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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.
Rhythm Pharmaceuticals (RYTM) presented five new data sets at ObesityWeek® 2024, showcasing positive results for setmelanotide therapy across multiple studies. Real-world data showed a mean BMI decrease of 12.8% in adult patients with acquired hypothalamic obesity after three months, extending to 21.3% at six months. The Phase 2 DAYBREAK trial demonstrated a 12.4% mean BMI reduction in patients with rare MC4R pathway diseases after 40 weeks. Notable results included a 23.8% BMI reduction in pediatric patients aged 2-6 years with BBS or POMC/LEPR Deficiency at 18 months. Analysis of 43,000 genetic samples revealed associations between genetic variants and early-onset obesity.
Rhythm Pharmaceuticals (RYTM) and Axovia Therapeutics announced a joint research collaboration to advance the understanding of Bardet-Biedl syndrome (BBS). The partnership combines Rhythm's expertise in melanocortin-4 receptor pathway research and their commercially available drug for treating hyperphagia and severe obesity in BBS patients with Axovia's focus on gene therapy addressing loss of sight and obesity in BBS patients. The collaboration aims to pool knowledge from their respective screening efforts to improve patient care.
Rhythm Pharmaceuticals, a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, has announced new employment inducement grants. On October 4, 2024, the company's Compensation & Management Development Committee granted inducement restricted stock units (RSUs) covering 30,050 shares of common stock to nine new employees.
These RSUs are subject to the Rhythm Pharmaceuticals 2022 Employment Inducement Plan, which is used exclusively for granting equity awards to new employees as per Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% of the shares vesting on each anniversary of the hire date, contingent on continued employment.
Rhythm Pharmaceuticals (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, has announced new employment inducement grants. On September 11, 2024, the company's Compensation & Management Development Committee granted inducement restricted stock units (RSUs) covering 15,450 shares of common stock to four new employees.
These RSUs are subject to the terms of Rhythm's 2022 Employment Inducement Plan, adopted on February 9, 2022, and used exclusively for equity awards to new employees as per Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% of the shares vesting annually on the hire date anniversary, contingent on continued employment.
Rhythm Pharmaceuticals announced that the FDA has accepted their supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) with Priority Review. The sNDA aims to expand the label to treat obesity due to Bardet-Biedl syndrome (BBS) or POMC/LEPR deficiency in children as young as 2 years old. The FDA set a PDUFA goal date of December 26, 2024.
The sNDA is based on data from a Phase 3 trial in patients aged 2 to 6 years. Results showed a 3.04 mean reduction in BMI-Z score and 18.4% mean reduction in BMI. In July 2024, the European Commission expanded IMCIVREE's marketing authorization for children as young as 2 years old with these conditions.
Rhythm Pharmaceuticals (Nasdaq: RYTM), a commercial-stage biopharmaceutical company specializing in rare neuroendocrine diseases, has announced its participation in the upcoming Wells Fargo Healthcare Conference. The event will take place at Encore Boston Harbor on Thursday, September 5, 2024.
Dr. David Meeker, Chair, President and CEO of Rhythm Pharmaceuticals, will engage in a fireside chat at 3:45 p.m. ET. Investors and interested parties can access a live webcast of the presentation through the company's website at www.rhythmtx.com under the 'Events & Presentations' section of the Investor Relations page. A replay of the webcast will be available for 30 days following the presentation.
Rhythm Pharmaceuticals (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, has announced new employment inducement grants. On August 8, 2024, the company's Compensation & Management Development Committee granted inducement restricted stock units (RSUs) covering 16,200 shares of common stock to five new employees. These RSUs are part of the Rhythm Pharmaceuticals 2022 Employment Inducement Plan, adopted on February 9, 2022, and are used exclusively for equity awards to new hires as per Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% vesting on each employment anniversary, contingent on continued employment.
Rhythm Pharmaceuticals reported Q2 2024 financial results and business updates. Key highlights include:
- Net revenue from global IMCIVREE sales: $29.1 million
- Dosed first patients in Japanese cohort of Phase 3 trial for setmelanotide in hypothalamic obesity
- Completed sNDA submission to expand IMCIVREE label for pediatric patients as young as 2 years old
- Cash on-hand expected to support operations into 2026
- Approximately 100 new U.S. prescriptions for IMCIVREE in BBS; payor approval for ~70 prescriptions
- European Commission expanded IMCIVREE marketing authorization for children as young as 2 years old
- Dosed first patients in Phase 2 trial of oral MC4R agonist LB54640 in hypothalamic obesity
- Financial results: R&D expenses $30.2M, S,G&A expenses $36.4M, net loss $33.6M
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that the European Commission has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include children between 2 and 6 years old with obesity due to Bardet Biedl syndrome (BBS) or POMC, PCSK1, or LEPR deficiency. This expansion makes IMCIVREE the first-ever authorized precision medicine in the European Union for control of hunger and treatment of obesity in adults and children as young as 2 years old with these rare genetic conditions. The company believes this is an important milestone for European patients, offering an opportunity to address severe hunger and early-onset obesity associated with these conditions at a young age.
Rhythm Pharmaceuticals (Nasdaq: RYTM) has initiated dosing in a Phase 2 clinical trial for LB54640, an oral melanocortin-4 receptor (MC4R) agonist, targeting hypothalamic obesity. The study aims to evaluate the drug's safety and efficacy in patients aged 12 and older. Key points:
- LB54640 showed promising results in preclinical work and Phase 1 trials
- The drug potentially offers targeted MC4R effects without hyperpigmentation
- The Phase 2 trial involves 28 patients over 14 weeks, with possible extension to 52 weeks
- Primary endpoint: change in body mass index after 14 weeks
- Rhythm acquired global licensing for LB54640 from LG Chem in January 2024
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