Amylyx Pharma wins FDA advisory committee backing for ALS drug

Sep. 07, 2022 6:26 PM ETAmylyx Pharmaceuticals, Inc. (AMLX)By: Anuron Mitra, SA News Editor12 Comments

ALS acronym on colorful wooden cubes

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A U.S. Food and Drug Administration (FDA) advisory committee on Wednesday voted in favor to recommend approval of Amylyx Pharmaceuticals' (NASDAQ:AMLX) treatment for neurodegenerative disease amyotrophic lateral sclerosis (ALS).

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 7 in favor and 2 against for the drug, known as AMX0035. There were two abstain votes.

Shares of Amylyx (AMLX) have been halted for trading as the closely watched meeting has continued. Meanwhile, shares of Reata Pharmaceuticals (RETA) and Ardelyx (ARDX), fellow clinical-stage biopharma companies that face their own upcoming AdCom meetings, ended ~21% and ~6% higher, respectively.

Today's AdCom is the second second review for the drug after the FDA's independent experts reached a negative vote in March and extended its review period by three months to analyze additional data.

AMLX stock plunged ~23% last week on Friday after the FDA posted briefing documents ahead of today's meeting.

The company backs its candidate with data from its phase 2 trial called CENTAUR. A phase 3 trial named PHOENIX is also currently underway to further evaluate the safety and efficacy of AMX0035 in ALS.

Earlier in the opening remarks of the meeting, the FDA noted that it had the right to force the company to withdraw a drug if further clinical data turned out to be negative, to which AMLX CEO Justin Klee said that if AMX0035 were to be approved and the PHOENIX trial were to eventually fail, the company would pull it from the market.

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