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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.

Rhea-AI Summary
Rhythm Pharmaceuticals, Inc. granted inducement equity grants to four new employees, consisting of inducement stock options and inducement restricted stock units. The grants cover an aggregate of 13,020 shares of its common stock. The stock options have an exercise price of $42.52 per share and will vest over a three-year period. The RSUs will vest over four years. These grants are subject to the terms of the Inducement Plan adopted by Rhythm's board of directors on February 9, 2022.
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Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) has entered into a global licensing agreement with LG Chem, Ltd. for LB54640, an investigational oral small molecule melanocortin-4 receptor (MC4R) agonist now in Phase 2 clinical trials. The Phase 1 trial in healthy overweight adults demonstrated dose-dependent weight reduction and a favorable safety profile. LB54640 has received orphan drug designation from the U.S. Food and Drug Administration for leptin receptor (LEPR) deficiency and proopiomelanocortin(POMC). Rhythm will sponsor two Phase 2 studies to evaluate weight loss efficacy, safety, tolerability, and pharmacokinetics of LB54640.
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Rhythm Pharmaceuticals, a global commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, provided a business update. The company completed screening for enrollment in a pivotal, Phase 3 clinical trial evaluating setmelanotide in patients with acquired hypothalamic obesity. Rhythm anticipates overenrolling the trial with over 140 patients consented. The top-line study results are expected in H1 2025. Positive reimbursement decisions were achieved in Spain for IMCIVREE to treat patients with Bardet-Biedl syndrome and POMC/LEPR deficiencies. Additionally, the FDA accepted the IND application for RM-718, a new, weekly treatment designed to be more targeted and potent than setmelanotide.
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Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced the grant of inducement equity grants to a new employee, consisting of stock options and restricted stock units. The options have an exercise price of $38.00 per share and will vest over a period of three years, while the RSUs will vest over four years.
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Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) sponsors the second annual International Meeting on Pathway-Related Obesity: Vision & Evidence (IMPROVE) in Paris, France. The event will highlight new scientific developments for rare MC4R pathway diseases, with over 50 poster presentations and approximately 150 healthcare professionals from 20 countries expected to attend.
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Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced positive results from its Phase 3 trial evaluating setmelanotide in pediatric patients ages 2-<6yo. The trial achieved the primary endpoint with a 3.04 mean reduction in BMI-Z score and an 18.4 percent mean reduction in BMI in patients with obesity due to POMC/LEPR deficiency or BBS. RM-718 also showed potential to reduce body weight and hyperphagia with no off-target cardiovascular effects. Responder rates of 25 to 56 percent were demonstrated in six genetic cohorts of Phase 2 DAYBREAK trial of setmelanotide.
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Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced the grant of inducement equity grants to two new employees through inducement stock options and restricted stock units, subject to the terms of the Inducement Plan. The stock options have an exercise price of $27.42 per share and will vest over a period of three years, while the RSUs will vest over four years.
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Rhythm Pharmaceuticals, Inc. reported a net revenue of $22.5 million from global sales of IMCIVREE in Q3 2023, with over 100 international patients on reimbursed IMCIVREE therapy. They also achieved a 25.5% mean BMI reduction in patients with hypothalamic obesity on setmelanotide therapy. The company has a cash on-hand of $299.3 million and plans to provide an R&D update on December 6.
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Rhythm Pharmaceuticals announced that CADTH has recommended reimbursement for weight management in patients with obesity due to Bardet-Biedl syndrome (BBS). The recommendation is based on the positive results from Rhythm's Phase 3 trial, which showed a reduction in weight-related parameters. BBS is a rare genetic disease with an estimated prevalence of 1 in 100,000 to 160,000 in North America and Europe.
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Rhythm Pharmaceuticals will host a live conference call to report its Q3 2023 financial results and provide a corporate update. The CEO will also participate in a fireside chat at the Stifel Healthcare Conference.
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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