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Healthcare

Amylyx Pharmaceuticals Inc.

08/27/2025 | Press release | Distributed by Public on 08/27/2025 05:06

Material Event (Form 8-K)

Item 8.01 Other Events

On August 27, 2025, Amylyx Pharmaceuticals, Inc. (the "Company") announced it is discontinuing the ORION program of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in adults living with progressive supranuclear palsy.

AMX0035 did not show differences compared to placebo on primary or secondary outcomes at Week 24. Based on these results, the Company will discontinue the Phase 2b trial and open-label extension and will not initiate the Phase 3 portion of the program. Safety data were consistent with safety data from prior studies of AMX0035.

Amylyx Pharmaceuticals Inc. published this content on August 27, 2025, and is solely responsible for the information contained herein. Distributed via SEC EDGAR on August 27, 2025 at 11:06 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]