Metabolic disorders

Expanding in the metabolic space, Eli Lilly has struck a back-loaded licensing deal with South Korea’s Hanmi Pharm for a mid-stage GLP-2 agonist being trialed for short bowel syndrome.
The American Diabetes Association’s annual congress will feature a superstar lineup, including weight loss giants Eli Lilly and Novo Nordisk. But several scrappy biotechs will also present obesity candidates with the potential to match—if not outperform—their deep-pocketed competitors.
After trial flops in spinal muscular atrophy, depression and bipolar disorder—and a costly rare disease drug rejection—Biohaven is undergoing a reset, recasting its former SMA candidate for obesity.
Kailera Therapeutics is advancing a pipeline of weight loss medicines that mirrors Eli Lilly’s: an injectable GLP-1/GIP dual agonist like Zepbound, an oral GLP-1 like Foundayo and a triple-G therapy like retatrutide.
Eli Lilly continues to spend its GLP-1 landfall with four new deals in the past week, including three in the vaccine space; the obesity leader also touted surgery-like results for its next-gen weight loss drug; Moderna’s stock climbs on the hantavirus “fear trade”; and in oncology, all eyes are on Revolution at ASCO this week.
Lilly met analysts’ sky-high expectations with 28.3% weight loss over 80 weeks for the triple hormone receptor agonist retatrutide in a highly anticipated readout on Thursday.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Aardvark Therapeutics had previously voluntarily suspended studies of ARD-101—and a related asset called ARD-201—after detecting anomalous echocardiographic readings in healthy volunteers that could indicate reduced heart efficiency.
Despite seeing some regain, patients in two trials maintained most of their weight loss after switching to either Foundayo or lower-dose Zepbound from other injectable incretin therapies.
FDA
Acting Center for Drug Evaluation and Research Director Tracy Beth Høeg reportedly disagreed with staff who wanted to approve Sanofi’s type 1 diabetes drug. It’s far from the first time a political appointee has allegedly meddled in a recent FDA decision.
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