8-K - Aquestive Therapeutics, Inc. | StockGist

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Aquestive Therapeutics announced the successful completion of a Type A meeting with the FDA regarding the resubmission of its Anaphylm NDA, reaffirming its guidance to resubmit in Q3 2026.

Key Takeaways

1Aquestive Therapeutics successfully completed an in-person Type A meeting with the FDA on March 30, 2026, regarding the resubmission of the Anaphylm NDA.

2The company reaffirmed its guidance to resubmit the Anaphylm New Drug Application in the third quarter of 2026.

3The FDA provided preliminary comments on the pharmacokinetic study design, focusing on consistency with past studies.

4The FDA provided preliminary comments on the human factors validation study design, recommending changes to user groups.

5The company shared revisions to the product container closure opening mechanisms with the FDA, which will be tested in the upcoming human factors study.

6Final FDA meeting minutes from the Type A meeting are expected by early May 2026.

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

(including Exhibit 99.1) shall not be deemed to be “filed” for purposes of, or otherwise subject to the liabilities of, Section 18 of the Securities Exchange Ac

Regulation Fd

9.01

| Financial Statements and Exhibits. (d) Exhibits. Exhibit Number: 99.1 | Description: Aquestive Therapeutics, Inc. Press Release, dated March 30, 2026 Exhibit

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1