BioCryst Pharma Shares Rise 21% After FDA Drops Partial Hold on BCX9930
August 04 2022 - 10:19AM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
August 04, 2022 10:04 ET (14:04 GMT)
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