Amylyx Phase 3 ALS trial misses primary endpoint; may withdraw RELYVRIO

Amylyx Pharmaceuticals, Inc.

PHOENIX trial: no significant difference on ALSFRS-R at Week 48 (p=0.667); secondary endpoints also missed.
Company may voluntarily withdraw RELYVRIO/ALBRIOZA from market; will decide within 8 weeks after regulatory discussions.
Promotion paused immediately; drug and patient support remain available for now.
Study enrolled 664 adults; safety profile consistent, no new signals.
Phase 3 ORION in PSP and Phase 2 HELIOS in Wolfram syndrome continue as planned.

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