Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients as Young as 2 Years Old 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® (setmelanotide) to include children as young as 2 years old. IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long-t...
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 include Children as Young as 2 Years Old 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 Regu...
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 -- 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 -- BOSTON, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceut...
Two Directors at Rhythm Pharmaceuticals Inc sold after exercising options/sold 80,142 shares at between 66.330USD and 66.436USD. The significance rating of the trade was 83/100. 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...
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 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 receptor (MC4R) agonist, in children between the ages of 2 and younger than 5 year...
Rhythm Pharmaceuticals Announces New Employment Inducement Grants BOSTON, Nov. 13, 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 on November 7, 2024, the Compensation & Management Development Committee of Rhythm’s Board of Directors granted inducement restricted stock units, or RSUs, covering an aggregate of 15,750 shares of its common stock to three new employees. These inducement RSUs are subject to the terms o...
Rhythm Pharmaceuticals Announces Participation in Upcoming Investor Conferences BOSTON, Nov. 06, 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 David Meeker, M.D., Chair, President and Chief Executive Officer, will participate in fireside chats at two upcoming investor conferences: Guggenheim Securities Healthcare Innovation Conference on Monday, November 11 at 11:30 a.m. ET Stifel 2024 Healthcare Conferenc...
Rhythm Pharmaceuticals Reports Third Quarter 2024 Financial Results and Business Update -- Third quarter 2024 net revenue from global sales of IMCIVREE® (setmelanotide) of $33.3 million -- -- Adult patients with acquired hypothalamic obesity (N=8) achieved mean BMI reduction of 12.8% on setmelanotide therapy at three months in French early-access program -- -- Top-line data readout for Phase 3 trial evaluating setmelanotide in 120 patients with acquired hypothalamic obesity on track for 1H 2025 -- -- sNDA to expand IMCIVREE label to include patients as young as 2 years old in approved i...
Rhythm Pharmaceuticals Announces Five New Data Presentations at ObesityWeek® 2024 -- Real-world data showed mean BMI decrease of 12.8% in adult patients with acquired hypothalamic obesity (N=8) at three months on setmelanotide therapy; mean BMI decrease of 21.3% in patients (n=5) who reached six months -- -- Greater reduction in fat mass (29.7%) versus reduction in lean muscle mass (7.7%) reported from Phase 2 trial extension in patients with acquired hypothalamic obesity (n=11) after 12 months -- -- Positive data from Phase 2 DAYBREAK stage 2 showed mean BMI reduction of 12.4% in patien...
Rhythm Pharmaceuticals and Axovia Therapeutics Announce Joint Research Collaboration in Bardet-Biedl Syndrome BOSTON and LONDON, Oct. 24, 2024 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: RYTM) and . today announced a joint research collaboration designed to advance the understanding of Bardet-Biedl syndrome (BBS). “We believe there is a significant need and opportunity with the growing awareness of BBS to better understand the disease and its epidemiology,” said Prof. Phil Beales, Axovia Therapeutics’ Chief Executive Officer and Co-Founder. “At Axovia, we are utilizing gene therapy to address th...
Rhythm Pharmaceuticals to Report Third Quarter 2024 Financial Results on Tuesday, November 5, 2024 -- Five posters to be presented at ObesityWeek® -- BOSTON, Oct. 23, 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 it will host a live conference call and webcast at 5:00 p.m. ET on Tuesday, November 5, 2024 to report its third quarter 2024 financial results and provide a corporate update. The conference call will be...
Rhythm Pharmaceuticals Announces New Employment Inducement Grants BOSTON, Oct. 08, 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 on October 4, 2024, the Compensation & Management Development Committee of Rhythm’s Board of Directors granted inducement restricted stock units, or RSUs, covering an aggregate of 30,050 shares of its common stock to nine new employees. These inducement RSUs are subject to the terms...
Rhythm Pharmaceuticals Announces New Employment Inducement Grants BOSTON, Sept. 16, 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 on September 11, 2024, the Compensation & Management Development Committee of Rhythm’s Board of Directors granted inducement restricted stock units, or RSUs, covering an aggregate of 15,450 shares of its common stock to four new employees. These inducement RSUs are subject to the terms...
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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 -- Label expansion sought to treat younger children with Bardet-Biedl syndrome or POMC/LEPR deficiency -- -- FDA sets PDUFA goal date of December 26, 2024 -- BOSTON, Aug. 26, 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 ...
Rhythm Pharmaceuticals to Present at Wells Fargo Healthcare Conference in September BOSTON, Aug. 26, 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 David Meeker, M.D., Chair, President and Chief Executive Officer, will participate in a fireside chat at the upcoming Wells Fargo Healthcare Conference at Encore Boston Harbor on Thursday, September 5, 2024 at 3:45 p.m. ET. The fireside cha...
Rhythm Pharmaceuticals Announces New Employment Inducement Grants BOSTON, Aug. 13, 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 on August 8, 2024, the Compensation & Management Development Committee of Rhythm’s Board of Directors granted inducement restricted stock units, or RSUs, covering an aggregate of 16,200 shares of its common stock to five new employees. These inducement RSUs are subj...
Rhythm Pharmaceuticals Reports Second Quarter 2024 Financial Results and Business Update -- 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 -- -- Completed sNDA submission seeking to expand U.S. label of IMCIVREE to treat pediatric patients as young as 2 years old in approved indications -- -- Cash on-hand expected to support pla...
Rhythm Pharmaceuticals Announces European Commission Expands ▼IMCIVREE® (setmelanotide) Marketing Authorization to include Children as Young as 2 Years Old 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 BOSTON, July 31, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine disease...
Rhythm Pharmaceuticals Announces First Patients Dosed in Phase 2 Trial Evaluating Oral MC4R Agonist LB54640 in Hypothalamic Obesity -- LB54640 has shown targeted effect on MC4R without hyperpigmentation -- 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 the first patients have been dosed in the Company’s Phase 2 clinical trial evaluating LB54640, an investigational oral melanocor...
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