Avexitide

Amylyx announced the design of its Phase 3 LUCIDITY trial for avexitide, a GLP-1 receptor antagonist for post-bariatric hypoglycemia. The trial, expected to start in Q1 2025, will evaluate reduction in hypoglycemia events and safety, with topline data anticipated in 2026.

Amylyx Pharmaceuticals announces the design of its pivotal Phase 3 LUCIDITY trial for avexitide, an investigational GLP-1 receptor antagonist for post-bariatric hypoglycemia. The trial aims to reduce hypoglycemia events and aligns with previous Phase 2 designs. Amylyx expects to dose the first participant in Q1 2025 and anticipates topline data in 2026. Avexitide has FDA Breakthrough Therapy and Orphan Drug designations.

Amylyx Pharmaceuticals announces Phase 3 LUCIDITY trial design for avexitide in post-bariatric hypoglycemia, aiming to reduce hypoglycemia events. The trial, set to begin in Q1 2025 with topline results expected in 2026, aligns closely with previous Phase 2 designs. Avexitide holds FDA Breakthrough Therapy and Orphan Drug designations.

Amylyx Pharmaceuticals announces Phase 3 LUCIDITY trial for avexitide, a GLP-1 receptor antagonist for post-bariatric hypoglycemia, with first participant dosing in Q1 2025 and topline results expected in 2026.

Amylyx Pharmaceuticals announces design of pivotal Phase 3 LUCIDITY trial for avexitide, an investigational GLP-1 receptor antagonist for post-bariatric hypoglycemia, with first participant dosing expected in Q1 2025 and topline results anticipated in 2026. Avexitide has FDA Breakthrough Therapy and Orphan Drug designations.

Amylyx Pharmaceuticals announces Phase 3 LUCIDITY trial design for avexitide, a GLP-1 receptor antagonist, to treat post-bariatric hypoglycemia (PBH). The trial aims to reduce hypoglycemia events and is expected to start dosing in Q1 2025, with topline data anticipated in 2026. Avexitide has shown consistent, dose-dependent effects in previous PBH trials.

Amylyx reports Q3 2024 financials: $234.4M cash, positive Phase 2 HELIOS trial data for AMX0035 in Wolfram syndrome, plans Phase 3 avexitide program for PBH in Q1 2025, and expects interim data from ORION trial in mid-2025.