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Rhythm Pharmaceuticals, Inc. - RYTM STOCK NEWS

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.

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Rhythm Pharmaceuticals (Nasdaq: RYTM) announced it will hold a live conference call on March 1, 2023, at 8:00 a.m. ET to disclose its fourth quarter and full-year 2022 financial results and provide a corporate update. This call will be accessible via registration. Additionally, CEO David Meeker will participate in the Cowen 43rd Annual Health Care Conference on March 6, 2023. Rhythm focuses on treating hyperphagia and severe obesity linked to rare melanocortin-4 receptor pathway diseases through its FDA-approved drug, setmelanotide, which is also authorized in Europe for similar conditions.

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Rhythm Pharmaceuticals (Nasdaq: RYTM) announced on February 2, 2023, that its board's Compensation Committee granted equity awards to five new employees. The inducement equity grants cover 24,525 shares, including stock options for 16,350 shares at an exercise price of $28.90, and restricted stock units (RSUs) for 8,175 shares. The stock options vest 25% after the first year, with the remaining shares vesting quarterly over three years, while the RSUs vest 25% each year for four years. These grants are part of the Inducement Plan adopted on February 9, 2022, designed to attract talent as per Nasdaq regulations.

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Rhythm Pharmaceuticals announced significant improvements in quality of life for patients with Bardet-Biedl syndrome (BBS) following a 52-week treatment with setmelanotide, as published in the Orphanet Journal of Rare Diseases. The global Phase 3 clinical trial reported an average increase of +11.2 points on the Pediatric Quality of Life Inventory (PedsQL) for younger patients and +12.0 points on the Impact of Weight on Quality of Life Questionnaire-Lite (IWQOL-Lite) for adults. Setmelanotide is designed to target the MC4R pathway impairment and is FDA-approved for chronic weight management in patients with genetically confirmed BBS.

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Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the granting of equity awards to three new employees, totaling 29,925 shares. The awards consist of inducement stock options for 19,950 shares and restricted stock units (RSUs) for 9,975 shares, as part of the 2022 Employment Inducement Plan. The stock options have an exercise price of $28.32 and vest over four years, with RSUs vesting annually. This move aligns with Nasdaq Listing Rule 5635(c)(4) and aims to attract talented individuals to support the company's focus on treatments for hyperphagia and severe obesity linked to rare genetic disorders.

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BOSTON, Dec. 1, 2022 - Rhythm Pharmaceuticals (Nasdaq: RYTM) announced CEO David Meeker will participate in a fireside chat at the BofA Securities 2022 Virtual Biotech SMID Cap Conference on December 8, 2022, at 9:40 a.m. ET. The live audio webcast will be accessible on the Investor Relations section of their website, with a replay available for 30 days post-event. Rhythm focuses on treating severe obesity from rare melanocortin-4 receptor pathway diseases with its FDA-approved medication setmelanotide, which targets specific genetic obesity conditions.

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Rhythm Pharmaceuticals (Nasdaq: RYTM) announced significant advancements in its Phase 3 clinical trial of IMCIVREE (setmelanotide) for Bardet-Biedl syndrome (BBS), with results published in The Lancet Diabetes and Endocrinology. The trial met its primary and all key secondary endpoints, achieving substantial weight and hunger reductions after one year. Approximately 32.3% of patients aged 12 and older met the primary endpoint. Setmelanotide is now approved as the first therapy for chronic weight management in patients with BBS in the U.S. and EU, addressing a critical need for this rare genetic condition.

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Rhythm Pharmaceuticals (RYTM) reported strong demand for IMCIVREE® (setmelanotide), with over 120 prescriptions since FDA approval for Bardet-Biedl Syndrome (BBS). The company successfully completed a $140 million public offering, extending its cash runway into 2025. Setmelanotide received FDA Breakthrough Therapy Designation for hypothalamic obesity, with a Phase 3 trial expected to begin early 2023. Revenue for Q3 2022 reached $4.3 million, up from $1.0 million in Q3 2021, while net loss was $40.9 million, compared to $35.1 million in the prior year.

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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.

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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.

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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.

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FAQ

What is the current stock price of Rhythm Pharmaceuticals (RYTM)?

The current stock price of Rhythm Pharmaceuticals (RYTM) is $56.12 as of December 20, 2024.

What is the market cap of Rhythm Pharmaceuticals (RYTM)?

The market cap of Rhythm Pharmaceuticals (RYTM) is approximately 3.5B.

What does Rhythm Pharmaceuticals, Inc. specialize in?

Rhythm Pharmaceuticals specializes in developing and commercializing therapies for rare neuroendocrine diseases, focusing on peptide therapeutics for gastrointestinal and metabolic disorders.

What is setmelanotide (IMCIVREE®) used for?

Setmelanotide (IMCIVREE®) is used for chronic weight management in adults and children aged 6 years and older with monogenic or syndromic obesity due to genetic deficiencies.

Which regulatory bodies have approved setmelanotide?

Setmelanotide is approved by the U.S. FDA, the European Commission (EC), and the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) for treating obesity and hunger control associated with specific genetic conditions.

What are Rhythm Pharmaceuticals' recent achievements?

Recent achievements include adding a cohort of Japanese patients to their global Phase 3 trial for hypothalamic obesity and initiating a Phase 1 trial for RM-718.

Where is Rhythm Pharmaceuticals headquartered?

Rhythm Pharmaceuticals is headquartered at 855 Boylston Street, 11th Floor, Boston, MA, United States.

What is RM-718?

RM-718 is an investigational MC4R-specific agonist designed to reduce hyperphagia and severe obesity without causing hyperpigmentation. It is currently in Phase 1 clinical trials.

How is Rhythm Pharmaceuticals financially positioned?

Rhythm Pharmaceuticals has secured sufficient funding from recent financing and existing cash on-hand to support planned operations into 2026.

In which markets is setmelanotide available?

Setmelanotide is available in 14 markets, including the United States, and also generates revenue from Germany and other countries.

What are the limitations of using setmelanotide?

Setmelanotide is not indicated for patients with certain conditions and has specific contraindications, including serious hypersensitivity reactions.

What are common adverse reactions to setmelanotide?

Common adverse reactions include skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, and depression.

Rhythm Pharmaceuticals, Inc.

Nasdaq:RYTM

RYTM Rankings

RYTM Stock Data

3.54B
54.69M
0.53%
115.89%
10.92%
Biotechnology
Pharmaceutical Preparations
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United States of America
BOSTON