IntraBio Announces U.S. FDA Accepts New Drug Application for IB1001 for the Treatment of Niemann-Pick Disease Type C
IntraBio's NDA for IB1001, a treatment for Niemann-Pick Disease Type C, has been accepted by the FDA with a PDUFA date of September 24, 2024. IB1001 showed improvement in neurological signs, functioning, and quality of life in Phase 3 and IIb trials. IntraBio raised $40 million to support IB1001's commercialization.
Reference News
IntraBio Announces U.S. FDA Accepts New Drug Application for IB1001 for the Treatment of Niemann-Pick Disease Type C
IntraBio's NDA for IB1001, a treatment for Niemann-Pick Disease Type C, has been accepted by the FDA with a PDUFA date of September 24, 2024. IB1001 showed improvement in neurological signs, functioning, and quality of life in Phase 3 and IIb trials. IntraBio raised $40 million to support IB1001's commercialization.