Sangamo Therapeutics Announces Alignment With FDA on Accelerated Approval Pathway for ST-920 in Fabry Disease With BLA Submission Expected in 2025
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) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025. RICHMOND, Calif.--(BUSINESS WIRE)--Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced the outcome of a recent successful interaction with the U.S. FDA, providing a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec, or ST-920, its wholly ow
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News
- Sangamo Therapeutics Announces U.S. FDA Clearance of IND Application for ST-503 for the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic Pain [Yahoo! Finance]Yahoo! Finance
- Sangamo Therapeutics Announces U.S. FDA Clearance of IND Application for ST-503 for the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic PainBusiness Wire
- Sangamo Therapeutics Third Quarter 2024 Earnings: Beats Expectations [Yahoo! Finance]Yahoo! Finance
- Sangamo Therapeutics, Inc. (NASDAQ: SGMO) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Sangamo Therapeutics, Inc. (NASDAQ: SGMO) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $10.00 price target on the stock.MarketBeat
SGMO
Earnings
- 11/12/24 - Beat
SGMO
Sec Filings
- 11/20/24 - Form EFFECT
- 11/12/24 - Form S-8
- 11/12/24 - Form S-3
- SGMO's page on the SEC website