Maze Therapeutics Inc. continues its journey toward a pivotal program after sharing positive top-line data from the phase II Horizon study with MZE-829, an oral, small-molecule, dual-mechanism APOL1 inhibitor, in patients with broad APOL1-mediated kidney disease (AMKD).
The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. A short time after the agency approved Lifyorli, it cleared Denali Therapeutics Inc.’s Avlayah (tividenofusp alfa) under the accelerated approval pathway for mucopolysaccharidosis II, also called Hunter syndrome, ahead of the April 5 PDUFA date.
Yuhan Corp. has discovered glucagon-like peptide 1 receptor (GLP-1R) agonists reported to be useful for the treatment of obesity, diabetes, hypertension, hyperlipidemia, hypoglycemia, coronary artery disease, chronic kidney disease and cardiovascular disorders, as well as hepatic steatosis and alcoholic fatty liver disease.
Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.
Omass Therapeutics Ltd. has described new melanocortin MC2 receptor antagonists reported to be useful for the treatment of congenital adrenal hyperplasia, Cushing syndrome, depression, ectopic ACTH syndrome, polycystic ovary syndrome and septic shock.
Congruence Therapeutics Inc. has closed a $39.5 million financing to advance into its portfolio of small-molecule correctors for diseases of protein misfolding into the clinic.
Kalohexis LLC has launched as a spin-out from Endevica Bio Inc. with the goal of advancing the clinical development of a portfolio of drug candidates harnessing the melanocortin system for the treatment of metabolic disorders such as obesity and cancer cachexia.
Minimed Group Inc. secured U.S. FDA approval for Minimed Flex, its next-generation discreet, smartphone-controlled insulin pump. The nod from the FDA follows the company’s debut on Nasdaq March 6. About half the size of the Minimed 780G pump and roughly the size of two stacked insulin vials, the screenless pump was designed in collaboration with people living with diabetes to offer a more intuitive, lifestyle‑friendly way to manage the condition.
In a sea of uncertainty, a large-scale, long-term Swedish study is the first to show that people using GLP-1 receptor agonists are less likely to have worsening mental illness. The study involved a national cohort of 95,490 people diagnosed with depression or anxiety disorder, who also were treated with any diabetes drug (apart from insulin).
Further weight loss details are yet to come this year, but Eli Lilly and Co. scored positive top-line results in Transcend-T2D-1, a phase III trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise in type 2 diabetes (T2D).
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