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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), a commercial-stage biopharmaceutical company focusing on rare neuroendocrine diseases, has announced two upcoming events. First, the company will host a conference call and webcast on August 6, 2024, at 8:00 a.m. ET to report its second quarter 2024 financial results and provide a corporate update. Participants can register for the call online.
Additionally, David Meeker, M.D., Chair, President and CEO of Rhythm, will participate in a fireside chat at the Canaccord Genuity 44th Annual Growth Conference in Boston on August 13, 2024, at 11:00 a.m. ET. Both events will be webcast live and archived on the company's website for 30 days following the presentations.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced on July 11, 2024, that its Board of Directors' Compensation & Management Development Committee granted inducement restricted stock units (RSUs) covering 19,200 shares to six new employees on July 8, 2024. These RSUs are part of the 2022 Employment Inducement Plan, created exclusively for equity awards to attract new hires in line with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% of shares vesting each year on the anniversary of the hire date, contingent on the employees' continued employment. This move aims to incentivize and retain new talent in the company.
Rhythm Pharmaceuticals has appointed Alastair Garfield, Ph.D., as Chief Scientific Officer, effective July 1, 2024. Dr. Garfield, who has a robust background in appetite and body weight regulation, rejoined Rhythm after his tenure at Rectify Pharma, where he developed first-in-class therapeutics for rare diseases. His leadership will be pivotal as Rhythm continues to develop therapies targeting the MC4R pathway, which plays a important role in managing hyperphagia and severe obesity. Dr. Garfield's previous research has been published in prestigious journals like Nature and Nature Neuroscience.
Rhythm Pharmaceuticals announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for IMCIVREE (setmelanotide). This recommendation is for children aged 2 to younger than 6 with obesity due to Bardet Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. If approved by the European Commission (EC), this will expand IMCIVREE's authorization beyond its current scope, which covers adults and children aged 6 and above. The EC's final decision is expected in the second half of 2024. This development highlights the unmet medical need for treating severe early-onset obesity and uncontrolled hunger associated with these rare neuroendocrine diseases.
On June 11, 2024, Rhythm Pharmaceuticals (Nasdaq: RYTM) announced new equity grants for ten new employees. The grants, approved on June 6, 2024, by the Compensation & Management Development Committee, include 56,080 shares of common stock. This comprises 9,230 stock options and 46,850 restricted stock units (RSUs) under the 2022 Employment Inducement Plan. The stock options have an exercise price of $39.68 per share, with a four-year vesting schedule: 25% after one year and the remainder in 12 quarterly installments. The RSUs also vest over four years, with 25% vesting annually. These inducement grants aim to attract new talent to the company, adhering to Nasdaq Listing Rule 5635(c)(4).
Rhythm Pharmaceuticals presented new patient-reported data from their Phase 2 trial on setmelanotide for hypothalamic obesity (HO) at ENDO 2024. Participants reported improved sleep, energy, and reduced hunger. Another study found setmelanotide improved weight classifications for multiple MC4R pathway diseases after one year. Stage two data from the Phase 2 DAYBREAK trial is expected in Q3 2024. Preclinical data for RM-718 showed promising results in reducing body weight and hunger. Rhythm also presented the design for a Phase 1 RM-718 trial and the RESTORE real-world study on setmelanotide's effectiveness.
Rhythm Pharmaceuticals (Nasdaq: RYTM), a biopharmaceutical company specializing in rare neuroendocrine diseases, announced that its CEO, David Meeker, will participate in the Goldman Sachs 45th Annual Global Healthcare Conference. The event is scheduled for June 10, 2024, at 9:20 a.m. The fireside chat will be webcast live and accessible via the company's Investor Relations website. A replay of the webcast will remain available for 30 days post-presentation.
Rhythm Pharmaceuticals announced that NICE has recommended IMCIVREE (setmelanotide) for treating obesity and hyperphagia in patients with Bardet-Biedl syndrome (BBS) aged 6 and above. This recommendation aligns with EMA and MHRA approvals. IMCIVREE is expected to be funded by the NHS in England and Wales within three months. Clinical trials showed a reduction in hyperphagia, weight, and BMI among patients. Common adverse events include skin hyperpigmentation, injection site reactions, nausea, and headache. Rhythm plans to submit to the Scottish Medicines Consortium with a decision expected in 2025.
Rhythm Pharmaceuticals, Inc. announced the granting of inducement restricted stock units to seven new employees as part of their 2022 Employment Inducement Plan. These RSUs cover 15,150 shares of common stock and will vest over a four-year period. The company aims to attract and retain top talent through equity awards.
Rhythm Pharmaceuticals reported first quarter 2024 financial results with $26.0 million in net revenue from global sales of IMCIVREE® (setmelanotide). The company is on track to submit an sNDA to the FDA for pediatric patients aged 2-6 in approved indications. Phase 3 trial for hypothalamic obesity remains on track for topline data readout in 1H 2025. Rhythm secured $150 million in convertible preferred stock financing, funding operations into 2026. The company continues to focus on expanding the global opportunity for setmelanotide and advancing the MC4R portfolio with RM-718 and LB54640 programs.
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