Highest-materiality recent filing
Aquestive Q1 revenue up 66% to $14.4M; secures $150M Oaktree debt facility
Q1 total revenue $14.4M (+66% YoY); license/royalty $5.4M, manufacture/supply $8.8M.
Aquestive posts Q4 net loss of $31.9M; Anaphylm resubmission delayed to Q3 2026
Q4 revenue $13.0M (+10% YoY); net loss $31.9M ($0.26/share) incl $13.6M legal; excl legal net loss $18.7M.
Aquestive receives FDA CRL for Anaphylm; deficiencies limited to packaging, administration
FDA CRL Jan 30, 2026 for Anaphylm NDA; deficiencies in human factors validation study and request for PK study.
FDA identifies deficiencies in Aquestive's Anaphylm NDA, precluding labeling talks
FDA letter notes deficiencies in Anaphylm NDA that preclude labeling and post-marketing discussions; review ongoing with PDUFA date Jan 31, 2026.
Aquestive Q3 net loss $15.4M; Anaphylm PDUFA Jan 31, 2026, launch prep ongoing
Total revenue $12.8M (+4% YoY excluding one-time 2024 deferred revenue); net loss $15.4M ($0.14/sh) vs $11.5M loss in Q3 2024.
Aquestive receives two new US patents for Anaphylm, extending protection to 2037
USPTO issued U.S. patent nos. 12,427,121 and 12,443,850 covering epinephrine prodrug compositions for sublingual film delivery.
FDA will not require advisory committee for Aquestive's Anaphylm NDA; PDUFA Jan 31, 2026
FDA informed Aquestive that no advisory committee meeting is required for Anaphylm (dibutepinephrine) Sublingual Film NDA.
Aquestive prices $85M common stock offering of 21.25M shares at $4.00/share
Offers 21.25M shares at $4.00/share; expected gross proceeds $85M, closing Aug 15, 2025.
Aquestive secures $75M funding from RTW for Anaphylm launch, contingent on FDA approval
$75M purchase price from RTW, subject to FDA approval of Anaphylm and refinancing of existing 13.5% senior notes.
Aquestive Q2 net loss $13.5M; FDA accepts Anaphylm NDA, PDUFA Jan 31, 2026
Total revenue $10.0M, down 50% YoY; excluding one-time deferred revenue, up 3% to $10.0M.
Aquestive obtains Health Canada meeting for Anaphylm NDS; EMA briefing book submitted
Health Canada grants Q3 2025 meeting for planned New Drug Submission of Anaphylm (epinephrine) Sublingual Film.
FDA accepts Aquestive's NDA for Anaphylm; PDUFA date Jan 31, 2026
FDA accepted NDA for Anaphylm (epinephrine oral film) to treat Type 1 allergic reactions, including anaphylaxis.
Aquestive Q1 net loss $22.9M; cuts FY revenue guidance on Libervant setback
Total revenue $8.7M, down 28% YoY from $12.1M; net loss $0.24/share vs $0.17 loss last year.
Aquestive reports positive pediatric PK results for Anaphylm; NDA submitted to FDA
Pediatric study (32 patients aged 7-17, >30 kg) shows PK consistent with adult studies; no serious adverse events.
Aquestive starts Anaphylm NDA filing; Q4 net loss $17.1M; 2025 revenue guidance $47-56M
Q4 2024 total revenues $11.9M, down 10% YoY; full-year revenues $57.6M, up 14%.
Median symptom resolution time 12 min vs 74 min without treatment; mean angioedema resolution within 5 min.
Aquestive provides business update; on track to submit Anaphylm NDA in Q1 2025; cash ~$70M
On track to submit Anaphylm (epinephrine) Sublingual Film NDA to FDA in Q1 2025; potential approval/launch as early as Q1 2026.
FDA granted 7 years of orphan drug exclusivity to Libervant (diazepam) Buccal Film for treating seizure clusters in patients aged 2-5.
Aquestive receives positive FDA feedback for Anaphylm; reaffirms Q1 2025 NDA submission
FDA agreed on NDA content, safety evaluation, and pediatric trial plan; no additional adult trials needed.
Aquestive Q3 net loss $11.5M vs $2.0M; revenue up 4% to $13.5M; Anaphylm pre-NDA meeting in Q4
Total revenues $13.5M (+4% YoY); net loss $11.5M ($0.13/sh) vs $2.0M loss in Q3 2023.
Aquestive presents Anaphylm data showing consistent PK/PD regardless of film movement
87.5% of subjects had no film movement; 12.5% showed movement with no significant PK/PD impact.
Aquestive positive OAS study: Anaphylm resolves symptoms in 12 min median, meets endpoints
OAS challenge study met primary and secondary endpoints; no significant PK difference with vs. without allergen.
Anaphylm (epinephrine sublingual film) oral allergen challenge study fully enrolled; topline data expected Q4 2024.
Aquestive Q2 revenue up 52% to $20.1M; narrows net loss; raises FY guidance
Total revenue $20.1M vs $13.2M YoY; net loss $2.7M ($0.03/sh) improves from $5.8M loss.
Aquestive reports positive topline PK data for Anaphylm self-administration study
Self-administration PK study met primary endpoints; PK comparable whether administered by subjects or HCPs.
Aquestive Therapeutics reports Q1 2024 results, FDA approval of Libervant, and progress on Anaphylm
Met all endpoints in Phase 3 pivotal study for Anaphylm (epinephrine) Sublingual Film compared to EpiPen and other injectors.
FDA approves Libervant for seizure clusters in children 2-5; Anaphylm NDA on track for end of 2024
Libervant is first FDA-approved oral rescue treatment for seizure clusters in patients ages 2-5.
Aquestive Therapeutics raises $77.5M in public offering; over-allotment exercised
Underwriters exercised over-allotment for 559,801 shares at $4.50 on April 22, 2024.
On November 1, 2024, Santo J. Costa, a member of the Board of Directors of Aquestive Therapeutics, Inc. (the “Company”) and the Chairman of the Compensation Committee thereof (the “Compensation Committee”), notified the Company of his intention to resign from the Company's Board of Directors for personal reasons, effective November 4, 2024.
Aquestive Therapeutics, Inc. (the “Company”) has promoted Cassie Jung, 45, to Chief Operating Officer, effective June 3, 2024.
Max materiality 0.90 · Median 0.65 · Most common event other_material