-- 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 indicat ...

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Rhythm Pharmaceuticals, Inc. (RYTM) shares soared 7.4% in the last trading session to close at $53.17. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 5.1% gain over the past four weeks. Last month, Rhythm announced the FDA's acceptance of the supplemental new drug application for its only marketed drug, Imcivree (setmelanotide), to treat obesity in children as young as two years old. The FDA granted Priority Review to the applic ...

Rhythm Pharmaceuticals' (RYTM) shares gained 8.4% on Aug. 26 after announcing the FDA's acceptance of the supplemental new drug application (sNDA) for its only marketed drug, Imcivree (setmelanotide), to treat obesity in children as young as two years old, under the Priority Review pathway. A filing designated as a Priority Review reduces the review period to four months. A final decision from the FDA is expected on Dec. 26, 2024. Imcivree, an MC4R agonist, is already approved in the United States and EU fo ...

Core Viewpoint - Rhythm Pharmaceuticals has received FDA acceptance for a supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) aimed at treating obesity in children as young as 2 years old with Bardet-Biedl syndrome or POMC/LEPR deficiency, with a PDUFA goal date set for December 26, 2024 [1][2] Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, with its lead product IMCIVREE® designed to treat hyperphagia and severe obesity [4] - The company has been operational for over two years, with IMCIVREE already prescribed to hundreds of patients aged 6 and older [2] Product Information - IMCIVREE is an MC4R agonist approved for chronic weight management in patients aged 6 years and older with specific genetic obesity conditions, including POMC, PCSK1, or LEPR deficiencies, and Bardet-Biedl syndrome [5][6] - The recent sNDA submission is based on a Phase 3 trial involving 12 patients aged 2 to under 6 years, demonstrating a mean reduction of 3.04 in BMI-Z score and an 18.4% mean reduction in BMI [2] Regulatory Developments - The European Commission expanded the marketing authorization for IMCIVREE to include children as young as 2 years old in July 2024, aligning with the recent FDA application [3][6] - The FDA has granted Priority Review status to the sNDA, indicating a faster review process [1]

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 ...