SEC Form 8-K filed by Amylyx Pharmaceuticals Inc.
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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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AMYLYX PHARMACEUTICALS, INC. | ||||||
| Date: August 27, 2025 | By: | /s/ James M. Frates | ||||
| James M. Frates | ||||||
| Chief Financial Officer | ||||||