Aquestive makes oral film medicines for partners and is developing Anaphylm, an epinephrine film placed under the tongue for severe allergic reactions; Anaphylm is not approved.
Aquestive's value rests on Anaphylm, an oral epinephrine rescue film awaiting FDA action after rejection over usability and supporting drug-level data. Improved studies and an accepted resubmission support its recovery path. Partner manufacturing provides revenue, but Suboxone orders fluctuate. Eton's Libervant license adds cash and potential royalties, subject to regulatory and commercial execution. Additional Anaphylm financing remains conditional. AQST-108 offers earlier-stage dermatology potential, with further clinical work expected in the first quarter of 2027.
Thesis checklist
0 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: FDA approves Anaphylm
Does FDA accept the revised usability and drug-level package and approve Anaphylm?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
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Anaphylm resubmission accepted; FDA decision due March 16, 2027
Anaphylm clears CRL remediation studies; FDA resubmission filed — approval determines whether a film-based epinephrine alternative reaches a large, entrenched market
Anaphylm Complete Response Letter from FDA
FDA identifies NDA deficiencies for Anaphylm
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Neurology and pain, Psychiatric disorders, Liver and digestive diseases, Skin diseases, Autoimmune and inflammatory diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
10 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.