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Rhythm Pharmaceuticals Reports Second Quarter 2024 Financial Results and Business Update
GlobeNewswire News Room· 2024-08-06 19:00
-- 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 planned op ...
Rhythm Pharmaceuticals Announces European Commission Expands ▼IMCIVREE® (setmelanotide) Marketing Authorization to include Children as Young as 2 Years Old
Newsfilter· 2024-07-31 21:10
"Today marks what we believe to be an important milestone for European patients with BBS and POMC/LEPR deficiencies ages 2 to 6, who now have the opportunity to address the severe and insatiable hunger and early onset obesity associated with their conditions at an early age," said Yann Mazabraud, Executive Vice President, Head of International at Rhythm Pharmaceuticals. "Early-onset obesity that goes untreated can manifest in multiple comorbidities and negatively affect quality of life and life expectancy. ...
Rhythm Pharmaceuticals Announces European Commission Expands ▼IMCIVREE® (setmelanotide) Marketing Authorization to include Children as Young as 2 Years Old
GlobeNewswire News Room· 2024-07-31 21:10
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 diseases, today announced that the European Commission (EC) expanded the marketing authorization for IMCIVREE® (setmelanotide) to include children between 2 and younger than 6 years old with obesity due to Bardet Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein ...
Rhythm Pharmaceuticals Announces First Patients Dosed in Phase 2 Trial Evaluating Oral MC4R Agonist LB54640 in Hypothalamic Obesity
Newsfilter· 2024-07-23 20:00
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 melanocortin-4 receptor (MC4R) agonist, in hypothalamic obesity. About Rhythm Pharmaceuticals In the European Union, setmelanotide is ...
Rhythm Pharmaceuticals to Report Second Quarter 2024 Financial Results on Tuesday, August 6, 2024
GlobeNewswire News Room· 2024-07-23 19:30
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, 2024 to report its second quarter 2024 financial results and provide a corporate update. Also today, Rhythm announced that David Meeker, M.D., Chair, President and Ch ...
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
Newsfilter· 2024-06-28 20:00
Heart rate and blood pressure monitoring: In Europe, heart rate and blood pressure should be monitored as part of standard clinical practice at each medical visit (at least every 6 months) for patients treated with setmelanotide. Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity. USE IN SPECIFIC POPULATIONS Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) ha ...
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
GlobeNewswire News Room· 2024-06-28 20:00
BOSTON, June 28, 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 diseases, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization for IMCIVREE® (setmelanotide) include children between 2 and younger than 6 years ...
Rhythm Pharmaceuticals Announces New Employment Inducement Grants
Newsfilter· 2024-06-12 04:01
BOSTON, June 11, 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 June 6, 2024, the Compensation & Management Development Committee of Rhythm's Board of Directors granted inducement equity grants covering an aggregate of 56,080 shares of its common stock to ten new employees, consisting of inducement stock options ...
Rhythm Pharmaceuticals Announces New Employment Inducement Grants
GlobeNewswire News Room· 2024-06-12 04:01
Corporate Contact: David Connolly Head of Investor Relations and Corporate Communications Rhythm Pharmaceuticals, Inc. 857-264-4280 dconnolly@rhythmtx.com Media Contact: Adam Daley Berry & Company Public Relations 212-253-8881 adaley@berrypr.com Please see the full Prescribing Information for additional Important Safety Information. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release ...
Rhythm Pharmaceuticals Presents Patient-reported Experiences with Hyperphagia in Hypothalamic Obesity at ENDO 2024
Newsfilter· 2024-06-04 04:02
BOSTON, June 03, 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 diseases, today announced the presentation of the first patient and caregiver reported experiences from qualitative interviews following the completion of a Phase 2 trial that evaluated treatment with setmelanotide in hypothalamic obesity (HO). These results were among six Rhy ...