Welcome to our dedicated page for Rhythm Pharmaceu news (Ticker: RYTM), a resource for investors and traders seeking the latest updates and insights on Rhythm Pharmaceu stock.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) is a commercial-stage biopharmaceutical company whose news flow centers on rare neuroendocrine diseases and MC4R pathway–targeted therapies. The company’s updates frequently highlight global commercial performance of its lead product IMCIVREE (setmelanotide), regulatory milestones, and clinical data across multiple rare obesity indications.
Investors following RYTM news can expect regular announcements on net product revenues from global sales of IMCIVREE, including the relative contributions from the United States and international markets. Rhythm also issues press releases on reimbursement developments, such as public reimbursement agreements for IMCIVREE in Canadian provinces and under federal programs for patients with Bardet-Biedl syndrome–related obesity.
Clinical and regulatory news is a major focus. Rhythm reports on Phase 3 trials like TRANSCEND in acquired hypothalamic obesity and EMANATE in genetically caused MC4R pathway diseases, as well as exploratory and Phase 2 studies in Prader-Willi syndrome and other rare conditions. Updates often include topline efficacy and safety data, cardiometabolic outcomes, and patient- and caregiver‑reported measures presented at scientific meetings.
Regulatory communications include FDA actions on supplemental New Drug Applications, PDUFA goal dates and extensions, and EMA validation of Type II variations to existing marketing authorizations. Rhythm also provides information on development of investigational MC4R agonists bivamelagon and RM-718 and preclinical small molecules for congenital hyperinsulinism.
For users tracking RYTM, this news feed offers a centralized view of earnings releases, clinical trial readouts, regulatory decisions and access milestones related to IMCIVREE and Rhythm’s broader rare disease pipeline.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced an extension of the FDA review period for its supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) to June 16, 2022, due to a request for additional subgroup analyses from its Phase 3 trial data. The company also withdrew the proposed Alström syndrome indication from its Type II variation application under EMA review to maintain the timeline for Bardet-Biedl Syndrome (BBS). Rhythm remains committed to bringing this treatment to market for patients with these rare genetic obesity disorders.
Rhythm Pharmaceuticals (Nasdaq: RYTM) has announced the promotions of key executives, including Joe Shulman to Chief Technical Officer, Patrick Kleyn, Ph.D., to Senior Vice President and Head of Translational Research and Development, and Elisabeth Crönert-Bendell, M.D., to Senior Vice President and Head of Strategy. These promotions aim to strengthen the company's leadership as it focuses on advancing its lead product, IMCIVREE (setmelanotide), approved for chronic weight management in rare genetic obesity diseases. IMCIVREE is the first FDA-approved therapy for these conditions.
Rhythm Pharmaceuticals (Nasdaq: RYTM) will host a live conference call on March 1, 2022, at 8:00 a.m. ET to discuss its Q4 and full-year 2021 financial results. The call can be accessed via phone or through a webcast available on their Investor Relations website. Rhythm is focused on treating rare genetic diseases of obesity, with its drug IMCIVREE (setmelanotide) being the first FDA-approved therapy for specific genetic deficiencies related to obesity. The company is advancing its clinical development program while managing risks including regulatory approval uncertainties.
Rhythm Pharmaceuticals announced promising interim results from its long-term study of setmelanotide for Bardet-Biedl Syndrome (BBS), revealing sustained weight loss over 24 months. The mean BMI reduction was -14.3%, with significant improvements in older patients as well. The results showcased that setmelanotide was well-tolerated, with no new safety concerns identified. Rhythm is preparing for the potential U.S. commercial launch of IMCIVREE, pending FDA approval, where a supplemental NDA has a PDUFA goal date of March 16, 2022. Detailed results will be presented at an upcoming medical meeting.
Rhythm Pharmaceuticals (Nasdaq: RYTM) will host a virtual event on February 16, 2022, to discuss the patient experience of Bardet-Biedl Syndrome (BBS) and its commercialization plans for setmelanotide, aimed at addressing obesity and hyperphagia in BBS patients. The event features key opinion leaders and updates on the FDA review of the supplemental New Drug Application (sNDA) for setmelanotide, with a PDUFA goal date of March 16, 2022. The company aims to enhance awareness and understanding of BBS and its treatments.
Rhythm Pharmaceuticals (RYTM) announced the initiation of the DAYBREAK Phase 2 clinical trial, the most extensive of its kind for rare genetic obesity diseases, dosing the first patient with setmelanotide. This trial aims to treat severe obesity and hyperphagia linked to variants in 31 genes. Concurrently, a Phase 3 switch trial evaluates a weekly setmelanotide formulation for patients currently on a daily dosage. DAYBREAK is set to enroll approximately 500 participants across 12 countries, with significant potential to shape future treatments for obesity linked to genetic variants.
Rhythm Pharmaceuticals (RYTM) announced an exclusive licensing agreement with RareStone for IMCIVREE (setmelanotide) to treat genetic obesity in China, including Hong Kong and Macau. Rhythm will receive a $12 million upfront payment, with potential future payments of up to $63.5 million plus sales royalties. The agreement aims to enhance patient access in China for severe genetic obesity, addressing a significant unmet medical need. This partnership marks Rhythm's first expansion into the Asian market, enhancing its global outreach.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) targeting Bardet-Biedl syndrome and Alström syndrome. The FDA granted Priority Review status, setting a PDUFA goal date of March 16, 2022. This acceptance is regarded as a significant advancement in addressing unmet medical needs for these ultra-rare genetic diseases that affect obesity and hunger regulation.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that CEO David Meeker will present at the Stifel 2021 Virtual Healthcare Conference on November 15, 2021, at 11:20 a.m. ET. A live webcast will be accessible on the company’s website, with a replay available for 30 days post-event.
Rhythm specializes in therapies for rare genetic obesity diseases. Their product, IMCIVREE (setmelanotide), approved in the U.S. and Europe for specific genetic obesity conditions, continues to show promise with ongoing development in additional obesity-related disorders.
Rhythm Pharmaceuticals (RYTM) has submitted regulatory filings for IMCIVREE® (setmelanotide) for treating Bardet-Biedl and Alström syndromes, with launch preparations set for mid-2022. In Q3 2021, IMCIVREE net sales reached $1 million, marking a revenue milestone since its FDA approval in November 2020. The company presented 22 data studies at major medical conferences, including positive outcomes on health-related quality of life for patients with rare genetic obesity diseases. Cash position as of September 30, 2021, was approximately $328.4 million, indicating strong financial support for ongoing operations.
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