An FDA panel is scheduled to reconvene on September 7, 2022, to discuss the regulatory application of Amylyx Pharmaceutical Inc.’s (AMLX) AMX0035.AMX0035 is proposed for the treatment of amyotrophic lateral sclerosis, a progressive and fatal neurodegenerative disorder affecting nerve cells in the brain and spinal cord.This is for the second time that AMX0035 is being reviewed by the FDA panel.In March of this year, the panel had voted 4 "Yes" and 6 "No" to the question "Do the data from the single randomized, controlled trial and the open-label extension study establish a conclusion that AMX0035 is effective in the treatment of patients with amyotrophic lateral sclerosis?"With the company submitting additional analyses from its clinical studies supporting the previously reported functional and overall survival benefit for AMX0035, the FDA notified that company that it is reconvening the Advisory Committee.The FDA’s final decision on AMX0035 is expected on September 29, 2022.Mitsubishi Tanabe’s Radicava; Sanofi-Aventis’ Rilutek; ITF Pharma’s Tiglutik; Aquestive Therapeutics’ Exservan; and Avanir Pharma’s Nuedexta are some of the drugs approved by the FDA to treat amyotrophic lateral sclerosis and its symptoms.AMLX closed Friday’s trading at $26.31, down 0.57%.