Rhythm Pharmaceuticals, Inc. announced that the FDA accepted the Company's Investigational New Drug (IND) application for RM-718, a new, weekly treatment designed to be more targeted and potent than setmelanotide with the potential to not cause hyperpigmentation. Rhythm's lead asset, IMCIVREE®? (setmelanotide), an MC4R antagonist designed to treat hyperphagia and severe obesity, is approved by the FDA for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome (BBS).

Setmelanotide Indication: In the United States, setmelanotide is indicated for chronic weight management in adults and pediatric patients 6 years of years of age and older with Monogenic or syndromic obesity Due to POMC, PCSK1 or LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PC SK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) or BBS. Prolonged penile erection: Spontaneous penile erections have been reported in clinical trials with setmelanotide. Depression: In clinical trials, depression has been reported in patients treated with setmelanotide.

All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, including the anticipated timing for initiation of clinical trials and release of clinical trial data and expectations surrounding potential regulatory submissions, approvals and timing thereof, including for RM-718 and setmelanotide, business strategy and plans, including regarding commercialization of setmelanotide in the United States and Europe, the application of genetic testing and related growth potential, and expectations surrounding the potential market opportunity for product candidates. Such statements are subject to numerous risks and uncertainties, including, but not limited to, risks relating to, risks relating to liquidity and expenses, ability to enroll patients in clinical trials, the design and outcome of clinical trials, the ability to achieve necessary regulatory approvals, risks associated with data analysis and reporting, failure to identify and develop additional product candidates, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing international operations and the costs of any related compliance programs, the impact of competition, risks relating to product liability lawsuits, inability to maintain collaborations, or the failure of these collaborations, and the failure of these collaborations, reliance on third parties, risks relating to intellectual property, ability to hire and retain necessary personnel, the impact of the COVID-19 pandemic and general economic conditions on business and operations, including preclinical studies, clinical trials and commercialization prospects, failure to realize the anticipated benefits of acquisition of Xinvento B.V. or significant integration difficulties related to the acquisition, and the other important factors discussed under the caption "Risk Factors" in Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and other filings with the Securities and Exchange Commission. Except as required by law, the company undertake no other filings with the Securities and exchange Commission.