Business
Aquestive Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update
Sympazan® (clobazam) continues to meet key performance metrics and market penetrationFDA Type A meeting for Libervant™ (diazepam) Buccal Film scheduled for
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Sympazan® (clobazam) continues to meet key performance metrics and market penetrationFDA Type A meeting for Libervant™ (diazepam) Buccal Film scheduled for November 12, 2020Completed dosing in Phase 1 Pharmacokinetic (PK) trial for AQST-108 (epinephrine)Execution of monetization agreement providing up to $125 million for royalty rights in KYNMOBI™ (apomorphine HCI)Updates full year 2020 financial guidance, improving its outlook for revenue and adjusted loss before interest, taxes, depreciation and amortizationHosts conference call at 8:00 a.m. ET on November 5, 2020 WARREN, N.J., Nov. 04, 2020 (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 third quarter ended September 30, 2020 and provided an update on recent developments in its business. \n “Amidst the unprecedented uncertainty of the COVID-19 pandemic, our Company has made progress this quarter in advancing our CNS product portfolio and other important therapeutics in our product pipeline, highlighted by the completion of dosing in a Phase 1 pharmacokinetic trial for our product candidate AQST-108, a “first of its kind” oral sublingual film formulation delivering systemic epinephrine, and we are on track to assess the validity and quality of that data in the coming weeks,” said Keith J. Kendall, President and Chief Executive Officer of Aquestive. “Importantly, we are advancing our lead product candidate, Libervant™ (diazepam) Buccal Film for the management of seizure clusters, through the approval process with the Food and Drug Administration (FDA). We received confirmation from the FDA that, after submitting our meeting package this past October, a review meeting with the Agency is set for November 12, 2020. We look forward to working with the FDA in seeking feedback and clarity on the pathway for approval of Libervant. Moreover, the KYNMOBI royalty monetization transaction, which was signed this week and is expected to close and fund later this month, provides the Company with substantial capital to support our key clinical and commercial initiatives and reduce our senior debt,” concluded Mr. Kendall. Despite limitations on provider in-person interactions caused...