Amylyx Pharmaceuticals (AMLX) Q3 2026 earnings summary

Executive summary

• Phase 3 LUCIDITY met its primary and all secondary endpoints, reducing the composite rate of Level 2 and Level 3 hypoglycemic events by 55% versus placebo (p=0.000003).

• Avexitide NDA submission remains targeted for year-end 2026, with a potential 2027 launch subject to approval; commercial readiness work is advancing.

• Pipeline includes AMX0318 for PBH and rare diseases, AMX0035 for Wolfram syndrome and AMX0114 for ALS.

Financial highlights

• Q3 2026 operating expenses were $49.7M, up 38% YoY; net loss was $45.5M versus $34.4M, and net loss per share was $0.38 versus $0.37.

• Q3 R&D was $28.4M versus $19.9M, and SG&A was $21.3M versus $16.2M; higher avexitide trial costs and pre-commercial spending contributed to increases.

• 9M 2026 operating expenses were $139.1M, up 19% YoY; net loss was $130.2M versus $111.7M, and loss per share was $1.15 versus $1.25.

• Cash, cash equivalents and marketable securities totaled $768.1M at September 30, 2026, versus $317.0M at December 31, 2025 and $250.8M at June 30, 2026.

Outlook and guidance

• Avexitide NDA submission to the FDA is targeted by year-end 2026; potential commercialization is planned for 2027 if approved.

• AMX0318 IND-enabling studies are underway, with an IND filing targeted for 2027; Phase 3 planning for AMX0035 in Wolfram syndrome continues with the FDA.

• R&D and SG&A are expected to rise with clinical development, manufacturing and commercial readiness; existing liquidity is expected to fund planned operations for the foreseeable future, subject to assumptions.