AQST Aquestive

Aquestive Anaphylm NDA resubmission accepted with PDUFA of March 16, 2027

FDA accepted the Class 2 NDA resubmission for Anaphylm (dibutepinephrine) sublingual film as complete. A PDUFA goal date of March 16, 2027 has been assigned. This follows the company's September 2026 resubmission addressing the January 2026 CRL.

Aquestive Resubmits NDA for Anaphylm (dibutepinephrine) Sublingual Film

Aquestive resubmitted its NDA to the FDA for Anaphylm (dibutepinephrine) sublingual film for Type I allergic reactions including anaphylaxis. The resubmission follows a January 2026 CRL and is supported by new human factors and confirmatory PK studies using revised packaging and instructions for use. The FDA will classify the resubmission and set the review timeline.

Aquestive to resubmit Anaphylm NDA in Q3 2026

Aquestive completed the human factors validation and PK studies required to address the FDA’s January 30, 2026 CRL. The company plans to resubmit the Anaphylm NDA in Q3 2026 and will request expedited review; no CMC deficiencies were cited in the CRL.

Aquestive reports positive Anaphylm human factors & PK study results

The company announced positive results from its human factors validation study and pharmacokinetic study for Anaphylm sublingual film. These data support the planned resubmission of the NDA to the FDA for the treatment of Type 1 allergic reactions, including anaphylaxis.

Aquestive reaffirms Anaphylm NDA resubmission target for Q3 2026

Following the January 30, 2026 CRL, Aquestive completed a Type A meeting with the FDA and aligned on required human-factors and PK study designs. The company reaffirms its plan to resubmit the Anaphylm NDA in Q3 2026, with no CMC deficiencies cited and existing clinical data deemed sufficient for ex-US filings.

Aquestive completes FDA Type A meeting for Anaphylm NDA resubmission

The company completed an in-person Type A meeting with the FDA and received preliminary comments on the resubmission of its NDA for Anaphylm (dibutepinephrine) sublingual film. This meeting provides regulatory feedback ahead of the planned NDA resubmission for the treatment of Type 1 allergic reactions including anaphylaxis.

Aquestive Therapeutics Inc. · complete response letter (NDA 219870)

FDA issued a complete response letter for NDA 219870 dated 2026-01-30.

Aquestive receives FDA deficiencies notice for Anaphylm NDA

FDA notified Aquestive of deficiencies in the Anaphylm (epinephrine) Sublingual Film NDA that preclude labeling discussions and post-marketing commitments. The notice does not constitute a final decision and review remains ongoing. Company is working to resolve issues ahead of the January 31, 2026 PDUFA goal date, but the development could delay approval.

Aquestive: Anaphylm NDA on track for Jan 31 2026 PDUFA

FDA confirmed no Advisory Committee meeting is required for the Anaphylm NDA. The application remains on schedule for its January 31 2026 PDUFA goal date. The company is advancing U.S. launch preparations and regulatory activities in Canada and the EU.

Aquestive: two new patents extend Anaphylm protection to 2037

USPTO issued U.S. patents 12,427,121 and 12,443,850 covering epinephrine prodrug compositions for Anaphylm, extending exclusivity to May 4, 2037. The PDUFA target action date remains January 31, 2026.