LX9851 / Lexicon Pharma, Novo Nordisk - LARVOL DELTA

Lexicon Pharmaceuticals…announced that it has earned a third $10 million milestone payment in 2026 from Novo Nordisk A/S following the achievement of a key patient dosing milestone in the ongoing Phase 1 clinical development program for LX9851…being developed for obesity and associated metabolic disorders (GlobeNewswire) - "With the achievement of this milestone, Lexicon has now earned $75 million of the $1 billion in potential upfront, development, regulatory and commercial milestone payments available under its collaboration with Novo Nordisk. In addition, Lexicon is entitled to receive tiered royalties on future net sales of LX9851....The Phase 1 development program for LX9851 was initiated by Novo Nordisk in March 2026 and is investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of LX9851 compared to placebo in adult subjects who are overweight or obese."

Financing • Trial status • Metabolic Disorders • Obesity

Obesity and Associated Cardiometabolic Disorders (The Manila Times) - "In March 2026, Novo Nordisk initiated a Phase 1 study investigating single and multiple ascending doses of LX9851 compared to placebo in overweight or obese people. The Phase 1 program is expected to be completed in the first quarter of 2027."

Trial completion date • Obesity

Lexicon Pharmaceuticals and Novo Nordisk Announce initiation of Phase 1 study with oral obesity drug candidate LX9851 (GlobeNewswire) - "Lexicon has earned a second $10 million milestone payment in 2026 from Novo Nordisk following initial dosing requirements in the Phase 1 study and is eligible for a third $10 million milestone payment that may be achieved later this year...The Phase 1 study is investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of LX9851 compared to placebo in 96 people with overweight or obesity. The trial is expected to be completed in the first quarter of 2027."

Financing • Trial completion date • Trial status • Obesity

Lexicon Pharmaceuticals Announces Exclusive License Agreement with Novo Nordisk for LX9851 (GlobeNewswire) - "Lexicon Pharmaceuticals, Inc...announced that it has entered into an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development candidate in obesity and associated metabolic disorders. Under the terms of the agreement, Novo Nordisk obtains an exclusive, worldwide license to develop, manufacture and commercialize LX9851 in all indications. Lexicon will be responsible for completing agreed upon Investigational New Drug (IND) application-enabling activities for LX9851. Novo Nordisk will be responsible for filing the IND, all further development, manufacturing and commercialization of LX9851. Lexicon is eligible to receive upfront and near-term milestone payments of up to $75 million. In total, Lexicon will be eligible to receive $1 billion in upfront and potential development, regulatory and sales milestone payments. Lexicon is also entitled to tiered royalties on net sales of LX9851."

Licensing / partnership • Metabolic Disorders • Obesity

Lexicon Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "Pilavapadin (LX9211) for DPNP: The Company is moving toward an end of Phase 2 meeting with FDA and targeting initiation of U.S. and ex-U.S. Phase 3 trials in DPNP in 2025, while selecting a future medical meeting for release of additional clinical data later this year....LX9851 for Obesity and Associated Cardiometabolic Disorders: LX9851 is progressing in IND-enabling studies and on track for a 2025 investigational new drug (IND) application submission. Zynquista (sotagliflozin): Discontinued preparation for potential Zynquista launch in type 1 diabetes following receipt of complete response letter from FDA."

Discontinued • IND • New P3 trial • P3 data • Diabetic Neuropathy • Obesity • Peripheral Neuropathic Pain • Type 1 Diabetes Mellitus