Aquestive(AQST) GlobeNewswire·2025-01-13 12:00Core Insights - Aquestive Therapeutics is focused on advancing innovative medicines to improve patients' lives through unique delivery technologies and has outlined key objectives for 2025 [1][2] Group 1: Business Developments - In 2024, the company achieved significant milestones, positioning it for continued success in 2025, including the potential approval and launch of Anaphylm, Libervant, and AQST-108 [2] - The company plans to submit the New Drug Application (NDA) for Anaphylm in the first quarter of 2025, aiming to address unmet needs in severe allergy management [4] - Libervant received FDA approval in 2024 for treating seizure clusters in pediatric patients aged two to five years, ensuring access to essential treatment for this age group [7][8] Group 2: Product Development - Anaphylm, an innovative epinephrine delivery system, is on track for NDA submission, with a successful pre-NDA meeting with the FDA and a Phase 1 pediatric trial initiated [3][4] - AQST-108, a topical gel for alopecia areata, is set to begin its Phase 2a clinical trial in the second quarter of 2025 after a supportive pre-IND meeting with the FDA [5][6] - The market opportunity for JAK inhibitors in alopecia areata is estimated to exceed one billion U.S. dollars, highlighting the potential for AQST-108 to capture market share if approved [6] Group 3: Financial Position - As of December 31, 2024, the company reported unaudited cash and cash equivalents of approximately $70 million, providing a solid financial foundation for ongoing and future projects [7]