The shares of clinical-stage biopharma companies Reata Pharmaceuticals ( NASDAQ: RETA ) and Ardelyx ( ARDX ) gained on Wednesday as an expert panel of the FDA is set to decide whether to recommend approval for an amyotrophic lateral sclerosis treatment developed by Amylyx Pharmaceuticals ( AMLX ).
However, AMLX shares are currently on hold for trading as the FDA's Peripheral and Central Nervous System Drugs Advisory Committee is set to vote on the ALX treatment known as AMX0035 later in the day.
Meanwhile, RETA expects the FDA to conduct an advisory committee meeting over its marketing application for Friedreich's ataxia therapy, omaveloxolone, ahead of the PDUFA date on Feb 28, 2022.
ARDX is facing its own AdCom meeting in November over its marketing application for hyperphosphatemia therapy Xphozah which the agency declined to approve in 2021.
AMLX backs the candidate with data from its single double-blind, placebo-controlled Phase 2 study called CENTAUR. A Phase 3 trial titled PHOENIX is also currently underway to further evaluate the safety and efficacy of AMX0035 in ALS.
In his opening remarks at the meeting, the director of the FDA's Office of Neuroscience noted that the agency has the legal authority to force a company to withdraw a drug if further clinical evidence turns out to be negative.
In response, AMLX Chief Executive Justin Klee said that the company would "do what is right for patients" and, if the drug is approved, it would voluntarily pull the drug from the market if the PHOENIX trial fails.
For further details see:
Amylyx drives Reta, Ardelyx higher ahead of AdCom decision on ALS drug