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Amylyx Pharmaceuticals Stock Trading Halted Today

Amylyx Pharmaceuticals Stock Trading Halted Today

Food and drug administration Advisory Committee Meeting to Go over NDA for AMX0035 for the Therapy of ALS

CAMBRIDGE, Mass., March 30, 2022–(Organization WIRE)–Amylyx Prescribed drugs, Inc. (Nasdaq: AMLX) right now introduced that Nasdaq has halted trading of the company’s popular inventory.

The U.S. Food and Drug Administration’s (Food and drug administration) Peripheral and Central Anxious System Medication Advisory Committee (PCNSDAC) is assembly now to evaluation the New Drug Software (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the cure of amyotrophic lateral sclerosis (ALS).

The Advisory Committee conference is scheduled for 10:00 a.m. ET. The briefing elements can be identified on the Food and drug administration website listed here.

The Prescription Drug Person Charge Act (PDUFA) target motion day for the AMX0035 NDA is June 29, 2022.

About Amylyx Prescribed drugs

Amylyx Pharmaceuticals, Inc. is a medical-phase biopharmaceutical company doing work on acquiring a novel therapeutic for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. For extra facts, visit www.amylyx.com and follow us on LinkedIn and Twitter. For traders remember to take a look at www.traders.amylyx.com.

Forward-Looking Statements

Statements contained in this push launch regarding matters that are not historical specifics are “ahead-wanting statements” within just the which means of the Non-public Securities Litigation Reform Act of 1995, as amended. For the reason that these statements are matter to dangers and uncertainties, precise outcomes could vary materially from individuals expressed or implied by these kinds of ahead-on the lookout statements. This kind of statements include, but are not restricted to, statements with regards to the likely acceptance of AMX0035 for the procedure of ALS the prospective of AMX0035 as a treatment for ALS and expectations relating to our more time-phrase tactic. Any ahead-looking statements in this statement are based on management’s present-day anticipations of long run situations and are issue to a quantity of pitfalls and uncertainties that could bring about actual results to vary materially and adversely from all those set forth in or implied by these kinds of ahead-hunting statements. Dangers that add to the uncertain character of the ahead-searching statements incorporate: regulatory developments and anticipations pertaining to the timing of Fda critique of AMX0035 for the remedy of ALS, and the affect that the ongoing COVID-19 pandemic will have on Food and drug administration evaluate timelines, as nicely as those people risks and uncertainties set forth in Amylyx’ United States Securities and Trade Commission filings. All ahead-wanting statements contained in this push launch converse only as of the date on which they ended up built. Amylyx undertakes no obligation to update these kinds of statements to reflect functions that occur or situations that exist following the date on which they had been built.

Check out supply variation on businesswire.com: https://www.businesswire.com/information/home/20220330005162/en/

Contacts

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

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