8-K - Amylyx Pharmaceuticals, Inc. | StockGist

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Amylyx Pharmaceuticals updated its corporate presentation for investor meetings, reflecting completion of enrollment in the Phase 3 LUCIDITY trial for avexitide in post-bariatric hypoglycemia (PBH), an addition to the exploratory analysis of the Phase 2 PREVENT study, and completion of enrollment for Cohort 2 in the Phase 1 LUMINA trial for AMX0114. Topline data from LUCIDITY is expected in Q3 2026, with commercial launch anticipated in 2027 if approved.

Key Takeaways

1Enrollment completed in Phase 3 LUCIDITY trial for avexitide in PBH (FDA-agreed primary outcome: reduction in composite Level 2 and Level 3 hypoglycemic events through Week 16)

2Topline data from LUCIDITY expected Q3 2026

3Commercial launch of avexitide anticipated 2027 if approved

4Completed enrollment in Cohort 2 (n=12) of Phase 1 LUMINA trial for AMX0114 in ALS in March 2026

5Addition to exploratory analysis of Phase 2 PREVENT study (previously presented at ENDO 2025 Annual Meeting)

6Pending FDA alignment, plan to initiate pivotal Phase 3 trial of AMX0035 in Wolfram syndrome

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1. The information in Item 7.01 of this Curren

Regulation Fd

9.01

Financial Statements and Exhibits. (d) Exhibits. Exhibit Number Description 99.1 Corporate Presentation, furnished herewith. 104 Cover Page Interactive Data Fil

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1