Aquestive sees upping revenue, cutting EBITA loss outlook for 2023
- Receives positive feedback from FDA on pivotal study protocol for Anaphylm™ (epinephrine) Sublingual Film
- Reaffirms fourth quarter 2023 Anaphylm pivotal Phase 3 study start and first quarter 2024 topline data readout
- Outlines expected remaining activities for Anaphylm program prior to NDA submission
- Indicates FDA review of Libervant™ (diazepam) Buccal Film NDA on track with no open questions
- Anticipates increasing 2023 revenue and decreasing non-GAAP adjusted EBITDA loss guidance in upcoming earnings release
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