AQST-108 (epinephrine) Topical Gel

March 04, 2026 — Aquestive Therapeutics, Inc. (NASDAQ: AQST) reported Q4 and full-year 2025 results and updated plans for key programs. For Anaphylm™ (dibutepinephrine) sublingual film for anaphylaxis, the company received an FDA Complete Response Letter (Jan 30, 2026) citing human factors validation issues (pouch opening/film placement) and requesting a single PK study to assess packaging/labeling changes; FDA did not raise CMC deficiencies and did not question clinical comparability data vs. auto-injectors. Aquestive plans new human factors and PK studies (in parallel), has requested a Type A meeting, and reaffirmed NDA resubmission in Q3 2026; regulatory filings in Canada and the EU are targeted in 2026.

Pipeline: AQST-108 topical epinephrine prodrug gel (alopecia areata/dermatology) opened an IND in Dec 2025; first-in-human showed no serious/topical AEs; a second Phase 1 completed dosing in Q1 2026 with data expected Q2 2026.

Business/financing: RTW agreement amended to extend Anaphylm marketing approval deadline to June 30, 2027; RTW warrant for 375,000 shares at $4.00 (exp. Mar 3, 2029) plus a $5M share purchase commitment.

Financials: Q4 2025 revenue $13.0M (+10% YoY); FY2025 revenue $44.5M (vs $57.6M in FY2024, which included one-time deferred revenue recognition). FY2025 net loss $83.8M (or $70.6M excluding one-time legal expenses). Cash at Dec 31, 2025: $121.2M. FY2026 guidance: revenue $46–$50M; non-GAAP adjusted EBITDA loss $35–$30M; company guides to end FY2026 with ~$70M cash.