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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 FDA approval for expanded indication of IMCIVREE® (setmelanotide) to treat children as young as 2 years old with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed POMC, PCSK1, and LEPR deficiencies. IMCIVREE is the first precision medicine targeting MC4R pathway impairment, addressing hyperphagia and obesity in these rare conditions.
The approval follows successful clinical trials showing significant weight and hunger reduction. The drug was previously approved for patients 6 years and older, and has received marketing authorization in the UK and EU for patients as young as 2 years. BBS affects approximately 4,000-5,000 people in the US, while POMC, PCSK1, and LEPR deficiency obesities affect 600-2,500 people.
Rhythm Pharmaceuticals (NASDAQ: RYTM) announced that the UK's MHRA has expanded marketing authorization for IMCIVREE (setmelanotide) to treat obesity and control hunger in patients as young as 2 years old with Bardet-Biedl syndrome (BBS) or POMC, PCSK1, or LEPR deficiency. Previously approved for patients 6 years and older in 2022, IMCIVREE received NICE recommendation for NHS reimbursement in May 2024 for BBS patients aged 6-17. The drug will be available through the Medicines for Children program by year-end. A similar application is under FDA priority review with a PDUFA date of December 26, 2024.
Rhythm Pharmaceuticals (NASDAQ: RYTM) presented new real-world data at ESPE 2024 showing positive results from setmelanotide treatment in pediatric patients with hypothalamic obesity. Four pediatric patients achieved >5% weight reduction at three months, with weight decreases ranging from 5.2% to 9.6%. The patients included two cases each of acquired and congenital hypothalamic obesity, treated under France's early-access program. All patients remain on therapy with no new safety signals observed.
The company also announced plans for a new 34-week substudy to evaluate setmelanotide in 39 patients with congenital hypothalamic obesity, with first patient enrollment expected in Q1 2025. Rhythm maintains its timeline for topline data from its pivotal Phase 3 trial in acquired hypothalamic obesity in H1 2025.
Rhythm Pharmaceuticals (RYTM) published results from its Phase 3 VENTURE trial evaluating setmelanotide in children aged 2-5 years with rare genetic obesity disorders. The study, published in The Lancet Diabetes & Endocrinology, showed significant results: 83% of patients achieved BMI Z-score reduction, with an 18% mean decrease in BMI from baseline. 91% of caregivers reported reduced hunger in patients. The treatment was generally well-tolerated with no serious adverse events. The FDA has granted Priority Review for label expansion with a PDUFA date of December 26, 2024.
Rhythm Pharmaceuticals (Nasdaq: RYTM) has granted inducement restricted stock units (RSUs) to three new employees, totaling 15,750 shares of common stock. The grants were approved on November 7, 2024, under the company's 2022 Employment Inducement Plan. The RSUs will vest over four years, with 25% vesting annually on each hire date anniversary, contingent on continued employment. These grants comply with Nasdaq Listing Rule 5635(c)(4) and are specifically designed as employment inducements.
Rhythm Pharmaceuticals (RYTM), a global commercial-stage biopharmaceutical company specializing in rare neuroendocrine diseases, has announced its participation in two upcoming investor conferences. David Meeker, Chair, President and CEO, will participate in fireside chats at the Guggenheim Securities Healthcare Innovation Conference on November 11 and the Stifel 2024 Healthcare Conference on November 18, both at 11:30 a.m. ET. The presentations will be webcasted and available on the company's website under the Investor Relations section, with replays accessible for 30 days.
Rhythm Pharmaceuticals (RYTM) reported Q3 2024 global sales of IMCIVREE® at $33.3 million, up 14% from Q2 2024. Early-access program data showed adult patients with acquired hypothalamic obesity achieved 12.8% mean BMI reduction after three months. The FDA accepted sNDA for Priority Review to expand IMCIVREE label for patients as young as 2 years, with PDUFA date of Dec. 26, 2024. Q3 net loss was $45.0 million ($0.73 per share). The company has $298.4 million cash on hand, expected to support operations into 2026.
Rhythm Pharmaceuticals (RYTM) presented five new data sets at ObesityWeek® 2024, showcasing positive results for setmelanotide therapy across multiple studies. Real-world data showed a mean BMI decrease of 12.8% in adult patients with acquired hypothalamic obesity after three months, extending to 21.3% at six months. The Phase 2 DAYBREAK trial demonstrated a 12.4% mean BMI reduction in patients with rare MC4R pathway diseases after 40 weeks. Notable results included a 23.8% BMI reduction in pediatric patients aged 2-6 years with BBS or POMC/LEPR Deficiency at 18 months. Analysis of 43,000 genetic samples revealed associations between genetic variants and early-onset obesity.
Rhythm Pharmaceuticals (RYTM) and Axovia Therapeutics announced a joint research collaboration to advance the understanding of Bardet-Biedl syndrome (BBS). The partnership combines Rhythm's expertise in melanocortin-4 receptor pathway research and their commercially available drug for treating hyperphagia and severe obesity in BBS patients with Axovia's focus on gene therapy addressing loss of sight and obesity in BBS patients. The collaboration aims to pool knowledge from their respective screening efforts to improve patient care.
Rhythm Pharmaceuticals, a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, has announced new employment inducement grants. On October 4, 2024, the company's Compensation & Management Development Committee granted inducement restricted stock units (RSUs) covering 30,050 shares of common stock to nine new employees.
These RSUs are subject to the Rhythm Pharmaceuticals 2022 Employment Inducement Plan, which is used exclusively for granting equity awards to new employees as per Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% of the shares vesting on each anniversary of the hire date, contingent on continued employment.
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