Rhythm Phramaceuticals ( RYTM Quick Quote RYTM - Free Report) rallied 42.2% on Jul 12 after the company announced positive results from a phase II study on its lead product candidate, setmelanotide. The candidate will be used for treating severe obesity and hyperphagia in people with hypothalamic obesity.
Hypothalamic obesity is an extreme form of obesity that occurs due to damage to the brain’s hypothalamus. The symptoms of hypothalamic obesity may vary but mostly include uncontrollable hunger and rapid, excessive weight gain
The phase II study is a multi-center, open-label, proof-of-concept study evaluating the efficacy of setmelanotide for 16 weeks, in 18 patients between 6 and 28 years of age, with hypothalamic obesity. As of May 6, 2022, 11 patients were evaluable for assessment, including nine patients who completed the 16-week treatment and two patients who, due to treatment-related adverse events, discontinued early.
The primary endpoint of the study was to achieve more than a 5% reduction in BMI from baseline in evaluable patients, at 16 weeks, on setmelaotide therapy.
Setmelanotide also achieved a meaningful reduction in hunger scores.
Based on positive results from this mid-stage study, Rhythm intends to proceed to phase III clinical development, following consultations with regulatory agencies.
Shares of Rhythm have declined 33.1% so far this year compared with the
industry’s fall of 19.7%. Image Source: Zacks Investment Research
Rhythm’s lead product candidate, setmelanotide, for chronic weight management, marketed under the brand name, Imcivree, received its FDA approval in November 2020.
The drug was approved 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 confirmed by genetic testing.
Recently, FDA approved Rhythm’s supplemental New Drug Application (sNDA), seeking the label expansion of Imcivree to include patients with Bardet-Biedl syndrome (BBS), a rare genetic obesity disease.
Following the recent approval, the drug has become the first and only FDA-approved treatment for BBS patients.
However, the FDA issued a complete response letter (CRL) for another sNDA seeking label expansion of Imcivree for the treatment of patients with Alström syndrome, another genetic disease that can cause obesity.
Zacks Rank & Stocks to Consider
Rhythm Pharmaceuticals currently carries a Zacks Rank #3 (Hold). Some similar ranked stocks in the overall health sector are
Aquestive Therapeutics ( AQST Quick Quote AQST - Free Report) , Merck & Co. ( MRK Quick Quote MRK - Free Report) ., and Seagen ( SGEN Quick Quote SGEN - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Aquestive Therapeutics’ loss per share estimates for 2022 have narrowed from $1.50 to $1.34 cents in the past 30 days. The same for 2023 has narrowed from 95 cents to 74 cents in the same time frame.
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