Aquestive Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update
Key Highlights
- ➤Anaphylm NDA resubmission accepted; FDA set March 16, 2027 PDUFA goal date
- ➤Eton Pharmaceuticals (ETON) received exclusive U.S. Libervant rights from Aquestive
- ➤Libervant deal provides $10 million upfront, up to $47.5 million milestones, and mid-teens royalties
- ➤Q3 revenue fell 41% to $7.6 million, primarily from Suboxone order timing
- ➤2026 revenue guidance unchanged at $46 million-$50 million
Expert Statements
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
“With a PDUFA goal date of March 16, 2027, we believe we have a clear path to making Anaphylm available to patients and caregivers, if approved. For decades, people at risk of anaphylaxis have had limited treatment options. We believe Anaphylm - designed to be easy to carry and use confidently whenever and wherever it may be needed - has the potential to address important unmet needs. As we work with the FDA to support an efficient review, we continue to advance our commercial preparations, including building our field sales organization to engage allergists following approval. These efforts are intended to position us to move quickly toward launch following potential FDA approval.”
* Anaphylm resubmission accepted with PDUFA goal date of March 16, 2027 * Anaphylm would be the first and only oral rescue medication for the treatment of severe allergic reactions, including anaphylaxis, if approved * Commercial preparations remain on track to support a potential U.S. launch of Anaphylm following FDA approval * Ex-U.S. Anaphylm strategy progressing, with Health Canada submission expected in Q4 2026 and an EU filing planned for Q1 2027 * Company to host investor call on November 4, 2026, at 8:00 a.m. ET WARREN, N.J., Nov. 03, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a biopharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science, today announced financial results for the third quarter ended September 30, 2026, and provided a strategic business update.
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