Aquestive Therapeutics, Inc.
AQST evidence brief
What we can confirm
- BioSniper Score:
- 4.4 / 10
- Market Cap:
- $581.1M
- Lead Asset:
- anaphylm (BLA Filed)
What it means
What to watch
Prepared research question
What matters most for AQST—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · AQST
Aquestive Therapeutics is a specialty pharmaceutical company developing orally delivered prodrug alternatives to invasively administered standard-of-care therapies, with a lead candidate (Anaphylm) for anaphylaxis and a pipeline of epinephrine prodrugs, while also manufacturing and licensing several commercial products.
Key risk: Regulatory approval uncertainty for Anaphylm
BioSniper Score
Based on 5 of 6 signals
Market Cap
$581.1M
Cash Runway
—
Lead Asset
anaphylm (BLA Filed)
Next Catalyst
Patent_Expiry · Jul 13, 2030Financial data as of Jun 30, 2026.
Tracking 4 pipeline candidates · 2 clinical trials · 1 catalyst for Aquestive Therapeutics, Inc..
Aquestive Therapeutics is a specialty pharmaceutical company developing orally delivered prodrug alternatives to invasively administered standard-of-care therapies, with a lead candidate (Anaphylm) for anaphylaxis and a pipeline of epinephrine prodrugs, while also manufacturing and licensing several commercial products.
- Lead candidate Anaphylm (dibutepinephrine sublingual film) is positioned as the first non-invasive oral epinephrine prodrug for anaphylaxis, with clinical results comparable to auto-injectors [sec_mda · as of 2026-08-11].
- Company completed human factors and pharmacokinetic studies for Anaphylm and remains on track to resubmit the NDA to the FDA in Q3 2026 [news · published 2026-08-11].
- Cash & equivalents were $98.5M as of 2026-06-30, with total revenue of $13.8M and net income of -$22.9M for the period [sec].
- Aquestive manufactures and licenses several commercial products including Suboxone, Emylif, Sympazan, and Ondif [sec_mda · as of 2026-08-11].
- The company entered a $150 million debt facility with Oaktree Capital Management in Q1 2026 [news · published 2026-05-13].
What works
- Anaphylm has shown clinical results comparable to epinephrine auto-injectors (EpiPen, Auvi-Q) in a non-invasive oral film format, addressing a large market opportunity [sec_mda · as of 2026-08-11].
- The company has a diversified revenue stream from manufacturing and licensing multiple commercial products (Suboxone, Emylif, Sympazan, Ondif) [sec_mda · as of 2026-08-11].
- Aquestive secured a $150 million debt facility with Oaktree Capital Management, providing additional financial flexibility [news · published 2026-05-13].
What to weigh
- The company reported a net loss of $22.9M on revenue of $13.8M for the period ending 2026-06-30, with negative shareholders' equity of -$56.6M [sec].
- U.S. market access for Libervant is blocked by orphan drug exclusivity of a competitor's nasal spray product extending to January 2027 [sec_mda · as of 2026-08-11].
- Anaphylm's NDA resubmission and approval timeline remain subject to FDA feedback, protocol alignment, and data sufficiency, which are outside the company's control [sec_mda · as of 2026-08-11].
From the filings
Quoted directly from source documents.
Anaphylm is the first non-invasive oral epinephrine prodrug with clinical results comparable to auto-injectors
“the first and only non-invasive, orally delivered epinephrine prodrug product candidate in development that has shown clinical results comparable to auto-injectors (such as EpiPen ® and Auvi-Q ® ) for the emergency treatment of allergic reactions, including anaphylaxis”
SEC MD&A · August 11, 2026
Company on track to resubmit Anaphylm NDA in Q3 2026
“Remains on track to resubmit Anaphylm NDA to the FDA in Q3 2026”
News · August 11, 2026
Libervant U.S. market access blocked by competitor orphan exclusivity until January 2027
“the approval for U.S. market access of Libervant and overcoming the orphan drug market exclusivity of an FDA approved nasal spray product of another company extending to January 2027”
SEC MD&A · August 11, 2026
Catalyst timeline
- 2030-07-13 · Patent_Expiry · ONDANSETRON — Patent_Expiry: NDA022524 — Patent expiry for ondansetron product may open generic competition or affect related licensed product revenue.
Risks & what to watch (4)›
Key risks
- Regulatory approval uncertainty for Anaphylm — NDA resubmission and approval depend on FDA feedback, protocol alignment, and data sufficiency outside company control [sec_mda · as of 2026-08-11]
- Negative shareholders' equity — Shareholders' equity of -$56.6M as of 2026-06-30 indicates accumulated losses exceed assets [sec]
- Libervant market access blocked — Orphan drug exclusivity of competitor nasal spray blocks U.S. launch of Libervant until at least January 2027 [sec_mda · as of 2026-08-11]
- Cash runway dependent on execution — Company guided to end FY2026 with $70M cash, down from $98.5M as of mid-2026, requiring disciplined spending [news · published 2026-03-04]
What to watch
- Anaphylm NDA resubmission to the FDA in Q3 2026 and subsequent FDA review timeline [news · published 2026-08-11]
- Ex-U.S. regulatory filings for Anaphylm in Canada and Europe expected to begin in Q4 2026 [news · published 2026-08-11]
- Progress of AQST-108 (epinephrine topical gel) phase 2 study for alopecia areata [sec_mda · as of 2026-05-13]
- Cash position trajectory toward guided $70M at end of FY2026 [news · published 2026-03-04]
Sources: Catalysts · News · SEC filings · SEC MD&A · Generated October 1, 2026 · How we verify sources →
Run Aquestive Therapeutics, Inc. through your own thesis
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
Cash runway data unavailable
Net income -$23M
Lead: Approved
4 candidates
1 upcoming, next in ~1368d
0 buys · 6 sells (180d)
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
178
Total value held
$293.1M
| Holder | Shares | Value |
|---|---|---|
| bratton capital management, l.p. | 9,810,958 | $40.7M |
| blackrock, inc. | 7,509,071 | $31.2M |
| rtw investments, lp | 7,426,471 | $30.8M |
| vanguard capital management llc | 4,443,698 | $18.4M |
| federated hermes, inc. | 2,940,339 | $12.2M |
| balyasny asset management l.p. | 2,900,570 | $12.0M |
| state street corp | 2,546,191 | $10.6M |
| samsara biocapital, llc | 2,500,000 | $10.4M |
| geode capital management, llc | 2,408,191 | $10.0M |
| bank of america corp /de/ | 2,405,050 | $10.0M |
Showing top 10 of 178 institutional holders of Aquestive Therapeutics, Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 13.1%
- Days to cover
- 13.1
- Shares short
- 15,497,249
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
AQST short interestGovernance
Frequently asked questions
What is the AI investment thesis for Aquestive Therapeutics, Inc.?
Aquestive Therapeutics is a specialty pharmaceutical company developing orally delivered prodrug alternatives to invasively administered standard-of-care therapies, with a lead candidate (Anaphylm) for anaphylaxis and a pipeline of epinephrine prodrugs, while also manufacturing and licensing several commercial products.
What is Aquestive Therapeutics, Inc.'s lead drug candidate?
Aquestive Therapeutics, Inc.'s most advanced tracked candidate is anaphylm (BLA Filed) for severe allergic reactions, including anaphylaxis.
What is Aquestive Therapeutics, Inc.'s next catalyst?
Aquestive Therapeutics, Inc.'s next tracked catalyst is a Patent_Expiry event — "Patent_Expiry: NDA022524" — expected July 13, 2030.
Who is the CEO of Aquestive Therapeutics, Inc.?
Mr. Daniel Barber is the chief executive officer of Aquestive Therapeutics, Inc. (AQST).
Where is Aquestive Therapeutics, Inc. headquartered?
Aquestive Therapeutics, Inc. (AQST) is headquartered in Warren, NJ, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.