UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On June 13, 2022, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that Canada’s national healthcare regulatory agency, Health Canada, has approved ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine), with conditions, for the treatment of amyotrophic lateral sclerosis (ALS). This decision marks the first marketing approval for ALBRIOZA (also known as AMX0035) issued to the Company worldwide.
The approval of ALBRIOZA was authorized under Health Canada’s Notice of Compliance with Conditions policy. One of the conditions of the approval is the provision of data from the Company’s ongoing Phase 3 PHOENIX trial. Other conditions include additional planned or ongoing studies. The Company anticipates topline results from the PHOENIX trial in 2024.
A copy of the press release, dated June 13, 2022, is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release of the Company, dated June 13, 2022 | |
| 104 | Cover Page Interactive Data File (embedded with the Inline XBRL document). | |
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 thereunto duly authorized.
| AMYLYX PHARMACEUTICALS, INC. | ||||||
| Date: June 13, 2022 | By: | /s/ James M. Frates | ||||
| James M. Frates | ||||||
| Chief Financial Officer | ||||||