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 has announced the launch of IMCIVREE (setmelanotide) in Germany for treating obesity and controlling hunger associated with Bardet-Biedl syndrome (BBS). The German Federal Joint Committee (G-BA) has approved IMCIVREE for federal reimbursement by Statutory Health Insurances, recognizing its necessity for patients suffering from severe obesity and hyperphagia linked to this rare genetic disorder. With an estimated 1,200 patients in Germany, this launch marks an important milestone, positioning IMCIVREE as the first and only therapy approved for BBS in the country. The therapy is already available in nine global markets, including the U.S., and further launches are planned in the Netherlands, Italy, Spain, and the UK. This response to a pressing medical need underscores the clinical significance of addressing rare melanocortin-4 receptor pathway diseases.
Rhythm Pharmaceuticals (RYTM) announced it will host a live conference call and webcast on May 2, 2023, at 8:00 a.m. ET, to report its Q1 2023 financial results and provide a corporate update.
David Meeker, M.D., CEO, will also participate in a fireside chat at the BofA Securities 2023 Healthcare Conference on May 9, 2023. The live webcasts can be accessed via the Investor Relations section of the Rhythm Pharmaceuticals website, with archives available for 30 days after the events.
Rhythm focuses on patients affected by severe obesity and hyperphagia due to MC4R pathway diseases, with its lead product, setmelanotide, approved for chronic weight management in certain pediatric and adult patients.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company, announced that CEO Dr. David Meeker will participate in a fireside chat at the 22nd Annual Needham Virtual Healthcare Conference on April 17, 2023, at 3:00 p.m. ET. The presentation will be accessible via a live audio webcast on the company's Investor Relations webpage, with a replay available for 30 days afterward.
Rhythm focuses on patients with hyperphagia and severe obesity linked to rare melanocortin-4 receptor (MC4R) diseases. Their leading product, IMCIVREE (setmelanotide), is FDA-approved for treating obesity caused by specific genetic deficiencies and is also authorized in the EU and UK for related conditions. The company actively pursues further development for additional MC4R pathway diseases.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced on April 4, 2023, that its Compensation Committee granted inducement equity grants totaling 21,870 shares of common stock to three new employees. This includes inducement stock options for 14,580 shares and restricted stock units (RSUs) for 7,290 shares, all governed by the 2022 Employment Inducement Plan. The options have an exercise price of $17.97 per share and vest over four years, while the RSUs also vest over four years. The Inducement Plan was adopted on February 9, 2022, to attract key talent to the company, focusing on therapies for hyperphagia and severe obesity linked to rare MC4R diseases. Rhythm’s lead product, IMCIVREE (setmelanotide), is FDA-approved for chronic weight management in specific genetic obesity cases, with regulatory authorizations in the EU and UK as well.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced significant findings from an interview-based study published in Advances in Therapy, highlighting how setmelanotide improved hyperphagia, reduced body weight, and lessened obsessive food focus in patients with Bardet-Biedl syndrome (BBS). The study included insights from 19 interviews, revealing 78.9% of participants reported lacking control over eating before treatment. Post-treatment, all noted improvements in hyperphagia and family dynamics. Additionally, a study on hyperphagia's impact on quality of life was released, showing its effects comparable to severe conditions like stroke. Rhythm aims to enhance lives through innovation in treating rare MC4R pathway diseases.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced equity grants of 34,215 shares to three new employees on March 1, 2023. This includes 22,810 stock options and 11,405 restricted stock units (RSUs), in line with its 2022 Employment Inducement Plan. The stock options have an exercise price of $25.85, with a vesting schedule that completes over four years. The RSUs will vest similarly over four years. Rhythm is focused on treating hyperphagia and severe obesity linked to rare MC4R pathway diseases, with its primary product, IMCIVREE (setmelanotide), already FDA-approved for chronic weight management in targeted patient populations.
Rhythm Pharmaceuticals reported a strong performance in 2022, highlighted by over 200 new prescriptions for IMCIVREE for Bardet-Biedl syndrome since FDA approval. The company launched IMCIVREE in eight international markets and initiated a Phase 3 trial for setmelanotide in acquired hypothalamic obesity. Rhythm's acquisition of Xinvento B.V. expands its pipeline to include congenital hyperinsulinism. Financially, the company recorded $8.8 million in product revenue for Q4 2022 and $16.9 million for the full year, a significant increase from 2021. However, net loss was $42.5 million for Q4 and $181.1 million for the year. Rhythm anticipates 2023 operating expenses of $200-$220 million.
Rhythm Pharmaceuticals (NASDAQ: RYTM) announced the acquisition of Xinvento B.V., a biotech firm focused on congenital hyperinsulinism (CHI), a rare genetic disease characterized by excessive insulin secretion. This acquisition, valued at up to $61 million including milestone payments, aligns with Rhythm's strategy in rare endocrinology and allows for new development opportunities. Clinical development for CHI is expected to begin in 2024. The acquisition includes Xinvento's team, enhancing Rhythm's expertise in CHI therapies.
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