Welcome to our dedicated page for Rhythm Pharmaceu news (Ticker: RYTM), a resource for investors and traders seeking the latest updates and insights on Rhythm Pharmaceu stock.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) is a commercial-stage biopharmaceutical company whose news flow centers on rare neuroendocrine diseases and MC4R pathway–targeted therapies. The company’s updates frequently highlight global commercial performance of its lead product IMCIVREE (setmelanotide), regulatory milestones, and clinical data across multiple rare obesity indications.
Investors following RYTM news can expect regular announcements on net product revenues from global sales of IMCIVREE, including the relative contributions from the United States and international markets. Rhythm also issues press releases on reimbursement developments, such as public reimbursement agreements for IMCIVREE in Canadian provinces and under federal programs for patients with Bardet-Biedl syndrome–related obesity.
Clinical and regulatory news is a major focus. Rhythm reports on Phase 3 trials like TRANSCEND in acquired hypothalamic obesity and EMANATE in genetically caused MC4R pathway diseases, as well as exploratory and Phase 2 studies in Prader-Willi syndrome and other rare conditions. Updates often include topline efficacy and safety data, cardiometabolic outcomes, and patient- and caregiver‑reported measures presented at scientific meetings.
Regulatory communications include FDA actions on supplemental New Drug Applications, PDUFA goal dates and extensions, and EMA validation of Type II variations to existing marketing authorizations. Rhythm also provides information on development of investigational MC4R agonists bivamelagon and RM-718 and preclinical small molecules for congenital hyperinsulinism.
For users tracking RYTM, this news feed offers a centralized view of earnings releases, clinical trial readouts, regulatory decisions and access milestones related to IMCIVREE and Rhythm’s broader rare disease pipeline.
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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.