Lexicon Pharmaceuticals

Highly anticipated FDA approvals by year-end include acoramidis for ATTR-CM, olezarsen for FCS, sotagliflozin for type 1 diabetes, oral sulopenem for uUTI, and DFD-29 for rosacea.

Lexicon Pharmaceuticals announced the initiation of patient randomization in SONATA-HCM, a Phase 3 trial evaluating sotagliflozin for hypertrophic cardiomyopathy (HCM). The multinational study aims to support a supplemental new drug application (sNDA) with a broad label for both obstructive and non-obstructive HCM. The trial will be presented at the virtual Hypertrophic Cardiomyopathy Medical Society (HCMS) 2024 Scientific Sessions.

Lexicon Pharmaceuticals announced positive sotagliflozin clinical trial results for type 2 diabetes, improving time-in-range (TIR) and glucose variability. The data, presented at the 60th EASD Annual Meeting, showed sotagliflozin 400 mg and 200 mg doses approaching the ADA TIR target of 70%.

Lexicon Pharmaceuticals announced the FDA acknowledged the resubmission of its NDA for Zynquista (sotagliflozin) for type 1 diabetes and CKD, with a PDUFA goal date of December 20, 2024.

Lexicon Pharmaceuticals resubmits sotagliflozin NDA for type 1 diabetes and CKD, aiming to provide an adjunct to insulin therapy for glycemic control. The company is optimistic about the benefit/risk profile and expects a six-month regulatory review period.