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News  ›  GlobeNewswire Inc.

Aquestive Therapeutics Announces Regulatory Development for Anaphylm™ (dibutepinephrine) Sublingual Film and Provides Business Update

GlobeNewswire Inc. Logo GlobeNewswire Inc. By Na
Aquestive Therapeutics Announces Regulatory Development for Anaphylm™ (dibutepinephrine) Sublingual Film and Provides Business Update

Aquestive Therapeutics received an FDA letter identifying deficiencies in its Anaphylm (dibutepinephrine) sublingual film NDA that preclude labeling discussions, though the FDA confirmed its review remains ongoing with no final decision made. The company maintains confidence in Anaphylm's potential and is advancing global regulatory expansion in Canada, Europe, and the UK. Aquestive reported approximately $120 million in cash and cash equivalents as of December 31, 2025.

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The company received an FDA letter identifying unspecified deficiencies in its Anaphylm NDA that preclude labeling discussions, creating regulatory uncertainty and potential delays to the January 31, 2026 PDUSA action date. While management expresses confidence and the company has adequate cash reserves, the identification of deficiencies represents a setback in the approval process for their lead product candidate.