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© Globe Newswire
11.12.2025
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Rhythm Pharmaceuticals Announces Preliminary Data from Exploratory Phase 2 Trial that showed Setmelanotide Demonstrated Positive Efficacy Signal in Prader-Willi Syndrome
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-- 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 --...
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© Globe Newswire
10.12.2025
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Rhythm Pharmaceuticals to Announce Preliminary Data from Exploratory Phase 2 Trial Evaluating Setmelanotide in Prader-Willi Syndrome
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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...
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© Globe Newswire
07.11.2025
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Rhythm Pharmaceuticals Announces FDA Extension of Review Period for IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity
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-- FDA sets updated PDUFA goal date of March 20, 2026 – ...
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20.10.2025
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© Globe Newswire
04.11.2025
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Rhythm Pharmaceuticals Reports Third Quarter 2025 Financial Results and Business Update
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-- 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 --...
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20.10.2025
© Globe Newswire
20.08.2025
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Rhythm Pharmaceuticals Announces FDA Acceptance of sNDA for Setmelanotide in Acquired Hypothalamic Obesity
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– U.S. Food and Drug Administration accepts sNDA for filing with priority review; sets PDUFA goal date of December 20, 2025 -- – European Medicines Agency accepts and validates submission for Type II variation MAA for setmelanotide to treat acquired hypothalamic obesity –...
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© Globe Newswire
12.07.2025
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Rhythm Pharmaceuticals Presents Data on MC4R Agonists Setmelanotide and Bivamelagon at ENDO 2025
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- Presentations highlight clinically meaningful reductions in BMI in patients with acquired hypothalamic obesity –...
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© Globe Newswire
10.07.2025
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Rhythm Pharmaceuticals, Inc. Announces Pricing of Upsized Public Offering of Common Stock
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Rhythm announced pricing of its upsized public offering of 2,058,824 shares of common stock at a price of $85.00 per share....
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© Globe Newswire
09.07.2025
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Rhythm Pharmaceuticals, Inc. Announces Proposed Public Offering of Common Stock
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BOSTON, July 09, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) (“Rhythm”), a global, commercial-stage biopharmaceutical company dedicated to transforming the lives of patients living with rare neuroendocrine diseases, today announced a proposed public offering of $150 million of its common stock. All securities in the offer...
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© Globe Newswire
09.07.2025
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Rhythm Pharmaceuticals Announces Oral MC4R Agonist Bivamelagon Achieved Statistically Significant, Clinically Meaningful BMI Reductions in Placebo-controlled Phase 2 Trial in Acquired Hypothalamic Obesity
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-- Bivamelagon achieved BMI reductions in patients with acquired hypothalamic obesity of -9.3% and -7.7% in 600mg and 400mg cohorts, respectively, at 14 weeks -- -- Post-hoc analysis showed BMI reductions in bivamelagon trial were consistent with BMI reductions achieved by setmelanotide in past trials in similar patient populations --...
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© Globe Newswire
25.06.2025
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Rhythm Pharmaceuticals Announces Three Late-breaking Data Abstracts Accepted for Presentation at ENDO 2025
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BOSTON, June 25, 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 three late-breaking abstracts have been accepted for presentation at The Endocrine Society’s Annual...
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© Globe Newswire
07.05.2025
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Rhythm Pharmaceuticals Reports First Quarter 2025 Financial Results and Business Update
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-- First quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $37.7 million -- -- Setmelanotide pivotal Phase 3 TRANSCEND trial met primary endpoint with -19.8% placebo-adjusted BMI reduction in patients (N=120) with acquired hypothalamic obesity --...
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© Globe Newswire
07.04.2025
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Rhythm Pharmaceuticals Announces Pivotal Phase 3 TRANSCEND Trial Meets Primary Endpoint with -19.8% Placebo-adjusted BMI Reduction in Patients (N=120) with Acquired Hypothalamic Obesity
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-- Patients with acquired hypothalamic obesity on setmelanotide therapy (n=81) achieved mean BMI change of -16.5% compared with +3.3% for placebo (n=39) at 52 weeks (p<0.0001) -- -- -19.2% placebo-adjusted BMI reduction achieved in adult patients 18 years old and older (n=49) at 52 weeks --...
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20.10.2025
© Globe Newswire
06.04.2025
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Rhythm Pharmaceuticals to Announce Topline Results from Pivotal Phase 3 TRANSCEND Trial Evaluating Setmelanotide in Patients with Acquired Hypothalamic Obesity
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Company to host conference call on April 7 at 8 a.m. ET Company to host conference call on April 7 at 8 a.m. ET...
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© Globe Newswire
18.03.2025
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Rhythm Pharmaceuticals and Raymond A. Wood Foundation Announce Research Collaboration
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New registry study to focus on impact of fatigue in people with craniopharyngioma New registry study to focus on impact of fatigue in people with craniopharyngioma...
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© Globe Newswire
26.02.2025
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Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Business Update
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-- Fourth quarter 2024 net revenue from global sales of IMCIVREE® (setmelanotide) of $41.8 million -- -- On track to report topline data from global Phase 3 trial evaluating setmelanotide in acquired hypothalamic obesity in the second quarter of 2025 --...
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© Globe Newswire
10.01.2025
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Rhythm Pharmaceuticals Announces Preliminary Fourth Quarter and Full Year 2024 Net Product Revenues, Pipeline Advancements and Upcoming Milestones
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-- Preliminary unaudited net revenues from global sales of IMCIVREE® (setmelanotide) of approximately $42 million for the fourth quarter of 2024 and approximately $130 million for the full year of 2024 -- -- On track to report topline data from global Phase 3 trial evaluating setmelanotide in acquired hypothalamic obesity in the first half of 2025...
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© Globe Newswire
20.12.2024
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Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients as Young as 2 Years Old
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BOSTON, Dec. 20, 2024 (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 announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotid...
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© Globe Newswire
03.12.2024
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Rhythm Pharmaceuticals Announces ▼ IMCIVREE® (setmelanotide) Receives Expanded Marketing Authorization in the United Kingdom for Treatment of Obesity and Control of Hunger in Patients with Bardet Biedl Syndrome or POMC, PCSK1, or LEPR Deficiency to includ
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BOSTON, Dec. 03, 2024 (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 United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the m...
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© Globe Newswire
18.11.2024
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Rhythm Pharmaceuticals Announces Five Presentations at ESPE 2024, including New Real-world Data in Pediatric Patients with Acquired or Congenital Hypothalamic Obesity Treated with Setmelanotide
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-- Four Pediatric patients treated in French early-access program achieved meaningful weight reduction at three months on setmelanotide therapy -- -- Rhythm announced plans for a new substudy to evaluate setmelanotide therapy in patients with congenital hypothalamic obesity --...
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© Globe Newswire
13.11.2024
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Rhythm Pharmaceuticals Announces Publication of Results from Phase 3 Study of Setmelanotide in Patients Between 2 and 5 Years Old in The Lancet Diabetes & Endocrinology
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BOSTON, Nov. 13, 2024 (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 the publication of results from its Phase 3 VENTURE trial evaluating setmelanotide, a melanocortin-4 rece...
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© Globe Newswire
24.10.2024
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Rhythm Pharmaceuticals and Axovia Therapeutics Announce Joint Research Collaboration in Bardet-Biedl Syndrome
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BOSTON and LONDON, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) and Axovia Therapeutics Ltd. today announced a joint research collaboration designed to advance the understanding of Bardet-Biedl syndrome (BBS)....
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© Globe Newswire
26.08.2024
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Rhythm Pharmaceuticals Announces FDA Acceptance for Priority Review of Supplemental New Drug Application for IMCIVREE® (setmelanotide) in Patients as Young as 2 years old
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-- Label expansion sought to treat younger children with Bardet-Biedl syndrome or POMC/LEPR deficiency -- -- FDA sets PDUFA goal date of December 26, 2024 --...
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© Globe Newswire
06.08.2024
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Rhythm Pharmaceuticals Reports Second Quarter 2024 Financial Results and Business Update
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-- Second quarter 2024 net revenue from global sales of IMCIVREE® (setmelanotide) of $29.1 million -- -- Dosed first patients in supplemental, 12-patient Japanese cohort in global Phase 3 trial evaluating setmelanotide in hypothalamic obesity; On track for topline data from 120-patient, pivotal cohort in 1H 2025 --...
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© Globe Newswire
31.07.2024
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Rhythm Pharmaceuticals Announces European Commission Expands ▼IMCIVREE® (setmelanotide) Marketing Authorization to include Children as Young as 2 Years Old
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IMCIVREE now authorized as treatment of obesity and control of hunger in adult patients and pediatric patients 2 years old or older with Bardet Biedl syndrome or POMC, PCSK1, or LEPR deficiency IMCIVREE now authorized as treatment of obesity and control of hunger in adult patients and pediatric patients 2 years old or older with Bardet Biedl syndro...
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© Globe Newswire
23.07.2024
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Rhythm Pharmaceuticals to Report Second Quarter 2024 Financial Results on Tuesday, August 6, 2024
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BOSTON, July 23, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families 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, August 6, 20...
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© Globe Newswire
28.06.2024
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Rhythm Pharmaceuticals Receives Positive CHMP Opinion for ▼IMCIVREE® (setmelanotide) for the Treatment of Obesity and Control of Hunger in Patients between 2 and 6 years old with Bardet Biedl Syndrome or POMC, PCSK1, or LEPR Deficiency
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- European Commission decision anticipated in the second half of 2024 -...
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© Globe Newswire
03.06.2024
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Rhythm Pharmaceuticals Announces Participation at Upcoming Investor Conference
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RYTM CEO at David Meeker at Goldman Sachs Global Healthcare Conference June 10....
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© Globe Newswire
22.05.2024
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Rhythm Pharmaceuticals Receives Positive Recommendation from NICE for ▼IMCIVREE® (setmelanotide) for Treatment of Obesity and Hyperphagia in Patients with Bardet-Biedl Syndrome
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IMCIVREE expected to be funded and available for use in England and Wales within three months through the National Health Service in specialist centres IMCIVREE expected to be funded and available for use in England and Wales within three months through the National Health Service in specialist centres...
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© Globe Newswire
07.05.2024
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Rhythm Pharmaceuticals Reports First Quarter 2024 Financial Results and Business Update
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-- First quarter 2024 net revenue from global sales of IMCIVREE® (setmelanotide) of $26.0 million -- -- On track to submit sNDA to the FDA to treat pediatric patients between 2 and younger than 6 years old in approved indications in second quarter of 2024 --...
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