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TORONTO - PharmaTher Holdings Ltd. (OTCQB:PHRRF) (CSE:PHRM), a $25.12 million market cap specialty pharmaceutical company, announced it has received FDA approval for its ketamine product KETARx for use in surgical pain management, specifically anesthesia and sedation. The stock has shown significant momentum, gaining over 90% in the past six months according to InvestingPro data.
The approval letter was received on Friday, August 8, 2025, according to a statement from the company’s Founder, Chairman and CEO Fabio Chianelli in a press release issued Thursday.
The specialty pharmaceutical company is now moving into pre-launch commercialization of KETARx in the U.S. while preparing international regulatory filings. The company plans to launch the product this year through sales channels targeting hospitals, specialty clinics, government institutions including the U.S. Department of Defense and Veterans Health Administration, as well as clinical research programs.
PharmaTher also reported that partnership discussions with specialty pharmaceutical companies are currently underway, though the company is simultaneously advancing its own commercial plan.
Beyond the surgical pain management indication, the company has several clinical-stage programs for ketamine, including treatments for Parkinson’s disease, Amyotrophic Lateral Sclerosis (ALS), Complex Regional Pain Syndrome (CRPS), and development of a ketamine patch and wearable pump for mental health and pain conditions.
These programs are being developed under the FDA’s 505(b)(2) pathway, which can potentially offer a more streamlined approval process for drugs with previously established safety profiles.
PharmaTher, founded in April 2020, focuses exclusively on developing ketamine-based therapeutics for mental health, neurological, and pain disorders. While analysts expect challenging near-term profitability, InvestingPro analysis reveals 12 additional key insights about the company’s financial outlook and market position. Subscribers can access detailed valuation metrics and comprehensive financial health indicators to make informed investment decisions.
In other recent news, PharmaTher Holdings Ltd. announced it has received approval from the U.S. Food and Drug Administration for its ketamine product, KETARx. This approval is specifically for surgical pain management applications. The development marks a notable milestone for the company as it continues to focus on ketamine-based treatments. The FDA’s decision is expected to have significant implications for PharmaTher’s product offerings in the medical field. Investors and stakeholders are likely to keep a close watch on how this approval impacts the company’s future developments and market position. While the company’s stock performance was not discussed, the FDA approval could potentially influence investor interest. The company has not announced any further details regarding the commercial rollout of KETARx following this approval.
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