Sangamo Therapeutics Announces U.S. FDA Alignment on Abbreviated Pathway to Potential Approval and EMA Prime Eligibility for ST-920 in Fabry Disease [Yahoo! Finance]
Sangamo Therapeutics, Inc. (SGMO)
Last sangamo therapeutics, inc. earnings: 2/28 07:00 am
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Source: Yahoo! Finance
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. RICHMOND, Calif., February 12, 2024 BUSINESS WIRE )--Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced important U.S. and European regulatory updates for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease. The FDA has agreed in a Type D meeting that data from a single, adequate, and well-controlled study may form the primary basis of approval of a BLA for isaralgagene
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SGMO
Earnings
- 3/13/24 - Miss
SGMO
Sec Filings
- 4/30/24 - Form 8-K
- 4/19/24 - Form ARS
- 4/19/24 - Form DEF
- SGMO's page on the SEC website