Aquestive Therapeutics' FDA Packaging Setback: Impact on Investment Narrative

Aquestive Therapeutics received a Complete Response Letter from the FDA for its Anaphylm sublingual epinephrine film, focusing on packaging, labeling, and instructions for use. The company is addressing the concerns, redesigning the pouch, and planning new human factors and pharmacokinetics studies. This setback reshapes the investment narrative, with investors now focusing on whether the redesigned pouch and new studies can keep the program on track. Funding Anaphylm's path to market without diluting shareholders is a key issue investors should understand.