Lexicon Pharmaceuticals

The FDA rejected Lexicon Pharmaceuticals' sotagliflozin (Zynquista) for type 1 diabetes and chronic kidney disease, citing risks outweighing benefits. Despite clinical trial promise, the decision aligns with Lexicon's shift to focus on other pipeline candidates, including LX9211 for diabetic neuropathic pain.

Lexicon Pharmaceuticals received a complete response letter from the FDA regarding the NDA for Zynquista as an adjunct to insulin therapy for adults with type 1 diabetes and chronic kidney disease. The company will discontinue launch preparations for Zynquista and focus on its clinical development pipeline, including LX9211 for diabetic neuropathic pain.

Joseph Pantginis, H.C. Wainwright analyst, maintains Buy rating on PDS Biotechnology (PDSB) with a $21.00 price target, citing the company's promising cancer treatment advancements, particularly its VERSAMUNE platform and VERSATILE-003 study for HPV-16 positive head and neck cancers, supported by oncology key opinion leaders. Comparisons with KEYNOTE-048 and LEAP-010 highlight PDS’s competitive edge and favorable response rates.

Lexicon Pharmaceuticals completed enrolment for the Phase IIb PROGRESS trial of LX9211, an AAK1 inhibitor for diabetic peripheral neuropathic pain, enrolling 494 subjects, 20% more than the target. The placebo-controlled trial aims to reduce Average Daily Pain Score at eight weeks and includes secondary endpoints for burning pain and sleep interference. Top-line data is expected in Q1 next year.

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Lexicon Pharmaceuticals to lay off 60% of workforce, eliminate commercial organization, and save $100 million in operating costs following FDA's 'deficiencies' in Zynquista approval application. The company will pivot to focus on research pipeline, including Phase 2 diabetic peripheral neuropathic pain drug and preclinical obesity therapy.

Lexicon Pharmaceuticals, Inc. announced Ivan H. Cheung's election to its Board of Directors. Cheung, a biopharmaceutical executive with over 25 years of experience, currently serves as CEO of NextPoint Therapeutics and senior advisor to TPG Growth. His appointment coincides with Robert J. Lefkowitz's retirement after 23 years on the board.

Lexicon Pharmaceuticals reported $1.8M in Q3 2023 revenues from INPEFA sales, with a net loss of $(64.8)M. The company is commercializing INPEFA for cardiovascular risks and pursuing FDA approval for ZYNQUISTA for type 1 diabetes. Lexicon faces challenges including commercialization risks, clinical trial outcomes, and financial needs, but aims to manage these through strategic initiatives and collaborations.

FDA considers removing oral phenylephrine from OTC guidelines due to lack of efficacy, not safety concerns. Public comments invited until May 7, 2025, before final decision. Phenylephrine is in many nasal decongestants like Sudafed and Mucinex. FDA's proposal does not affect nasal spray decongestants.

Lexicon Pharmaceuticals faces FDA rejections for sotagliflozin, its type 1 diabetes and chronic kidney disease drug, with an advisory committee voting against its approval. Despite setbacks, Lexicon continues development and anticipates an FDA decision by December 20.