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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 (OTCQB: PHRRF) announced an update on its New Drug Application for Ketamine with the FDA. The FDA has assigned a GDUFA goal date of October 29, 2024, and confirmed that the review is ongoing with no additional information needed at this time. Following anticipated FDA approval, PharmaTher aims to pursue international approvals and explore novel uses and delivery methods of ketamine for various indications. The company's goal is to address the ketamine shortage in the U.S., which has been on the FDA's drug shortage list since February 2018. PharmaTher's ketamine will adhere to strict FDA manufacturing guidelines and prescribing labels, addressing concerns about compounded ketamine products not approved for psychiatric disorders.
PharmaDrug Inc. (CSE: PHRX) (OTC: LMLLF) has announced strategic plans to advance the clinical development of PD-001, its patented enteric-coated Cepharanthine formulation, for viral infectious diseases. Sairiyo Therapeutics Inc., 51% owned by PharmaDrug, received approval to initiate a first-in-human Phase 1 clinical study. This follows a $3.4 million contract from the Defense Threat Reduction Agency for the Ebola virus.
PD-001 aims to improve the bioavailability of Cepharanthine, a Japanese-approved drug with potential antiviral activity against various viruses, including coronavirus, HIV-1, and Zika. The new formulation addresses Cepharanthine's low solubility and bioavailability issues, potentially enabling oral administration and eliminating the need for frequent intravenous dosing.
PharmaTher Holdings (OTCQB: PHRRF) (CSE: PHRM) announced that Sairiyo Therapeutics Inc., a company it partially owns, reported independent screening results highlighting cepharanthine's potential to bind to monkeypox (Mpox) proteins. The study, published in the Journal of Infection, showed cepharanthine's significant binding affinities to all ten target proteins of Mpox, with high affinities to four specific proteins (I1L, VITF3L, A42R, and E8L).
This discovery may enhance understanding of viral entry and replication mechanisms for potential Mpox treatments. Additionally, Sairiyo received approval to initiate a first-in-human Phase 1 clinical study with PD-001, targeting Medical Countermeasures. PD-001 previously received a $3.4 million contract from the Defense Threat Reduction Agency for Ebola virus research.
PharmaTher Holdings (OTCQB: PHRRF) announced that Sairiyo Therapeutics, its 49% owned subsidiary, has received approval to initiate a Phase 1 clinical trial for PD-001, a reformulated enteric coated version of oral cepharanthine. The study aims to assess the bioavailability and pharmacokinetics of PD-001 in healthy volunteers. This milestone follows years of research and development and a $3.4 million contract from the Defense Threat Reduction Agency for Ebola virus research.
The trial's completion will support Sairiyo's submission of an Investigational New Drug application to the FDA for Phase 2 and 3 clinical trials in the United States. PD-001 is being developed as a potential treatment for Medical Countermeasures and cancer, with applications in infectious diseases, terrorist attacks, and pandemics.
PharmaTher, a specialty pharmaceutical company, announced that Sairiyo Therapeutics, a company partly owned by PharmaTher, has submitted a Clinical Trial Application for a Phase 1 study of its reformulated cepharanthine (PD-001). The study will assess the bioavailability and pharmacokinetics of PD-001 in healthy volunteers, comparing different dosages. Set to begin in June 2024 upon approval from Australian regulators, this will be the first human trial of PD-001. Sairiyo aims to take advantage of Australia's 43.5% R&D tax incentive and plans to pursue further trials in the U.S. upon successful completion.
PharmaTher Holdings announced receiving an Amendment Acknowledgment Letter from the FDA for its Priority Original Abbreviated New Drug Application for Ketamine, with a goal date of October 29, 2024. The company addressed FDA comments promptly to meet the goal date. PharmaTher aims to solve the ketamine shortage problem in the U.S., adhere to FDA guidelines, and expand globally. They focus on novel uses of ketamine for pain, mental health, and neurological disorders.
PharmaTher announced that its subsidiary Sairiyo Therapeutics has completed the clinical and regulatory package for a Phase 1 study of a reformulated version of cepharanthine for infectious diseases and oncology. Sairiyo plans to conduct the study in Australia and then apply for FDA approval to begin clinical trials in the United States.
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