By Chris Wack
BioCryst Pharmaceuticals Inc. shares rose 21% to $13.49 after the company said that the U.S. Food and Drug Administration 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 trials in patients with paroxysmal nocturnal hemoglobinuria and with C3 glomerulopathy, immunoglobulin A nephropathy and primary membranous nephropathy.
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.
On April 8, BioCryst said the company had voluntarily paused enrollment in BCX9930 clinical trials while it investigated observed elevations in serum creatinine seen in some patients at the 500 mg twice\-daily dose. The FDA subsequently placed the program on a partial clinical hold. Patients already enrolled in the trials and demonstrating clinical benefit were able to continue on therapy.
Write to Chris Wack at firstname.lastname@example.org
(END) Dow Jones Newswires
August 04, 2022 10:04 ET (14:04 GMT)
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