Lexicon Pharmaceuticals, Inc. LXRX
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) is a cardio-renal-metabolic drug developer. Its lead program, INPEFA (sotagliflozin), is in Phase 3 for reduce CV death, HF hospitalization and urgent HF visits in adults with heart failure or T2DM, CKD and other CV risk factors.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| INPEFA (sotagliflozin) | heart failure / T2DM with CKD and CV risk | small molecule | Approved |
| sotagliflozin (SONATA-HCM) | hypertrophic cardiomyopathy (pivotal Phase 3; enrollment complete) | small molecule | Phase 3 |
| ZYNQUISTA (sotagliflozin) | type 1 diabetes (two CRLs; NOOH proceedings ongoing; possible NDA resubmission) | small molecule | Phase 3 |
| pilavapadin (LX9211) | diabetic peripheral neuropathic pain (completed Phase 2b; seeking partner) | small molecule | Phase 2 |
| LX9851 (licensed to Novo Nordisk) | obesity and cardiometabolic disorders | small molecule | Phase 1 |
Recent results and decisions
- Aug 6, 2026completed enrollment Enrollment completed in Phase 3 SONATA-HCM, substantially exceeding the 500-patient target, with a majority of non-obstructive HCM patients; topline expected Q1 2027.
Enrollment has been completed in SONATA-HCM, a pivotal Phase 3 placebo-controlled study, substantially exceeding its enrollment target of 500 patients across both non-obstructive (nHCM) or obstructive HCM (oHCM).
Filing - Mar 5, 2026n/a Successful FDA End-of-Phase 2 meeting in Q4 2025: FDA raised no objections to advancing pilavapadin 10 mg into two 12-week placebo-controlled Phase 3 registrational studies.
The FDA raised no objections to the advancement of pilavapadin into Phase 3 development, which would include two placebo-controlled, 12-week, two arm registrational studies comparing the 10 mg daily dose to placebo.
Filing - Nov 6, 2025positive PROGRESS Phase 2b (re-presented at EASD/NEUROdiab): pilavapadin 10 mg gave a two-point reduction from baseline in average daily pain score by week 12 and was generally well tolerated; no formal endpoint outcome stated.
demonstrating that pilavapadin 10 mg resulted in a two-point reduction from baseline in average daily pain scores (ADPS) by week 12 and was generally well tolerated in the PROGRESS Phase 2b study in DPNP.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
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- Phase 2 evidence behind each Phase 3 readout
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Other phase 3 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.