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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 (Nasdaq: RYTM) will host a virtual event on February 16, 2022, to discuss the patient experience of Bardet-Biedl Syndrome (BBS) and its commercialization plans for setmelanotide, aimed at addressing obesity and hyperphagia in BBS patients. The event features key opinion leaders and updates on the FDA review of the supplemental New Drug Application (sNDA) for setmelanotide, with a PDUFA goal date of March 16, 2022. The company aims to enhance awareness and understanding of BBS and its treatments.
Rhythm Pharmaceuticals (RYTM) announced the initiation of the DAYBREAK Phase 2 clinical trial, the most extensive of its kind for rare genetic obesity diseases, dosing the first patient with setmelanotide. This trial aims to treat severe obesity and hyperphagia linked to variants in 31 genes. Concurrently, a Phase 3 switch trial evaluates a weekly setmelanotide formulation for patients currently on a daily dosage. DAYBREAK is set to enroll approximately 500 participants across 12 countries, with significant potential to shape future treatments for obesity linked to genetic variants.
Rhythm Pharmaceuticals (RYTM) announced an exclusive licensing agreement with RareStone for IMCIVREE (setmelanotide) to treat genetic obesity in China, including Hong Kong and Macau. Rhythm will receive a $12 million upfront payment, with potential future payments of up to $63.5 million plus sales royalties. The agreement aims to enhance patient access in China for severe genetic obesity, addressing a significant unmet medical need. This partnership marks Rhythm's first expansion into the Asian market, enhancing its global outreach.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) targeting Bardet-Biedl syndrome and Alström syndrome. The FDA granted Priority Review status, setting a PDUFA goal date of March 16, 2022. This acceptance is regarded as a significant advancement in addressing unmet medical needs for these ultra-rare genetic diseases that affect obesity and hunger regulation.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced that CEO David Meeker will present at the Stifel 2021 Virtual Healthcare Conference on November 15, 2021, at 11:20 a.m. ET. A live webcast will be accessible on the company’s website, with a replay available for 30 days post-event.
Rhythm specializes in therapies for rare genetic obesity diseases. Their product, IMCIVREE (setmelanotide), approved in the U.S. and Europe for specific genetic obesity conditions, continues to show promise with ongoing development in additional obesity-related disorders.
Rhythm Pharmaceuticals (RYTM) has submitted regulatory filings for IMCIVREE® (setmelanotide) for treating Bardet-Biedl and Alström syndromes, with launch preparations set for mid-2022. In Q3 2021, IMCIVREE net sales reached $1 million, marking a revenue milestone since its FDA approval in November 2020. The company presented 22 data studies at major medical conferences, including positive outcomes on health-related quality of life for patients with rare genetic obesity diseases. Cash position as of September 30, 2021, was approximately $328.4 million, indicating strong financial support for ongoing operations.
Rhythm Pharmaceuticals (Nasdaq: RYTM) presented comprehensive data on setmelanotide at ObesityWeek 2021, focusing on its effects on Bardet-Biedl Syndrome (BBS). Key findings include that 85% of patients reported improved health-related quality of life (HRQOL) after one year on therapy, along with significant reductions in BMI—9.1% for adults and 9.5% for pediatric patients. New data from Phase 2 trials showed setmelanotide also reduced hunger in patients with SH2B1 and SRC1 deficiencies. The company aims to expand clinical evaluations to 36 relevant genes affecting obesity.
Rhythm Pharmaceuticals (Nasdaq: RYTM) will host a conference call on November 2, 2021, at 8:00 a.m. ET to provide its Q3 2021 financial results and corporate updates. The biopharmaceutical company focuses on rare genetic obesity disorders and has developed IMCIVREE (setmelanotide), the first FDA-approved treatment for obesity due to specific genetic deficiencies. The drug received recent approvals from European authorities. The call will be available via phone and webcast, with an archived version accessible for 30 days after.
Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the submission of a Type II variation application to the European Medicines Agency for its obesity treatment, IMCIVREE (setmelanotide), targeting Bardet-Biedl syndrome (BBS) and Alström syndrome. This submission leans on positive data from a Phase 3 trial showing significant weight loss and hunger control. The company estimates around 1,500 patients in the EU with BBS could benefit, enhancing its position in the rare genetic obesity market.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) reported promising findings from the Obesity Medicine Association’s Overcoming Obesity 2021 Conference. Setmelanotide, an obesity treatment for POMC and LEPR deficiencies, showed significant improvements in health-related quality of life and hunger management for patients. Updated data from the Uncovering Rare Obesity program revealed that 64.5% of participants with early-onset obesity may carry genetic variants linked to rare obesity diseases. Rhythm plans to launch Phase 3 EMANATE and Phase 2 DAYBREAK trials, furthering its commitment to treating genetic obesity.