-- Fourth quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $57.3 million -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity (HO) ---- Phase 2 open-label extension data showed bivamelagon achieved persistent BMI reductions at six and nine months; Completed positive end-of-Phase-2 meeting with FDA ---- On track to report topline data from 12-patient Japanese cohort of setmelanotide Phase 3 trial in acquired HO in March 2026 -- -- ...

BOSTON, Feb. 17, 2026 (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 it will host a live conference call and webcast at 8 a.m. ET on Thursday, February 26, 2026 to report its fourth quarter and full year 2025 financial results and provide a corporate update. To access the live conference call, participants may register here. While ...

BOSTON, Feb. 05, 2026 (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 Hunter C. Smith, Chief Financial Officer, will participate in a fireside chat at the upcoming Guggenheim Emerging Outlook: Biotech Summit 2026 conference on Wednesday, February 11 at 11:00 a.m. ET in New York. The fireside chat will be webcasted and available unde ...

Core Viewpoint - Rhythm Pharmaceuticals reported strong preliminary unaudited net product revenues for IMCIVREE, indicating significant growth in 2025 and outlining future milestones for product development and regulatory approvals [2][3][6]. Financial Performance - Preliminary unaudited net product revenues for Q4 2025 are expected to be approximately $57 million, reflecting an 11% increase from Q3 2025 [3][6]. - Full-year 2025 net product revenues are projected to be around $194 million, a 50% increase compared to $130 million in 2024 [3][6]. - U.S. sales contributed approximately 68% of Q4 revenues and about 69% of full-year revenues for 2025 [3][6]. Upcoming Milestones - The company plans to launch IMCIVREE for acquired hypothalamic obesity in the U.S. pending FDA approval, with a PDUFA goal date set for March 20, 2026 [7]. - Top-line data from the Japanese cohort of the Phase 3 trial in acquired hypothalamic obesity is expected in Q1 2026 [6][8]. - Top-line data from the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases is also anticipated in Q1 2026 [6][8]. Product Development - Rhythm is advancing setmelanotide for Prader-Willi syndrome, with positive preliminary data from a Phase 2 trial showing reductions in BMI and hyperphagia [9]. - The company plans to initiate a pivotal Phase 3 trial for bivamelagon in acquired hypothalamic obesity in 2026, pending feedback from regulatory agencies [10]. - Enrollment in the Phase 1 trial for RM-718 is expected to be completed in Q1 2026 [11].

Core Insights - Rhythm Pharmaceuticals announced positive preliminary results from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS), showing reductions in BMI and hyperphagia [1][4] - The company plans to advance setmelanotide into a Phase 3 registrational trial, pending the successful completion of the Phase 2 trial [2] - Rhythm has initiated a Part D arm in the Phase 1 trial of MC4R agonist RM-718, which will enroll up to 20 patients with PWS [2] Company Developments - Six out of eight patients who reached Month 3 of setmelanotide therapy achieved BMI reductions from baseline, and three out of five patients who reached Month 6 also saw reductions [6] - Six out of seven evaluable patients at Month 3 achieved meaningful reductions in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) scores [6] - Seventeen out of the 18 enrolled patients remain on active setmelanotide therapy, with safety and tolerability results consistent with the drug's established clinical profile [6] Clinical Trial Details - The Phase 2 trial is a single-site, open-label study evaluating setmelanotide for the treatment of PWS, originally designed for 26 weeks but extended to 52 weeks [8] - Eighteen patients aged 6 to 65 years with PWS and obesity were enrolled, with a primary focus on safety and tolerability, and key secondary endpoints assessing weight, hyperphagia, behavior, and pharmacokinetics [9] - The trial aims to address the profound unmet need in the PWS patient population, where hyperphagia and severe obesity present significant health challenges [3] Future Outlook - The company anticipates additional data in the first half of 2026 and remains committed to exploring the potential of MC4R agonism for patients with limited treatment options [4] - The first patient for the RM-718 study is expected to be screened in December 2025 [2][4]

Core Viewpoint - Rhythm Pharmaceuticals has announced an extension of the FDA review period for the supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) by three months, moving the PDUFA goal date from December 20, 2025, to March 20, 2026 [1][2] Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, with its lead product IMCIVREE® (setmelanotide) aimed at treating acquired hypothalamic obesity [1][6] - Setmelanotide is already approved by the FDA for reducing excess body weight in patients aged 2 years and older with specific genetic obesity syndromes [6][7] Regulatory Update - The FDA requested additional sensitivity analyses of clinical efficacy data from Rhythm's Phase 3 pivotal trial, which has been classified as a 'major amendment' allowing for an extended review period [2] - No new safety or manufacturing data was requested by the FDA, indicating that the focus remains on the efficacy data [2] Management Commentary - David Meeker, CEO of Rhythm, expressed confidence in the product profile of setmelanotide and the ongoing collaboration with the FDA to bring the treatment to patients who currently lack approved options [3] Conference Call Information - Rhythm Pharmaceuticals will hold a conference call and webcast to discuss the update at 8:00 a.m. ET, with registration recommended ten minutes prior to the start [4][5]

Core Viewpoint - Rhythm Pharmaceuticals, Inc. is set to report its third quarter 2025 financial results and provide a corporate update on November 4, 2025, at 8:00 a.m. ET [1] Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases [3] - The company's lead product, IMCIVREE® (setmelanotide), is an MC4R agonist approved by the FDA for treating obesity related to specific genetic conditions [3][4] - Setmelanotide is indicated for patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or deficiencies in POMC, PCSK1, or LEPR [4][5] Upcoming Events - Rhythm will host a live conference call and webcast for its financial results on November 4, 2025 [1] - The company will also participate in two fireside chats on November 12, 2025, at the Guggenheim Healthcare Innovation Conference and the Stifel Healthcare Conference [7] Product Indications - In the U.S., setmelanotide is indicated for long-term weight reduction in patients with specific genetic obesity conditions [4] - In the EU and UK, it is indicated for obesity treatment and hunger control associated with genetically confirmed BBS or related deficiencies [5] Limitations and Contraindications - Setmelanotide is not indicated for obesity due to benign variants of POMC, PCSK1, or LEPR [6][8] - Serious hypersensitivity reactions have been reported, contraindicating its use in patients with prior serious hypersensitivity to the drug [9] Warnings and Precautions - Patients may experience disturbances in sexual arousal, depression, and hypersensitivity reactions [10][11][12] - Skin hyperpigmentation and the development of new melanocytic nevi have been observed, necessitating regular skin examinations [13] Adverse Reactions - Common adverse reactions (≥20% incidence) include skin hyperpigmentation, injection site reactions, nausea, headache, and depression [15]

Core Viewpoint - Rhythm Pharmaceuticals, Inc. is set to report its second quarter 2025 financial results and provide a corporate update on August 5, 2025, highlighting its focus on rare neuroendocrine diseases and the development of its lead asset, setmelanotide [1][4]. Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with rare neuroendocrine diseases [4]. - The company's lead product, IMCIVREE® (setmelanotide), is an MC4R agonist approved by the FDA for reducing excess body weight and maintaining weight reduction in patients aged 2 years and older with specific genetic obesity conditions [4][5]. - Setmelanotide is also authorized by the European Commission and the UK's MHRA for similar indications in adults and children [4][6]. Upcoming Events - Rhythm Pharmaceuticals will host a live conference call and webcast on August 5, 2025, at 8:00 a.m. ET to discuss its financial results [1]. - Alastair Garfield, Chief Scientific Officer, and David Connolly, Head of Investor Relations, will participate in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference on August 13, 2025, at 12:30 p.m. ET [2]. Product Indications - In the U.S., setmelanotide is indicated for patients with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or deficiencies in POMC, PCSK1, or LEPR [5]. - In the EU and UK, it is indicated for obesity treatment and hunger control associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1 and LEPR deficiencies [6]. Clinical Development - Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases and is also exploring investigational MC4R agonists, bivamelagon and RM-718, along with a preclinical suite of small molecules for congenital hyperinsulinism [4].