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Aquestive resubmits New Drug Application for Anaphylm, targeting expedited FDA review

AQSTAquestive Therapeutics, Inc.

Aquestive Therapeutics filed an 8-K to furnish an investor presentation dated September 23, 2026. The filing discloses that the company resubmitted its New Drug Application for Anaphylm (dibutepinephrine) sublingual film on September 17, 2026, addressing deficiencies from a January 30, 2026 Complete Response Letter. Aquestive intends to request expedited FDA review and projects a potential commercial launch in 2027 with over $1 billion in annual revenue. The presentation highlights a cash position of $98.5 million as of June 30, 2026, alongside access to up to $95 million in contingent funding upon Anaphylm approval. The company also outlined pipeline progress for Libervant and AQST-108. Aquestive Therapeutics operates in the pharmaceutical industry, developing innovative drug delivery technologies and commercializing medicines.

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