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Rhythm Pharmaceuticals plans to add a cohort of Japanese patients to its global Phase 3 trial for hypothalamic obesity treatment, targeting a significant unmet need in Japan with 5,000 to 8,000 patients estimated. Dosing for the Japanese cohort is expected to start in the third quarter of 2024, with the company aiming for potential approval in Japan. The company also completed enrollment in the pivotal 120-patient cohort for its global Phase 3 trial, with top-line study results expected in the first half of 2025.
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-9.73%
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Rhythm Pharmaceuticals reported fourth quarter 2023 net revenue of $24.2 million from IMCIVREE sales, completed enrollment in a Phase 3 trial for hypothalamic obesity, acquired global rights to LB54640, and received reimbursement approvals for IMCIVREE in Spain and Italy. The Company also announced Phase 3 development plans for setmelanotide in Japan and the FDA acceptance of an IND application for RM-718. Financially, Rhythm had $275.8 million in cash as of December 31, 2023, with net product revenues of $77.4 million for the full year 2023.
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Rhythm Pharmaceuticals, Inc. (RYTM) granted inducement equity grants covering 20,295 shares of its common stock to six new employees. The grants include stock options and restricted stock units (RSUs) subject to the terms of the 2022 Employment Inducement Plan. The options have an exercise price of $44.88 per share and will vest over four years. The RSUs also vest over four years, subject to continued employment. The Inducement Plan was adopted by the board of directors on February 9, 2022.
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Rhythm Pharmaceuticals, Inc. (RYTM) announced that the Italian Medicine Agency approved reimbursement for IMCIVREE for the treatment of obesity and control of hunger associated with Bardet-Biedl syndrome (BBS). This allows families in Italy affected by this rare neuroendocrine disease to access the first and only treatment option authorized in the European Union. BBS is a rare melanocortin-4 receptor (MC4R) pathway disease with hallmark symptoms of hyperphagia and early-onset, severe obesity. AIFA previously approved reimbursement for IMCIVREE for the treatment of obesity and control of hunger associated with other conditions.
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Rhythm Pharmaceuticals, Inc. (RYTM) will participate in fireside chats at Guggenheim’s 6th Annual Biotechnology Conference on Feb. 7 and TD Cowen 44th Annual Health Care Conference on March 5. The company will also host a live conference call and webcast on Feb. 22 to report its Q4 and full year 2023 financial results and provide a corporate update. David Meeker, M.D., Chair, President, and CEO, will represent the company at the conferences. Live webcasts of the events will be available on the company's website.
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Rhythm Pharmaceuticals, Inc. granted inducement equity grants to four new employees, consisting of inducement stock options and inducement restricted stock units. The grants cover an aggregate of 13,020 shares of its common stock. The stock options have an exercise price of $42.52 per share and will vest over a three-year period. The RSUs will vest over four years. These grants are subject to the terms of the Inducement Plan adopted by Rhythm's board of directors on February 9, 2022.
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Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) has entered into a global licensing agreement with LG Chem, Ltd. for LB54640, an investigational oral small molecule melanocortin-4 receptor (MC4R) agonist now in Phase 2 clinical trials. The Phase 1 trial in healthy overweight adults demonstrated dose-dependent weight reduction and a favorable safety profile. LB54640 has received orphan drug designation from the U.S. Food and Drug Administration for leptin receptor (LEPR) deficiency and proopiomelanocortin(POMC). Rhythm will sponsor two Phase 2 studies to evaluate weight loss efficacy, safety, tolerability, and pharmacokinetics of LB54640.
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Rhythm Pharmaceuticals, a global commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, provided a business update. The company completed screening for enrollment in a pivotal, Phase 3 clinical trial evaluating setmelanotide in patients with acquired hypothalamic obesity. Rhythm anticipates overenrolling the trial with over 140 patients consented. The top-line study results are expected in H1 2025. Positive reimbursement decisions were achieved in Spain for IMCIVREE to treat patients with Bardet-Biedl syndrome and POMC/LEPR deficiencies. Additionally, the FDA accepted the IND application for RM-718, a new, weekly treatment designed to be more targeted and potent than setmelanotide.
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Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced the grant of inducement equity grants to a new employee, consisting of stock options and restricted stock units. The options have an exercise price of $38.00 per share and will vest over a period of three years, while the RSUs will vest over four years.
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Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) sponsors the second annual International Meeting on Pathway-Related Obesity: Vision & Evidence (IMPROVE) in Paris, France. The event will highlight new scientific developments for rare MC4R pathway diseases, with over 50 poster presentations and approximately 150 healthcare professionals from 20 countries expected to attend.
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Rhythm Pharmaceuticals, Inc.
Nasdaq:RYTM
RYTM Rankings
RYTM Stock Data
2.31B
44.99M
0.52%
112.26%
16.19%
Pharmaceutical Preparation Manufacturing
Manufacturing
United States of America
BOSTON
About RYTM
rhythm pharmaceuticals inc. is a biotechnology company located in 855 boylston street, 11th floor, boston, ma, united states.