Amylyx Pharmaceuticals (NASDAQ:AMLX) stock is rising higher on Friday following an update from the U.S. Food and Drug Administration (FDA).
The FDA alerted Amylyx Pharmaceuticals of an extension to the review timeline for its New Drug Application (NDA) for AMX0035. This is the company’s drug in development to treat amyotrophic lateral sclerosis (ALS).
According to the FDA, the Prescription Drug User Fee Act (PDUFA) goal date is Sept. 29, 2022. The FDA extended the review period for the NDA to go over additional data from Amylyx Pharmaceuticals’ clinical trials of the treatment.
This comes after Amylyx Pharmaceuticals submitted additional data as part of its NDA. The FDA considers this a major amendment, which warrants going over as part of the NDA review process.
Justin Klee and Joshua Cohen, the co-founders and co-CEOs of Amylyx Pharmaceuticals, said the following in a statement.
“We are confident in the potential of AMX0035 to help people living with ALS and other neurodegenerative diseases, and we continue to work closely with the FDA as they complete their review.”
The FDA extension news also has AMLX stock seeing heavy trading today! As of this writing, more than 16 million shares of the stock have changed hands. That’s well above its daily average trading volume of 724,000 shares.
AMLX stock is up 23.5% as of Friday morning.
Investors looking for more recent stock market news are in the right place!
We’ve got all the hottest stock news for traders to read about on Friday! A few examples include what’s happening with shares of Tesla (NASDAQ:TSLA), Twitter (NYSE:TWTR), and Greenidge Generation (NASDAQ:GREE) stock today. You can read that news at the links below!
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
