Codexis Gets FDA Orphan Drug and Rare Pediatric Disease Tags for CDX-6512 in Homocystinuria

 Codexis Inc. on Monday said the U.S. Food and Drug Administration granted the company orphan drug designation for CDX-6512 for the treatment of homocystinuria.

Codexis said the FDA also granted rare pediatric disease designation for CDX-6512, which is currently in pre-IND development and the most advanced wholly-owned program in the company's biotherapeutics pipeline.

Homocystinuria is a rare inborn error of metabolism and is characterized by elevated levels of homocysteine in blood and urine that when left untreated can lead to learning and intellectual disabilities, cardiovascular disease, osteoporosis, and stroke.

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