5 days ago
Psychedelic Pharma Stock Surges on FDA Breakthrough
The psychedelic pharmaceutical sector continues gaining mainstream acceptance as regulatory barriers fall and medical applications expand beyond traditional treatments. With mental health disorders reaching epidemic proportions and conventional therapies showing limited efficacy for many patients, regulators are increasingly open to alternative treatments that were once considered fringe. This paradigm shift has created significant opportunities for companies positioned at the intersection of established pharmaceutical development and emerging psychedelic therapeutics.
Shares of PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) are moving higher in Monday afternoon trading following the announcement that the company received FDA approval for its ketamine product, KETARx™, on August 8th for surgical pain management applications. This milestone represents a significant breakthrough for the specialty pharmaceutical company focused on unlocking ketamine's therapeutic potential across multiple medical conditions.
The FDA approval positions PharmaTher to capitalize on the rapidly expanding ketamine market, which is currently valued at $750 million and projected to reach $3.42 billion by 2034, representing a compound annual growth rate of 16.4%. Ketamine stands out among psychedelic compounds as the only one included on the World Health Organization's Model List of Essential Medicines, providing additional validation for its therapeutic applications.
The approval comes at an opportune time, as ketamine has been regularly listed on the FDA drug shortage list since February 2018, highlighting significant supply challenges in the market. The FDA has also issued compounding risk alerts regarding potential safety issues with non-approved ketamine products, creating demand for high-quality, FDA-approved alternatives like KETARx™.
PharmaTher's FDA approval provides a strong foundation for expanding ketamine development across diverse therapeutic areas within the company's pipeline, including mental health conditions like depression, neurological disorders such as Parkinson's disease and ALS, and chronic pain management including Complex Regional Pain Syndrome.
The market potential is demonstrated by SPRAVATO (esketamine), an FDA-approved depression treatment currently tracking a $1.6 billion sales run rate with guidance projecting $3 billion to $3.5 billion by 2027-2028. Additionally, the Veterans Health Administration currently approves and funds ketamine infusions for retired military personnel with depression, PTSD, and chronic pain, indicating established institutional acceptance.
"Today marks a new chapter for PharmaTher," commented CEO Fabio Chianelli. "With FDA approval for ketamine now in hand, we are closer to realizing our goal of becoming a global leader in ketamine-based pharmaceuticals. This historic FDA approval for PharmaTher is a testament to years of dedicated development, signaling a new era of growth."
U.S. shares of PHRRF are up 8.6% at $0.39, while Canadian shares of PHRM are ahead 8.0% at C$0.54 in Monday afternoon trading.
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