Business
Rhythm Pharmaceuticals Reports Third Quarter 2022 Financial Results and Business Update
-- U.S. launch of IMCIVREE® (setmelanotide) for Bardet-Biedl Syndrome progresses with strong demand with more than 120 prescriptions since FDA approval -- --
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- U.S. launch of IMCIVREE® (setmelanotide) for Bardet-Biedl Syndrome progresses with strong demand with more than 120 prescriptions since FDA approval -- -- EC authorization for IMCIVREE expanded to include BBS; UK launch in POMC and LEPR deficiencies underway -- -- Setmelanotide received FDA Breakthrough Therapy Designation for hypothalamic obesity; Phase 3 trial expected to be initiated in early 2023 -- -- Successfully completed $140 million public offering with exercise of underwriters’ option, extending cash runway into 2025 -- -- Management to host conference call today at 8:00 a.m. ET -- BOSTON, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) today reported financial results and provided a business update for the third quarter ended September 30, 2022. “The third quarter of 2022 was transformative for Rhythm and our global strategy to deliver IMCIVREE® (setmelanotide) as the first precision medicine to address the needs of patients and families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “We are pleased with our U.S. commercial launch and the initial reception of IMCIVREE for Bardet-Biedl syndrome (BBS), and we look forward to continuing to build on early market access successes in Europe.” Dr. Meeker continued, “We also are excited by the potential of setmelanotide to achieve a profound, consistent and sustained reduction in body weight in patients with hypothalamic obesity as demonstrated in our Phase 2 and long-term-extension trials. Following recent feedback from the U.S. Food and Drug Administration (FDA), we look forward to initiating our pivotal Phase 3 trial early in 2023.” Third Quarter and Recent Business Highlights: Development, Regulatory and Commercial Updates:Hypothalamic Obesity In November 2022, Rhythm announced that it had reached alignment with the FDA on the design of its Phase 3 clinical trial to evaluate setmelanotide for the treatment of acquired hypothalamic obesity. The trial, which is anticipated to initiate in early 2023, is expected to enroll 120 patients randomized 2:1 to setmelanotide therapy or placebo. The primary endpoint will be the percent change in body mass index (BMI) from baseline to after approximately 52 weeks ...