Policy, Research

Advisory Committee's Split Decision on Biogen's Tofersen

Ira Loss, EVP Health Care Analyst
22 March 2023


We expect FDA to grant accelerated approval instead of full approval to Biogen’s (BIIB) tofersen for the reatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene by the April 25 user fee date after the Peripheral and Central Nervous System Drugs Advisory Committee split their votes on the two questions shown below.

Want to learn more? Download the Report.


Public Policy Research
Identify opportunity and risks driven by public policy.
Fundamental Equity Research
Gain a comprehensive view of global themes, industries, and companies.
Forensic Accounting Research
Understand implications of public company financial reporting.