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BioCryst Pharmaceuticals Inc.
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Reviewing BCX9930 Safety Data reported by the company on Nov 3, 2021A Long Term Safety Study of BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)• 200 participants enrolled • As of end of September 2021, average dosing duration now exceeds 11 months, with the longest duration 19 months • Data continues to support safety and tolerability of BCX9930, with no safety signals observed • Hb responses have been maintained • No RBC transfusions have been needed during dosing at 400 mg or 500 mg BID BCX9930 • Improvement in biomarkers of hemolysis and PNH RBC clone size have been maintained • No discontinuations from the trial • The safety and efficacy data collected from these patients in the long-term safety trial provides the company with a high degree of confidence for the success of the pivotal trial |
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