David Amsellem

Jason Butler

Kristen Kluska

Raghuram Selvaraju

Thomas Flaten

Denis Reznik

François Brisebois

Gary Nachman

James Molloy

Roanna Clarissa Ruiz

Andreas Argyrides

Daniel Smith

Mazahir Alimohamed

Nelson Cox

- Aquestive Therapeutics, Inc. announced that the United States Patent and Trademark Office (USPTO) has issued two additional U.S. patents related to **Anaphylm**, the company's novel epinephrine prodrug sublingual film.  **[1398733_0001398733-25-000022_iprelease10-6x25.htm:0]** 
- These new patents are expected to extend protection for Anaphylm through at least **2037**.  **[1398733_0001398733-25-000022_iprelease10-6x25.htm:0]** 
- Anaphylm, if approved by the FDA, is anticipated to be the **first and only oral medication** for the rescue treatment of severe allergic reactions, including anaphylaxis.  **[1398733_0001398733-25-000022_iprelease10-6x25.htm:0]** 
- The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm is scheduled for **January 31, 2026**.  **[1398733_0001398733-25-000022_iprelease10-6x25.htm:0]**

Aquestive Therapeutics Broadens Anaphylm Patent Estate

- Aquestive Therapeutics announced the issuance of **two new U.S. patents** for its Anaphylm™ (dibutepinephrine) Sublingual Film, extending its patent protection through at least **2037**.  **[1398733_d2af9c209f5748ec9fe67a1c4f8bc0ef_0]** **[1398733_d2af9c209f5748ec9fe67a1c4f8bc0ef_1]** 
- These patents cover the proprietary composition of Anaphylm, which, if approved by the FDA, is expected to be the **first and only oral medication** for the rescue treatment of severe allergic reactions, including anaphylaxis.  **[1398733_d2af9c209f5748ec9fe67a1c4f8bc0ef_0]** **[1398733_d2af9c209f5748ec9fe67a1c4f8bc0ef_1]** 
- The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm is scheduled for **January 31, 2026**.  **[1398733_d2af9c209f5748ec9fe67a1c4f8bc0ef_1]**

Aquestive Therapeutics Secures New Anaphylm Patents

- Aquestive Therapeutics, Inc. filed a Current Report on Form 8-K on **October 1, 2025**, to furnish an investor presentation.  **[1398733_0001398733-25-000020_aqst-20251001.htm:0]** **[1398733_0001398733-25-000020_aqst-20251001.htm:1]** 
- The company's lead asset, Anaphylm (dibutepinephrine) Sublingual Film, has a PDUFA action date scheduled for **January 31, 2026**, following its NDA submission in Q2 2025 and acceptance in Q3 2025.  **[1398733_0001398733-25-000020_corporatepresentationoct.htm:4]**  
- Aquestive completed an equity raise of **$85 million** on **August 14, 2025**, and secured strategic funding with RTW Investments, LP, providing a cash runway into **2027**.  **[1398733_0001398733-25-000020_corporatepresentationoct.htm:6]** 
- The U.S. epinephrine market is projected to grow to **~$2 billion** in value by **2031**, representing a significant opportunity for Anaphylm if approved.   
- The company is also advancing AQST-108 (epinephrine) Topical Gel, with an Investigational New Drug (IND) application expected to be opened in **Q4 2025** for a Phase 2a clinical study in alopecia areata.  **[1398733_0001398733-25-000020_corporatepresentationoct.htm:4]**

Aquestive Therapeutics Files Investor Presentation 8-K with Anaphylm Update and Capital Raise

Aquestive Therapeutics (AQST)