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.
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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.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that David Meeker, M.D., will participate in a fireside chat at the BofA Securities 2021 Virtual Health Care Conference on May 12, 2021, at 4:15 p.m. ET. A live audio webcast will be available on the company's investor relations website, with a replay accessible for 30 days following the event.
Rhythm focuses on treating rare genetic diseases of obesity and has FDA-approved IMCIVREE™ (setmelanotide) for chronic weight management in patients aged six and older with specific genetic deficiencies.
Rhythm Pharmaceuticals reported promising developments in Q1 2021, including the first U.S. commercial sales of IMCIVREE™ (setmelanotide), which occurred late in March. The company showcased significant weight loss results in clinical trials for individuals with rare genetic obesity disorders. Financially, Rhythm raised $172.5 million through a public offering and generated $35,000 in product revenues. The net income for the quarter was $43.8 million, reversing a loss from the previous year. The cash position improved to $404.8 million, providing ample funding to sustain operations into 2023.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that David Meeker, M.D., will participate in a fireside chat at the 20th Annual Needham & Co. Virtual Healthcare Conference on April 14, 2021, at 11:45 a.m. ET. A live audio webcast will be accessible on the company’s website, with a replay available for 30 days after the event.
The company focuses on therapies for rare genetic diseases of obesity, featuring its FDA-approved precision medicine, IMCIVREE™ (setmelanotide), for chronic weight management in eligible patients.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced notable results from Phase 2 and Phase 3 studies of setmelanotide, presented at ENDO 2021. Heterozygous (HET) obesity patients achieved a mean weight loss of 12.3% at nine months. Phase 3 data showed significant weight and hunger reduction in patients with Bardet-Biedl and Alström syndromes. Overall, the safety profile was consistent with prior findings, including common adverse events like skin hyperpigmentation and nausea. These results reinforce setmelanotide's potential in treating rare genetic obesity disorders.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced three late-breaking abstracts accepted for presentation at the ENDO 2021 Annual Meeting, occurring virtually from March 20-23. Dr. Sadaf Farooqi will present clinical data from a Phase 2 study of setmelanotide for heterozygous obesity linked to POMC, PCSK1, or LEPR gene variants. Additional presentations will cover data from a Phase 3 trial in patients with Bardet-Biedl Syndrome and safety analyses from two Phase 3 trials. Rhythm continues to advance therapies for rare genetic obesity disorders.
Rhythm Pharmaceuticals (RYTM) has received FDA approval for IMCIVREE, the first treatment for chronic weight management in patients with obesity due to POMC, PCSK1, or LEPR deficiencies. The company reported positive topline data from a Phase 3 trial for Bardet-Biedl syndrome and is advancing a broad development program for setmelanotide, with multiple clinical studies slated for 2021. Financially, Rhythm has strengthened its position with $98.5M from a Rare Pediatric Disease PRV sale and $161.6M from a public offering, extending its cash runway through at least mid-2023.