Business
BioCryst Reports Third Quarter 2020 Financial Results and Upcoming Key Milestones
—ORLADEYO™ (berotralstat) PDUFA date December 3, 2020— —Approval decisions expected in Japan in December 2020, EU in early 2021— RESEARCH TRIANGLE PARK, N.C.,
About this update from Biocryst Pharmaceuticals, Inc.
[{"type":"text","content":"—ORLADEYO™ (berotralstat) PDUFA date December 3, 2020—\n —Approval decisions expected in Japan in December 2020, EU in early 2021— RESEARCH TRIANGLE PARK, N.C., Nov. 05, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced financial results for the third quarter ended September 30, 2020, and provided a corporate update. “We are 28 days from our PDUFA date and we are ready to launch ORLADEYO to bring HAE patients the oral, once-daily medicine they have been waiting for to prevent attacks, reduce their burden of therapy and live a normal life,” said Jon Stonehouse, president and chief executive officer of BioCryst. “In addition to this commercial transformation of the company, and the revenue it brings, our pipeline of BioCryst-discovered molecules continues to advance, with several upcoming near-term data readouts,” 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 a decision on approval 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 12 months from MAA validation. BioCryst has completed the build-out of the commercial infrastructure to support the successful launch of ORLADEYO in the U.S. The company has hired and trained accomplished U.S. rare disease sales and market access teams and has deployed a robust patient services support hub.The company is well-positioned in terms of product supply and inventory on-hand to support the launch and anticipated demand for ORLADEYO. On October 30, 2020, the company announced that...