Amylyx pairs avexitide Phase 3 win with $768m cash pile ahead of filing

Amylyx Pharmaceuticals has put a substantial balance sheet behind its lead late-stage programme. The company reported cash of $768.1m at the end of the third quarter and disclosed a public share offering with net proceeds of roughly $544.6m. The figures came in its 5 November results statement, which also carried the pivotal data for avexitide.

The Phase 3 LUCIDITY study, in post-bariatric hypoglycaemia (PBH), met its goal. Amylyx said avexitide reduced Level 2 and Level 3 hypoglycaemic events by 55% against placebo. The company plans to file a New Drug Application with the US Food and Drug Administration by the end of 2026.

Avexitide already carries the FDA's Breakthrough Therapy Designation, which gives a sponsor closer agency contact during development and review. The designation does not guarantee approval, and the material available gives no indication of when the agency might decide. It also does not describe LUCIDITY's design, the safety profile or how the events were defined.

Amylyx plans to present the full dataset at ObesityWeek on 15 November. That presentation is the first chance for outside analysts, payers and prospective competitors to examine the safety findings and the endpoint definitions that will underpin any label.