We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Rhythm (RYTM) Up on FDA Approval of Weight Management Drug
Read MoreHide Full Article
Shares of Rhythm Pharmaceuticals, Inc. (RYTM - Free Report) gained 21.15% after it announced that the FDA has approved its lead product candidate, setmelanotide, for chronic weight management under the brand name, Imcivree.
The drug has been 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.
The approval makes Imcivree the first-ever FDA approved therapy for these rare genetic diseases of obesity.
The FDA approval was based on results from the largest studies conducted to date in obesity due to POMC, PCSK1 or LEPR deficiency. Results from the phase III studies showed that 80% of patients with obesity due to POMC or PCSK1 deficiency achieved greater than 10% weight loss and 45.5% of patients with obesity due to LEPR deficiency achieved greater than 10% weight loss after one year of treatment with Imcivree.
The FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Rhythm, which can be redeemed to receive priority review for any subsequent marketing application or sold or transferred to other companies for their programs.
The approval is a major boost as it is the company’s first new drug approval and will generate a stream of revenues for it.
Meanwhile, the company’s Marketing Authorization Application (MAA) for setmelanotide to treat people living with obesity due to POMC, PCSK1 or LEPR deficiency is currently under review by the European Medicines Agency (EMA). The candidate was granted the PRIority MEdicines (PRIME) designation for the treatment of obesity and the control of hunger associated with deficiency diseases of the MC4 receptor pathway in the EU.
Rhythm’s stock has rallied 27.5% in the year so far compared with the industry’s growth of 2.1%.
Additionally, Rhythm is currently evaluating setmelanotide for reduction in hunger and body weight in a phase III study in people living with Bardet-Biedl or Alström syndrome, with top-line data expected late in the fourth quarter of 2020 or early first quarter of 2021. Rhythm also continues to enroll patients in its phase II basket study designed to rapidly facilitate proof-of-concept in new indications.
Halozyme’s earnings estimates are up 18 cents for 2020 in the past 30 days.
Repligen’s earnings estimates are up 13 cents for 2020 in the past 30 days.
Vanda’s earnings estimates are up 12 cents for 2020 in the past 60 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Rhythm (RYTM) Up on FDA Approval of Weight Management Drug
Shares of Rhythm Pharmaceuticals, Inc. (RYTM - Free Report) gained 21.15% after it announced that the FDA has approved its lead product candidate, setmelanotide, for chronic weight management under the brand name, Imcivree.
The drug has been 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.
The approval makes Imcivree the first-ever FDA approved therapy for these rare genetic diseases of obesity.
The FDA approval was based on results from the largest studies conducted to date in obesity due to POMC, PCSK1 or LEPR deficiency. Results from the phase III studies showed that 80% of patients with obesity due to POMC or PCSK1 deficiency achieved greater than 10% weight loss and 45.5% of patients with obesity due to LEPR deficiency achieved greater than 10% weight loss after one year of treatment with Imcivree.
The FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Rhythm, which can be redeemed to receive priority review for any subsequent marketing application or sold or transferred to other companies for their programs.
The approval is a major boost as it is the company’s first new drug approval and will generate a stream of revenues for it.
Meanwhile, the company’s Marketing Authorization Application (MAA) for setmelanotide to treat people living with obesity due to POMC, PCSK1 or LEPR deficiency is currently under review by the European Medicines Agency (EMA). The candidate was granted the PRIority MEdicines (PRIME) designation for the treatment of obesity and the control of hunger associated with deficiency diseases of the MC4 receptor pathway in the EU.
Rhythm’s stock has rallied 27.5% in the year so far compared with the industry’s growth of 2.1%.
Additionally, Rhythm is currently evaluating setmelanotide for reduction in hunger and body weight in a phase III study in people living with Bardet-Biedl or Alström syndrome, with top-line data expected late in the fourth quarter of 2020 or early first quarter of 2021. Rhythm also continues to enroll patients in its phase II basket study designed to rapidly facilitate proof-of-concept in new indications.
Rhythm currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech space include Halozyme Therapeutics, Inc. (HALO - Free Report) , Repligen (RGEN - Free Report) and Vanda Pharmaceuticals (VNDA - Free Report) . All three carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Halozyme’s earnings estimates are up 18 cents for 2020 in the past 30 days.
Repligen’s earnings estimates are up 13 cents for 2020 in the past 30 days.
Vanda’s earnings estimates are up 12 cents for 2020 in the past 60 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>