- Commercial-stage biotech BioCryst Pharmaceuticals ( NASDAQ: BCRX ) gained ~16% in the pre-market Thursday after the company announced that the FDA lifted its partial clinical hold on the development program of kidney disease drug BCX9930.
- The program includes two pivotal trials for BCX9930 in paroxysmal nocturnal hemoglobinuria and a proof-of-concept study in C3 glomerulopathy (C3G), immunoglobulin A nephropathy (IgAN), and primary membranous nephropathy (PMN).
- Accordingly, the company plans to resume patient enrollment in global clinical trials with a revised protocol to lower the BCX9930 dose level to 400 mg twice daily.
- In April, BioCryst ( BCRX ) announced a voluntary pause in enrollment in BCX9930 program after findings indicated elevated serum creatinine levels in some patients.
- Later, the FDA placed the program, consisting of REDEEM-1, REDEEM-2, or RENEW clinical trials, on a partial clinical hold.
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The update on the BCX9930 program coincided with BioCryst’s ( BCRX ) financials for 2Q 2022 which exceeded Street forecasts on Thursday.
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BioCryst adds 16% as FDA lifts clinical hold on kidney disease program