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 (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.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a public offering of 5,000,000 shares at $30.00 each, aiming to fund its efforts in treating rare genetic obesity diseases. Additionally, underwriters have a 30-day option for 750,000 more shares. The offering, structured under an SEC shelf registration filed in 2018, is set to conclude on February 9, 2021. Morgan Stanley, BofA Securities, Cowen, and Stifel are managing the offering. The company emphasizes that this announcement is not a sales offer and acknowledges potential risks, including market conditions and clinical trial outcomes.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a proposed public offering of $150 million of its common stock, with a potential additional $22.5 million if underwriters exercise their option. The offering is managed by Morgan Stanley, BofA Securities, Cowen, and Stifel, and is subject to market conditions. The shares will be offered under a shelf registration statement filed with the SEC. This move aims to bolster the company's capabilities to develop therapies for rare genetic obesity diseases.
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