Aquestive Therapeutics (AQST) Leerink Global Healthcare Conference 2026 summary

Strategic focus and pipeline

• Anaphylm is the current core focus, but the company has a broader pipeline, including the Adrenoverse technology and six FDA-approved products to date.

• Revenue streams exist from legacy products, and future value is expected from ongoing technology development.

Regulatory progress and timelines

• The FDA's complete response letter (CRL) for Anaphylm identified no clinical deficiencies; remediation focuses on human factors and PK studies.

• Protocols, CROs, and timelines for both required studies are already in place, with resubmission targeted for Q3 2024 and potential approval in early 2025.

• High confidence in meeting regulatory timelines, with a possibility of faster-than-expected FDA review based on industry precedent.

Study details and label implications

• Human factors study changes include simplified packaging and clearer instructions to address FDA concerns.

• PK study includes five arms, with three focused on approvability and two providing additional FDA information.

• Labeling changes are expected to be straightforward, with potential upside for additional characterization.