BioCryst Shelves Development Of Rare Blood Disorder Candidate

BioCryst Pharmaceuticals Inc BCRX said that based on new data recently presented at the American Society of Hematology (ASH) annual meeting, the company no longer believes that BCX9930 would be commercially competitive and is discontinuing the development of BCX9930.
In August FDA lifted a partial clinical hold on the BCX9930 program after elevated serum creatinine in some patients at the 500 mg twice daily dose was reported in April.
This decision allows the company to focus its complement inhibitor development efforts on BCX10013.
BioCryst expects to report preliminary data from healthy volunteers receiving single ascending doses and multiple ascending doses of BCX10013 in Q1 of 2023.
The preclinical and early clinical profile from approximately 90 healthy volunteers suggests BCX10013 could have the properties of a once-daily oral therapy.
The pause in the program earlier this year allowed the company to reduce 2022 operating expense guidance by approximately $100 million. The company plans to provide the full-year 2023 operating expense guidance in the first quarter of 2023.
Price Action: BCRX shares are down 1.31% at $11.04 on the last check Thursday.