Amylyx Pharmaceuticals (AMLX) Stock: Why It Increased Today

By Amit Chowdhry ● Jul 5, 2022
  • The stock price of Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) increased by 0.15% today. This is why.

The stock price of Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) increased by 0.15% today. Investors responded positively to Amylyx Pharmaceuticals announcing that the U.S. Food and Drug Administration (FDA) has informed the company that the FDA is planning to reconvene the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) to discuss the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate (PB) and taurursodiol (TURSO; also known as ursodoxicoltaurine) for the treatment of amyotrophic lateral sclerosis (ALS) on Wednesday, September 7, 2022.

The FDA is going to formally announce the scheduling of the planned PCNSDAC meeting in the Federal Register. Discussions will focus on the additional analyses of data from the Company’s clinical studies that were determined by the FDA to constitute a major amendment to the NDA. The Prescription Drug User Fee Act (PDUFA) target action date for the AMX0035 NDA is September 29, 2022, which was extended from June 29, 2022, to allow more time for the FDA to review additional analyses of data from the Company’s clinical studies. The PCNSDAC previously met on March 30, 2022, to discuss the NDA for AMX0035 for the treatment of ALS.

KEY QUOTE:

“We remain engaged with the FDA to advance AMX0035 through the review process as efficiently as possible. We are pleased that the members of the advisory panel will review additional analyses from our clinical studies, including recently published analyses, supporting the previously reported functional and overall survival benefit for AMX0035. As we have heard from the ALS community, there is a crucial need for new and effective treatments in ALS, and our team will continue to work around the clock to advance treatments for ALS in the U.S.”

— Tammy Sarnelli, Global Head of Regulatory Affairs of Amylyx

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