Aquestive Therapeutics Inc Dossier - Source-backed chat

Aquestive Therapeutics Inc

AQSTNASDAQ

SectorHealth Care

IndustryPharmaceuticals

Beta (adjusted)1.29

Intrinsic Value

Insufficient data for a value estimateNot enough reliable inputs to publish a fair value for this company yet.

Market Price $4.63Price as of 30 Sep 2026

Data confidenceNot applicable

Market Cap $581.1M

Enterprise Value $537.6M

Shares Outstanding 133.3M diluted

Next Earnings Date4 Nov 2026

All prices and values are periodic snapshots, not live quotes. Source dates are shown for reference.

Thesis

Street consensus, scenarios, merits, risks, and invalidation triggers

AI-assisted

Thesis Summary

Aquestive Therapeutics is transitioning from a legacy drug-delivery manufacturing business to a high-value proprietary pipeline story. The primary value driver is Anaphylm (dibutepinephrine) sublingual film, which has the potential to become the first non-invasive, orally delivered epinephrine treatment for severe allergic reactions, including anaphylaxis. Although the FDA issued a Complete Response Letter (CRL) in January 2026 citing human factors validation deficiencies, a clear regulatory path has been established following a successful Type A meeting. With an NDA resubmission guided for Q3 2026 and a robust cash position bolstered by a recent $150 million debt refinancing, Aquestive represents a compelling asymmetric risk-reward opportunity.

This section is the 12-month view: analyst targets and the probability-weighted scenarios built from them. The intrinsic value at the top of this page answers a different question: what the business is worth today.

Street view · analyst 12-month targets9 analysts · as of 18 Aug 2026

Low · most bearish analyst$6.00

Mean target$8.89

High · most bullish analyst$11.00

Our research · scenarios, merits, risks, and invalidation triggersResearch as of 19 Jun 2026

Scenarios · 12-month scenario targetsAnchored at research date

Bear CaseDownside scenario

$4.45

The human factors validation study fails to satisfy FDA requirements, or the requested PK study reveals unexpected tolerability or absorption issues, leading to another CRL or multi-year approval delay. The cash runway is depleted, forcing highly dilutive equity financing or unfavorable debt terms.

Base CaseCentral scenario

$8.89

Matches the consensus mean

Aquestive successfully resubmits the Anaphylm NDA in Q3 2026. The FDA approves the product in mid-2027 after reviewing the updated human factors and PK study data. Commercial launch begins in late 2027, supported by the expanded medical affairs team and strategic commercial partnerships.

Bull CaseUpside scenario

$11.55

Anaphylm receives FDA approval in early 2027 with a rapid commercial launch, capturing significant market share from traditional auto-injectors like EpiPen. The company successfully draws down on its $75 million RTW Investments funding, avoiding dilutive equity raises. International approvals in the EU, UK, and Canada follow shortly, driving exponential revenue growth.

Scenarios are anchored to street consensus at the research date, with our probabilities and rationale.

Key Investment Merits

First-in-class potential for Anaphylm as a non-invasive, postage-stamp-sized oral epinephrine film.
Clear regulatory alignment with the FDA on study designs needed to address the January 2026 CRL.
Strong balance sheet with over $110 million in cash and a completed $150 million debt refinancing with Oaktree.
Additional non-dilutive funding of $75 million from RTW Investments pre-arranged upon Anaphylm approval.

Key Investment Risks

Binary regulatory risk associated with the FDA approval of Anaphylm.
Execution risk in conducting the human factors validation study across 9 distinct user groups.
Commercialization risk in competing against established epinephrine auto-injectors and other emerging non-invasive alternatives.

Thesis Invalidation Triggers

Failure or significant delay of the human factors validation study.
Receipt of a second Complete Response Letter (CRL) from the FDA for Anaphylm.
Inability to resubmit the NDA within the guided Q3 2026 timeframe.

All scenarios are estimates and subject to change. Past performance is not indicative of future results.

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Explore this dossier

ValuationIntrinsic value, the six-method breakdown, peer medians, and your assumptions sandbox.Financial SnapshotRevenue, profitability, returns, balance sheet, dividends, and the filing-level detail.Qualitative AnalysisBusiness overview, strategic initiatives, and mergers, acquisitions & partnerships.Outlook & Key DatesForward estimates, reporting calendar, and the monitoring framework.