-- 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 the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application ( ...

Rhythm Pharmaceuticals, Inc. (RYTM) came out with a quarterly loss of $0.55 per share versus the Zacks Consensus Estimate of a loss of $0.70. This compares to loss of $0.82 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 21.43%. A quarter ago, it was expected that this company would post a loss of $2.34 per share when it actually produced a loss of $2.35, delivering a surprise of -0.43%. Over the last four quarters, the compa ...

-- 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 ...

"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. ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...