Anaphylm™ is a clinical-stage drug being developed for the treatment of Anaphylaxis is a severe, life-threatening systemic hypersensitivity reaction that requires immediate treatment with epinephrine. In the United States, its estimated lifetime prevalence is around 1.6–5%, with annual incidence rates of approximately 50–200 cases per 100,000 people (1), and both food- and drug-induced reactions have been increasing steadily over the past two decades. The disease poses a substantial burden on the healthcare system, accounting for more than 200,000 emergency department visits and nearly 1,000 deaths each year, while also causing significant psychological distress and reduced quality of life among affected individuals. Anaphylaxis arises from IgE-mediated activation of mast cells and basophils following re-exposure to an allergen, leading to the release of potent mediators such as histamine, tryptase, prostaglandins, and leukotrienes that trigger vasodilation, increased vascular permeability, airway obstruction, cardiovascular collapse.. It is being developed by Aquestive Therapeutics, Inc.. The FDA Prescription Drug User Fee Act (PDUFA) date is January 30, 2026. Premium analysis including detailed clinical trial status, revenue predictions, and comprehensive company insights are available for members.