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Epicrispr Biotechnologies Announces FDA Clearance of IND Application for EPI-321, A First-in-Class Epigenetic Therapy for FSHD [Yahoo! Finance]

Gilead Sciences, Inc. (GILD)  More Company Research Source: Yahoo! Finance
Last gilead sciences, inc. earnings: 4/30 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.gilead.com
- Global Phase 1/2 clinical trial expected to commence in 2025 SOUTH SAN FRANCISCO, Calif., April 03, 2025 BUSINESS WIRE Epicrispr Biotechnologies , a biotechnology company focused on developing curative therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for EPI-321, a first-in-class epigenetic therapy for the treatment of facioscapulohumeral muscular dystrophy (FSHD), a genetic neuromuscular disease. IND clearance in the US is part of a global development strategy for EPI-321 and follows the recent approval of its clinical trial application by New Zealand's Medsafe. The company plans to initiate a global Phase 1/2 clinical trial in 2025. EPI-321 is an investigational one-time gene-modulating therapy designed to silence aberrant expression of DUX4, a gene that is incorrectly activated in FSHD and leads to progressive muscle degeneration. Delivered systemically via a clinically validate [Read more]
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Epicrispr Biotechnologies Announces FDA Clearance of IND Application for EPI-321, A First-in-Class Epigenetic Therapy for FSHD [Yahoo! Finance]

Gilead Sciences, Inc.  (GILD) 
More Company Research Source: Yahoo! Finance
Last gilead sciences, inc. earnings: 4/30 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.gilead.com
- Global Phase 1/2 clinical trial expected to commence in 2025 SOUTH SAN FRANCISCO, Calif., April 03, 2025 BUSINESS WIRE Epicrispr Biotechnologies , a biotechnology company focused on developing curative therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for EPI-321, a first-in-class epigenetic therapy for the treatment of facioscapulohumeral muscular dystrophy (FSHD), a genetic neuromuscular disease. IND clearance in the US is part of a global development strategy for EPI-321 and follows the recent approval of its clinical trial application by New Zealand's Medsafe. The company plans to initiate a global Phase 1/2 clinical trial in 2025. EPI-321 is an investigational one-time gene-modulating therapy designed to silence aberrant expression of DUX4, a gene that is incorrectly activated in FSHD and leads to progressive muscle degeneration. Delivered systemically via a clinically validate [Read more]
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