Bank of America analyst Tim Anderson raised the firm’s price target on Amylyx to $14 from $10 while keeping a ‘Buy’ rating on the shares after the company reiterated earlier this week that it has a cash runway until the end of 2026.
The U.S. Food and Drug Administration (FDA) announced on Thursday that it is withdrawing its approval of the new drug application (NDA) for Amylyx Pharmaceuticals’ (AMLX) Relyvrio.
Amylyx has voluntarily requested that the FDA withdraw approval of this application and has waived its opportunity for a hearing, the agency said. The FDA approved the application for Relyvrio for the treatment of amyotrophic lateral sclerosis (ALS) in adults in September 2022. Amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, is a progressive, fatal neurodegenerative disorder that causes muscle weakness and paralysis by destroying motor neurons, the cells that control voluntary muscle movement.
However, last year, the company reported to the agency that a late-stage trial evaluating the drug in patients living with ALS did not meet its prespecified goals. It also notified the agency that it plans to discontinue marketing of Relyvrio as of Oct. 31, 2024.
On Stocktwits, retail sentiment around AMLX stock stayed within ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘extremely high’ levels. Shares of the company traded 1% lower at the time of writing.
Bank of America analyst Tim Anderson raised the firm’s price target on Amylyx to $14 from $10 while keeping a ‘Buy’ rating on the shares after the company reiterated earlier this week that it has a cash runway until the end of 2026 on the heels of discontinuing its AMX0035 program in adults living with progressive supranuclear palsy.
The decision to discontinue the program was made after it failed to show differences compared to the placebo on primary or secondary outcomes at week 24 in a mid-stage trial. The company will not initiate the late-stage portion of the program, it then said.
AMLX stock is up 148% this year and approximately 349% over the past 12 months.
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