharmaceuticals' (RYTM) Chief Technical Officer Sells 9,748 Shares for $1.1 Million

Rythm Pharmaceuticals' Chief Technical Officer, Joseph Shulman, recently exercised and sold some stock options. Shulman still held 8,509 shares directly after the trade.

The Motley Fool • Nov 8, 2025

Rhythm Pharmaceuticals Announces FDA Extension of Review Period for IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity

-- FDA sets updated PDUFA goal date of March 20, 2026 –  -- Company to hold conference today at 8:00 a.m. -- BOSTON, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review period for the supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) for the treatment of acquired hypothalamic obesity.

GlobeNewsWire • Nov 7, 2025