Aquestive Therapeutics, Inc. (AQST)
NASDAQHealth CareDrug Manufacturers - Specialty & GenericSnapshot 2026-09-09
$5.15-1.15%
Close 2026-09-09 · 1-day change
NASDAQHealth CareDrug Manufacturers - Specialty & GenericSnapshot 2026-09-09
Warn: Primary pillar under pressure — Resubmit Anaphylm NDA in Q3 2026: NDA resubmission target Q3 2026 vs current date 2026-09-09 (no confirmation of filing).
Aquestive aims for $46-$50 million revenue in 2026. Operating loss is improving, down from -$19.37M to -$4.20M in Q1. The company plans to resubmit its Anaphylm drug application in Q3 2026. These steps show progress in fixing the business.
Aquestive is still losing money and faces regulatory risks. The FDA rejected its drug in early 2026. Revenue growth may slow or miss targets. The company’s credit deals and equity sales add financial pressure.
The stock price is about 59% above our fair value near $2.7. Analysts expect 27% revenue growth, but we see slower growth and ongoing losses. The price is too high for the risks.
Breaks if: NDA resubmission delayed beyond Q3 2026
Complete required human factors and pharmacokinetic studies and resubmit the Anaphylm New Drug Application to the FDA in the third quarter of 2026.
This is not a price target or investment advice.
A long-form read on the 1–3 year hold thesis. It updates when the weekly evidence changes.
AQST represents a speculative growth investment. The company is currently loss-making but has shown some positive momentum in revenue growth and expense management.
The market appears to price in a significant expectations gap, indicating that investors may be anticipating better performance than what has been demonstrated. Valuation is considered expensive compared to peers, which suggests that the current price may not fully reflect the underlying risks.
Management has reaffirmed revenue growth targets for 2026, which could support a more stable financial performance. However, there is a near-term risk of missing earnings expectations, as the company has a history of erratic earnings surprises.
The long-term thesis hinges on the successful resubmission of the Anaphylm NDA and the ability to meet revenue and EBITDA loss targets. Additionally, broader healthcare sector performance and macroeconomic conditions will play a crucial role in shaping AQST's trajectory.
The most important moves since the prior daily snapshot.
Our read on the company is unchanged since the prior snapshot.
as of 2026-09-09
Review the evidence to watch, what would become a concern, and what would make it less concerning.
Not investment advice. Scores describe historical and current data; they are not forecasts of future returns. Consult a licensed advisor before making investment decisions.
Stated as a priority in 3 of last 3 quarters. Management has consistently targeted the third quarter of 2026 for the Anaphylm NDA resubmission, supported by completion of human factors and pharmacokinetic studies. This timeline matches management's repeated guidance and study progress, indicating delivery on this regulatory milestone.
“Human factors and clinical study results support planned resubmission of Anaphylm NDA in the third quarter of 2026.”
“We successfully completed our Type A meeting with the FDA, aligning on study designs needed to support resubmission of the Anaphylm NDA, targeted for Q3 2026.”
“Company reaffirms guidance to resubmit Anaphylm NDA in Q3 2026, subject to completion of required studies and FDA timelines.”
Breaks if: EBITDA loss exceeds $35 million in FY26
Breaks if: Revenue falls below $44 million in FY26
Over the next 1 to 3 years, AQST's performance will depend on management's execution and external market conditions. Not investment advice.