H.R. 8205: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

H.R. 8205 keeps a federal ALS therapy and research program from expiring in 2026, extending it through 2031.

That means the grant program created under the original ALS law can keep supporting research on investigational therapies instead of shutting off on schedule. For patients and researchers, this is mainly about continuity: trials, applications, and planning do not have to work around a looming end date.

The bill also changes what happens when researchers ask to renew an ALS therapy grant. Federal reviewers would have to look at three concrete things: how many people enrolled, what safety problems appeared, and whether there is any evidence the treatment is helping.

It also requires faster reporting of serious, unexpected safety problems in late-stage trials, so grant-making institutions are not waiting in the dark while studies continue.

Another update is aimed at newer trial designs. A combined phase 2/3 study can count as a qualifying late-stage trial if enrollment starts within the timeframe set by the Health and Human Services Secretary.

Beyond ALS itself, the bill tells the FDA to publish a rare neurodegenerative disease action plan within 18 months of enactment. That plan must lay out 5 years of intended FDA actions, and the agency would later have to post a public report on what it actually did.

In plain English: this bill extends an ALS research pathway that already exists, adds more scrutiny to renewals, and gives patients a public clock to track the FDA's follow-through.