Aquestive Therapeutics Receives FDA Letter Identifying Deficiencies That Preclude Labeling Discussions For Anaphylm (Dibutepinephrine) Sublingual Film

AQUESTIVE THERAPEUTICS, INC. -1.61%

AQUESTIVE THERAPEUTICS, INC.

AQST

4.27

-1.61%

  • Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time 
  • Receives confirmation from FDA that Agency's review of Anaphylm NDA application is ongoing and no final FDA decision has been made
  • Progresses global regulatory expansion activities in Canada, Europe, and the United Kingdom for Anaphylm
  • Unaudited cash and cash equivalents of approximately $120 million as of December 31, 2025
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