Welcome to our dedicated page for Pharmather Holdings news (Ticker: PHRRF), a resource for investors and traders seeking the latest updates and insights on Pharmather Holdings stock.
PharmaTher Holdings Ltd. (OTCQB: PHRRF, CSE: PHRM) generates news centered on its ketamine-focused pharmaceutical programs, drug delivery platforms, and related asset monetization activities. Company announcements describe a specialty pharmaceutical and life sciences business focused on unlocking the pharmaceutical and therapeutic potential of ketamine, psychedelics, and GLP-1 drugs, particularly for neuropsychiatric, mental health, pain, neurological, and obesity-related disorders.
News updates cover several recurring themes. One major area is the development of ketamine-based therapies, including a program for levodopa-induced dyskinesia in Parkinson's disease (LID-PD) that the company is preparing to advance under the FDA 505(b)(2) pathway toward a Phase 3 strategy. Releases describe regulatory planning, prior Phase I/II data, intellectual property coverage, and discussions with potential pharmaceutical partners. Another frequent topic is the evolution of a long-acting injectable ketamine franchise under an exclusive evaluation and option-to-license agreement with Oakwood Laboratories, which is intended to address neuropsychiatric indications such as treatment-resistant depression and major depressive disorders.
PharmaTher also issues news about its PharmaPatch™ microneedle patch platform, including initiatives to deliver ketamine, psychedelic compounds, and GLP-1 drugs, and its expansion into GLP-1 therapies for the potential treatment of obesity. Additional updates highlight the Digital Health AI division, featuring KetaVault™ and KetAImine™, which are presented as ketamine data and AI discovery platforms designed to generate new indications and combination programs.
Corporate communications further report on the FDA-approved ketamine ANDA, its sale to a sterile-injectables partner with milestone and profit-sharing economics, and the company's broader asset strategy, including its 49% equity interest in Sairiyo Therapeutics Inc. Investors and observers who follow PHRRF news can use this page to review company statements on clinical plans, regulatory interactions, partnering discussions, and platform expansions as disclosed in official releases.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced an update regarding its KETARX™ (ketamine) treatment for levodopa-induced dyskinesia in Parkinson's disease, following a Type C meeting with the FDA. The FDA supported the company's regulatory approach and indicated that a single confirmatory trial could suffice for marketing approval under specific conditions. PharmaTher will adjust its clinical development plans according to the FDA's feedback and aims to pursue FDA Fast Track designation. Recent Phase I/II results showed ketamine was safe and well-tolerated, with significant reductions in dyskinesias for all subjects treated.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has submitted its Type B meeting package to the FDA to discuss requirements for the KETARX™ On-Body Pump System. The meeting is scheduled for March 23, 2023. PharmaTher aims to submit a New Drug Application (NDA) by the end of 2023, using its clinical and non-clinical data. The company intends to seek FDA approval for the device to enhance general anesthesia and sedation procedures. The KETARX™ system may provide improved administration of ketamine while potentially extending its use in mental health and pain disorders. However, no assurance of expedited approval is provided.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has received its 5th FDA orphan drug designation for KETARX™ (racemic ketamine) to treat Rett Syndrome, a rare neurological disorder that primarily affects girls. This designation paves the way for proposed Phase 3 clinical trials. The company has previously received orphan designations for conditions including Ischemia-reperfusion injury and Status Epilepticus. Currently, no FDA-approved treatments exist for Rett Syndrome, impacting 1 in 10,000 female births. KETARX™ shows potential in treating this condition, validated through prior research and ongoing clinical trials.
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