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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 27, 2025
AMYLYX PHARMACEUTICALS, INC.
(Exact name of Registrant as Specified in Its Charter)
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| Delaware |
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001-41199 |
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46-4600503 |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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| 43 Thorndike St., |
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| Cambridge, MA |
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02141 |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (617) 682-0917
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Trading Symbol(s) |
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Name of each exchange
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| Common Stock, $0.0001 par value per share |
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AMLX |
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Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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.
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AMYLYX PHARMACEUTICALS, INC. |
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| Date: August 27, 2025 |
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By: |
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/s/ James M. Frates |
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James M. Frates |
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Chief Financial Officer |
