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. announced that the FDA has accepted its IND application to initiate a Phase 2 clinical trial for ketamine in treating Amyotrophic Lateral Sclerosis (ALS). Conducted at the University of Missouri and led by Dr. Richard Barohn, this trial will include 36 participants and evaluate ketamine's safety and efficacy over 24 weeks. Following positive results, the company plans to meet with the FDA to discuss progression to Phase 3 trials. With ALS affecting around 50,000 individuals annually in the U.S. and Europe, ketamine may offer a new therapeutic avenue for this challenging condition.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced the publication of a study validating the efficacy of KETABET™, a combination of ketamine and betaine, in mitigating adverse psychiatric effects from ketamine in treating depression and chronic pain. The study, published in Biomedicine & Pharmacotherapy, suggests that betaine can protect against cognitive deficits associated with repeated ketamine use. With patent protection until 2036, PharmaTher aims to advance KETABET™ into Phase 2 clinical studies in H2-2022.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) focuses on specialty ketamine-based products. In 2022, it plans to initiate Phase 3 clinical studies for treating Parkinson's disease (KETLID), complete Phase 2 studies for ALS (KETALS), and develop a ketamine microneedle patch (KETAPATCH). Additionally, the company anticipates FDA approval for its Ketamine Hydrochloride Injection (KETARX). Key partnerships and exclusive licenses with universities strengthen its treatment pipeline, aiming to enhance therapeutic options for mental health and neurological disorders.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has entered a process development agreement with LTS LOHMANN Therapie-Systeme AG for the clinical trial scale-up of its proprietary Ketamine microneedle patch. The partnership aims to advance the development and non-commercial manufacturing of this innovative drug delivery system, targeting neuropsychiatric and pain disorders. The microneedle patch, developed with Queen’s University of Belfast, promises efficient delivery of ketamine and will support upcoming FDA and EMA submissions. PharmaTher plans to initiate Phase 1/2 clinical studies in 2022.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has announced the successful completion of its first research study on MicroDose-MN™, a microneedle patch for intradermal delivery of psychedelics, specifically LSD. The study supports filing an IND application with the FDA for Phase 2 clinical studies in 2022. The MicroDose-MN™ patch aims to provide flexible dosing and controlled release while allowing patients to self-administer their medication safely. Additionally, the company is evaluating the patch for MDMA and DMT, with results expected by year-end 2021.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced that the Japan Patent Office granted Patent No. 6967532 for KETABET™, a combination of FDA-approved ketamine and betaine anhydrous. This patent, valid until 2036, enhances the company's global patent portfolio and suggests KETABET™ could address multiple mental health disorders while reducing ketamine's side effects. The microneedle patch delivery system is designed to improve drug delivery for various conditions, potentially increasing market opportunities in Japan and beyond.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has applied to the FDA for Orphan Drug Designation for ketamine to treat Status Epilepticus (SE), expanding its portfolio of rare neurological disorder treatments. SE affects 120,000-180,000 individuals annually in the U.S. and requires emergency care. The company aims to utilize ketamine's therapeutic potential for various severe conditions. ODD provides benefits such as seven years of marketing exclusivity and tax credits for clinical testing costs, reinforcing PharmaTher's commitment to treating rare disorders.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has successfully completed a research study on its MicroDose-MN™ microneedle patch for psilocybin delivery. The study supports filing for an IND application with the FDA for Phase 2 clinical studies planned for 2022. The MicroDose-MN™ aims to enhance safety and effectiveness through controlled release and flexible dosing. PharmaTher is also finalizing agreements to develop this technology further and is evaluating additional psychedelics. The company emphasizes innovative features designed to promote safe and convenient patient use.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has announced a research collaboration with Revive Therapeutics Ltd. to evaluate psilocybin delivery via its proprietary microneedle patch technology for neuropsychiatric disorders. The MicroDose-MN™ and MacroDose-MN™ patches aim to provide efficient, tamper-resistant psychedelic delivery systems, potentially overcoming limitations of existing methods. The collaboration seeks to establish pathways for partners to enter FDA Phase 1 and 2 clinical studies in 2022. This partnership is geared towards enhancing the potential therapeutic application of psychedelics in treating mental health conditions.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has announced significant advancements in its microneedle patch delivery technology for psychedelics, targeting mental health and neurological disorders. The company is completing IND-enabling studies to facilitate FDA Phase 1 and Phase 2 clinical studies by Q2-2022. Collaborations with Terasaki Institute and Queen’s University of Belfast are underway to evaluate its MicroDose-MN™ and MacroDose-MN™ patches. Research results for psilocybin and LSD are expected in November 2021, followed by MDMA and DMT in December 2021, with promising initial outcomes.
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