Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
The U.S. Food and Drug Administration (FDA) has extended the review of New Drug Application (NDA) by three months, submitted by Amylyx Pharmaceuticals (NASDAQ:AMLX) for its lead drug candidate AMX0035 with regard to the treatment of patients with amyotrophic lateral sclerosis (ALS).
The regulatory agency has assigned Standard Review for the application and set a new PDUFA target action date of 29th September 2022.
The New Drug Application (NDA) was supported by CENTAUR Phase 2 clinical trial evaluated AMX0035 in 137 participants with ALS.
The FDA extended the goal date to allow more time to review additional analyses of data from the Company's clinical studies.
Justin Klee and Joshua Cohen, Co-CEOs and Co-Founders, commented : "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".
Amylyx Pharmaceuticals shares are currently trading at $11.80, up 21 percent in the pre-market session, compared with the previous day closing price of $8.55.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
ENTER TO WIN $500 IN STOCK OR CRYPTO
Enter your email and you'll also get Benzinga's ultimate morning update AND a free $30 gift card and more!