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Rhythm Pharmaceuticals, Inc. develops and commercializes therapies for rare neuroendocrine diseases, centered on IMCIVREE (setmelanotide), an MC4R agonist for hyperphagia and severe obesity linked to rare MC4R pathway disorders. Company updates commonly cover U.S. and international commercialization of setmelanotide, regulatory authorizations and label expansions for acquired hypothalamic obesity, Bardet-Biedl syndrome, POMC/PCSK1 deficiency and LEPR deficiency, and safety information tied to approved uses.
Rhythm news also follows clinical data from setmelanotide studies, including acquired hypothalamic obesity and genetically caused MC4R pathway diseases, along with development of investigational MC4R agonists bivamelagon and RM-718 and preclinical small molecules for congenital hyperinsulinism. Recurring corporate items include financial results, specialty-pharmacy access arrangements, healthcare conference presentations and board governance changes.
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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