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 (RYTM) announced promising interim results from a Phase 2 trial of setmelanotide, focusing on treating severe obesity and hyperphagia in hypothalamic obesity patients. Positive outcomes include a mean BMI reduction of 17.2% and a weight decrease of 15.8% after 16 weeks. Notably, all evaluable patients experienced over a 5% BMI decrease. The company plans to advance to Phase 3 development. Setmelanotide was well-tolerated, with common side effects including nausea and vomiting. The results suggest potential transformation in treatment for this rare condition.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced on July 6, 2022, the grant of equity awards as inducement to six new employees, totaling 33,135 shares. This includes inducement stock options for 22,085 shares at an exercise price of $4.74 per share, and RSUs for 11,050 shares, vesting over four years. The grants adhere to the company's 2022 Employment Inducement Plan and comply with Nasdaq rules. Rhythm is focused on treating obesity linked to genetic disorders through its FDA-approved product, IMCIVREE (setmelanotide), which targets the melanocortin-4 receptor pathway.
Rhythm Pharmaceuticals announced that IMCIVREE (setmelanotide) is now available for patients in Germany. This precision medicine targets obesity linked to rare genetic disorders such as POMC and LEPR deficiencies. The European Commission previously granted marketing authorization for IMCIVREE, making it eligible for national coverage and reimbursement following a decision by the German Federal Joint Committee. Rhythm is committed to improving care for patients with these conditions through ongoing clinical research and regulatory submissions.
BOSTON, June 22, 2022 - Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the European Commission's authorization for a dosing variation of IMCIVREE® (setmelanotide) in patients with POMC or LEPR deficiency experiencing mild to severe renal impairment. This authorization allows treatment for patients 6 years and older, with no dose adjustments required for mild or moderate renal impairment. Additionally, Rhythm's Type II application for setmelanotide for Bardet-Biedl syndrome is under review, with a recommendation expected in Q3 2022.
Rhythm Pharmaceuticals has secured a $100 million Revenue Interest Financing Agreement with HealthCare Royalty Partners to enhance its commercialization efforts for IMCIVREE (setmelanotide). The initial investment of $37.5 million follows FDA approval for IMCIVREE for treating obesity linked to Bardet-Biedl syndrome (BBS). Another $37.5 million is expected post-European marketing authorization, with a final $25 million contingent on sales milestones in 2023. This funding will extend Rhythm's cash runway into 2H 2024.
Rhythm Pharmaceuticals announced the FDA approval of IMCIVREE for chronic weight management in patients 6 years and older with monogenic or syndromic obesity linked to Bardet-Biedl syndrome (BBS). This marks the first FDA-approved therapy targeting the MC4R pathway, addressing severe obesity and hyperphagia. The approval is based on successful Phase 3 trial data showing significant weight and hunger reduction. The company also launched the Rhythm InTune program for patient support. However, a complete response letter was issued for the sNDA regarding Alström syndrome.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced positive long-term results from its extension trial showing sustained weight loss in patients with Bardet-Biedl syndrome (BBS) and POMC or LEPR deficiency obesity after 18 to 36 months of setmelanotide therapy. Data reveal a mean BMI reduction of 9.5% and 14.3% at 18 and 24 months for BBS patients. Among patients with POMC or LEPR deficiency, BMI decreased by 16.7% and 17.5% after 24 and 36 months. Setmelanotide was well-tolerated, supporting its use as a chronic treatment. A PDUFA goal date for BBS is set for June 16, 2022.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) reported positive results from its long-term extension trial of setmelanotide, demonstrating sustained reductions in body mass index (BMI) among patients with specific genetic obesity disorders such as SH2B1 and SRC1 deficiencies, as well as POMC and LEPR insufficiencies. Initial findings indicated mean BMI changes of -3.4% to -9.7% over 12 months. The ongoing Phase 3 EMANATE trial aims to further evaluate the efficacy of setmelanotide, targeting patients with impaired signaling in the melanocortin-4 receptor pathway. No significant safety concerns were raised.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the grant of inducement equity awards on June 1, 2022, covering 27,100 shares to three new employees. The inducement includes stock options for 18,065 shares at an exercise price of $3.37 each and RSUs for 9,035 shares, according to the 2022 Employment Inducement Plan. Stock options vest progressively over four years, while RSUs vest annually. Rhythm is focused on treating obesity linked to rare genetic diseases and has launched the FDA-approved drug IMCIVREE, with ongoing developments and regulatory submissions for expanded indications.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced equity grants for 10 new employees on May 3, 2022, totaling 50,730 shares. This includes 16,915 stock options and 33,815 restricted stock units (RSUs). The stock options have an exercise price of $6.13 per share, vesting over four years, while RSUs vest over four years as well. The Inducement Plan was established to attract new talent and complies with Nasdaq rules. Rhythm's precision medicine, IMCIVREE, is FDA-approved for treating certain genetic obesity conditions.
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