FDA Grants Fast Track Designation to GCBP and Novel Pharma's GC1130A [Yahoo! Finance]
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ITOCHU CORP UNSP/ADR (ITOCY)
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Source: Yahoo! Finance
KS) and Novel Pharma have announced that the U.S. FDA has granted Fast Track Designation for their jointly developed MPSIIIA (Sanfilippo syndrome Type A) treatment, GC1130A. This designation follows the FDA's clearance of the investigational new drug (IND) application for GC1130A last month. With Fast Track Designation, the development process for GC1130A is set to be expedited. About Sanfilippo Syndrome Type A Sanfilippo syndrome Type A is a rare genetic disorder that causes central nervous system damage through the accumulation of heparan sulfate, leading to progressive neurological decline. Without treatment, patients face life-threatening complications by the age of 15. GC1130A represents a potential breakthrough as the first and only treatment option specifically targeting MPSIIIA. GC1130A GC1130A is a biological drug that is being developed using high-concentration protein formulation technology, designed for administration to the central nervous system. It is delivere
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