Rhythm Pharmaceuticals Announces Expanded Access Program for Setmelanotide for Patients with Bardet-Biedl Syndrome
Rhythm Pharmaceuticals, Inc. (RYTM)
Last rhythm pharmaceuticals, inc. earnings: 3/8 08:12 am
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Source: GlobeNewswire
BOSTON, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today announced an Expanded Access Program (EAP) for setmelanotide for the treatment of eligible patients in the United States with severe obesity and hyperphagia due to Bardet-Biedl Syndrome (BBS). Rhythm expects to submit to the U.S. Food and Drug Administration (FDA) a supplemental new drug application (sNDA) for setmelanotide for the treatment of adult and pediatric patients 6 years of age and older with hunger and obesity due to BBS by the end of September. “BBS is a serious disease with significant unmet needs,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “Following the completion of our Phase 3 clinical trial and as we advance through the regulatory review process, we are pleased to make setmelanotide available through
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- 4/16/24 - Form 8-K
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