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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 equity grants of 34,215 shares to three new employees on March 1, 2023. This includes 22,810 stock options and 11,405 restricted stock units (RSUs), in line with its 2022 Employment Inducement Plan. The stock options have an exercise price of $25.85, with a vesting schedule that completes over four years. The RSUs will vest similarly over four years. Rhythm is focused on treating hyperphagia and severe obesity linked to rare MC4R pathway diseases, with its primary product, IMCIVREE (setmelanotide), already FDA-approved for chronic weight management in targeted patient populations.
Rhythm Pharmaceuticals reported a strong performance in 2022, highlighted by over 200 new prescriptions for IMCIVREE for Bardet-Biedl syndrome since FDA approval. The company launched IMCIVREE in eight international markets and initiated a Phase 3 trial for setmelanotide in acquired hypothalamic obesity. Rhythm's acquisition of Xinvento B.V. expands its pipeline to include congenital hyperinsulinism. Financially, the company recorded $8.8 million in product revenue for Q4 2022 and $16.9 million for the full year, a significant increase from 2021. However, net loss was $42.5 million for Q4 and $181.1 million for the year. Rhythm anticipates 2023 operating expenses of $200-$220 million.
Rhythm Pharmaceuticals (NASDAQ: RYTM) announced the acquisition of Xinvento B.V., a biotech firm focused on congenital hyperinsulinism (CHI), a rare genetic disease characterized by excessive insulin secretion. This acquisition, valued at up to $61 million including milestone payments, aligns with Rhythm's strategy in rare endocrinology and allows for new development opportunities. Clinical development for CHI is expected to begin in 2024. The acquisition includes Xinvento's team, enhancing Rhythm's expertise in CHI therapies.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced it will hold a live conference call on March 1, 2023, at 8:00 a.m. ET to disclose its fourth quarter and full-year 2022 financial results and provide a corporate update. This call will be accessible via registration. Additionally, CEO David Meeker will participate in the Cowen 43rd Annual Health Care Conference on March 6, 2023. Rhythm focuses on treating hyperphagia and severe obesity linked to rare melanocortin-4 receptor pathway diseases through its FDA-approved drug, setmelanotide, which is also authorized in Europe for similar conditions.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced on February 2, 2023, that its board's Compensation Committee granted equity awards to five new employees. The inducement equity grants cover 24,525 shares, including stock options for 16,350 shares at an exercise price of $28.90, and restricted stock units (RSUs) for 8,175 shares. The stock options vest 25% after the first year, with the remaining shares vesting quarterly over three years, while the RSUs vest 25% each year for four years. These grants are part of the Inducement Plan adopted on February 9, 2022, designed to attract talent as per Nasdaq regulations.
Rhythm Pharmaceuticals announced significant improvements in quality of life for patients with Bardet-Biedl syndrome (BBS) following a 52-week treatment with setmelanotide, as published in the Orphanet Journal of Rare Diseases. The global Phase 3 clinical trial reported an average increase of +11.2 points on the Pediatric Quality of Life Inventory (PedsQL) for younger patients and +12.0 points on the Impact of Weight on Quality of Life Questionnaire-Lite (IWQOL-Lite) for adults. Setmelanotide is designed to target the MC4R pathway impairment and is FDA-approved for chronic weight management in patients with genetically confirmed BBS.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the granting of equity awards to three new employees, totaling 29,925 shares. The awards consist of inducement stock options for 19,950 shares and restricted stock units (RSUs) for 9,975 shares, as part of the 2022 Employment Inducement Plan. The stock options have an exercise price of $28.32 and vest over four years, with RSUs vesting annually. This move aligns with Nasdaq Listing Rule 5635(c)(4) and aims to attract talented individuals to support the company's focus on treatments for hyperphagia and severe obesity linked to rare genetic disorders.
BOSTON, Dec. 1, 2022 - Rhythm Pharmaceuticals (Nasdaq: RYTM) announced CEO David Meeker will participate in a fireside chat at the BofA Securities 2022 Virtual Biotech SMID Cap Conference on December 8, 2022, at 9:40 a.m. ET. The live audio webcast will be accessible on the Investor Relations section of their website, with a replay available for 30 days post-event. Rhythm focuses on treating severe obesity from rare melanocortin-4 receptor pathway diseases with its FDA-approved medication setmelanotide, which targets specific genetic obesity conditions.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced significant advancements in its Phase 3 clinical trial of IMCIVREE (setmelanotide) for Bardet-Biedl syndrome (BBS), with results published in The Lancet Diabetes and Endocrinology. The trial met its primary and all key secondary endpoints, achieving substantial weight and hunger reductions after one year. Approximately 32.3% of patients aged 12 and older met the primary endpoint. Setmelanotide is now approved as the first therapy for chronic weight management in patients with BBS in the U.S. and EU, addressing a critical need for this rare genetic condition.
Rhythm Pharmaceuticals (RYTM) reported strong demand for IMCIVREE® (setmelanotide), with over 120 prescriptions since FDA approval for Bardet-Biedl Syndrome (BBS). The company successfully completed a $140 million public offering, extending its cash runway into 2025. Setmelanotide received FDA Breakthrough Therapy Designation for hypothalamic obesity, with a Phase 3 trial expected to begin early 2023. Revenue for Q3 2022 reached $4.3 million, up from $1.0 million in Q3 2021, while net loss was $40.9 million, compared to $35.1 million in the prior year.
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