Aquestive Therapeutics, Inc. 8-K

What Happened

• On January 9, 2026, Aquestive Therapeutics, Inc. announced receipt of an FDA notice that, during its ongoing review, the agency identified deficiencies in the New Drug Application (NDA) for Anaphylm™ (epinephrine) Sublingual Film that preclude discussion of labeling and post‑marketing commitments. The FDA did not specify the deficiencies and stated the notice is not a final decision; review is ongoing. Aquestive is working to understand and address the FDA’s concerns prior to the PDUFA goal date of January 31, 2026.
• The company also said it is advancing global regulatory efforts (engagements in Canada, Europe and the U.K. initiated in 2025) and plans to seek approval in Canada and Europe in 2026. Aquestive reported approximately $120 million in cash and cash equivalents as of December 31, 2025 and completed a recent equity raise, saying it believes it has the capital to execute its current long‑term strategy.

Key Details

• FDA notice received: January 9, 2026; PDUFA goal date: January 31, 2026.
• FDA identified unspecified deficiencies that currently preclude discussion of labeling and post‑marketing commitments.
• Cash position: ~ $120 million as of December 31, 2025; recent equity raise completed.
• Global regulatory activity: engagement in Canada, Europe and U.K. (2025); plans to seek approvals in Canada and Europe in 2026.

Why It Matters

• For investors, the FDA notice means the potential timeline for U.S. approval and commercialization of Anaphylm could be delayed, though the notice is not a rejection and the agency’s review remains active.
• Aquestive’s reported cash balance and recent equity raise suggest the company believes it has runway to address FDA questions and pursue international regulatory filings, but upcoming FDA communications and any additional details about the deficiencies will be key near‑term catalysts to watch.