Core Insights - Aquestive Therapeutics is progressing towards the potential launch of Anaphylm, an innovative sublingual film for treating severe allergic reactions, with a scheduled PDUFA goal date of January 31, 2026 [2][4] - The company is expanding its commercial readiness and regulatory discussions in the U.S., Canada, and the EU, aiming to enhance patient access to epinephrine treatments [5][6] - Financial results for Q3 2025 show a 4% year-over-year revenue increase, although total revenues decreased from $13.5 million in Q3 2024 to $12.8 million in Q3 2025 due to prior year deferred revenue recognition [13][17] Financial Performance - Total revenues for Q3 2025 were $12.8 million, a decrease from $13.5 million in Q3 2024, primarily due to the one-time recognition of deferred revenue in the previous year [13] - Manufacture and supply revenue increased to $11.5 million in Q3 2025 from $10.7 million in Q3 2024, driven by growth in Sympazan and Suboxone revenues [14] - Net loss for Q3 2025 was $15.4 million, or $0.14 per share, compared to a net loss of $11.5 million, or $0.13 per share, in Q3 2024 [17] Product Development - Anaphylm, if approved, would be the first oral medication for severe allergic reactions, designed to improve patient compliance and accessibility [3][22] - The company is also advancing AQST-108, a topical epinephrine gel for alopecia areata, with an IND application expected to be submitted in Q4 2025 [7][24] - Recent patent expansions for Anaphylm extend protection into 2037, highlighting the product's long-term commercial potential [6] Strategic Initiatives - The company is enhancing its commercial and medical infrastructure in preparation for a potential U.S. launch of Anaphylm in Q1 2026 [5] - Strategic funding commitments and equity financing have positioned the company to support its mission of making epinephrine treatments more accessible [2] - The addition of new leadership for the AdrenaVerse clinical pipeline indicates a commitment to developing further products from this technology platform [8]

Company Overview - Aquestive Therapeutics is a publicly traded pharmaceutical company (NASDAQ: AQST) focused on advancing medicines through innovative science and delivery technologies[7] - The company has shipped over 25 billion PharmFilm doses worldwide[10] - Aquestive Therapeutics reported over $57 million in revenue in 2024[13, 14] - The company anticipates 2 product launches in the U S by 2027[17] - The company estimates over $15 billion in potential peak annual net sales from pipeline assets[18] Anaphylm (epinephrine) Sublingual Film - The U S epinephrine market has the potential to grow to approximately $2 billion in value by 2031[54] - The current market size in 2024 is approximately $800 million[55] - The epinephrine market has experienced a 15% CAGR from 2021 to 2023[55, 56] - 95% of patients are interested in a film-dosing option for epinephrine[66] - The PDUFA action date for Anaphylm is scheduled for January 31, 2026[27, 69] AQST-108 (epinephrine) Topical Gel - The company is pursuing alopecia areata (AA) as a potential initial indication for AQST-108[75] - The market opportunity for JAK inhibitors for alopecia areata is estimated at over $1 billion[80]