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, Inc. (Nasdaq: RYTM) announced the grant of inducement equity covering 84,800 shares of its common stock to 15 new employees on September 2, 2022. The grants include stock options for 56,520 shares at an exercise price of $25.20 and restricted stock units (RSUs) for 28,280 shares, aimed at incentivizing new hires under the 2022 Employment Inducement Plan. Options vest 25% after one year, with the remainder vesting quarterly, while RSUs vest 25% annually over four years. This plan aligns with Nasdaq Listing Rule 5635(c)(4).
Rhythm Pharmaceuticals announced that setmelanotide has received marketing authorization from the European Commission for treating obesity and hunger control in patients with Bardet-Biedl syndrome (BBS). This approval makes Rhythm eligible for a $37.5 million tranche under its agreement with HealthCare Royalty Partners. Additionally, Health Canada has granted Priority Review for setmelanotide to treat obesity related to BBS and other genetic deficiencies, shortening the review time to 180 days.
Rhythm Pharmaceuticals (NASDAQ: RYTM) announced its participation in three upcoming investor conferences in September 2022. David Meeker, CEO, will present at the Wells Fargo Healthcare Conference on September 8, followed by the Morgan Stanley 20th Annual Global Healthcare Conference on September 12. Hunter Smith, CFO, will present at the Ladenburg Thalmann Healthcare Conference on September 29. The live webcasts will be available on the company’s website for 30 days post-event. Rhythm focuses on treatments for hyperphagia and severe obesity linked to rare genetic conditions.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced inducement equity grants for three new employees on August 2, 2022. The grants total 63,035 shares, including stock options for 38,690 shares and 24,345 restricted stock units (RSUs), under the 2022 Employment Inducement Plan. The stock options have an exercise price of $14.17 and vest over four years, while RSUs vest 25% annually. Rhythm focuses on treating severe obesity linked to rare genetic disorders with its FDA-approved therapy, IMCIVREE (setmelanotide), which shows promising clinical advancements.
BOSTON, Aug. 03, 2022 - Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that David Meeker, M.D., will participate in a fireside chat at the Canaccord Genuity 42nd Annual Growth Conference on August 10, 2022, at 12:30 p.m. ET in Boston, MA. The presentation will be accessible via a live audio webcast on Rhythm's website, with a replay available for 30 days. Rhythm focuses on treating hyperphagia and severe obesity linked to MC4R pathway diseases, with IMCIVREE (setmelanotide) approved for chronic weight management in specific genetic obesity cases. The company is advancing clinical programs for additional rare genetic disorders.
Rhythm Pharmaceuticals received FDA approval for IMCIVREE (setmelanotide), the first therapy for Bardet-Biedl syndrome (BBS). In the first six weeks post-approval, over 50 prescriptions were written. The EMA recommended expanding IMCIVREE's authorization for obesity and hunger control in genetically confirmed BBS patients, with EC approval expected in Q4 2022. Positive interim results from a Phase 2 trial in hypothalamic obesity were announced, and a Phase 3 trial is planned for early 2023. Additionally, a $100 million non-dilutive revenue financing agreement has been secured, extending cash runway into H2 2024.
Rhythm Pharmaceuticals (RYTM) announced a live conference call on August 2, 2022, at 8:00 a.m. ET to discuss its Q2 2022 financial results and provide a corporate update. The biopharmaceutical company focuses on treatment for hyperphagia and severe obesity linked to rare MC4R pathway diseases. Its FDA-approved therapy, setmelanotide, is intended for chronic weight management in specific pediatric and adult populations. Setmelanotide has also received authorizations from the EC and MHRA for similar indications. A positive CHMP opinion regarding BBS treatment is expected in Q4 2022.
Rhythm Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanding marketing authorization for setmelanotide to treat obesity and control hunger in patients with genetically confirmed Bardet-Biedl syndrome. The positive opinion is a significant step towards offering a precision medicine therapy for severe obesity in patients aged six and older. About 1,500 patients in Europe are currently diagnosed with this syndrome. The final decision from the European Commission is expected in Q4 2022.
Rhythm Pharmaceuticals has received pre-marketing authorization AP1 from the French National Agency for Medicines and Health Products Safety (ANSM) for setmelanotide, facilitating access for patients with Bardet-Biedl syndrome (BBS). This program allows early access to innovative therapies when no alternatives are available. Setmelanotide aims to tackle severe obesity and hyperphagia related to BBS, impacting approximately 700 patients in France. Coverage under France’s National Health System is assured, enabling reimbursement for treatments.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that the National Institute for Health and Care Excellence (NICE) has recommended IMCIVREE (setmelanotide) for treating obesity related to POMC and LEPR deficiencies. This recommendation allows for its funding and availability within 90 days in the National Health Service in England and Wales. IMCIVREE is the first approved therapy addressing the underlying causes of these rare genetic conditions. The recommendation aligns with existing EU and UK market approvals, offering hope for many affected families.
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