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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, Inc. announces new employment inducement grants for eight new employees, covering 31,220 shares of common stock through stock options and restricted stock units. The grants are subject to the terms of the Inducement Plan adopted by the board of directors.
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Rhythm Pharmaceuticals, Inc. secures $150 million through a preferred stock sale to fund clinical development and commercialization activities.
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Rhythm Pharmaceuticals, Inc. initiates Phase 1 clinical trial for RM-718, a potential treatment for rare neuroendocrine diseases. The drug aims to reduce hyperphagia and obesity without causing hyperpigmentation. The trial will evaluate safety, tolerability, and pharmacokinetics in three parts, targeting both healthy individuals with obesity and patients with hypothalamic obesity.
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Rhythm Pharmaceuticals, Inc. granted inducement equity grants to new employees, covering 13,780 shares of common stock. The grants include stock options and restricted stock units subject to the 2022 Employment Inducement Plan. The options have an exercise price of $41.10 per share and vest over time, while the RSUs vest over four years.
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Rhythm Pharmaceuticals, Inc. (RYTM) will participate in two investor conferences to discuss their progress in rare neuroendocrine diseases. David Meeker, M.D., and Hunter Smith will engage in fireside chats at the Barclays and Needham conferences, respectively, with webcasts available on their website.
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Rhythm Pharmaceuticals plans to add a cohort of Japanese patients to its global Phase 3 trial for hypothalamic obesity treatment, targeting a significant unmet need in Japan with 5,000 to 8,000 patients estimated. Dosing for the Japanese cohort is expected to start in the third quarter of 2024, with the company aiming for potential approval in Japan. The company also completed enrollment in the pivotal 120-patient cohort for its global Phase 3 trial, with top-line study results expected in the first half of 2025.
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Rhythm Pharmaceuticals reported fourth quarter 2023 net revenue of $24.2 million from IMCIVREE sales, completed enrollment in a Phase 3 trial for hypothalamic obesity, acquired global rights to LB54640, and received reimbursement approvals for IMCIVREE in Spain and Italy. The Company also announced Phase 3 development plans for setmelanotide in Japan and the FDA acceptance of an IND application for RM-718. Financially, Rhythm had $275.8 million in cash as of December 31, 2023, with net product revenues of $77.4 million for the full year 2023.
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Rhythm Pharmaceuticals, Inc. (RYTM) granted inducement equity grants covering 20,295 shares of its common stock to six new employees. The grants include stock options and restricted stock units (RSUs) subject to the terms of the 2022 Employment Inducement Plan. The options have an exercise price of $44.88 per share and will vest over four years. The RSUs also vest over four years, subject to continued employment. The Inducement Plan was adopted by the board of directors on February 9, 2022.
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Rhythm Pharmaceuticals, Inc. (RYTM) announced that the Italian Medicine Agency approved reimbursement for IMCIVREE for the treatment of obesity and control of hunger associated with Bardet-Biedl syndrome (BBS). This allows families in Italy affected by this rare neuroendocrine disease to access the first and only treatment option authorized in the European Union. BBS is a rare melanocortin-4 receptor (MC4R) pathway disease with hallmark symptoms of hyperphagia and early-onset, severe obesity. AIFA previously approved reimbursement for IMCIVREE for the treatment of obesity and control of hunger associated with other conditions.
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Rhythm Pharmaceuticals, Inc. (RYTM) will participate in fireside chats at Guggenheim’s 6th Annual Biotechnology Conference on Feb. 7 and TD Cowen 44th Annual Health Care Conference on March 5. The company will also host a live conference call and webcast on Feb. 22 to report its Q4 and full year 2023 financial results and provide a corporate update. David Meeker, M.D., Chair, President, and CEO, will represent the company at the conferences. Live webcasts of the events will be available on the company's website.
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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
Link
United States of America
BOSTON