Core Viewpoint - PharmaTher Holdings Ltd. has received FDA approval for its ketamine product KETARx™, marking a significant milestone in the company's efforts to become a leader in ketamine-based pharmaceuticals and contributing to the psychedelic pharmaceutical revolution [1][2]. Company Summary - The FDA approved KETARx™ on August 8, 2025, for surgical pain management, which positions PharmaTher strategically in the market [1]. - The company aims to leverage this approval to expand its product pipeline into various therapeutic areas, including mental health, neurological disorders, and chronic pain management [3]. - CEO Fabio Chianelli emphasized that this approval is a testament to years of development and signals a new era of growth for PharmaTher [2]. Industry Summary - Ketamine is the only psychedelic drug listed on the World Health Organization's Model List of Essential Medicines, highlighting its importance in the pharmaceutical landscape [2]. - The global ketamine market is currently valued at $750 million and is projected to grow to $3.42 billion by 2034, with a compound annual growth rate of 16.4% [2]. - SPRAVATO® (esketamine), an FDA-approved treatment for depression, is on track for a sales run rate of $1.6 billion, with expectations of reaching $3 billion to $3.5 billion by 2027-2028 [2]. - The FDA's approval of KETARx™ comes amid ongoing drug shortages, indicating a significant demand for a reliable supply of ketamine [4]. - The Veterans Health Administration is currently funding ketamine infusions for veterans suffering from depression, PTSD, and chronic pain, further underscoring the therapeutic potential of ketamine [4].