Aquestive Therapeutics, Inc. (AQST) Aquestive Therapeutics, Inc. is a pharmaceutical company focused on discovering, developing, and commercializing products to address significant unmet medical needs across both the United States and international markets. The company's commercialized portfolio includes: Sympazan, an oral soluble film formulation of clobazam for individuals with Lennox-Gastaut syndrome. Suboxone, a sublingual film containing buprenorphine and naloxone, indicated for the treatment of opioid dependence. Zuplenz, an oral soluble film of ondansetron, used to manage nausea and vomiting associated with chemotherapy and post-operative recovery. Azstarys, a once-daily medication for attention deficit hyperactivity disorder. Aquestive maintains a robust proprietary pipeline of drug candidates. These include: Libervant, a buccal soluble film formulation of diazepam currently in development for the treatment of seizures. Exservan, an oral soluble film of riluzole, aimed at treating amyotrophic lateral sclerosis (ALS). Within its complex molecule pipeline, the company is advancing: AQST-108, a sublingual film designed to deliver systemic epinephrine for conditions other than anaphylaxis. AQST-305, a sublingual film formulation of octreotide for managing acromegaly. AQST-109, an orally administered epinephrine product candidate intended for the emergency treatment of severe allergic reactions, including anaphylaxis. Furthermore, Aquestive Therapeutics played a role in the development of KYNMOBI, a sublingual film formulation of apomorphine, used to address episodic "off" periods in patients with Parkinson's disease. Established in 2004, Aquestive Therapeutics, Inc. is headquartered in Warren, New Jersey.
Sector: Pharmaceutical Preparations
Industry: Drug Manufacturers - Specialty & Generic
Aquestive Therapeutics, Inc. NASDAQ:AQST Healthcare · Drug Manufacturers - Specialty & Generic
Mkt Cap $488.24M
Vol 0
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Press Release
Aquestive Therapeutics to Report Third Quarter 2026 Financial Results and Recent Business Highlights on November 3 and Host Conference Call on November 4 at 8:00 a.m. ET
Aquestive Therapeutics will report third quarter 2026 financial results and recent business highlights after market close on Tuesday, November 3, 2026.
Management will host a conference call at 8:00 a.m. ET on Wednesday, November 4, 2026, with a live webcast and 30-day replay available on the company's investor relations site.
This is a scheduling notice only and contains no financial results; investors should watch the November 3 release for updates on Anaphylm's FDA review and AQST-108 clinical progress.
• 5d ago AI analysis › Press Release ⚠ 3
Aquestive Therapeutics Announces FDA Acceptance of Anaphylm™ NDA Resubmission and PDUFA Goal Date of March 16, 2027
The FDA accepted Aquestive's resubmission of the Anaphylm NDA as complete and assigned a Class 2 PDUFA goal date of March 16, 2027.
The resubmission, filed September 16, 2026, followed positive human factors and pharmacokinetic study results addressing the FDA's January 30, 2026 Complete Response Letter.
If approved, Anaphylm would be the first and only oral rescue medication for severe allergic reactions, including anaphylaxis; the company is also on track to file its New Drug Submission with Health Canada in Q4 2026.
• 17d ago AI analysis › Press Release ⚠ 2
Eton Pharmaceuticals and Aquestive Therapeutics Announce Exclusive U.S. Licensing Agreement for LIBERVANT® (diazepam) Buccal Film
Aquestive and Eton announced an exclusive U.S. licensing and supply agreement for LIBERVANT (diazepam) buccal film, transferring U.S. commercialization rights to Eton.
Eton anticipates commercial availability in April 2027, subject to final FDA approval; full approval in patients 12+ is expected after VALTOCO's orphan exclusivity expires January 10, 2027, and a label-expansion NDA (ages 6-11) has a PDUFA date of March 29, 2027.
For Aquestive, the deal creates a path to upfront, milestone, and royalty payments plus CDMO manufacturing revenue, addressing a U.S. seizure rescue market the companies size at over $450 million annually.
• 18d ago AI analysis › Press Release
Aquestive Therapeutics Strengthens Board of Directors with Appointment of Richard Daly
Aquestive Therapeutics appointed Rich Daly, a 30-year life sciences executive, to its Board of Directors effective October 14, 2026, expanding the board to eight members, seven of whom are independent.
Daly was President and CEO of Catalyst Pharmaceuticals and now leads Global Rare Disease at Angelini Pharma, with prior senior roles at Takeda and AstraZeneca including launches of Farxiga and Agamree.
The appointment adds commercial launch expertise as Aquestive prepares for the potential launch of Anaphylm, its sublingual epinephrine film candidate pending FDA approval.
• 1mo ago AI analysis › Press Release ⚠ 3
Aquestive Therapeutics Announces Resubmission of New Drug Application to FDA for Anaphylm™ (dibutepinephrine) Sublingual Film
Aquestive Therapeutics has resubmitted its New Drug Application to the FDA for Anaphylm (dibutepinephrine) sublingual film, a needle-free epinephrine prodrug film for Type I allergic reactions including anaphylaxis.
The resubmission responds to the Complete Response Letter issued January 30, 2026, and is supported by completed human factors and confirmatory PK studies — including a cut in median pouch-opening time from 17 seconds to 3 seconds and no protocol-defined use errors in the self-administration arm, with pharmacodynamic responses previously comparable to or greater than auto-injectors.
The FDA will determine the resubmission classification and review timeline after its initial review, so approval is not yet assured; the company plans a focused, allergist-first launch if cleared.
• 1mo ago AI analysis › Press Release
Aquestive Therapeutics to Participate in Upcoming September Investor Conferences
Aquestive Therapeutics management plans to participate in four investor conferences in September 2026, including events hosted by Wells Fargo, Cantor, Citi, and H.C. Wainwright.
The company will host fireside chats and presentations, with webcasts for the Cantor and H.C. Wainwright sessions available on its investor website.
• 2mo ago AI analysis › Press Release ⚠ 1
Aquestive Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update
Aquestive Therapeutics reported Q2 revenue of $13.8 million, up 38% year-over-year, driven by manufacturing and royalty revenue, while reaffirming full-year revenue guidance of $46 million to $50 million.
The company successfully completed the required human factors validation and pharmacokinetic studies for Anaphylm and remains on track to resubmit the NDA to the FDA in the third quarter of 2026.
Cash and cash equivalents stood at $98.5 million as of June 30, 2026, with the non-GAAP adjusted EBITDA loss narrowing to $5.2 million from $9.3 million in the prior year period.
• 2mo ago AI analysis › Press Release ● Major
Aquestive Therapeutics Announces Positive Topline Human Factors and Pharmacokinetic Study Results for Anaphylm™ (dibutepinephrine) Sublingual Film
Aquestive Therapeutics reported positive topline results from Human Factors and PK studies for Anaphylm, demonstrating that the revised packaging addresses the issues raised in the FDA's previous Complete Response Letter.
The new data showed a significant reduction in pouch opening time to 3 seconds and an over 80% decrease in incorrect film placement, while pharmacokinetic profiles met required endpoints comparable to clinician administration.
The company plans to include this data in its Anaphylm NDA resubmission, which remains on track for the third quarter of 2026.
• 2mo ago AI analysis › Press Release
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 announced it will report its second quarter 2026 financial results after market close on Tuesday, August 11, 2026.
Management will host a conference call to discuss the results and recent business highlights on Wednesday, August 12, at 8:00 a.m. ET.
A live webcast and replay will be available on the Investors section of the company's website.
• 3mo ago AI analysis › Press Release
Aquestive Therapeutics to Participate in Leerink Partners Therapeutics Forum: I&I and Metabolism
Aquestive Therapeutics announced that its management team will participate in the Leerink Partners Therapeutics Forum on July 14, 2026.
The forum focuses on immunology, inflammation, and metabolism themes, and will include 1x1 investor meetings.
The release serves as a standard calendar notification with no new operational or financial disclosures.
• 3mo ago AI analysis › Press Release
Lifshitz Law PLLC Announces Investigations of Apollo Global Management, Inc. (NYSE:APO), Aquestive Therapeutics, Inc. (NASDAQ:AQST), Boston Scientific (NYSE:BSX), and Eos Energy Enterprises, Inc. (NASDAQ:EOSE)
Lifshitz Law PLLC announced an investigation into possible securities laws violations by Apollo Global Management, Inc. (APO).
The firm alleges that APO made materially false statements regarding its leadership's communications with Jeffrey Epstein and the company's business history.
This release is a standard law-firm solicitation inviting investors to contact the firm; it does not represent a filing by the company or a court action.
• 5mo ago AI analysis › Press Release ● Major
Aquestive Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update
globenewswire.com • 5mo ago Press Release
Aquestive Therapeutics Completes $150 Million Debt Refinancing with Oaktree
globenewswire.com • 5mo ago Press Release
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 announced it will report first quarter 2026 financial results after market close on May 13, 2026.
Management will host a conference call to discuss the results and business highlights on May 14 at 8:00 a.m. ET.
The company continues to advance its proprietary pipeline, including Anaphylm for severe allergic reactions and AQST-108 for dermatological conditions.
• 5mo ago AI analysis › 
