Rhythm Pharmaceu Stock Price, News & Analysis

Rhythm Pharmaceuticals announced interim Phase 2 data for setmelanotide, showing that its once-weekly formulation has safety and efficacy comparable to daily doses in treating obesity. Additionally, long-term extension study data indicated durable weight loss and decreased hunger over three years. The FDA has granted Breakthrough Therapy designation for setmelanotide, which targets rare genetic obesity disorders. The company aims for FDA approval for POMC and LEPR deficiency obesity by November 27, 2020, while maintaining a focus on developing precision therapies for patients with severe obesity.

Rhythm Pharmaceuticals reported its third-quarter 2020 financial results, highlighting key developments in its drug candidate setmelanotide. The FDA's PDUFA goal date for setmelanotide's approval for POMC and LEPR deficiency obesities is November 27, 2020. The company appointed Jennifer Chien and Yann Mazabraud to lead global commercial strategies. R&D expenses decreased to $23 million from $26.6 million year-over-year, while net loss narrowed to $33.8 million. As of September 30, 2020, cash reserves stood at $201.8 million, sufficient to fund operations through 2021.

Rhythm Pharmaceuticals released crucial findings from two significant Phase 3 studies indicating that setmelanotide effectively reduced weight and hunger in patients with POMC and LEPR deficiency obesity. Published in The Lancet Diabetes & Endocrinology, the studies showed 80% of participants with POMC deficiency and 45% with LEPR deficiency achieved at least a 10% weight loss. The FDA has accepted the New Drug Application for setmelanotide, with a PDUFA goal date set for November 27, 2020. These results underscore a promising treatment avenue for rare obesity disorders.

Rhythm Pharmaceuticals (Nasdaq:RYTM) has appointed Jennifer Chien as Executive Vice President, Head of North America, effective November 9, 2020. Ms. Chien, with over 20 years in rare diseases, will co-lead global commercial strategies alongside newly appointed EVP, Head of International, Yann Mazabraud. This leadership change comes as Rhythm prepares for the potential approval of setmelanotide, a therapy for rare genetic obesity disorders. The FDA has set a PDUFA date of November 27, 2020, for Rhythm's New Drug Application for setmelanotide.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced the appointment of Yann Mazabraud as Executive Vice President, Head of International, effective October 5, 2020. This organizational change aims to enhance the company's global strategy, particularly for its lead product, setmelanotide, which targets severe obesity linked to rare genetic disorders. Dr. Meeker praised Mazabraud's extensive experience in the biopharmaceutical sector. Additionally, Nithya Desikan, the previous CCO, will leave to pursue other opportunities, while a search for a Head of North American Operations is underway.

BOSTON, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals (Nasdaq: RYTM) announced participation in two investor conferences this September. At the Morgan Stanley 18th Annual Global Healthcare Conference on September 16, 2020, David Meeker, M.D., will speak at 3:30 p.m. ET. On September 17, 2020, CFO Hunter Smith will present at the Cantor Virtual Global Healthcare Conference at 2:00 p.m. ET. Live webcasts of both events will be accessible on the company's website, with replays available for 30 days following each presentation.

Rhythm Pharmaceuticals (Nasdaq: RYTM) announced a corporate overview presentation at the Canaccord Genuity 40th Annual Growth Conference on August 13, 2020, at 9:30 a.m. ET. The company's leadership, including David Meeker, M.D., and Hunter Smith, will present insights on developing therapies for rare genetic disorders of obesity. Rhythm's investigational drug, setmelanotide, has FDA filing acceptance for certain obesity conditions with a PDUFA date of November 27, 2020. A live audio webcast will be accessible on their website, with a replay available for 30 days.

Rhythm Pharmaceuticals (Nasdaq: RYTM) has appointed David Meeker, M.D. as the new President and CEO, taking over from Hunter Smith, who remains CFO. Dr. Meeker, a seasoned leader in biopharmaceuticals with extensive experience in rare genetic diseases, aims to enhance the company’s strategy as it approaches potential FDA approval for setmelanotide, targeting POMC and LEPR deficiency obesity. The FDA has set a PDUFA goal date of November 27, 2020, for the drug's NDA. Meeker has been with Rhythm since 2015 and has a strong background in launching therapies for rare diseases.

Rhythm Pharmaceuticals announced promising results from its Phase 2 study of setmelanotide, a treatment for obesity and hyperphagia in individuals with Bardet-Biedl syndrome (BBS). Published in Diabetes, Obesity and Metabolism, the study shows that setmelanotide effectively reduced body weight and hunger. This marks the first Phase 2 trial of any investigational drug showing such efficacy for BBS. The company prepares for topline data from its pivotal Phase 3 trial on setmelanotide, expected by early 2021, further advancing treatment options for this ultra-rare genetic disorder.