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Rhythm Pharmaceuticals (RYTM) is a commercial-stage biopharmaceutical company pioneering precision medicines for rare neuroendocrine diseases, including genetic obesity disorders. This page aggregates all official announcements, press releases, and verified news coverage related to RYTM's therapeutic advancements and operational developments.
Investors and stakeholders will find timely updates on regulatory milestones, clinical trial outcomes, financial disclosures, and strategic partnerships. The curated collection prioritizes primary-source materials including FDA submissions, research publications, and executive communications to ensure informational accuracy.
Track RYTM's progress in developing MC4R pathway therapies like IMCIVREE® (setmelanotide), with updates spanning global approvals, research expansions, and market access initiatives. Content is organized chronologically to facilitate efficient monitoring of the company's progress in addressing rare genetic conditions.
Bookmark this page for direct access to Rhythm Pharmaceuticals' latest verified updates. For complete market analysis, combine these resources with broader sector research and regulatory filings.
Rhythm Pharmaceuticals (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company specializing in rare neuroendocrine diseases, has scheduled its first quarter 2025 financial results announcement for Wednesday, May 7, 2025 at 8:00 a.m. ET.
The company will host a live conference call and webcast to present the financial results and provide a corporate update. Participants are encouraged to join ten minutes before the scheduled start time. The webcast will be accessible through the Investor Relations section of Rhythm's website and will remain available for at least 30 days after the call.
Rhythm Pharmaceuticals (RYTM) announced positive topline results from its pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for treating acquired hypothalamic obesity. The trial met its primary endpoint, demonstrating a significant -19.8% placebo-adjusted BMI reduction in 120 patients at 52 weeks.
Key findings include:
- Patients on setmelanotide (n=81) achieved -16.5% BMI change vs +3.3% for placebo (n=39)
- Adult patients (18+ years) showed -19.2% placebo-adjusted BMI reduction
- Patients under 18 achieved -20.2% placebo-adjusted BMI reduction
- 80% of treated patients achieved ≥5% BMI reduction
The treatment was generally well-tolerated with no new safety concerns. Common side effects included nausea, vomiting, diarrhea, and injection site reactions. Rhythm plans to submit regulatory applications in the U.S. and EU by Q3 2025.
Rhythm Pharmaceuticals (RYTM) has scheduled a conference call and webcast for April 7, 2025, at 8:00 a.m. ET to present topline results from their Pivotal Phase 3 TRANSCEND trial. The trial evaluates setmelanotide, a melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity.
The biopharmaceutical company, which focuses on rare neuroendocrine diseases, will make the webcast available under the 'Events and Presentations' section of their investor relations website. The recording will remain accessible for at least 30 days after the call.
Rhythm Pharmaceuticals (RYTM) has announced the reacquisition of rights to IMCIVREE® (setmelanotide) in China, Hong Kong, and Macau through the termination of its 2021 licensing agreement with RareStone Group The company will repay $6.3 million in cash to RareStone and return all previously acquired RareStone shares without additional consideration.
The reacquisition aligns with Rhythm's strategy to develop setmelanotide and next-generation MC4R agonists globally. The company's global trial of setmelanotide in patients with acquired hypothalamic obesity is progressing as planned, with topline data expected in Q2 2025. The trial is currently being conducted across North America, Europe, and Japan.
Rhythm Pharmaceuticals (RYTM) has received orphan drug designation from Japan's Ministry of Health for setmelanotide, targeting acquired hypothalamic obesity treatment. Setmelanotide, an MC4R agonist designed to treat hyperphagia and obesity, is currently being evaluated in a global Phase 3 trial with topline data expected in Q2 2025.
The designation highlights the significant unmet medical need in Japan, where an estimated 5,000 to 8,000 patients live with acquired hypothalamic obesity. The condition affects approximately 5,000-10,000 people in the U.S. and 3,500-10,000 in the E.U. This rare disease typically occurs following hypothalamic injury from brain tumors, traumatic brain injury, stroke, or inflammation.
The orphan designation in both Japan and Europe positions Rhythm to potentially deliver the first-ever treatment targeting the underlying biology of hypothalamic obesity, pending successful Phase 3 trial results and regulatory approvals.
Rhythm Pharmaceuticals (RYTM) and the Raymond A. Wood Foundation have announced a research collaboration to study the impact of fatigue in people with craniopharyngioma. The initiative involves a registry study open to all diagnosed patients and their caregivers.
The study aims to investigate fatigue effects related to craniopharyngiomas and explore factors like weight gain and daytime sleepiness that may influence patient experiences. Participants can enroll through the Hypothalamic-Pituitary Brain Tumors Patient Registry at the foundation's website.
Rhythm Pharmaceuticals (RYTM) reported Q4 2024 global sales of $41.8 million for IMCIVREE, up 26% from Q3 2024. Full-year 2024 revenue reached $130.1 million, compared to $77.4 million in 2023.
Key developments include FDA approval for IMCIVREE's expanded label to treat children as young as 2 years old, and completion of enrollment in the Phase 2 trial of oral MC4R agonist bivamelagon. The company raised $75 million through ATM equity offering, extending cash runway into 2027.
Financial results show Q4 2024 net loss of $44.6 million ($0.72 per share). R&D expenses increased to $238.0 million for 2024, while SG&A expenses reached $144.3 million. Cash position as of December 31, 2024, was $320.6 million.
Rhythm Pharmaceuticals (RYTM), a global commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, has scheduled two important investor events. The company will host a conference call and webcast on February 26, 2025, at 8:00 a.m. ET to discuss its fourth quarter and full year 2024 financial results and provide a corporate update.
Additionally, CEO David Meeker will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference in Boston on March 3, 2025, at 1:10 p.m. ET. Both events will be available via webcast on the company's investor relations website, with recordings accessible for 30 days following each event.
Rhythm Pharmaceuticals (RYTM), a commercial-stage biopharmaceutical company specializing in rare neuroendocrine diseases, has announced its upcoming participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. David Meeker, M.D., who serves as Chair, President and Chief Executive Officer, will engage in a fireside chat on Wednesday, February 12, 2025, at 8:40 a.m. ET.
The presentation will be accessible via webcast in the Investor Relations section of Rhythm's website under 'Events & Presentations' at www.rhythmtx.com. Interested parties can access a replay of the webcast on the company's website for 30 days following the presentation.
Rhythm Pharmaceuticals (RYTM) announced preliminary Q4 2024 net revenues of approximately $42 million from global IMCIVREE sales, up 26% from Q3 2024, and full-year 2024 revenues of approximately $130 million compared to $77.4 million in 2023. U.S. sales contributed about 74% of Q4 and 73% of full-year revenues.
The company reported several pipeline developments: completion of enrollment in the Japanese cohort of Phase 3 trial for acquired hypothalamic obesity (HO), with topline data expected in H1 2025; completion of enrollment in two substudies of Phase 3 EMANATE trial for MC4R pathway diseases; and plans to initiate a new Phase 2 trial for Prader-Willi syndrome in Q1 2025. The company is also advancing trials for bivamelagon and RM-718 in HO treatment.
