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Amylyx Pharmaceuticals Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on AMX0035

Amylyx Pharmaceuticals Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on AMX0035

CAMBRIDGE, Mass., March 28, 2022–(Enterprise WIRE)–Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Foodstuff and Drug Administration (Fda) posted briefing documents for the March 30, 2022 Peripheral and Central Nervous Procedure Medication Advisory Committee (PCNSDAC) conference to review the Company’s New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS).

The Advisory Committee assembly is scheduled for 10 a.m. ET on Wednesday, March 30, 2022. The briefing materials and webcast facts can be accessed below. The Business is not liable for the content material of, nor the statements designed in, the briefing resources that were organized by the Fda.

The Prescription Drug Person Cost Act (PDUFA) focus on action date for the AMX0035 NDA is June 29, 2022.

About AMX0035

AMX0035 is a proprietary oral preset-dose combination of two tiny molecules: sodium phenylbutyrate (PB), which is a smaller molecular chaperone created to minimize the unfolded protein reaction (UPR), protecting against cell dying resulting from the UPR, and taurursodiol (TURSO also identified as ursodoxicoltaurine), which is a Bax inhibitor created to cut down cell demise via apoptosis. PB and TURSO ended up blended in a fastened-dose formulation in an effort and hard work to reduce neuronal demise and dysfunction. AMX0035 is built to focus on the endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases.

About Amylyx Prescribed drugs

Amylyx Prescription drugs, Inc. is a medical-phase biopharmaceutical company performing on producing a novel therapeutic for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. For more data, go to www.amylyx.com and observe us on LinkedIn and Twitter. For investors, be sure to stop by www.buyers.amylyx.com.

Forward-Seeking Statements

Statements contained in this push launch about issues that are not historical points are “forward-looking statements” within just the this means of the Non-public Securities Litigation Reform Act of 1995, as amended. Because these kinds of statements are topic to pitfalls and uncertainties, true results may perhaps vary materially from individuals expressed or implied by these kinds of ahead-searching statements. This sort of statements involve, but are not confined to, statements with regards to the likely approval of AMX0035 for the therapy of ALS and the opportunity of AMX0035 as a procedure for ALS. Any forward-wanting statements in this assertion are centered on management’s existing expectations of long run occasions and are subject matter to a amount of pitfalls and uncertainties that could bring about true final results to differ materially and adversely from individuals set forth in or implied by these kinds of forward-hunting statements. Challenges that lead to the unsure nature of the forward-wanting statements involve: regulatory developments and anticipations about the timing of Food and drug administration evaluate of AMX0035 for the cure of ALS, and the impression that the ongoing COVID-19 pandemic will have on Fda evaluate timelines, as perfectly as those people threats and uncertainties set forth in Amylyx’ United States Securities and Trade Fee filings. All forward-hunting statements contained in this press release talk only as of the day on which they were produced. Amylyx undertakes no obligation to update this kind of statements to mirror functions that manifest or conditions that exist just after the date on which they were being manufactured.

See source variation on businesswire.com: https://www.businesswire.com/information/house/20220328005619/en/

Contacts

Media
Becky Gohsler
Finn Partners
(646) 307-6307
[email protected]

Investors
Lindsey Allen
Amylyx Prescription drugs, Inc.
(857) 320-6244
[email protected]