FDA grants Fast Track designation to Coya Therapeutics' COYA 302 for ALS
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.
ALS
DiseaseDisease Profile
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative motor neuron disease characterized by loss of upper and lower motor neurons, leading to worsening weakness, speech/swallowing impairment, and respiratory failure. It is also known as Lou Gehrig’s disease.
- Category
- Neurodegenerative disease (motor neuron disease)
- Prevalence
- In the U.S., projected ALS prevalence for 2026 is 34,720 living adult cases.
- G12.2
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