This report tracks seven ALS therapies at the late clinical stage of development, each positioned at a key regulatory milestone: post-approval and in confirmatory post-marketing trials, approaching New Drug Application (NDA) or Biologics License Application (BLA) submission in the near term, wrapping up a pivotal Phase 3 trial ahead of an anticipated filing, actively progressing a pivotal trial, or on hold to commence pivotal trial kickoff. Together they represent the most advanced drug candidates with a plausible path to FDA action between 2023 and the end of the decade.
The report is organized around two components. The timeline below maps each therapy's pivotal trial period against its known or projected NDA or BLA submission window, providing a comparative view of the competitive landscape across a multi-year horizon. Following the timeline, each therapy is profiled individually with detail on its trial design, regulatory strategy, and the clinical data supporting or expected to support its regulatory filing.
