AQST-108 (epinephrine) Topical Gel

March 4, 2026: Aquestive Therapeutics, Inc. (NASDAQ: AQST) reported Q4/full-year 2025 results and updated 2026 objectives, highlighting regulatory next steps for Anaphylm™ (dibutepinephrine/epinephrine) sublingual film for Type I allergic reactions including anaphylaxis. The company said it expects a Type A FDA meeting within ~30 days and reaffirmed guidance to resubmit the Anaphylm NDA in Q3 2026 after a Jan. 30, 2026 FDA Complete Response Letter citing human factors validation deficiencies (pouch opening and film placement) and requesting one PK study to assess packaging/labeling modifications. The CRL reported no CMC deficiencies and did not question submitted clinical comparability to auto-injectors; FDA indicated the human factors and PK studies may run in parallel. The company also said it is on track to submit regulatory applications for Anaphylm in Canada and the EU in 2026 and plans to request accelerated review upon resubmission (not guaranteed).

AQST-108 topical gel (epinephrine prodrug) for alopecia areata: IND opened in Dec. 2025 with supportive FDA feedback; Phase 1 dosing completed in Q1 2026 with data expected in Q2 2026.

Other milestones: Libervant® remains tentatively approved until January 2027 (orphan exclusivity expiry). On March 3, 2026, Aquestive amended its RTW agreement extending Anaphylm marketing approval deadline to June 30, 2027, issued a warrant (375,000 shares at $4.00; expires March 3, 2029), and secured a $5.0M share purchase commitment.