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 (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, 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.
