FDA Pushes Extends Review For Biogen's Amyotrophic Lateral Sclerosis Drug

The FDA extended the review period for Biogen Inc's (NASDAQ: BIIB) experimental Tofersen treatment for an inherited form of amyotrophic lateral sclerosis (ALS) by three months.
Biogen had submitted responses to the FDA's information requests, which the agency said would require additional time for review, and set a new target action date of April 25, 2023.
The agency had accepted Biogen's application for the drug, tofersen, under its accelerated approval pathway in July, with an approval decision expected by January 25, 2023.
In October 2021, VALOR did not meet the primary endpoint. However, trends of reduced disease progression across multiple secondary and exploratory endpoints were observed.
Last month, Biogen released a new analysis showing that longer-term use and early initiation of tofersen effectively slowed disease progression.
Price Action: BIIB stock is up 0.97% at $267.21 on the last check Monday.