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) announced that David Meeker, M.D., will participate in a fireside chat at the BofA Securities 2022 Healthcare Conference on May 11, 2022, at 5:20 p.m. PT (8:20 p.m. ET) in Las Vegas, NV. A live audio webcast will be available on the company’s website, with replays for 30 days.
Rhythm is dedicated to addressing rare genetic diseases of obesity, with its drug IMCIVREE (setmelanotide) already FDA-approved for certain conditions. The company is also pursuing additional regulatory approvals and expanding its clinical programs.
Rhythm Pharmaceuticals (Nasdaq: RYTM) reported a net loss of $52.8 million for Q1 2022, compared to net income of $43.8 million in Q1 2021. Revenue from the sales of IMCIVREE reached $1.5 million, up from $35,000 a year prior. The company prepares for the U.S. launch of setmelanotide for Bardet-Biedl and Alström syndromes pending FDA approval by June 16, 2022. They also initiated multiple clinical trials with focus on rare genetic obesity, while cash reserves stood at approximately $241 million as of March 31, 2022.
Rhythm Pharmaceuticals (RYTM) presented new data on setmelanotide at the PES 2022 Virtual Annual Meeting, highlighting its potential to treat Bardet-Biedl syndrome (BBS) with clinically meaningful improvements in lipid parameters and weight management in pediatric and adolescent patients. The 52-week Phase 3 trial showed significant reductions in body weight, cholesterol, and triglycerides without affecting vital signs. Cumulative safety data from 561 patients indicated the treatment was well tolerated. The company anticipates a potential U.S. approval for setmelanotide for BBS later this quarter.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a live conference call on May 3, 2022, at 8:30 a.m. ET to discuss its Q1 2022 financial results and provide corporate updates. The company is known for its innovative treatment IMCIVREE (setmelanotide), approved for chronic weight management in patients with specific obesity-related genetic disorders. Additionally, Rhythm's supplemental New Drug Application for treating Bardet-Biedl Syndrome is under review by the FDA, with a decision expected by June 16, 2022.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the grant of 14,380 shares of its common stock to two new employees as part of an inducement equity grant on April 4, 2022. The grant includes inducement stock options for 9,585 shares and restricted stock units (RSUs) for 4,795 shares, governed by the Inducement Plan adopted on February 9, 2022. The stock options have an exercise price of $12.25 per share, and vesting is scheduled over four years. Rhythm focuses on transforming the care for people with rare genetic obesity diseases, highlighted by its FDA-approved treatment, IMCIVREE.
Rhythm Pharmaceuticals (RYTM) announced strategic modifications to its Phase 3 EMANATE and Phase 2 DAYBREAK clinical trials, focusing on rare patient populations to enhance success rates for setmelanotide, a treatment for genetic obesity disorders. The EMANATE trial has commenced with its first patient enrolled and now includes four independent sub-studies targeting specific genetic variants. The changes are aimed at optimizing trial design and extending the company's cash runway into Q4 2023, with anticipated enrollment of approximately 400 patients over 12-18 months.
Wren Therapeutics has appointed Bart Henderson as the new Chief Executive Officer. With extensive experience in biotechnology, including co-founding Rhythm (Nasdaq: RYTM), he aims to advance Wren's innovative drug discovery platform targeting toxic protein intermediates related to neurodegenerative diseases. Under the leadership of outgoing CEO Samuel Cohen, Wren has made significant progress in drug discovery, focusing on Alzheimer’s and Parkinson’s diseases. Henderson's experience is expected to strengthen the company's pipeline as they move towards clinical applications.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that its CEO, David Meeker, M.D., will participate in a fireside chat at the Cowen & Co. 42nd Annual Health Care Conference on March 8, 2022, at 10:30 a.m. ET. A live audio webcast will be accessible through the Investor Relations section of their website, with a replay available for 30 days post-event. Rhythm focuses on treating rare genetic diseases of obesity, having received FDA approval for IMCIVREE (setmelanotide) in 2020 for chronic weight management related to certain genetic deficiencies.
Rhythm Pharmaceuticals reported a net loss of $42.9 million in Q4 2021 with IMCIVREE sales of $1.8 million and total 2021 sales of $3.2 million. The company is preparing for a U.S. launch of IMCIVREE for Bardet-Biedl syndrome and Alström syndrome expected in June 2022, along with first sales in Germany and France anticipated in Q2 2022. Rhythm announced completion of enrollment in a Phase 2 trial for hypothalamic obesity, and recent increases in R&D expenses to $31.6 million in Q4 2021, attributed to expanded clinical trials and hiring. Cash reserves at year-end stood at approximately $294.9 million.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced an extension of the FDA review period for its supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) to June 16, 2022, due to a request for additional subgroup analyses from its Phase 3 trial data. The company also withdrew the proposed Alström syndrome indication from its Type II variation application under EMA review to maintain the timeline for Bardet-Biedl Syndrome (BBS). Rhythm remains committed to bringing this treatment to market for patients with these rare genetic obesity disorders.
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