- On track to refile Libervant™ (diazepam) Buccal Film New Drug Application (NDA) by end of second quarter 2021
- Initiated first-in-human Phase 1 pharmacokinetic (PK) study for AQST-109 epinephrinesublingual film candidate
- Sympazan® (clobazam) continues to meet key performance metrics and gain market share
- Hosts conference call at 8:00 a.m. ET on May 5, 2021
WARREN, N.J., May 04, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients' unmet needs and solve therapeutic problems, today reported financial results for the first quarter ended March 31, 2021 and provided an update on recent developments in its business.
We arefocused on continuing to make progress this year in advancing our proprietary products. In response to feedback from the FDA, we are developing additional analyses of the existing clinical data in the NDA for Libervant and expect to refile by the end of the second quarter of 2021. We recently initiated the first-in-human Phase 1 PK study with our second generation epinephrine candidate AQST-109 and anticipate reporting top-line data in the second half of the year, said Keith Kendall, President and Chief Executive Officer of Aquestive.