FDA Action Update, October 2026: Approval, Acceptance, and Designations

Here's some of what is coming soon to NeurologyLive® this week.

Here's some of what is coming soon to NeurologyLive® this week.

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending November 6, 2026.

Newly presented biomarker and clinical findings from the phase 2b PARADIGM trial of PrimeC informed the design of the global phase 3 PARAGON trial in ALS.

Two-year data from the phase 2 DAZALS trial showed a lower risk of death with dazucorilant 300 mg/day vs placebo in ALS, although the study did not meet its functional primary end point.

Servier reported that sevasemten did not meet its primary or secondary endpoints in the pivotal GRAND CANYON trial for Becker muscular dystrophy.

QurAlis reported interim ANQUR trial results showing target engagement, a biomarker signal, and a trend toward slower functional decline with QRL-201 in ALS.

The 500-participant study will assess whether pridopidine, an investigational sigma-1 receptor agonist, can slow functional decline and improve survival in patients with early, rapidly progressing amyotrophic lateral sclerosis.