AQST

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

Aquestive advances Anaphylm NDA resubmission to FDA in 2026 catalyst

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    <h3>Information</h3>
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    <h3>AI Summary</h3>
    <p>Aquestive reports Q2 2026 results and progress on Anaphylm NDA resubmission in Q3 2026 after human factors and PK validation. The company also targets Canada by year-end 2026 and the EU in early 2027, with an allergist-first launch if approved, signaling near-term regulatory catalysts and upside potential for AQST.</p>
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    <h3>Key Points</h3>
    <ul><li>Anaphylm NDA resubmission to FDA planned for Q3 2026; CRL issues addressed.</li><li>Completed human factors validation and PK study; primary endpoints met.</li><li>Ex-US filings planned: Canada by end-2026; EU by Q1 2027.</li><li>Investor call scheduled for August 12, 2026 at 8:00 a.m. ET.</li><li>Q2 2026 revenue rose 38% to $13.8M; net loss $22.9M; cash $98.5M.</li></ul>
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  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Aquestive Therapeutics, Inc. (AQST)</strong>: Regulatory milestones for Anaphylm; potential U.S. NDA resubmission catalyst.</li><li><strong>Indivior PLC (INVR)</strong>: Royalty flow from Suboxone Sublingual Film; AQST revenue could be influenced by licensing changes.</li><li><strong>Assertio Holdings, Inc. (ASRT)</strong>: License royalties for Sympazan; potential revenue impact from licensing/ownership changes.</li></ul>
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  <section data-block="category">
    <h3>Corporate Developments</h3>
    <p>Category: Corporate Developments. The article centers on regulatory progress, pipeline updates, and near-term milestones that could affect AQST&#039;s valuation and odds of approval, rather than financial results alone.</p>
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    <h3>Market-Moving</h3>
    <ul><li>NDA resubmission timing and potential FDA expedited review for Anaphylm.</li><li>Canada end-2026 and EU 1Q2027 regulatory timelines.</li><li>Q2 revenue growth and cash balance support near-term launch readiness.</li><li>One-time debt extinguishment loss weighs on near-term profitability.</li></ul>
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  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>Total revenues for Q2 2026: $13.8 million.</li><li>Net loss for Q2 2026: $22.9 million; Non-GAAP EBITDA loss: $5.2 million.</li><li>Cash and cash equivalents: $98.5 million as of 6/30/2026.</li><li>NDA resubmission guidance: Q3 2026; Canada end-2026; EU Q1-2027.</li><li>One-time debt extinguishment loss: $11.7 million in Q2 2026.</li></ul>
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  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>AQST could rally 3–9 months on NDA resubmission and possible FDA expedite, balanced by regulatory risk.</p>
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    <h2>AQST Update: Aquestive Therapeutics Reports Second Quarter 2026 Financial Results and Business Update</h2>
    <p>WARREN, N.J., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/AQST">AQST</a>) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced financial results for the second quarter ended June 30, 2026, and provided a strategic business update.</p>

    <ul>
      <li><em>Successfully completed human factors validation study and pharmacokinetic study for Anaphylm&#x2122; (dibutepinephrine) sublingual film</em></li>
      <li><em>Remains on track to resubmit Anaphylm NDA to the FDA in Q3 2026</em></li>
      <li><em>Continues pre-launch medical affairs activities and payer engagement</em></li>
      <li><em>On track to begin ex-U.S. filings of Anaphylm in Q4 2026</em></li>
      <li><em>Company to host investor call on August 12, 2026, at 8:00 a.m. ET</em></li>
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    <h2>Strategic Outlook and NDA Resubmission Timeline for Anaphylm</h2>
    <p>"The epinephrine rescue market continues to grow and remains available for conversion from older medical device technology including autoinjectors," said Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics. "As we bring Anaphylm to market, if approved by the FDA, we believe we can be instrumental in driving conversion in the allergist office and, ultimately, the broader market. As we prepare to resubmit our application to the FDA in the coming weeks, our full attention will be to prepare for a focused, allergist-first launch of Anaphylm as quickly as possible, if approved by the FDA. In the meantime, our medical affairs team continues to interact with the allergy community on a daily basis."</p>
    <p>"We also continue to expand our understanding of our AdrenaVerse epinephrine prodrug platform and the opportunity it presents," continued Daniel Barber. "Controlling the absorption and release of epinephrine allows us to target a variety of indications, especially in dermatological indications such as atopic dermatitis. The well-documented ability of epinephrine to lower histamine release through stabilizing mast cells while also downregulating key inflammatory components of atopic dermatitis creates the potential for a compelling product profile. Although AQST-108 is still in early-stage development, we are encouraged by the emerging data and plan on continuing to advance the program as we look towards 2027."</p>
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    <h2>Product Spotlight: Anaphylm&#x2122; (dibutepinephrine) Sublingual Film</h2>
    <p><strong>Anaphylm&#x2122; (dibutepinephrine) sublingual film</strong><br/>Anaphylm is an oral epinephrine product candidate being developed for the treatment of type I allergic reactions, including anaphylaxis. The Company believes Anaphylm has the potential to be the first and only non-invasive, orally delivered epinephrine product for the treatment of type I allergic reactions, including anaphylaxis, if approved by the U.S. Food and Drug Administration (FDA).</p>

    <p>In the second quarter of 2026, Aquestive completed the human factors validation study and the pharmacokinetic (PK) study required to address the deficiencies identified in the Complete Response Letter (CRL) issued by the FDA dated January 30, 2026. The human factors validation study evaluated a revised packaging design, incorporating modifications to the pouch opening, instructions for use, pouch and carton labeling. The study results showed significant improvement across each deficiency identified in the CRL. Based on preliminary data, the PK study met its primary endpoints. No administration errors were observed in the self-administration arm of the PK study. In addition, there were no serious adverse events and no events that led to study drug discontinuation. The Company reaffirms its guidance to resubmit the Anaphylm New Drug Application (NDA) in the third quarter of 2026. As previously disclosed, the CRL did not identify any chemistry, manufacturing, or controls (CMC) deficiencies, and clinical results supporting comparability to autoinjectors were not questioned by the FDA. The Company will request an expedited review upon resubmission, though no shortened or expedited review timeline can be guaranteed.</p>
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    <h2>Regulatory Strategy: Global Submissions on Track</h2>
    <p>AAquestive continues to advance its global regulatory strategy for Anaphylm. The Company remains on track to submit regulatory applications in Canada by the end of 2026 and in the European Union in the first quarter of 2027. The Company expects its existing clinical data to support regulatory submissions in additional markets in 2027, including the United Kingdom.</p>
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    <h2>Commercial Readiness and Market Access Initiatives</h2>
    <p>Aquestive continues to advance commercial readiness in anticipation of a potential Anaphylm launch. The Company's Medical Affairs team is driving healthcare professional awareness, and the Company recently strengthened its Scientific Advisory Board to further support scientific exchange and education. Aquestive also maintains active partnerships with leading allergy-focused patient advocacy organizations. In parallel, the commercial team continues to refine launch execution and market access strategies. These efforts are supported by the Company's experienced commercial team and its established infrastructure, enabling Aquestive to execute a focused and disciplined launch strategy, if Anaphylm is approved by the FDA.</p>
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  <section>
    <h2>AQST-108 (epinephrine) Topical Gel and AdrenaVerse Platform</h2>
    <p><strong>AQST-108 (epinephrine) topical gel</strong><br/>AQST-108 is a topical epinephrine prodrug gel product candidate being evaluated for various potential dermatologic indications. The Company completed the AQST-108 Phase 1 study in androgenic alopecia with no safety concerns observed, supporting continued development. The program is expanding into additional dermatologic inflammatory indications, including atopic dermatitis. This disciplined, data-driven approach is consistent with the Company’s strategy of maximizing the value of the AdrenaVerse&#x2122; platform while maintaining focus on the Anaphylm NDA resubmission.</p>

    <p>Atopic dermatitis affects approximately 7%–10% of U.S. adults and 10%–20% of children, making it one of the most common chronic inflammatory skin diseases in the U.S.</p>

    <p>AQST-108 is believed to have potential immunomodulatory effects, including downregulation of certain chemoattractants and inflammatory mediators, while stabilizing mast cells. Based on this mechanism, Aquestive believes AQST-108’s potential may extend beyond atopic dermatitis and alopecia areata to additional dermatologic inflammatory and immunologic indications.</p>

    <p>Aquestive’s AdrenaVerse&#x2122; platform comprises approximately 20 epinephrine prodrugs designed to enable control of absorption and conversion rates of epinephrine across a range of dosage forms and delivery sites. The Company continues to analyze the AdrenaVerse platform’s long-term potential to address multiple indications.</p>
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  <section>
    <h2>Commercial Collaborations and Manufacturing Excellence</h2>
    <p>Aquestae continues to manufacture products for the licensing and supply collaborations that it has established. The Company manufactured approximately <strong>48 million</strong> doses in the second quarter 2026, compared to approximately <strong>37 million</strong> doses in the second quarter 2025. The Company continues to manufacture Indivior’s Suboxone<Sup>®</Sup> Sublingual Film product and the Company’s other global collaborations, including Sympazan<Sup>®</Sup> (clobazam) oral film product for Cosette Pharmaceuticals, Inc. in the U.S., Ondif<Sup>®</Sup> (ondansetron) oral film product for Hypera Pharma in Brazil and Emylif<Sup>®</Sup> (riluzole) oral film product by Zambon S.p.A. in Europe. Aquestive’s manufacturing business remains steady.</p>
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Aquestive reports Q2 2026 results and progress on Anaphylm NDA resubmission in Q3 2026 after human factors and PK validation. The company also targets Canada by year-end 2026 and the EU in early 2027, with an allergist-first launch if approved, signaling near-term regulatory catalysts and upside potential for AQST.

News insight

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

AI summary

Sentiment rationale

Key facts

Corporate Developments