reports
Rhythm Pharmaceuticals Receives Positive CHMP Opinion for IMCIVREE® (s...
Rhythm Pharmaceuticals Receives Positive CHMP Opinion for IMCIVREE® (setmelanotide) for the Treatment of Obesity and Control of Hunger in Patients with Acquired Hypothalamic Obesity due to Hypothalamic Injury or Impairment -- European Commission decision anticipated in second quarter of 2026 -- BOSTON, March 26, 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 that the European Medicines Agency’s (EMA) Committee f...
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanot...
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity -- First and only FDA-approved therapy for the treatment of acquired hypothalamic obesity, a rare disease characterized by accelerated and sustained weight gain caused by hypothalamic injury or dysfunction – -- Indicated to reduce excess body weight and maintain reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity -- -- Approval based on -18.4% placebo-adjusted BMI reduction achieved by setmelanotide in globa...
Rhythm Pharmaceuticals Announces Topline Results from Phase 3 EMANATE ...
Rhythm Pharmaceuticals Announces Topline Results from Phase 3 EMANATE Trial -- Four substudies did not meet pre-specified primary endpoints -- -- Post hoc analyses show setmelanotide achieved statistically significant BMI reductions in patients with obesity due to a heterozygous variant of the POMC/PCSK1 and SRC1 (NCOA1) genes at 52 weeks – -- Conference call planned for 4:30 p.m. ET today – BOSTON, March 16, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living wi...
Rhythm Pharmaceuticals Inc: 1 director
A director at Rhythm Pharmaceuticals Inc sold/sold after exercising options 5,614 shares at 89.560USD and the significance rating of the trade was 78/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's d...
Rhythm Pharmaceuticals Announces Additional Positive Data from Phase 3...
Rhythm Pharmaceuticals Announces Additional Positive Data from Phase 3 TRANSCEND trial of Setmelanotide in Patients with Acquired Hypothalamic Obesity -- -18.8% placebo-adjusted difference in BMI reduction achieved in all patients (N=142) at 52 weeks, including 12 Japanese patients and 10 supplemental patients with acquired hypothalamic obesity -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity -- BOSTON, March 01, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focus...
Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Finan...
Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Business Update -- Fourth quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $57.3 million -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity (HO) ---- Phase 2 open-label extension data showed bivamelagon achieved persistent BMI reductions at six and nine months; Completed positive end-of-Phase-2 meeting with FDA ---- On track to report topline data from 12-patient Japanese cohort of setmelanotide Phase 3 trial in acquired HO ...
Rhythm Pharmaceuticals to Report Fourth Quarter and Full Year 2025 Fin...
Rhythm Pharmaceuticals to Report Fourth Quarter and Full Year 2025 Financial Results on Thursday, February 26, 2026 BOSTON, Feb. 17, 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 that it will host a live conference call and webcast at 8 a.m. ET on Thursday, February 26, 2026 to report its fourth quarter and full year 2025 financial results and provide a corporate update. To access the live conference call, part...
Rhythm Pharmaceuticals Announces Participation in Upcoming Guggenheim ...
Rhythm Pharmaceuticals Announces Participation in Upcoming Guggenheim Biotech Summit BOSTON, Feb. 05, 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 that Hunter C. Smith, Chief Financial Officer, will participate in a fireside chat at the upcoming Guggenheim Emerging Outlook: Biotech Summit 2026 conference on Wednesday, February 11 at 11:00 a.m. ET in New York. The fireside chat will be webcasted and available u...
Rhythm Pharmaceuticals Announces Preliminary, Unaudited Fourth Quarter...
Rhythm Pharmaceuticals Announces Preliminary, Unaudited Fourth Quarter and Full Year 2025 Net Product Revenues and Upcoming Milestones -- 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 c...
Rhythm Pharmaceuticals Announces Preliminary Data from Exploratory Pha...
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 -- -- Company initiated Phase 1, Part D study to evaluate weekly MC4R agonist RM-718 in patients with PWS -- -- Company to hold conference call on ...
Rhythm Pharmaceuticals to Announce Preliminary Data from Exploratory P...
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)...
Rhythm Pharmaceuticals Announces Presentation of Four Datasets at Obes...
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 biopharmaceu...
Rhythm Pharmaceuticals Announces FDA Extension of Review Period for IM...
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...
Rhythm Pharmaceuticals Announces Public Reimbursement for IMCIVREE® (s...
Rhythm Pharmaceuticals Announces Public Reimbursement for IMCIVREE® (setmelanotide) in Canada in Five Provinces and Under the Federal Non-Insured Health Benefits Program IMCIVREE now publicly covered for weight management due to Bardet-Biedl syndrome (BBS) in Ontario, Alberta, British Columbia, Saskatchewan, Nova Scotia and under NIHB 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 e...
Rhythm Pharmaceuticals annonce le remboursement public de l'IMCIVREE® ...
Rhythm Pharmaceuticals annonce le remboursement public de l'IMCIVREE® (setmélanotide) au Canada dans cinq provinces et dans le cadre du Programme fédéral des services de santé non assurés IMCIVREE est désormais remboursé pour le cadre de la gestion du poids chez les patients atteints du syndrome de Bardet-Biedl (BBS) en Ontario, en Alberta, en Colombie-Britannique, en Saskatchewan, en Nouvelle-Écosse et dans le cadre du programme SSNA BOSTON, 05 nov. 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq : RYTM), une société biopharmaceutique internationale axée sur la transforma...
Rhythm Pharmaceuticals Reports Third Quarter 2025 Financial Results an...
Rhythm Pharmaceuticals Reports Third Quarter 2025 Financial Results and Business Update -- 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 -- ...
Rhythm Pharmaceuticals to Report Third Quarter 2025 Financial Results ...
Rhythm Pharmaceuticals to Report Third Quarter 2025 Financial Results on Tuesday, November 4, 2025 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. To access the live conference call, participants may register . While n...
Rhythm Pharmaceuticals Announces Participation in Upcoming Investor Co...
Rhythm Pharmaceuticals Announces Participation in Upcoming Investor Conferences BOSTON, Aug. 27, 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 David Meeker, M.D., Chair, President and Chief Executive Officer, will participate in fireside chats at two upcoming investor conferences: Wells Fargo Healthcare Conference on Wednesday, September 3, 2025 at 9:30 a.m. ETMorgan Stanley Global Healthcare Conference on...
Rhythm Pharmaceuticals Announces FDA Acceptance of sNDA for Setmelanot...
Rhythm Pharmaceuticals Announces FDA Acceptance of sNDA for Setmelanotide in Acquired Hypothalamic Obesity – 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 – – Company to host “Commercial Readiness for Acquired Hypothalamic Obesity,” event for investors and analysts on Wednesday, September 24, in Boston – BOSTON, Aug. 20, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceutical...
Rhythm Pharmaceuticals Reports Second Quarter 2025 Financial Results a...
Rhythm Pharmaceuticals Reports Second Quarter 2025 Financial Results and Business Update -- Second quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $48.5 million -- -- U.S. and EU regulatory submissions for setmelanotide in acquired hypothalamic obesity on track to be completed in the third quarter of 2025 -- -- Bivamelagon Phase 2 trial met primary endpoint with statistically significant, clinically meaningful BMI reductions in patients with acquired hypothalamic obesity -- -- Raised approximately $189.2 million in net proceeds in upsized public offeri...
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