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 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.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the promotion of Linda Shapiro Manning, M.D., Ph.D., to Chief Medical Officer effective September 10, 2021. She succeeds Murray Stewart, M.D., who will become Senior Medical Advisor. This transition comes as the company prepares for pivotal clinical trials, including the EMANATE Phase 3 trial and DAYBREAK Phase 2 trial of setmelanotide. Dr. Shapiro brings over 20 years of experience in obesity medicine and has previously led clinical development at several major biopharmaceutical companies.
BOSTON, Sept. 2, 2021 – Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that David Meeker, M.D., will participate in a fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 9, 2021, at 8:45 a.m. ET. A live webcast will be available on the company’s website, with a replay for 30 days post-event. Rhythm focuses on therapies for rare genetic obesity diseases, with its precision medicine IMCIVREE® (setmelanotide) approved by the FDA in November 2020 and by the European Commission in July 2021. The company is advancing research in this field.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the acceptance of seven abstracts for presentation at the 59th Annual European Society for Paediatric Endocrinology (ESPE) Meeting, taking place virtually from September 22-26, 2021. The abstracts will showcase data from various clinical trials evaluating setmelanotide for rare genetic obesity disorders, including pivotal results from a Phase 3 trial in Bardet-Biedl Syndrome and a Phase 2 trial on SRC1 variants. Notable presentations will occur on September 22, focusing on obesity-related genetic deficiencies and management strategies.
Rhythm Pharmaceuticals, focused on therapies for rare genetic obesity diseases, announced David Meeker, M.D., will speak at the Canaccord Genuity 41st Annual Growth Conference on August 12, 2021, at 8 a.m. ET. A live audio webcast will be accessible on their website.
The company's drug IMCIVREE (setmelanotide), approved by the FDA and European Commission, targets obesity linked to specific genetic deficiencies. The ongoing development program leverages a vast obesity DNA database to enhance understanding and treatment.
Rhythm Pharmaceuticals (RYTM) received European Commission approval for IMCIVREE, aiding obesity treatment linked to genetic deficiencies. The company plans to submit supplemental applications to the FDA and EMA for setmelanotide targeting Bardet-Biedl and Alström syndromes in H2 2021. Additionally, five new Phase 2 and Phase 3 trials are set to initiate. Financially, RYTM reported Q2 2021 revenues of $0.3 million with a net loss of $35.4 million. Cash reserves stood at $368.2 million as of June 30, 2021, sufficient to support operations through at least H2 2023.
Rhythm Pharmaceuticals (RYTM) announces a significant expansion in its clinical development program for setmelanotide with five new trials. The pivotal Phase 3 EMANATE trial targets patients with specific genetic deficiencies related to obesity, expecting to enroll around 110 patients per sub-study. The company also plans to conduct a Phase 2 DAYBREAK trial and additional studies for pediatric patients and a new weekly formulation. Approximately 100,000-200,000 patients in the U.S. could benefit. All trials are expected to begin in the second half of 2021.
Rhythm Pharmaceuticals has appointed Pamela Cramer as Chief Human Resources Officer and Linda Shapiro Manning, M.D., Ph.D. as Senior Vice President, Clinical, as of July 26 and earlier in July, respectively. Cramer brings 20 years of experience in HR from notable companies, while Shapiro has over 20 years in obesity medicine, including leadership roles in clinical development. These appointments come as the company seeks to expand the reach of its first FDA-approved therapy, IMCIVREE (setmelanotide), aimed at treating rare genetic obesity disorders.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a research agreement with CRIBBS to study the natural history of weight gain and quality of life in patients with Bardet-Biedl syndrome (BBS). This study aims to analyze health outcomes related to severe obesity and hyperphagia, involving over 600 patients. Rhythm estimates that BBS affects approximately 1,500 to 2,500 individuals in the U.S. The collaboration seeks to improve care and develop tailored treatment solutions for affected individuals.
Rhythm Pharmaceuticals (RYTM) will hold a live conference call on August 3, 2021, at 8:00 a.m. ET to discuss its Q2 2021 financial results and provide a corporate update. The company focuses on therapies for rare genetic obesity diseases and has launched IMCIVREE (setmelanotide), the first FDA-approved treatment for specific genetic obesity conditions. The drug received EU approval in July 2021. Rhythm's proprietary database includes approximately 37,500 genetic samples to advance understanding of obesity genetics.