FDA grants Fast Track designation to Coya Therapeutics' COYA 302 for ALS
May 19, 2026
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
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JAMA Neurology Publishes PrimeC Phase 2b ALS Data as NeuroSense Advances Toward Phase 3
Apr 06, 2026
JAMA Neurology published Phase 2b PARADIGM results for PrimeC in ALS, showing slower functional decline, fewer ALS-related complications and longer survival. NeuroSense is preparing a Phase 3 trial and received Brazilian patent protection through October 2042.
Two Experimental ALS Therapies Report Positive Safety Data from Early-Stage Trials
Mar 16, 2026
PrimeC, an oral combination therapy, showed safety and signals of clinical benefit in a phase 2b trial, while PLL001, a gut-targeting therapy, demonstrated positive safety and tolerability in a phase I/II study for amyotrophic lateral sclerosis.