Business
BioCryst Reports Second Quarter 2020 Financial Results and Upcoming Key Milestones
—ORLADEYO™ (berotralstat) approvals expected in U.S. and Japan in Q4 2020, EU in early 2021— —200 mg/400mg BCX9930 data from treatment-naïve PNH patients
About this update from Biocryst Pharmaceuticals, Inc.
[{"type":"text","content":"—ORLADEYO™ (berotralstat) approvals expected in U.S. and Japan in Q4 2020, EU in early 2021—\n —200 mg/400mg BCX9930 data from treatment-naïve PNH patients expected in Q3 2020, 200 mg/400mg data from poor-responders to C5 inhibitors expected by year end 2020 — —Information from Part 1 of galidesivir trial in COVID-19 patients expected by end of Q3 2020— RESEARCH TRIANGLE PARK, N.C., Aug. 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced financial results for the second quarter ended June 30, 2020, and provided a corporate update. “BioCryst is currently in an exciting transformation from a company primarily focused on R&D to one that is about to launch its first oral drug to patients with HAE (ORLADEYO) this year, generating meaningful revenue starting next year, with global peak sales potential of greater than half a billion dollars. In parallel, we plan to fill our pipeline with a single molecule, BCX9930, by investing to accelerate this program across multiple rare disease indications based on the proof of concept data we have,” said Jon Stonehouse, president and chief executive officer of BioCryst. “We expect to end the year with ORLADEYO approved in the U.S. and Japan, additional data at 200 mg and 400 mg with BCX9930 in PNH patients, and clinical data from galidesivir in COVID-19 patients,” Stonehouse added. Program Updates and Key Milestones Hereditary Angioedema (HAE) Program – ORLADEYO: Oral, once-daily treatment for prevention of HAE attacks BioCryst expects three regulatory approvals for ORLADEYO in Q4 2020 and early 2021. The U.S. Food and Drug Administration (FDA) is reviewing a new drug application for ORLADEYO and has set an action date of December 3, 2020, under the Prescription Drug User Fee Act (PDUFA). In Japan, ORLADEYO is being reviewed under Sakigake designation. The Pharmaceutical and Medical Devices Agency (PMDA) has confirmed their regulatory review schedule and the company expects an approval decision in December 2020. On March 30, 2020, the company announced that the European Medicines Agency (EMA) had validated its marketing authorization application (MAA) submission for ORLADEYO and begun its formal review of the MAA under the centralized procedure. The company expects an opinion from the Committee for Medicinal Products for Human Use (CHMP) within approximately...