BioCryst Pharmaceuticals,Inc. (BCRX): 6:58a ET 8/4/2022

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Thursday, 08/04/2022 7:47:29 AM

Thursday, August 04, 2022 7:47:29 AM

6:58a ET 8/4/2022 - Globe Newswire
BioCryst Resumes Enrollment in BCX9930 Clinical Program
Mentioned: BCRX
EQNX::TICKER_START (NASDAQ:BCRX), EQNX::TICKER_END BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has lifted its partial clinical hold on the BCX9930 program. The company will resume enrollment in global clinical trials under revised protocols at a reduced dose of 400 mg twice daily of BCX9930. This includes the REDEEM-1 and REDEEM-2 pivotal trials in patients with paroxysmal nocturnal hemoglobinuria (PNH) and the RENEW proof-of-concept trial in patients with C3 glomerulopathy (C3G), immunoglobulin A nephropathy (IgAN) and primary membranous nephropathy (PMN).

Clinical evidence and recent laboratory studies have informed the company's hypothesis that crystals form in the kidneys of some patients. The company believes that lowering the dose to 400 mg and ensuring adequate hydration will dilute the concentration of drug in the urine below the threshold where crystals can form.