Sangamo Therapeutics Announces U.S. FDA Alignment on Abbreviated Pathway to Potential Approval and EMA Prime Eligibility for ST-920 in Fabry Disease
Sangamo Therapeutics, Inc. (SGMO)
Last sangamo therapeutics, inc. earnings: 2/28 07:00 am
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Source: Business Wire
- 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. RICHMOND, Calif.--(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 tha
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News
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- Sangamo Therapeutics, Inc. (NASDAQ: SGMO) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Sangamo Therapeutics to Present Neurology-Focused Pre-Clinical Data From Its Epigenetic Regulation, Capsid Delivery and Genome Engineering Platforms at the 27th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) [Yahoo! Finance]Yahoo! Finance
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