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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.
Rhythm Pharmaceuticals (RYTM) announced a live conference call on August 2, 2022, at 8:00 a.m. ET to discuss its Q2 2022 financial results and provide a corporate update. The biopharmaceutical company focuses on treatment for hyperphagia and severe obesity linked to rare MC4R pathway diseases. Its FDA-approved therapy, setmelanotide, is intended for chronic weight management in specific pediatric and adult populations. Setmelanotide has also received authorizations from the EC and MHRA for similar indications. A positive CHMP opinion regarding BBS treatment is expected in Q4 2022.
Rhythm Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanding marketing authorization for setmelanotide to treat obesity and control hunger in patients with genetically confirmed Bardet-Biedl syndrome. The positive opinion is a significant step towards offering a precision medicine therapy for severe obesity in patients aged six and older. About 1,500 patients in Europe are currently diagnosed with this syndrome. The final decision from the European Commission is expected in Q4 2022.
Rhythm Pharmaceuticals has received pre-marketing authorization AP1 from the French National Agency for Medicines and Health Products Safety (ANSM) for setmelanotide, facilitating access for patients with Bardet-Biedl syndrome (BBS). This program allows early access to innovative therapies when no alternatives are available. Setmelanotide aims to tackle severe obesity and hyperphagia related to BBS, impacting approximately 700 patients in France. Coverage under France’s National Health System is assured, enabling reimbursement for treatments.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that the National Institute for Health and Care Excellence (NICE) has recommended IMCIVREE (setmelanotide) for treating obesity related to POMC and LEPR deficiencies. This recommendation allows for its funding and availability within 90 days in the National Health Service in England and Wales. IMCIVREE is the first approved therapy addressing the underlying causes of these rare genetic conditions. The recommendation aligns with existing EU and UK market approvals, offering hope for many affected families.
Rhythm Pharmaceuticals (RYTM) announced promising interim results from a Phase 2 trial of setmelanotide, focusing on treating severe obesity and hyperphagia in hypothalamic obesity patients. Positive outcomes include a mean BMI reduction of 17.2% and a weight decrease of 15.8% after 16 weeks. Notably, all evaluable patients experienced over a 5% BMI decrease. The company plans to advance to Phase 3 development. Setmelanotide was well-tolerated, with common side effects including nausea and vomiting. The results suggest potential transformation in treatment for this rare condition.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced on July 6, 2022, the grant of equity awards as inducement to six new employees, totaling 33,135 shares. This includes inducement stock options for 22,085 shares at an exercise price of $4.74 per share, and RSUs for 11,050 shares, vesting over four years. The grants adhere to the company's 2022 Employment Inducement Plan and comply with Nasdaq rules. Rhythm is focused on treating obesity linked to genetic disorders through its FDA-approved product, IMCIVREE (setmelanotide), which targets the melanocortin-4 receptor pathway.
Rhythm Pharmaceuticals announced that IMCIVREE (setmelanotide) is now available for patients in Germany. This precision medicine targets obesity linked to rare genetic disorders such as POMC and LEPR deficiencies. The European Commission previously granted marketing authorization for IMCIVREE, making it eligible for national coverage and reimbursement following a decision by the German Federal Joint Committee. Rhythm is committed to improving care for patients with these conditions through ongoing clinical research and regulatory submissions.
BOSTON, June 22, 2022 - Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the European Commission's authorization for a dosing variation of IMCIVREE® (setmelanotide) in patients with POMC or LEPR deficiency experiencing mild to severe renal impairment. This authorization allows treatment for patients 6 years and older, with no dose adjustments required for mild or moderate renal impairment. Additionally, Rhythm's Type II application for setmelanotide for Bardet-Biedl syndrome is under review, with a recommendation expected in Q3 2022.
Rhythm Pharmaceuticals has secured a $100 million Revenue Interest Financing Agreement with HealthCare Royalty Partners to enhance its commercialization efforts for IMCIVREE (setmelanotide). The initial investment of $37.5 million follows FDA approval for IMCIVREE for treating obesity linked to Bardet-Biedl syndrome (BBS). Another $37.5 million is expected post-European marketing authorization, with a final $25 million contingent on sales milestones in 2023. This funding will extend Rhythm's cash runway into 2H 2024.
Rhythm Pharmaceuticals announced the FDA approval of IMCIVREE for chronic weight management in patients 6 years and older with monogenic or syndromic obesity linked to Bardet-Biedl syndrome (BBS). This marks the first FDA-approved therapy targeting the MC4R pathway, addressing severe obesity and hyperphagia. The approval is based on successful Phase 3 trial data showing significant weight and hunger reduction. The company also launched the Rhythm InTune program for patient support. However, a complete response letter was issued for the sNDA regarding Alström syndrome.