New drug application on-track

BioCryst Pharmaceuticals, Inc. has announced the financial results for the second quarter ended 30 June 2019 and provided a corporate update.

“We have just returned from the 2019 HAEA National Patient Summit with more than 1,000 attendees from the U.S. and around the world. Patients’ excitement about BCX7353 was resounding as they told us an oral option with our safety and efficacy profile could change their lives and the lives of their family members with HAE. Our customers want our product, and we cannot wait to deliver it to them next year,” said Jon Stonehouse, president and CEO of BioCryst.

“We are on-track to submit an NDA to the FDA in the fourth quarter, followed by regulatory submissions in Europe and Japan in the first quarter of 2020. We are also preparing for the commercial launch of BCX7353 in the U.S. later in 2020”, Stonehouse added.
(Source: BioCryst)

2019-08-13T09:27:10+02:00August 13, 2019|HAEi News|