Rhythm Pharmaceuticals Completes Submission of Supplemental New Drug Application to U.S. Food and Drug Administration for IMCIVREE® (setmelanotide) for the treatment of obesity and control...
Rhythm Pharmaceuticals, Inc. (RYTM)
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Source: GlobeNewswire
BOSTON, Sept. 20, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced that it has completed its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMCIVREE® (setmelanotide) for the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with Bardet-Biedl syndrome (BBS) or Alström syndrome. “This marks a major step in our efforts to bring IMCIVREE to more patients and families living with rare genetic diseases of obesity, including BBS, which affects approximately 1,500 to 2,500 people in the United States, and Alström syndrome, which affects approximately 500 to 1,000 people worldwide,” said David Meeker, M.D., Chairman, President and CEO of Rhythm. “Our application is based on data from the pivotal Phase 3 trial in which treatment wi
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RYTM
Earnings
- 2/22/24 - In-Line
RYTM
Sec Filings
- 4/17/24 - Form SC
- 4/16/24 - Form 4
- 4/16/24 - Form 8-K
- RYTM's page on the SEC website