Aquestive(US:AQST)2025-11-06 13:00Anaphylm (dibutepinephrine) Sublingual Film - The FDA confirmed that it will not require an Advisory Committee to review the Company's New Drug Application for Anaphylm[8] - The company is preparing for a U S launch in Q1 2026, if approved by the FDA[8] - The company broadened the patent estate for Anaphylm with the issuance of two new patents, extending patent protection into 2037[8] AQST-108 and AdrenaVerse Platform - The company plans to open Investigational New Drug application for AQST-108 with FDA in Q4 2025[11] - The company expects to initiate a clinical study for AQST-108 for Alopecia Areata in 1H 2026[11] Financial Position - The company successfully completed an equity raise of $85 million in August 2025[11] - The company also completed a strategic financing for $75 million with RTW Investments, LP, subject to FDA approval of Anaphylm and refinancing of the Company's existing debt[11] - The company's ending cash balance in Q3 2025 was $129.1 million[17] - The company expects to meet near-term milestones with projected cash runway into 2027[16] - The company's 2025 outlook includes total revenues of approximately $44-$50 million and a non-GAAP adjusted EBITDA loss of approximately $47-$51 million[23]