Business
BioCryst Reports First Quarter 2020 Financial Results and Upcoming Key Milestones
—Berotralstat approval/launch timelines in U.S., Japan, EU remain on track— —Early clinical data supports BCX9930 as oral monotherapy for complement-mediated
About this update from Biocryst Pharmaceuticals, Inc.
[{"type":"text","content":"—Berotralstat approval/launch timelines in U.S., Japan, EU remain on track—\n —Early clinical data supports BCX9930 as oral monotherapy for complement-mediated diseases— —Patient dosing underway in galidesivir trial in COVID-19 patients in Brazil— RESEARCH TRIANGLE PARK, N.C., May 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced financial results for the first quarter ended March 31, 2020, and provided a corporate update. “This is a transformational year for BioCryst as we prepare to launch berotralstat in multiple territories to bring our oral, once-daily prophylactic medicine to HAE patients, and begin generating significant revenue,” said Jon Stonehouse, president and chief executive officer of BioCryst. “We are excited to see the clinical response in treatment-naïve PNH patents at the 50 mg and 100 mg twice-daily dose levels, and more than 98 percent suppression of complement in both alternative pathway assays at the 200 mg and 400 mg twice-daily levels in healthy volunteers,” said Dr. William Sheridan, chief medical officer of BioCryst. “This profile provides strong support for BCX9930 as an oral monotherapy. We look forward to studying 200 mg and 400 mg twice-daily in PNH patients and advancing this program to treat multiple complement-mediated diseases,” Sheridan added. Program Updates and Key Milestones Hereditary Angioedema (HAE) Program – Berotralstat (BCX7353): Oral, once-daily treatment for prevention of HAE attacks BioCryst expects three regulatory approvals for berotralstat in 2020 and early 2021. These timelines remain on track. The U.S. Food and Drug Administration (FDA) is currently reviewing a new drug application for berotralstat and has set an action date of December 3, 2020, under the Prescription Drug User Fee Act (PDUFA). In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing a new drug application (JNDA) for berotralstat under the Sakigake timeline, and the company expects approval in Japan in the second half of 2020. On March 30, 2020, the company announced that the European Medicines Agency (EMA) had validated its marketing authorization application (MAA) submission for berotralstat and begun their formal review of the MAA under the centralized procedure. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected w...