Homology Medicines Announces FDA Fast Track Designation for HMI-102 Gene Therapy Development Candidate for Adults with PKU
Homology Medicines, Inc. (FIXX)
Last homology medicines, inc. earnings: 3/12 04:10 pm
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Source: GlobeNewswire
- Company Provides Details of pheNIX, the First Gene Therapy Trial for PKU, and Remains on Track to Report Initial Clinical Results from the Phase 1/2 Study in 2019 - BEDFORD, Mass., May 14, 2019 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HMI-102, Homology’s one-time gene therapy development candidate for the treatment of adults with phenylketonuria (PKU). PKU is an inborn error of metabolism primarily caused by mutations in the PAH gene that lead to phenylalanine hydroxylase (PAH) deficiency resulting in the inability to breakdown phenylalanine (Phe), an essential amino acid found in natural protein. “We believe FDA’s decision to grant Fast Track designation is a positive step forward for the development of HMI-102, which is designed to treat the underlying cause of this disease and allow freedom from a restrictive diet, the curren
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