Why BioCryst Pharmaceuticals (BCRX) Shares Are Trading Higher Today

The FDA lifted a partial clinical hold on BioCryst Pharmaceuticals Inc's (NASDAQ:BCRX) BCX9930 program. The company will resume enrollment under revised protocols at a reduced dose of 400 mg twice daily of BCX9930.
This includes the REDEEM-1 & REDEEM-2 trials in paroxysmal nocturnal hemoglobinuria and the RENEW trial in 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 dilutes the drug concentration in the urine below the threshold where crystals can form.
In April, BioCryst voluntarily paused enrollment in BCX9930 trials while investigating elevated serum creatinine (SCr) in some patients at the 500 mg twice daily dose.
The FDA subsequently placed the program on partial clinical hold.
PNH patients naive to C5 inhibitor therapy who received 400 mg twice daily in the Phase 1 program (n=7) experienced a mean change from baseline increase in hemoglobin of 4.3 g/dL and required no transfusions.
No patients experienced an elevation in their SCr during dose-ranging at the 400 mg twice daily dose. All observed cases of SCr elevations occurred at 500 mg twice daily.
Q2 Orladeyo revenue reached $65.2 million, with total sales of $65.5 million, +31.2% Y/Y, beating the consensus of $64.31 million.
EPS loss came in at $(0.32) up from $(0.24) a year ago, beating the consensus of $(0.34).
Guidance: BioCryst expects FY22 Orladeyo sales of $255 million - $265 million.
Price Action: BCRX shares are up 20.6% at $13.45 during the market session on the last check Thursday.

BCRXBioCryst Pharmaceuticals Inc

$8.22-%

Overview

Market News and Data brought to you by Benzinga APIs

To add Benzinga News as your preferred source on Google, click here.

Benzinga

Benzinga

FDA Lifts Clinical Hold On BioCryst's BCX9930 Program For Rare Blood Disorder