FDA Puts Hold on SIG-001 Phase 1/2 Trial for Hemophilia A

FDA Puts Hold on SIG-001 Phase 1/2 Trial for Hemophilia A

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FDA Puts Hold on SIG-001 Phase 1/2 Trial for Hemophilia A

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Sigilon Therapeutics’ Phase 1/2 study evaluating the investigational therapy SIG-001 in adults with severe or moderately severe hemophilia A. The move comes after a serious adverse event (SAE) occurred involving one of the three participants dosed thus far with SIG-001. Sigilon submitted data to the FDA and other regulatory agencies regarding that SAE, which prompted the company to temporarily pause enrollment for…

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