Amylyx Pharmaceuticals

Biogen's Qalsody (tofersen) receives FDA accelerated approval as the first therapy for SOD1-mutated ALS, marking a significant breakthrough in genetic-specific ALS treatment.

The FDA has lifted the clinical hold on Amylyx Pharmaceuticals' Phase 1 trial of AMX0114, an antisense oligonucleotide for ALS treatment.

Amylyx Pharmaceuticals has appointed Dan Monahan as Chief Commercial Officer to lead the commercialization of their product portfolio.

GLP-1 receptor agonists like semaglutide and tirzepatide showed potential beyond diabetes and weight loss, including cardiovascular and mental health benefits.

Amylyx Pharmaceuticals initiates Phase 3 LUCIDITY trial for avexitide, a GLP-1 receptor antagonist, targeting post-bariatric hypoglycemia (PBH).

Amylyx reported positive topline data from its Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome, showing improvement or stabilization across key disease measures.

Amylyx Pharmaceuticals' AMX0035 demonstrated sustained improvements in pancreatic function in adults with Wolfram syndrome in a Phase 2 trial.

Amylyx Pharmaceuticals' Relyvrio failed to demonstrate significant benefit in the Phase 3 PHOENIX trial for ALS, raising concerns about its efficacy.

Aldeyra Therapeutics' stock plummeted after the FDA identified substantive review issues with its NDA for reproxalap for dry eye disease, potentially delaying approval.

Post-hoc analysis using the PRO-ACT database suggests Relyvrio (sodium phenylbutyrate and taurursodiol) extends median overall survival by 10.39 months in ALS patients compared to treatment-naïve controls.