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- U.S. Food and Drug Administration (FDA) advises that a single study with up to 25 patients, in combination with confirmatory evidence, may be acceptable pathway to Biologics License Application (BLA) submission for isaralgagene civaparvovec, which would significantly reduce anticipated complexity, cost and time to potential approval.
- European Medicines Agency (EMA) granted priority medicines (PRIME) eligibility to isaralgagene civaparvovec, which includes enhanced regulatory support and scientific guidance.
- Sangamo is actively seeking a collaboration partner to advance isaralgagene civaparvovec through potential registration and commercialization.
Posted In: SGMO
