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Biotech Stocks Facing FDA Decision In June 2022

Rhythm Pharmaceuticals
Rhythm Pharmaceuticals

Rhythm Pharmaceuticals Inc. (RYTM) is seeking FDA approval for the expanded use of Imcivree in treating obesity and controlling hunger in adult and pediatric patients 6 years of age and older with Bardet-Biedl syndrome and Alström syndrome.

Bardet-Biedl syndrome and Alström syndrome are ultra-rare genetic diseases, with hyperphagia (insatiable hunger) being a common feature in both of these diseases.

Imcivree, a melanocortin-4 receptor agonist, known generically as Setmelanotide, is already approved in the U.S. for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency.

The regulatory decision on the proposed expanded indication is expected on June 16, 2022.

Imcivree, which became commercially available in the first quarter of 2021, generated sales of $3.2 million for the year ended December 31, 2021.

RYTM closed Thursday’s (May 26, 2022) trading at $3.22.