Rhythm Pharmaceuticals

RYTM

Market cap $7.23B

-- Q4 2025 preliminary net product revenues from global sales of IMCIVREE® (setmelanotide) of approximately $57 million for the fourth quarter of 2025, an 11% increase over Q3 2025 -- -- FY 2025 preliminary net product revenue of approximately $194 million, approximately 50% increase from FY2024 -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity -- -- On track to report topline data from 12-patient Japanese cohort of setmelanotide Phase 3 trial in acquired hypothalamic obesity in first quarter of 2026 -- -- On track to report topline data from Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in first quarter of 2026 -- BOSTON, Jan. 09, 2026 (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 preliminary unaudited net product revenues from global sales of IMCIVREE® (setmelanotide) for the fourth quarter and full year of 2025 and upcoming milestones. “2025 was a year of strong execution and reflects significant progress toward our mission of transforming the lives of patients with rare neuroendocrine diseases,” said David Meeker, M.D.

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.

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

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

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).

-- 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 --

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).

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.

– 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.

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