Aquestive Therapeutics, Inc.
AQST evidence brief
What we can confirm
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 focused on developing and commercializing differentiated products to address central nervous system (CNS) and allergy/immunology conditions, with its lead pipeline candidate Anaphylm (oral epinephrine) awaiting FDA approval.
Key risk: FDA approval risk for Anaphylm
BioSniper Score
Based on 6 of 6 signals
Market Cap
$630.1M
Cash Runway
33.2 moLead Asset
anaphylm (BLA Filed)
Next Catalyst
Patent_Expiry · Jul 13, 2030Financial data as of Jun 30, 2026.
Tracking 4 pipeline candidates · 1 clinical trial · 1 catalyst for Aquestive Therapeutics, Inc..
Aquestive Therapeutics is a specialty pharmaceutical company focused on developing and commercializing differentiated products to address central nervous system (CNS) and allergy/immunology conditions, with its lead pipeline candidate Anaphylm (oral epinephrine) awaiting FDA approval.
- Lead product candidate Anaphylm is an oral film formulation of epinephrine designed as an alternative to auto-injectors for severe allergic reactions; the company states it has the potential to be the first and only oral administration of epinephrine [sec · filed 2026-06-26].
- The company also has a pipeline including AQST-108 (epinephrine topical gel) for alopecia areata and Libervant (diazepam buccal film) for seizure clusters [sec · filed 2026-06-26].
- As of June 30, 2026, the company reported cash and equivalents of $98.5M, total revenue of $13.8M, net loss of -$22.9M, shareholders' equity of -$33.7M, and total debt of $50.7M [sec].
- The company faces significant risks including potential delays or failure to obtain FDA approval for Anaphylm, insufficient capital to fund operations, and reliance on external financing [sec · filed 2026-06-26].
- A key upcoming catalyst is the patent/exclusivity expiry for ZUPLENZ on July 13, 2030, which could affect revenue from that product.
What works
- Anaphylm, if approved, could address a large and growing U.S. epinephrine market as a novel oral alternative to existing injectable standards of care [sec · filed 2026-06-26].
- The company has a pipeline of prodrug candidates (AdrenaVerse™) targeting multiple indications, including AQST-108 for alopecia areata, which could diversify revenue sources [sec · filed 2026-06-26].
What to weigh
- The company has an accumulated net loss and negative shareholders' equity (-$33.7M as of June 30, 2026), indicating ongoing financial challenges [sec].
- There is substantial risk that Anaphylm may not receive FDA approval, or that approval may be delayed, which would materially impact the company's prospects [sec · filed 2026-06-26].
- The company's ability to continue as a going concern depends on securing additional capital, and it faces risks related to its existing indebtedness and debt service obligations [sec_mda · as of 2026-08-11].
From the filings
Quoted directly from source documents.
Anaphylm is positioned as a potential first oral epinephrine for anaphylaxis.
“Anaphylm's potential to be the first and only oral administration of epinephrine and to be accepted as an alternative to existing standards of care, if approved by the FDA”
SEC filings · June 26, 2026
FDA approval of Anaphylm is a key risk and assumption for the company's operations.
“risk of delays in advancement of the regulatory approval process through the FDA of our product candidates, including the filing of the respective NDAs, for Anaphylm, AQST-108, Libervant and other product candidates, or failure to receive FDA approval at all for any of these product candidates”
SEC filings · June 26, 2026
The company's pipeline includes AQST-108 for alopecia areata.
“AQST-108 (epinephrine) topical gel, through clinical development and FDA regulatory approval process, including design and timing of clinical studies including those necessary to support the targeted indication of alopecia areata for AQST-108”
SEC filings · June 26, 2026
Catalyst timeline
- 2030-07-13 · Patent_Expiry · ZUPLENZ — Patent/Exclusivity Expiry: ZUPLENZ — The patent or exclusivity protection for ZUPLENZ expires, which could lead to generic competition and affect revenue from that product.
Risks & what to watch (4)›
Key risks
- FDA approval risk for Anaphylm — Anaphylm may not receive FDA approval, or approval may be delayed, which would materially harm the company's prospects [sec · filed 2026-06-26].
- Capital and liquidity risk — The company may not have sufficient capital to fund operations and debt obligations, requiring additional financing that may not be available [sec_mda · as of 2026-08-11].
- Clinical and regulatory delays — Development timelines for Anaphylm, AQST-108, and Libervant may be delayed due to clinical trial or regulatory hurdles [sec · filed 2026-06-26].
- Debt and revenue dependency — The company's debt and royalty obligations could strain cash flow, especially if Suboxone revenue declines [sec_mda · as of 2026-05-13].
What to watch
- FDA decision on Anaphylm NDA submission and potential approval [sec · filed 2026-06-26].
- Progress of AQST-108 clinical trials for alopecia areata [sec · filed 2026-06-26].
- Company's ability to secure additional financing or partnerships to extend cash runway [sec_mda · as of 2026-08-11].
- Revenue trends from Suboxone and potential impact of generic competition [sec_mda · as of 2026-05-13].
Sources: SEC filings · SEC MD&A · Generated August 28, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
33.2 months
OCF -$9M · Net income -$23M
Lead: Approved
4 candidates
1 upcoming, next in ~1413d
0 buys · 13 sells (180d)
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
179
Total value held
$318.4M
| 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 |
| arete wealth advisors, llc | 121,485 | $14.1M |
| 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 |
Showing top 10 of 179 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 focused on developing and commercializing differentiated products to address central nervous system (CNS) and allergy/immunology conditions, with its lead pipeline candidate Anaphylm (oral epinephrine) awaiting FDA approval.
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/Exclusivity Expiry: ZUPLENZ" — 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.