Rhythm Pharmaceuticals, Inc. RYTM shares are trading higher after the French National Agency for Medicines and Health Products Safety and Haute Autorité de santé granted pre-marketing authorization AP1 for IMCIVREE for patients with genetically-confirmed Bardet-Biedl syndrome for the treatment of obesity and the control of hunger.
AP1 allows for early access to innovative therapies in France prior to regulatory approval when a positive benefit/risk ratio is recognized and when no other therapeutic alternatives are available. The AP1 for setmelanotide was granted following review of efficacy and safety data from clinical studies by the ANSM and HAS, said in the company's press release.
Yann Mazabraud, Executive Vice President and Head of International at Rhythm, said "We are delighted to announce that the French regulatory authorities granted AP1 status to setmelanotide, making it available for patients with BBS living with hyperphagia and severe obesity."
Rhythm Pharmaceuticals Inc is a biopharmaceutical company. It is focused on the development and commercialization of peptide therapeutics for the treatment of gastrointestinal, or GI, diseases, and genetic deficiencies that result in metabolic disorders.
The stock was trading 21.4% higher at $12.84 per share on Wednesday at the time of publication, according to data from Benzinga Pro.
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