Low expectations for Rhythm Pharmaceuticals Inc.’s phase III study dubbed Emanate with Imcivree (setmelanotide) in a handful of rare genetic obesities meant hardly any share price consequence, and the stock (NASDAQ:RYTM) closed March 17 at $87.68, down $2.83. “We’re not going to file [for approval] on any of these,” CEO David Meeker said, but the latest findings together represent “a solid building block going forward,” he added.
Multiple datasets are due to roll out soon in the Prader-Willi syndrome (PWS) space, where contenders are trying varied mechanisms of action to tackle the rare genetic disorder characterized by insatiable hunger, or hyperphagia. In the mix are Aardvark Therapeutics Inc., Acadia Pharmaceuticals Inc., Rhythm Pharmaceuticals Inc. and Soleno Therapeutics Inc.
Rhythm Pharmaceuticals Inc. will be sitting down with regulators in the U.S. and Europe to discuss phase III plans in the wake of positive phase II data from the study testing bivamelagon (formerly LB5-4640), an oral melanocortin-4 receptor agonist, in patients with acquired hypothalamic obesity.
Rhythm Pharmaceuticals Inc.’s sales with Imcivree (setmelanotide) in weight management could exceed $1 billion by 2028 if hypothalamic obesity (HO) is added to the label of the drug, Oppenheimer analyst Leland Gershell said in a report. Boston-based Rhythm rolled out positive top-line data from the pivotal phase III study called Transcend with the melanocortin-4 receptor agonist in HO. The global trial met its primary endpoint with a statistically significant and highly clinically meaningful reduction in body mass index in adult and pediatric HO patients vs. placebo.
Rhythm Pharmaceuticals Inc. has patented new Kir6.2/SUR1 activators reported to be useful for the treatment of disorders of sexual function, hyperinsulinemia, cancer, genitourinary, neurological and cardiovascular disorders.
Rhythm Pharmaceuticals Inc. is picking up LG Chem Ltd.’s oral small-molecule drug, LB-54640, for potentially $305 million, effectively growing its MC4R pipeline that houses U.S. FDA-approved Imcivree (setmelanotide) for genetic obesity disorders.
Rhythm Pharmaceuticals Inc. is picking up LG Chem Ltd.’s oral small-molecule drug, LB-54640, for potentially $305 million, effectively growing its MC4R pipeline that houses U.S. FDA-approved Imcivree (setmelanotide) for genetic obesity disorders.
Rhythm Pharmaceuticals Inc. has presented preclinical data on its new drug candidate, RM-718, a next-generation melanocortin MC4 receptor (MC4R) agonist for weekly administration with a potential development path for hypothalamic obesity.
Confo Therapeutics NV closed out March in much the same way as it began the month – with a deal. The Ghent, Belgium-based company has entered a collaboration agreement with Daiichi Sankyo Co. Ltd. to generate brain-penetrant small-molecule agonists to an undisclosed G protein-coupled receptor (GPCR) implicated in central nervous system diseases.
