FDA Puts APB-102 Gene Therapy for SOD1 ALS on Fast Track

FDA Puts APB-102 Gene Therapy for SOD1 ALS on Fast Track

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FDA Puts APB-102 Gene Therapy for SOD1 ALS on Fast Track

The U.S. Food and Drug Administration (FDA) has granted fast track status to Apic Bio’s experimental therapy APB-102, designed for amyotrophic lateral sclerosis (ALS) patients who carry mutations in the SOD1 gene that lead to misfolded proteins in cells. This designation accelerates the development of investigational therapies that address unmet medical needs in serious or life-threatening conditions. It makes Apic Bio eligible for more frequent meetings with the FDA and discussions about APB-102’s development plan.…

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