Rhythm Pharmaceuticals

RYTM

Market cap $7.28B

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.

-- 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.

BOSTON, Nov. 05, 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 has entered into Product Listing Agreements in the provinces of Ontario, Alberta, British Columbia, Saskatchewan, Nova Scotia and with the Federal Non-Insured Health Benefits (NIHB) Program for the public reimbursement of IMCIVREE for weight management in eligible adult and pediatric patients aged 6 years and older with clinically or genetically confirmed Bardet-Biedl syndrome (BBS) and obesity. “These listing agreements for IMCIVREE mark a significant milestone for individuals living with obesity due to Bardet-Biedl syndrome,” said Prof.

Rhythm Pharmaceuticals, Inc. ( RYTM ) Q3 2025 Earnings Call November 4, 2025 8:00 AM EST Company Participants David Connolly - Head of Investor Relations & Corporate Communications David Meeker - Chairman, President & CEO Jennifer Chien - Executive VP & Head of North America Yann Mazabraud - Executive VP & Head of International Hunter Smith - CFO & Treasurer Conference Call Participants Michael Ulz - Morgan Stanley, Research Division Philip Nadeau - TD Cowen, Research Division Derek Archila - Wells Fargo Securities, LLC, Research Division Angela Qian Faisal Khurshid - Leerink Partners LLC, Research Division Erik Wong Julian Pino Evan Wang Georgia Ban Raghuram Selvaraju - H.C. Wainwright & Co, LLC, Research Division Jonathan Wolleben - Citizens JMP Securities, LLC, Research Division Presentation Operator " David Connolly Head of Investor Relations & Corporate Communications " David Meeker Chairman, President & CEO " Jennifer Chien Executive VP & Head of North America " Yann Mazabraud Executive VP & Head of International " Hunter Smith CFO & Treasurer " Michael Ulz Morgan Stanley, Research Division " Morgan Stanley, Research Division Philip Nadeau TD Cowen, Research Division " TD Cowen, Research Division Derek Archila Wells Fargo Securities, LLC, Research Division " Wells Fargo Securities, LLC, Research Division Angela Qian " Canaccord Genuity, Research Division Faisal Khurshid Leerink Partners LLC, Research Division " Leerink Partners LLC, Research Division Erik Wong " Goldman Sachs, Research Division Julian Pino " Stifel, Nicolaus & Company, Incorporated, Research Division Evan Wang " Guggenheim Securities, LLC, Research Division Georgia Ban " Jefferies LLC, Research Division Raghuram Selvaraju H.C.

Rhythm Pharmaceuticals, Inc. (RYTM) came out with a quarterly loss of $0.82 per share versus the Zacks Consensus Estimate of a loss of $0.72. This compares to a loss of $0.73 per share a year ago.

-- Third quarter 2025 net product revenue from global sales of IMCIVREE ®  (setmelanotide) of $51.3 million -- -- December 20, 2025 PDUFA goal date set for sNDA for setmelanotide in acquired hypothalamic obesity -- -- Company is on track to report preliminary results from setmelanotide Phase 2 trial in Prader-Willi syndrome in fourth quarter of 2025 -- -- German observational study showed setmelanotide therapy was associated with improvement in measures of MASLD and kidney function in BBS patients -- -- Management to host conference call today at 8:00 a.m. ET -- BOSTON, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today reported financial results and provided a business update for the third quarter ended September 30, 2025.

Rhythm Pharmaceuticals (RYTM) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

BOSTON, Oct. 21, 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 at 8:00 a.m. ET on Tuesday, November 4, 2025 to report its third quarter 2025 financial results and provide a corporate update.