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PharmaTher Holdings Ltd. develops specialty pharmaceutical platforms centered on microneedle drug delivery. Company updates focus on PharmaPatch™ product programs for ketamine, psychedelics, GLP-1 drugs and therapeutic peptides, along with PatchPrint™, its automated tabletop microneedle patch 3D printer designed to support end-to-end patch manufacturing.
Recurring news themes include U.S. patent applications for patch manufacturing and peptide formulations, expansion of the PharmaPatch™ platform into new drug categories, regulatory and policy developments affecting ketamine, psychedelics and peptides, and the company's retained economic participation tied to its previously approved and sold U.S. generic ketamine ANDA.
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.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) reported significant progress in its clinical stage psychedelic programs for the three months ending August 31, 2021. Highlights include the initiation of an FDA Phase 2 clinical trial of ketamine for Parkinson's disease and granting of orphan drug designations for ketamine in two conditions. Financially, the company reported cash and equivalents of CAD 5.13 million, with a net loss of CAD 914,474 for Q1 Fiscal 2022. Following a CAD 10 million financing, PharmaTher confirmed it does not plan a reverse stock split.