Anaphylm clears CRL remediation studies; FDA resubmission filed — approval determines whether a film-based epinephrine alternative reaches a large, entrenched market

Aquestive Therapeutics is a clinical-stage company developing Anaphylm, a film-based alternative to injected epinephrine for severe allergic reactions, which is not yet approved by the FDA.

Aquestive's sublingual epinephrine film, Anaphylm, received a CRL in January 2026 for human factors and PK deficiencies, but remediation studies resolved both issues, and the NDA was resubmitted. The thesis resolves on FDA approval of the resubmission, without which Libervant's restricted revenue and AQST-108's early-stage pipeline cannot sustain the commercial buildout. The resubmission carries prior-CRL regulatory risk, and Suboxone revenue, which funds operations, is declining.