Aquestive Therapeutics Advances Resubmission of Anaphylm to FDA
Aquestive Therapeutics (NASDAQ:AQST) has completed necessary studies and is preparing to resubmit its epinephrine film, Anaphylm, for FDA approval in Q3 2026. The company addressed issues raised by the Complete Response Letter from January 2026 with a human factors validation study and pharmacokinetic trial that showed improvements without safety concerns. The second-quarter results show revenue growth to $13.8 million, up 38% year-over-year, driven largely by manufacturing contracts for Suboxone film and Sympazan. Cash reserves stood at $98.5 million as of June 30, providing financial runway during the FDA review process. Despite progress on Anaphylm, Aquestive reported a net loss of $22.9 million in Q2 due to one-time debt-related expenses and rising legal and administrative costs. The company remains dependent on regulatory approval for its key product candidate.
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