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 (RYTM) is a commercial-stage biopharmaceutical company pioneering precision medicines for rare neuroendocrine diseases, including genetic obesity disorders. This page aggregates all official announcements, press releases, and verified news coverage related to RYTM's therapeutic advancements and operational developments.
Investors and stakeholders will find timely updates on regulatory milestones, clinical trial outcomes, financial disclosures, and strategic partnerships. The curated collection prioritizes primary-source materials including FDA submissions, research publications, and executive communications to ensure informational accuracy.
Track RYTM's progress in developing MC4R pathway therapies like IMCIVREE® (setmelanotide), with updates spanning global approvals, research expansions, and market access initiatives. Content is organized chronologically to facilitate efficient monitoring of the company's progress in addressing rare genetic conditions.
Bookmark this page for direct access to Rhythm Pharmaceuticals' latest verified updates. For complete market analysis, combine these resources with broader sector research and regulatory filings.
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.
Rhythm Pharmaceuticals presented data from a Phase 3 pediatrics trial at the Pediatric Endocrine Society Annual Meeting, showcasing setmelanotide's achievement of a 3.04 mean reduction in BMI-Z score and an 18.4% mean reduction in BMI in pediatric patients with specific genetic disorders. The company is on track to submit an sNDA seeking label expansion for pediatric patients by the first half of 2024.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced the publication of results from its Phase 2 study of setmelanotide for treating hypothalamic obesity in The Lancet Diabetes & Endocrinology. The therapy resulted in a 15% reduction in BMI at 16 weeks and a 26% reduction at one year. Topline data from the Phase 3 clinical trial is expected in 2Q 2025.
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