Welcome to our dedicated page for Rhythm Pharmaceu news (Ticker: RYTM), a resource for investors and traders seeking the latest updates and insights on Rhythm Pharmaceu stock.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) is a commercial-stage biopharmaceutical company whose news flow centers on rare neuroendocrine diseases and MC4R pathway–targeted therapies. The company’s updates frequently highlight global commercial performance of its lead product IMCIVREE (setmelanotide), regulatory milestones, and clinical data across multiple rare obesity indications.
Investors following RYTM news can expect regular announcements on net product revenues from global sales of IMCIVREE, including the relative contributions from the United States and international markets. Rhythm also issues press releases on reimbursement developments, such as public reimbursement agreements for IMCIVREE in Canadian provinces and under federal programs for patients with Bardet-Biedl syndrome–related obesity.
Clinical and regulatory news is a major focus. Rhythm reports on Phase 3 trials like TRANSCEND in acquired hypothalamic obesity and EMANATE in genetically caused MC4R pathway diseases, as well as exploratory and Phase 2 studies in Prader-Willi syndrome and other rare conditions. Updates often include topline efficacy and safety data, cardiometabolic outcomes, and patient- and caregiver‑reported measures presented at scientific meetings.
Regulatory communications include FDA actions on supplemental New Drug Applications, PDUFA goal dates and extensions, and EMA validation of Type II variations to existing marketing authorizations. Rhythm also provides information on development of investigational MC4R agonists bivamelagon and RM-718 and preclinical small molecules for congenital hyperinsulinism.
For users tracking RYTM, this news feed offers a centralized view of earnings releases, clinical trial readouts, regulatory decisions and access milestones related to IMCIVREE and Rhythm’s broader rare disease pipeline.
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.