Amylyx is approaching key catalysts ahead of its May 7 earnings report, led by Phase 3 LUCIDITY data for avexitide in post-bariatric hypoglycemia due in the third quarter. The company is also expected to provide updates on AMX0035 in Wolfram syndrome and AMX0114 biomarker data in ALS.
Amylyx Pharmaceuticals is advancing avexitide toward potential FDA approval for post-bariatric hypoglycemia, with Phase 3 LUCIDITY trial results expected in Q3 2026 and a cash runway extending into 2028.
Belite Bio announced preliminary Q4 2025 results and plans to submit an NDA for tinlarebant in Q2 2026 following positive Phase 3 trial results. BioArctic reported record financial results with operating profit exceeding SEK 1.2 billion for 2025. Recordati delivered strong preliminary full-year 2025 results despite FX headwinds.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07029412 |
Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI) |
RECRUITING | PHASE2 |
| NCT06896682 |
Cortisol and Obesity - A Vicious Cycle? Hypoglycemia After Bariatric Surgery - Association With Cortisol Metabolism? |
RECRUITING | |
| NCT06036784 |
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects |
COMPLETED | PHASE1 |
| NCT05721729 |
Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions |
COMPLETED | PHASE2 |
| NCT05541939 |
Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects |
COMPLETED | PHASE2 |
| NCT03373435 |
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia |
COMPLETED | PHASE2 |
