BioCryst positioned for a transformational 2020

Announcing the financial results for the third quarter ended 30 September 2019 BioCryst Pharmaceuticals, Inc., President and CEO Jon Stonehouse says:

“BioCryst is positioned for a transformational 2020, with the potential approval and launch of BCX7353 in the U.S. and regulatory filings for BCX7353 in Japan and Europ. We are also actively evaluating multiple approaches to add capital to the balance sheet by the end of 2019, as we did with the Japanese licensing agreement for BCX7353, which we announced earlier this week.“

Upcoming Key Milestones

  • Submit a new drug application (NDA) for oral, once-daily BCX7353 for the prevention of hereditary angioedema (HAE) attacks with the U.S. Food and Drug Administration (FDA) (Q4 2019)
  • Submit a marketing authorization application for oral, once-daily BCX7353 for the prevention of HAE attacks with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA) (Q1 2020)
  • Commence ZENITH-2, a Phase 3 clinical trial of oral BCX7353 (750 mg) for the treatment of acute HAE attacks, in 2020, pending the completion of interactions with regulators on the Phase 3 program and additional work on the acute oral formulation (2020)

(Source: BioCryst)

2019-11-07T14:39:58+01:00November 7, 2019|HAEi News|