Amylyx Pharmaceuticals

Dan Monahan appointed Chief Commercial Officer at Amylyx, leading commercialization for avexitide, a GLP-1 receptor antagonist for post-bariatric hypoglycemia. With over 20 years in biopharma, Monahan aims to address high unmet medical needs, focusing on avexitide's Phase 3 trial and potential market launch.

The *NeurologyLive*® podcast *Mind Moments*® released nearly 30 episodes in a year, featuring expert interviews on neurologic care. Highlights include discussions on new McDonald criteria for MS, Alzheimer drug development lessons, RNA therapeutics for Alzheimer, AMX0035's phase 3 PHOENIX study for ALS, and vorasidenib's benefits in diffuse gliomas.

ALS News Today highlighted 2024's top ALS research, including TPN-101's Phase 2a success, IGFBP7 gene's link to ALS reversal, COYA 302's promise, SPG302's FDA clearance, Japan's high-dose B12 approval, Prilenia's Phase 3 plans, recreational activities' ALS risk, Relyvrio's discontinuation, monepantel's potential, and PrimeC's survival benefits.

Corcept Therapeutics' dazucorilant failed to slow ALS progression in a phase 2 trial, missing primary endpoints and causing more gastrointestinal upset. Despite earlier promise in animal models, the trial's outcome reflects the challenges in ALS treatment development. Corcept plans to continue dazucorilant's development with a long-term study.

GLP-1 drugs like semaglutide and tirzepatide have expanded uses beyond diabetes and weight loss, potentially treating cardiovascular disease, kidney disease, anxiety, depression, and substance use disorder. CRISPR drugs Casgevy for sickle cell disease and β-thalassemia entered the market, though uptake is slow due to complex treatment processes. Protein-folding algorithms by Baker, Hassabis, and Jumper revolutionized biochemical research and pharmaceutical applications. ADCs received significant investment, with firms exploring new linker chemistries. Amylyx Pharmaceuticals pulled an ALS drug after trial failure, continuing research for other uses. Kelly Chibale called for recognizing African scientific potential. Virologists monitored H5N1, mpox, and Marburg outbreaks, with ongoing research and emergency measures. Radiopharmaceuticals saw increased investment and market growth. Evidence suggests vaccines like shingles and flu jabs may protect against dementia.

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.