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 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.
Rhythm Pharmaceuticals (Nasdaq: RYTM) presented comprehensive data on setmelanotide at ObesityWeek 2021, focusing on its effects on Bardet-Biedl Syndrome (BBS). Key findings include that 85% of patients reported improved health-related quality of life (HRQOL) after one year on therapy, along with significant reductions in BMI—9.1% for adults and 9.5% for pediatric patients. New data from Phase 2 trials showed setmelanotide also reduced hunger in patients with SH2B1 and SRC1 deficiencies. The company aims to expand clinical evaluations to 36 relevant genes affecting obesity.
Rhythm Pharmaceuticals (Nasdaq: RYTM) will host a conference call on November 2, 2021, at 8:00 a.m. ET to provide its Q3 2021 financial results and corporate updates. The biopharmaceutical company focuses on rare genetic obesity disorders and has developed IMCIVREE (setmelanotide), the first FDA-approved treatment for obesity due to specific genetic deficiencies. The drug received recent approvals from European authorities. The call will be available via phone and webcast, with an archived version accessible for 30 days after.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the submission of a Type II variation application to the European Medicines Agency for its obesity treatment, IMCIVREE (setmelanotide), targeting Bardet-Biedl syndrome (BBS) and Alström syndrome. This submission leans on positive data from a Phase 3 trial showing significant weight loss and hunger control. The company estimates around 1,500 patients in the EU with BBS could benefit, enhancing its position in the rare genetic obesity market.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) reported promising findings from the Obesity Medicine Association’s Overcoming Obesity 2021 Conference. Setmelanotide, an obesity treatment for POMC and LEPR deficiencies, showed significant improvements in health-related quality of life and hunger management for patients. Updated data from the Uncovering Rare Obesity program revealed that 64.5% of participants with early-onset obesity may carry genetic variants linked to rare obesity diseases. Rhythm plans to launch Phase 3 EMANATE and Phase 2 DAYBREAK trials, furthering its commitment to treating genetic obesity.
Rhythm Pharmaceuticals, Inc. (RYTM) presented promising data from its Phase 2 and 3 trials of setmelanotide aimed at treating rare genetic obesity disorders at the 59th Annual ESPE Meeting. A subgroup analysis of the Phase 3 trial in Bardet-Biedl syndrome showed significant weight loss (3.8 kg) and hunger reduction. The Phase 2 Basket Study indicated 30% and 43% weight loss responses for SRC1 and SH2B1 deficiencies, respectively. These findings support the ongoing EMANATE Phase 3 trial, expanding setmelanotide's potential to treat obesity linked to genetic variants, with a targeted patient population of approximately 100,000-200,000 in the U.S.
Rhythm Pharmaceuticals announced that its drug IMCIVREE (setmelanotide) received marketing authorization in Great Britain for treating obesity linked to specific genetic deficiencies, including POMC, PCSK1, and LEPR. This marks the first authorized treatment option for these rare conditions in Great Britain. IMCIVREE, already approved in the EU and the US, showed significant efficacy in clinical trials, with notable weight loss results. It is set for review by NICE in December 2021, and NHS coverage guidance is expected in Q2 2022.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced the completion of its supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) to treat obesity and control hunger in patients aged 6 and older with Bardet-Biedl syndrome (BBS) or Alström syndrome. This application is based on a pivotal Phase 3 trial demonstrating significant weight and hunger reductions. Rhythm has requested priority review, potentially leading to a six-month review period. The company also plans to submit a marketing authorization application to the European Medicines Agency by Q4 2021.
Rhythm Pharmaceuticals announces an Expanded Access Program (EAP) for setmelanotide, targeting eligible patients in the U.S. with severe obesity and hyperphagia due to Bardet-Biedl Syndrome (BBS). The company plans to submit a supplemental new drug application (sNDA) to the FDA by the end of September 2021. This initiative is part of Rhythm's commitment to address the unmet needs of BBS patients, allowing access to a potential treatment option for those unable to participate in clinical trials.