Lexicon Pharmaceuticals

FDA Advisory Committee voted 11 to 3 that Zynquista's benefits do not outweigh risks for adults with type 1 diabetes and chronic kidney disease, though some committee members supported its use in alternative sub-populations. Lexicon Pharmaceuticals remains hopeful for FDA approval and potential benefits of Zynquista, especially for those with inadequate glycemic control and CKD.

FDA staff raises safety concerns about sotagliflozin for type 1 diabetes with chronic kidney disease, focusing on diabetic ketoacidosis risks and treatment durability.

Lexicon Pharmaceuticals expects to complete enrollment ahead of schedule in the PROGRESS study for LX9211, with top-line data anticipated in Q1 2025. LX9211, an AAK1 inhibitor, received FDA Fast Track designation for diabetic peripheral neuropathic pain.

Lexicon Pharmaceuticals announced a new analysis of its Phase 3 SCORED trial showing sotagliflozin's protective effects in diabetic kidney disease (DKD) patients, to be presented at Kidney Week 2024.

Lexicon Pharmaceuticals completes screening for Phase 2B PROGRESS study of LX9211 in DPNP, expecting enrollment ahead of schedule and top-line data in Q1 2025, earlier than previously anticipated Q2 2025.

Lexicon Pharmaceuticals sells sotagliflozin rights outside U.S. and Europe to Viatris for $25M upfront, with potential $200M in milestones. Lexicon focuses on Type 1 diabetes expansion, awaiting FDA advisory panel review on Oct 31 for sotagliflozin use in Type 1 diabetes and chronic kidney disease patients. The approval could open a $400M U.S. market, impacting Lexicon's stock by up to 40%.

Diabetic Peripheral Neuropathy market to surge due to increasing prevalence and awareness, with multiple-stage pipeline products revolutionizing market dynamics. Key companies include Grünenthal, Averitas Pharma, Daiichi Sankyo, Vertex Pharmaceuticals, Helixmith, and Lexicon Pharmaceuticals. Emerging therapies such as QUTENZA (capsaicin) and TARLIGE (mirogabalin besylate) are expected to drive market growth.

DelveInsight's report on Congestive Heart Failure Market (2020-2034) covers epidemiology, market trends, key companies, and therapies. Market size was ~USD 6,900 million in 2023, expected to grow significantly. Key companies include Novartis, Bayer, and Eli Lilly. Therapies like ENTRESTO and JARDIANCE are highlighted. Market drivers include aging population and disease prevalence, while barriers include generic therapies and diagnostic challenges.

The FDA will meet on October 31, 2024, to discuss sotagliflozin as an adjunct to insulin therapy for adults with type 1 diabetes and chronic kidney disease. Lexicon Pharmaceuticals anticipates sharing evidence supporting sotagliflozin's favorable benefit/risk profile. The PDUFA goal date is December 20, 2024.

The FDA faces decisions on Amgen's Lumakras for colorectal cancer, Camurus' subcutaneous octreotide for acromegaly, Iterum's oral sulopenem for uUTI, and Lexicon's Zynquista for type 1 diabetes and CKD, with target action dates in October.