Yasmeen Rahimi

Andrew Tsai

Joseph Pantginis

Joseph Stringer

Lin Tsai

Roanna Ruiz

Yigal Nochomovitz

Caroline DePaul

Joe Pantginis

Liam Hiester

Mazahir Alimohamed

- Lexicon Pharmaceuticals presented additional clinical data and program updates for its **pilavapadin Phase 2 program** in diabetic peripheral neuropathic pain (DPNP).  **[1062822_24148f6464814d45ac7360b602c88563_0]** 
- The data supports advancing the **10 mg dose** of pilavapadin into Phase 3 development, and the company's **end-of-Phase 2 meeting request with the U.S. FDA has been accepted**.  **[1062822_24148f6464814d45ac7360b602c88563_0]** 
- Additional analyses confirmed pilavapadin's **validated biological activity, clinically meaningful efficacy, and acceptable tolerability and safety profiles**.  **[1062822_24148f6464814d45ac7360b602c88563_0]** 
- Lexicon is **actively progressing discussions with potential partners** for pilavapadin.  **[1062822_24148f6464814d45ac7360b602c88563_0]**

Lexicon Pharmaceuticals Provides Update on Pilavapadin Phase 2 Program

- Lexicon Pharmaceuticals provided updates on its key pipeline assets, including the **licensing of LX9851 to Novo Nordisk** for obesity and related conditions in Q1 2025.  **[1062822_tx_380477_1]** 
- The company plans to advance **pilovapitan** into Phase 3 for diabetic peripheral neuropathic pain (DPNP) in **early 2026**, following an end of Phase 2 meeting with the FDA in late 2025, with data expected in **2027**.  **[1062822_tx_380477_1]** **[1062822_tx_380477_7]** **[1062822_tx_380477_9]**  Lexicon intends to partner this program.  **[1062822_tx_380477_9]** 
- For **sotagliflozin**, the **SONARDA trial** for hypertrophic cardiomyopathy (HCM) is enrolling well, with patient enrollment expected to complete in **2026** and data anticipated in **2027**.  **[1062822_tx_380477_1]** **[1062822_tx_380477_7]**  The company sees sotagliflozin as a potential first-line therapy for both HFpEF and HCM.  **[1062822_tx_380477_3]** **[1062822_tx_380477_4]**

Lexicon Pharmaceuticals Provides Pipeline and Clinical Trial Updates

- Lexicon Pharmaceuticals announced the presentation of a post-hoc analysis of sotagliflozin clinical data at the European Society of Cardiology (ESC) 2025 Congress in Madrid, Spain, on **August 31, 2025**.  **[1062822_c8ea2fdd36a44c8da134975b05f1c6d3_0]** 
- The analysis, which pooled data from the SCORED and SOLOIST-WHF studies, included nearly **12,000 participants**, with approximately **70% aged 65 or older**.  **[1062822_c8ea2fdd36a44c8da134975b05f1c6d3_0]** 
- Sotagliflozin consistently reduced heart failure endpoints (total CV death, hospitalization for HF, or urgent visit for HF) across all age ranges, with an overall hazard ratio of **0.72** compared to placebo.  **[1062822_c8ea2fdd36a44c8da134975b05f1c6d3_0]** **[1062822_c8ea2fdd36a44c8da134975b05f1c6d3_1]** 
- Total major cardiovascular adverse events (MACE) were also consistently reduced by sotagliflozin across all age groups, with an overall hazard ratio of **0.80** compared to placebo.  **[1062822_c8ea2fdd36a44c8da134975b05f1c6d3_0]** **[1062822_c8ea2fdd36a44c8da134975b05f1c6d3_1]** 
- These findings are considered **unique** among SGLT inhibitors, demonstrating that sotagliflozin can benefit patients of all ages, including the elderly.  **[1062822_c8ea2fdd36a44c8da134975b05f1c6d3_0]**

Lexicon Pharmaceuticals Presents Positive Sotagliflozin Data at ESC 2025 Congress

LEXICON PHARMACEUTICALS (LXRX)