Quarterly ResultNov 3, 2026, 04:22 PM
Aquestive Therapeutics Q3 Loss Widens to $16.5M; Anaphylm NDA PDUFA Date Set
AI Summary
Aquestive Therapeutics reported its third quarter 2026 financial results, announcing a net loss of $16.5 million. The company's total revenues decreased to $7.6 million from $12.8 million in the prior year's quarter, primarily due to fluctuations in Suboxone product orders. Key developments include the FDA's acceptance of the Anaphylm NDA resubmission with a PDUFA goal date of March 16, 2027, and ongoing commercial preparations for a potential launch. The company also provided an update on its AQST-108 program and the out-licensing of Libervant to Eton Pharmaceuticals.
Key Highlights
- Anaphylm NDA resubmission accepted with PDUFA goal date of March 16, 2027.
- Total revenues decreased to $7.6 million in Q3 2026 from $12.8 million in Q3 2025.
- Net loss for Q3 2026 was $16.5 million, or $0.13 per share, compared to a net loss of $15.4 million, or $0.14 per share, in Q3 2025.
- Non-GAAP adjusted EBITDA loss was $12.2 million in Q3 2026, compared to a loss of $8.6 million in Q3 2025.
- Cash and cash equivalents were $90.3 million as of September 30, 2026.
- Granted Eton Pharmaceuticals exclusive U.S. commercialization rights to Libervant for $10 million upfront, eligible for up to $47.5 million in milestones and royalties.
- Ex-U.S. Anaphylm strategy progressing with Health Canada submission expected in Q4 2026 and EU filing planned for Q1 2027.
Price Impact
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