“During the first quarter, we made continued progress across our pipeline, including strong clinical execution of our pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia. We remain focused on avexitide and continue to expect completion of enrollment in 2025 and topline data in the first half of 2026,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx (AMLX). “We also made important progress in dosing the first patient in our Phase 1 LUMINA trial of AMX0114 in ALS, with early cohort data expected later this year. Additionally, we look forward to presenting new, long-term data from the Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome in the coming days, and the topline data from the Phase 2b portion of the Phase 2b/3 ORION trial of AMX0035 are expected in the third quarter. With our momentum so far this year and current anticipated cash runway through the end of 2026, we remain confident in achieving our current goals and look forward to our upcoming milestones.”
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