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Aquestive Therapeutics, Inc.

AQST
OvervaluedPharma · Commercial
FDA catalysts, PDUFA dates & pipeline intelligence
$4.78
▲ +0.01 · +0.21%

Financials

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52W LOW $2.9352W HIGH $7.55
Volume
1.69 M
Value Traded
32.29 M
Short % Float
22.85%
+4.6%Week
-4.21%1 Month
+17.73%3 Month
+14.08%6 Month
+18.05%5 Year
-72.62%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
599.95 M
EPS (TTM)
-0.62
P/E Ratio
-
Ent. Value
556.46 M
Total Shares
125.50 M
Float Shares
118.89 M
Insiders
5.28%
Institutions
47.96%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

AQST Catalyst Timeline

Dated clinical, regulatory and corporate events for Aquestive Therapeutics, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Aquestive Therapeutics, Inc.

604Total events
10Upcoming
147Tier-1 (high impact)
2018 to 2037Coverage

Upcoming catalysts 2

T2Management Change
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T2Product Launch
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LibervantApproved

Event history 50

●NDA SubmissionAnaphylmFiledRegulatory Filing
Aquestive resubmits NDA to FDA for Anaphylm (dibutepinephrine) sublingual film
Type I allergic reactions, including anaphylaxissource ↗
●sNDA SubmissionAnaphylmFiledRegulatory Filing
Resubmission of NDA to FDA for Anaphylm (dibutepinephrine) sublingual film
Type I allergic reactions, including anaphylaxissource ↗
●Quarterly UpdateCorporate
Reported Q2 2026 financial results
▲Trial CompletionAnaphylmFiledTrial
Completed human factors validation study for Anaphylm
anaphylaxissource ↗
▲Topline ReadoutAnaphylmFiledClinical Data
Topline results from human factors validation study announced
Type 1 allergic reactions, including anaphylaxissource ↗
▲Topline ReadoutAnaphylmFiledClinical Data
Positive topline human factors and PK study results announced
Type I allergic reactions, including anaphylaxissource ↗
●NDA SubmissionAnaphylmFiledRegulatory Filing
Anaphylm NDA resubmission to FDA in Q3 2026
anaphylaxissource ↗
●EU MAA SubmissionAnaphylmFiledEx-US Regulatory
MAA submission for Anaphylm in Europe
severe allergic reactions including anaphylaxissource ↗
◆Quarterly UpdateCorporate
Conference Call for First Quarter 2026 Results
●Timing GuidancePresentation
Investor call scheduled for May 14, 2026
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How AQST actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-09-30Anaphylm (dibutepinephrine) Sublingual Film (AQST-109) NDA Submission NDA
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

C41 / 100
Pipeline Score
$167M
Pipeline Value
$128M
Commercial Value
Overvalued
Valuation Signal
1
Drugs Scored
0.4x
rNPV / MCap
Top 36%
Micro Cap
(rank 238 of 660)
Percentile Rank
Aquestive Therapeutics, Inc. carries a moderate pipeline score (41/100), with $836M risk-adjusted pipeline value, led by DESF in Allergic Reaction (Phase 2).
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026) Revenue $54.1M x 2.4 = $128M
Showing 1 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
DESF Small moleculeCompletedNCT07703982Allergic ReactionPhase 2 COMPLETED 68May 21, 2025
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Clinical Trial Results

Readouts, endpoints and source filings for every AQST program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
Anaphylm™ (epinephrine) Sublingual Film severe allergic reactions, including anaphylaxis2025-06-25Elicits Rapid and Consistent Pharmacokinetic and Pharmacodynamic ResponsesRead MoreAquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies of Anaphylm™ (epinephrine) Sublingual Film at the CFAAR Food Allergy SummitRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Barber DanielDirector, Officer (President and CEO)Sell -25,000 652,317 held$4.82 09/15/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
RTW INVESTMENTS, LP 0.3 % 30.89 M 7.43 M
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Shares held by hedge funds each quarter, and who bought or sold.

AQST Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How AQST ranks across every disease it competes in

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See how AQST ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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AQST News

AQST
Sep 29, 2026
AQSTGeneral

Aquestive Therapeutics Strengthens Board of Directors with Appointment of Richard Daly

Aquestive Therapeutics has appointed Rich Daly to its Board of Directors, effective October 14, 2026. Daly, a seasoned executive with over 30 years in the life sciences sector, will contribute his extensive experience in commercial launches and organizational development. His addition is seen as a strategic move as the company prepares for the potential launch of its product Anaphylm.

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AQST
Sep 17, 2026
AQSTFDA Updates

Aquestive Therapeutics Announces Resubmission of New Drug Application to FDA for Anaphylm™ (dibutepinephrine) Sublingual Film

Aquestive Therapeutics has resubmitted its New Drug Application for Anaphylm™ (dibutepinephrine) sublingual film to the FDA for treating Type I allergic reactions. The resubmission follows positive results from human factors and pharmacokinetic studies. The FDA will determine the classification and review timeline of the resubmission after its initial review.

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AQST
Sep 1, 2026
AQSTConferences/Events

Aquestive Therapeutics to Participate in Upcoming September Investor Conferences

Aquestive Therapeutics will participate in four investor conferences in September 2026, including the Wells Fargo Healthcare Conference and the H.C. Wainwright 27th Annual Global Investor Conference. The management team will host meetings and present key information about their innovative medicines. Webcasts of the events will be accessible for 30 days post-conference.

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AQST
Aug 11, 2026
AQSTFDA Updates

Aquestive Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update

Aquestive Therapeutics has reported its financial results for Q2 2026, highlighting the successful completion of a human factors validation study and a pharmacokinetic study for its Anaphylm sublingual film. The company remains on track to resubmit its New Drug Application (NDA) to the FDA in the third quarter of 2026 and is actively engaging in pre-launch activities.

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AQST
Aug 10, 2026
AQSTFDA Updates
▲ +8.9%on this newsshared move

Aquestive Therapeutics Announces Positive Topline Human Factors and Pharmacokinetic Study Results for Anaphylm™ (dibutepinephrine) Sublingual Film

Aquestive Therapeutics announced positive results from its human factors and pharmacokinetic studies for Anaphylm™ (dibutepinephrine) sublingual film. The studies support the planned resubmission of the New Drug Application (NDA) to the FDA in Q3 2026. Key improvements include faster pouch opening and reduced incorrect film placement, enhancing usability for patients at risk of anaphylaxis.

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AQST
Jul 29, 2026
AQSTGeneral

Aquestive Therapeutics to Report Second Quarter 2026 Financial Results and Recent Business Highlights on August 11 and Host Conference Call on August 12 at 8:00 a.m. ET

Aquestive Therapeutics will report its second quarter 2026 financial results on August 11, 2026, and host a conference call for investors on August 12. The company is focused on advancing its product candidates, including Anaphylm™ and AQST-108, which target severe allergic reactions and dermatological conditions. A live webcast of the call will be available on its website.

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AQST
Jul 7, 2026
AQSTConferences/Events

Aquestive Therapeutics to Participate in Leerink Partners Therapeutics Forum: I&I and Metabolism

Aquestive Therapeutics will participate in the Leerink Partners Therapeutics Forum on July 14, 2026, focusing on immunology and metabolism. The management team will also host one-on-one investor meetings. The company is known for its innovative delivery technologies and is advancing treatments for severe allergic reactions and dermatological conditions.

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AQST
May 13, 2026
AQSTGeneral

Aquestive Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update

Aquestive Therapeutics reported strong financial results for Q1 2026, with a revenue increase of 66% year-over-year. The company reaffirmed its plans to resubmit the Anaphylm NDA in Q3 2026 after a successful FDA Type A meeting. Additionally, AQST-108's phase 1 study showed no safety issues, supporting its potential in treating dermatological conditions. A new $150 million debt facility enhances the company's financial position for upcoming initiatives.

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AQST
May 12, 2026
AQSTGeneral

Aquestive Therapeutics Completes $150 Million Debt Refinancing with Oaktree

Aquestive Therapeutics has successfully refinanced its debt with a new $150 million facility from Oaktree Capital Management. This refinancing will support the potential launch of Anaphylm, an investigational treatment for severe allergic reactions, pending FDA approval. The new agreement reduces the company's principal debt repayments significantly and provides additional capital for growth.

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AQST
May 6, 2026
AQSTConferences/Events

Aquestive Therapeutics to Report First Quarter 2026 Financial Results and Recent Business Highlights on May 13 and Host Conference Call on May 14 at 8:00 a.m. ET

Aquestive Therapeutics will report its first quarter 2026 financial results on May 13, 2026, and host a conference call for investors on May 14, 2026. The company aims to provide updates on its business developments and product candidates, including Anaphylm and AQST-108. A live webcast will be available for interested parties.

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AQST
Mar 30, 2026
AQSTFDA Updates

Aquestive Therapeutics Announces Completion of Type A Meeting with FDA for Anaphylm™ (dibutepinephrine) Sublingual Film

Aquestive Therapeutics has completed a Type A meeting with the FDA regarding the resubmission of its NDA for Anaphylm, a sublingual film for treating Type 1 allergic reactions. The company received valuable feedback on pharmacokinetic and human factor study designs, which will aid in their upcoming studies. The NDA resubmission is planned for Q3 2026, with further regulatory submissions also progressing in Canada and the EU.

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AQST
Mar 20, 2026
AQSTGeneral

Aquestive Therapeutics Announces New Role of Lori J. Braender and Appointment of Thomas A. Zalewski as Chief Legal Officer and Chief Compliance Officer

Aquestive Therapeutics has appointed Thomas A. Zalewski as Chief Legal Officer and Chief Compliance Officer, effective April 2, 2026. He succeeds Lori J. Braender, who will remain as Corporate Secretary after nearly eight years in her previous roles. Zalewski's extensive experience in life sciences law is expected to support the company's mission, particularly in advancing Anaphylm, an oral epinephrine medication.

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AQST
Mar 9, 2026
AQSTGeneral

Aquestive Therapeutics Announces Grant of Inducement Award Pursuant to Nasdaq Listing Rule 5635(c)(4)

Aquestive Therapeutics has announced an inducement equity grant for Dr. Matthew Greenhawt, the newly appointed Chief Medical Officer. The grant includes 75,000 Restricted Stock Units and 50,000 non-qualified stock options, which will vest over a period of three years. This award is part of the company's 2022 Equity Inducement Plan and was approved by the Compensation Committee. The grants, scheduled for March 9, 2026, are intended to serve as a significant incentive for Dr. Greenhawt as he joins the company.

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AQST
Mar 5, 2026
AQSTGeneral

Aquestive Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Aquestive Therapeutics reported its financial results for Q4 and full year 2025, highlighting progress on Anaphylm, an oral epinephrine medication. The company received a Complete Response Letter from the FDA, necessitating further studies before resubmission. Despite challenges, Aquestive remains optimistic about Anaphylm's potential, bolstered by new leadership and a growing allergy market.

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AQST
Feb 25, 2026
AQSTConferences/Events

Aquestive Therapeutics to Participate in Upcoming March Investor Conferences

Aquestive Therapeutics announced its participation in four investor conferences in March 2026. The company aims to showcase its advancements in innovative medicines and delivery technologies. A webcast of the presentations will be available for 30 days post-event. The company is known for its proprietary products and contract development services.

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AQST
Feb 24, 2026
AQSTGeneral

Aquestive Therapeutics to Report Fourth Quarter 2025 Financial Results and Recent Business Highlights on March 4 and Host Conference Call on March 5 at 8:00 a.m. ET

Aquestive Therapeutics will report its fourth quarter 2025 financial results on March 4, 2026, and host a conference call for investors on March 5, 2026. The company aims to provide updates on recent business developments during this call. Their innovative product pipeline includes treatments for severe allergic reactions and dermatological conditions.

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AQST
Feb 23, 2026
AQSTConferences/Events

Aquestive Therapeutics to Participate in Oppenheimer 36th Annual Healthcare Life Sciences Conference

Aquestive Therapeutics will participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, 2026. The management team is scheduled to present on February 26 at 12 pm ET and will also conduct one-on-one meetings with investors. A webcast of the presentation will be available for 30 days post-event.

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AQST
Feb 20, 2026
AQSTConferences/Events

Aquestive Therapeutics to Present New Clinical Data on Anaphylm™ (dibutepinephrine) Sublingual Film at the 2026 AAAAI Annual Meeting

Aquestive Therapeutics announced that it will present new clinical data on Anaphylm™ (dibutepinephrine) sublingual film at the 2026 AAAAI Annual Meeting. The data highlights Anaphylm's potential to improve anaphylaxis management without the diastolic blood pressure dip associated with traditional epinephrine treatments. The meeting is scheduled for February 27 to March 2, 2026, in Philadelphia, PA.

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AQST
Feb 18, 2026
AQSTGeneral

Aquestive Therapeutics Appoints Internationally Recognized Allergist Dr. Matthew Greenhawt as Chief Medical Officer

Aquestive Therapeutics has appointed Dr. Matthew Greenhawt as Chief Medical Officer, enhancing its leadership as it prepares to resubmit the Anaphylm NDA to the FDA. Dr. Greenhawt, an expert in allergy and immunology, will leverage his experience to advance the company's clinical pipeline and address barriers to epinephrine use. His appointment is seen as a significant step for the company at this critical juncture.

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AQST
Feb 2, 2026
AQSTFDA Updates
▲ +39%on this news

Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™

Aquestive Therapeutics announced it received a Complete Response Letter from the FDA for its Anaphylm Sublingual Film application, highlighting human factors issues. The company is optimistic about addressing these concerns and plans to conduct a new validation study. They also aim for rapid resubmission in Q3 2026 while expanding regulatory efforts in international markets.

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About Aquestive Therapeutics, Inc.

Warren, NJ 147 employees aquestive.com
Headquarters30 TECHNOLOGY DRIVE, WARREN, NJ, 07059
Founded2004
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