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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.
BOSTON, Nov. 7, 2022 - Rhythm Pharmaceuticals (NASDAQ: RYTM) announced the grant of inducement equity awards to two new employees on November 3, 2022. The total of 23,400 shares comprises 15,600 stock options and 7,800 restricted stock units (RSUs). The stock options have an exercise price of $24.32 and vest over four years, while RSUs vest annually over the same period. These equity awards are part of Rhythm’s 2022 Employment Inducement Plan, adopted on February 9, 2022, aimed at attracting talent to support its mission in treating hyperphagia and severe obesity linked to rare MC4R pathway diseases.
Rhythm Pharmaceuticals presented important data at ObesityWeek® 2022, showcasing the efficacy of setmelanotide in treating Bardet-Biedl Syndrome (BBS). Notably, 84% of participants in a Phase 3 trial showed improvements in weight, hunger, or quality of life. The Clinical Registry Investigating Bardet-Biedl Syndrome (CRIBBS) revealed a positive correlation between hyperphagia severity and body mass index (BMI) in affected children. Furthermore, the research indicates that obesity remains prevalent, with many patients experiencing ongoing weight challenges. Rhythm aims to address hunger and weight issues linked to rare MC4R pathway diseases.
Rhythm Pharmaceuticals announced positive results from its Phase 2 trial of setmelanotide for hypothalamic obesity, showing that 89% of participants achieved a BMI reduction of over 5% at 16 weeks. The therapy also demonstrated sustained weight loss in a long-term extension, with a 21.1% average BMI reduction over 29 weeks and 26.7% over 41 weeks for some patients. Additionally, the FDA granted Breakthrough Therapy designation for setmelanotide, and a Phase 3 trial is set to begin in early 2023 to further evaluate its effectiveness.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announces that setmelanotide has received Breakthrough Therapy Designation from the FDA for treating hypothalamic obesity. This designation accelerates the development and review process for medications targeting serious conditions with unmet needs. Setmelanotide demonstrated significant efficacy in a Phase 2 trial, with all 11 patients achieving a BMI decrease of over 5%, averaging a 17.2% reduction. The company plans to initiate a Phase 3 trial in early 2023 to further evaluate this treatment.
Rhythm Pharmaceuticals (Nasdaq: RYTM) is set to present full data from its Phase 2 clinical trial of setmelanotide for hypothalamic obesity during the Obesity Society’s ObesityWeek 2022 on November 2, 2022. The conference call will include results from 18 patients. Additionally, Rhythm will report its Q3 2022 earnings on November 8, 2022, at 8:00 a.m. ET. Setmelanotide, approved for chronic weight management, targets hyperphagia and severe obesity linked to rare MC4R pathway diseases. Rhythm is actively advancing its clinical programs and has submitted a Type II variation application for setmelanotide in the EU.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced the inaugural International Meeting on Pathway-Related Obesity: Vision of Excellence (IMPROVE) 2022 in Berlin, focused on rare pathway-related obesities driven by MC4R variants. At the event, the company presented data from an exploratory Phase 2 Basket Study evaluating setmelanotide in patients with specific MC4R variants. Results showed that 30.4% of patients in the rescuable cohort achieved significant BMI reduction, while the predictive value of the in vitro assay was limited. Setmelanotide is FDA-approved for chronic weight management in certain genetic obesity cases.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the appointment of Dana Washburn, M.D., as Senior Vice President of Clinical Development, effective September 26, 2022. Dr. Washburn will lead the clinical program for setmelanotide, a treatment for hyperphagia and severe obesity linked to rare MC4R pathway diseases. With over 20 years of experience in biopharmaceuticals, he previously held leadership roles at Alexion Pharmaceuticals and other organizations. Rhythm is advancing setmelanotide through multiple clinical trials, supported by recent regulatory approvals in the U.S. and Europe.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced on October 3, 2022, that its Compensation Committee granted inducement equity awards totaling 205,995 shares to 10 new employees. These include stock options for 145,525 shares and restricted stock units (RSUs) for 60,470 shares. Dana Washburn, the new Senior VP of Clinical Development, received additional grants of 67,500 shares. The options have an exercise price of $23.71 per share and will vest over a four-year period based on continued employment.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the release of a children's book, Understanding Hunger & Bardet-Biedl Syndrome (BBS): Gabe’s Story, in collaboration with the Bardet-Biedl Syndrome Foundation. This book aims to assist families in understanding hyperphagia, a condition characterized by constant hunger, prevalent in children with BBS. The launch coincides with the second annual BBS Global Day on September 24, emphasizing the importance of awareness for this rare genetic disease.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the closing of a public offering on September 19, 2022, of 4,800,000 shares at $26.00 per share, raising $124.8 million in gross proceeds. The offering included an option for underwriters to purchase an additional 720,000 shares. Proceeds will fund the global commercialization of IMCIVREE for specific obesity types and support the clinical development of setmelanotide for hypothalamic obesity and various trials. Cowen, Stifel, and Wells Fargo acted as joint book-running managers for this offering.
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