Business
Aquestive Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update
Submitted proposed pivotal trial protocol for Anaphylm™ (epinephrine) Sublingual Film to the FDASubmitted an NDA to the FDA for Libervant™ (diazepam) Buccal
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Submitted proposed pivotal trial protocol for Anaphylm™ (epinephrine) Sublingual Film to the FDASubmitted an NDA to the FDA for Libervant™ (diazepam) Buccal Film for patients between two and five years of ageReported 24% year-over-year growth in quarterly revenue adjusted for the out-license of Sympazan®Raises full year 2023 revenue and improves non-GAAP adjusted EBITDA loss guidanceTo host investment community conference call at 8:00 am ET on August 8, 2023 WARREN, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today reported financial results for the second quarter ended June 30, 2023 and provided an update on recent developments in its business. “Our strong second quarter 2023 results continue to drive the Company forward,” said Daniel Barber, Chief Executive Officer of Aquestive. “At the beginning of the year, we outlined five key initiatives for the Company in 2023. Now that we are halfway through the year, I am delighted with the progress the team has made against these initiatives. We have meaningfully progressed both Anaphylm and Libervant, expanded our collaborations, strengthened our balance sheet, and continued to explore expanding our capabilities. Our focus is now on the important upcoming inflection points that we expect to occur in the second half of the year.” Anaphylm™Aquestive is advancing the development of Anaphylm, the first and only non-invasive, orally delivered epinephrine product candidate to demonstrate clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the emergency treatment of severe allergic reactions, including anaphylaxis. In May 2023, Aquestive released topline clinical data from recent pilot studies that were completed following the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”). These studies included examining (1) differences in pharmacokinetic (PK) results based on changes to administration instructions, (2) additional repeat dose data on Anaphylm, and (3) the differences between approved autoinjectors. In July 2023, Aquestive announced positive topline data from pilot PK study AQ109103 (the “103” study) that was designed to establish the fi...