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 (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
Rhythm Pharmaceuticals (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focusing on rare neuroendocrine diseases, has announced two upcoming events. First, the company will host a conference call and webcast on August 6, 2024, at 8:00 a.m. ET to report its second quarter 2024 financial results and provide a corporate update. Participants can register for the call online.
Additionally, David Meeker, M.D., Chair, President and CEO of Rhythm, will participate in a fireside chat at the Canaccord Genuity 44th Annual Growth Conference in Boston on August 13, 2024, at 11:00 a.m. ET. Both events will be webcast live and archived on the company's website for 30 days following the presentations.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced on July 11, 2024, that its Board of Directors' Compensation & Management Development Committee granted inducement restricted stock units (RSUs) covering 19,200 shares to six new employees on July 8, 2024. These RSUs are part of the 2022 Employment Inducement Plan, created exclusively for equity awards to attract new hires in line with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% of shares vesting each year on the anniversary of the hire date, contingent on the employees' continued employment. This move aims to incentivize and retain new talent in the company.
Rhythm Pharmaceuticals has appointed Alastair Garfield, Ph.D., as Chief Scientific Officer, effective July 1, 2024. Dr. Garfield, who has a robust background in appetite and body weight regulation, rejoined Rhythm after his tenure at Rectify Pharma, where he developed first-in-class therapeutics for rare diseases. His leadership will be pivotal as Rhythm continues to develop therapies targeting the MC4R pathway, which plays a important role in managing hyperphagia and severe obesity. Dr. Garfield's previous research has been published in prestigious journals like Nature and Nature Neuroscience.
FAQ
What is the current stock price of Rhythm Pharmaceuticals (RYTM)?
What is the market cap of Rhythm Pharmaceuticals (RYTM)?
What does Rhythm Pharmaceuticals, Inc. specialize in?
What is setmelanotide (IMCIVREE®) used for?
Which regulatory bodies have approved setmelanotide?
What are Rhythm Pharmaceuticals' recent achievements?
Where is Rhythm Pharmaceuticals headquartered?
What is RM-718?
How is Rhythm Pharmaceuticals financially positioned?
In which markets is setmelanotide available?
What are the limitations of using setmelanotide?
What are common adverse reactions to setmelanotide?
