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Rhythm Pharmaceuticals, Inc. develops and commercializes therapies for rare neuroendocrine diseases, centered on IMCIVREE (setmelanotide), an MC4R agonist for hyperphagia and severe obesity linked to rare MC4R pathway disorders. Company updates commonly cover U.S. and international commercialization of setmelanotide, regulatory authorizations and label expansions for acquired hypothalamic obesity, Bardet-Biedl syndrome, POMC/PCSK1 deficiency and LEPR deficiency, and safety information tied to approved uses.
Rhythm news also follows clinical data from setmelanotide studies, including acquired hypothalamic obesity and genetically caused MC4R pathway diseases, along with development of investigational MC4R agonists bivamelagon and RM-718 and preclinical small molecules for congenital hyperinsulinism. Recurring corporate items include financial results, specialty-pharmacy access arrangements, healthcare conference presentations and board governance changes.
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.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced participation of David Meeker, M.D., CEO, in the Cowen & Co. 41st Annual Health Care Conference on March 3, 2021. He will partake in a fireside chat at 2:40 p.m. ET and a panel discussion on "New Drug Launches" at 10:20 a.m. ET. A live audio webcast will be accessible on the company's Investor Relations website, with a replay available for 30 days. Rhythm focuses on therapies for rare genetic diseases of obesity and has FDA-approved IMCIVREE™ for chronic weight management in specific genetic conditions.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the closing of its public offering of 5,750,000 common shares at $30.00 each on February 9, 2021, raising approximately $172.5 million in gross proceeds. This included the full exercise of a 750,000-share underwriter option. The offering was facilitated by Morgan Stanley, BofA Securities, Cowen, and Stifel as joint managers and was conducted under a previously filed shelf registration. Rhythm focuses on therapies for rare genetic obesity diseases and has FDA-approved treatment IMCIVREE for specific genetic deficiencies.