Welcome to our dedicated page for Rhythm Pharmaceuticals news (Ticker: RYTM), a resource for investors and traders seeking the latest updates and insights on Rhythm Pharmaceuticals stock.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) is a commercial-stage biopharmaceutical company based in Boston, MA, focused on transforming the lives of patients and their families living with rare neuroendocrine diseases. The company's core mission is to develop and commercialize peptide therapeutics for treating gastrointestinal diseases and genetic deficiencies that result in metabolic disorders.
At the heart of Rhythm's portfolio is setmelanotide (IMCIVREE®), an MC4 receptor agonist designed to treat hyperphagia and severe obesity caused by specific genetic conditions. Setmelanotide is already approved by the U.S. Food and Drug Administration (FDA) for chronic weight management in adults and children aged 6 years and older with monogenic or syndromic obesity due to certain genetic deficiencies. The European Commission (EC) and the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) have also authorized setmelanotide for the treatment of obesity and hunger control associated with Bardet-Biedl syndrome (BBS) and other genetic deficiencies.
Rhythm is advancing a broad clinical development program for setmelanotide, including ongoing global Phase 3 trials for hypothalamic obesity. Recent achievements include the addition of a cohort of Japanese patients to this trial, with dosing expected to begin in the third quarter of 2024. The company has enrolled 120 patients in its pivotal Phase 3 trial, aiming to achieve top-line results by the first half of 2025.
In addition to setmelanotide, Rhythm is also advancing investigational MC4R agonists, such as RM-718, which targets hyperphagia and severe obesity without causing hyperpigmentation. The company recently dosed the first patients in a Phase 1 clinical trial for RM-718 and is committed to exploring its potential benefits.
Financially, Rhythm Pharmaceuticals is well-positioned with proceeds from recent financing and existing cash on-hand expected to fund operations into 2026. The company's global reach includes generating revenues from the United States, Germany, and other countries, with the majority coming from the U.S.
For more information, visit Rhythm's Investor Relations page or contact their corporate communications team.
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.
Rhythm Pharmaceuticals announced that the European Commission has granted marketing authorization for IMCIVREE (setmelanotide), the first treatment for rare genetic obesity diseases in the EU. This approval covers patients with genetically confirmed POMC, PCSK1, or LEPR deficiencies aged 6 and older. Phase 3 trials showed significant weight loss—80% of patients with POMC or PCSK1 deficiency achieved over 10% weight loss. IMCIVREE is designed to address severe hunger and obesity by restoring the functioning of the MC4 receptor pathway, aiming to improve patients' quality of life.
Rhythm Pharmaceuticals (Nasdaq: RYTM) has announced an exclusive distribution agreement with Medison Pharma to commercialize its MC4 receptor agonist, IMCIVREE™ (setmelanotide), in Israel. IMCIVREE is FDA-approved for chronic weight management in patients aged 6 and older with obesity due to specific genetic deficiencies, notably POMC, PCSK1, or LEPR. This partnership aims to expand access for patients with rare genetic obesity conditions, leveraging Medison's expertise in navigating the registration and reimbursement landscape.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that its CEO, Dr. David Meeker, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 4, 2021, at 12 noon ET. A live audio webcast will be available on the Company's website under ‘Events & Presentations’. Rhythm is focused on therapies for rare genetic diseases of obesity and has developed IMCIVREE™ (setmelanotide), the first FDA-approved treatment for specific genetic obesity conditions. The company is based in Boston, MA.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) regarding marketing authorization for setmelanotide. This treatment targets severe obesity and insatiable hunger linked to confirmed genetic deficiencies (POMC, PCSK1, LEPR) in adults and children over 6. The final decision by the European Commission is expected in July 2021. Two pivotal trials demonstrated significant weight loss and hunger reduction, highlighting setmelanotide's potential as the first approved treatment in the EU for these conditions.
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