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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. (CSE: PHRM, OTCQB: PHRRF) has filed a provisional patent application for ketamine as a treatment for Type 2 diabetes and obesity, utilizing its AI platform, panaceAI™. The company is pursuing an IND application with the FDA for a Phase 2 trial of ketamine targeting Parkinson’s disease.
PharmaTher is also investigating other psychedelics like DMT, MDMA, and LSD for clinical development. The company aims to commercialize its findings through internal development or partnerships, enhancing its patent portfolio.
PharmaTher Holdings Ltd. announced the submission of an Investigational New Drug (IND) application to the FDA for a Phase 2 clinical trial examining low-dose ketamine's efficacy in treating levodopa-induced dyskinesia in Parkinson’s disease patients. This application marks a significant milestone for the company in its efforts to commercialize ketamine. The trial aims to enroll 36 subjects across multiple U.S. sites, with the primary endpoint being the change in the Unified Dyskinesia Rating Scale total score after 8 weeks. A positive trial outcome may lead to a pivotal Phase 3 study.
PharmaTher Inc., a subsidiary of Newscope Capital Corporation (CSE: PHRM, OTCQB: PHRRF), has announced a research partnership with Queen's University Belfast to develop a microneedle patch for delivering ketamine and its proprietary formulation, KETABET™. This novel delivery method aims to improve treatment for neuropsychiatric and pain disorders, addressing issues associated with traditional ketamine administration. The patented technology promises increased drug delivery efficiency and incorporates anti-abuse features. Progress in clinical development is anticipated to meet unmet medical needs in mental health.
PharmaTher, a subsidiary of Newscope Capital Corporation (CSE: PHRM, OTCQB: PHRRF), has secured an exclusive license from The University of Kansas for the development of ketamine as a treatment for amyotrophic lateral sclerosis (ALS). Preclinical studies indicate that ketamine may enhance muscle function and prolong life expectancy in ALS patients. Currently, ALS lacks a cure, with FDA-approved treatments failing to significantly slow disease progression. The company plans to seek FDA orphan drug designation and conduct Phase II clinical trials this year.
Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF) has announced that their shares are now eligible for electronic clearing and settlement through The Depository Trust Company (DTC) in the U.S. This development is expected to enhance accessibility and visibility for U.S. investors, potentially increasing liquidity and expanding the shareholder base. CEO Fabio Chianelli noted the company is focused on developing psychedelic pharmaceuticals for neuropsychiatric and neurological diseases, including novel delivery methods for substances like ketamine and psilocybin.
PharmaTher Inc., a subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), has partnered with the Terasaki Institute to develop a microneedle patch for delivering psychedelic pharmaceuticals like psilocybin and MDMA. This innovative technology utilizes biodegradable GelMA material, aiming to address issues with oral and injection methods. PharmaTher's goal is to gain FDA approval for treatments targeting mental health and neurological disorders through this delivery system, enhancing patient compliance and treatment outcomes.
PharmaTher Inc. (CSE: PHRM, OTCQB: PHRRF) has reported a successful Type B pre-IND meeting with the FDA regarding its clinical development plan for ketamine to treat levodopa-induced dyskinesia in Parkinson’s disease patients. The FDA confirmed the acceptability of a 505(b)(2) regulatory pathway, potentially expediting drug approval. The proposed Phase 2 study has received FDA support for its primary efficacy endpoint and safety parameters. PharmaTher plans to file an IND application in Q1-2021, aiming to initiate the Phase 2 study in Q2-2021.
PharmaTher Inc., a subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), has entered into an exclusive worldwide license agreement with The Queen’s University of Belfast for a patented microneedle delivery technology. This partnership will support the development of the KETABET™ microneedle patch, combining ketamine and betaine for treating mental health and neurological disorders. The patch aims to provide a non-invasive delivery method that enhances patient compliance and reduces side effects associated with ketamine treatment.