UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On July 5, 2022, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has informed the Company that it is planning to reconvene the Peripheral and Central Nervous System Drugs Advisory Committee (“PCNSDAC”) to discuss the New Drug Application (“NDA”) for AMX0035 (sodium phenylbutyrate and taurursodiol (also known as ursodoxicoltaurine)) for the treatment of amyotrophic lateral sclerosis (“ALS”) on Wednesday, September 7, 2022. PCNSDAC discussions will focus on the additional analyses of data from the Company’s clinical studies that were determined by the FDA to constitute a major amendment to the NDA. The Prescription Drug User Fee Act target action date for the AMX0035 NDA is September 29, 2022, which was extended from June 29, 2022 to allow more time for the FDA to review additional analyses of data from the Company’s clinical studies.
A copy of the press release, dated July 5, 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 July 5, 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: July 5, 2022 | By: | /s/ James M. Frates | ||||
| James M. Frates | ||||||
| Chief Financial Officer | ||||||