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) has submitted a meeting package to the FDA to advance its ketamine product, KETARX™, into Phase 3 development for treating levodopa-induced dyskinesia in Parkinson's disease. The company aims to utilize the 505(b)(2) pathway for a new drug application. Notably, KETARX™ has shown promising results in prior studies, with 100% of subjects experiencing reduced dyskinesias. The FDA is expected to respond by March 20, 2023. Additionally, PharmaTher is seeking Fast Track Designation, which could expedite KETARX™'s development process, benefiting patients with this debilitating condition affecting over 10 million globally.
PharmaTher Holdings Ltd. has applied for Orphan Drug Designation from the FDA for ketamine to treat Rett Syndrome, a rare neurological disorder. This follows a completed Phase 2 clinical trial, with unpublished results expected to support a future Phase 3 study. The company holds four existing orphan drug designations for ketamine, including conditions such as Status Epilepticus and Amyotrophic Lateral Sclerosis. If approved, ketamine would qualify for marketing exclusivity, tax credits, and other benefits. Rett syndrome affects 1 in 10,000 female births with no current FDA-approved treatments.
PharmaTher Holdings Ltd. aims to commercialize KETARX™ (racemic ketamine) for mental health, neurological, and pain disorders. The company is seeking FDA approvals via the ANDA and 505(b)(2) pathways by H2-2023. Key development initiatives include Phase 3 studies for Parkinson’s disease and Phase 2 studies for amyotrophic lateral sclerosis (ALS) and microneedle patch delivery. PharmaTher has received four FDA orphan drug designations, enhancing its market potential. The projected revenue from KETARX™ could reach up to USD $40 million based on one million unit sales at an average price of USD $25-40.
PharmaTher Holdings Ltd. announced that the FDA has granted its fourth orphan drug designation for ketamine, aimed at preventing ischemia-reperfusion injury from organ transplantation. This designation is pivotal as it qualifies ketamine for various benefits including seven years of marketing exclusivity upon regulatory approval. The company now holds four orphan designations for ketamine, targeting conditions like Status Epilepticus and Amyotrophic Lateral Sclerosis. In 2022, there were over 39,000 organ transplants in the U.S., highlighting the ongoing need for effective treatments in this area.
PharmaTher Holdings Ltd. announced plans to engage with the FDA for a Phase 3 clinical study of KETARX™ (ketamine) aimed at treating levodopa-induced dyskinesia in Parkinson's disease. A recent Phase 1/2 study demonstrated that 100% of patients showed a reduction in dyskinesias, measuring a significant 51% reduction in symptoms at two weeks post-infusion. The company aims for FDA approval under the 505(b)(2) regulatory pathway, with market potential exceeding $3 billion in the U.S. alone as the global Parkinson's market is projected to grow to $7.5 billion by 2025.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has entered an exclusive option agreement with Case Western Reserve University to develop ketamine for treating Rett Syndrome, a rare neurological disorder. This follows a Phase 2 clinical trial demonstrating ketamine's potential benefits. Currently, there are no approved treatments for Rett Syndrome, which impacts girls predominantly and leads to severe impairments. The agreement grants PharmaTher a 12-month evaluation period for CWRU’s intellectual property, with potential for future licensing negotiations.
PharmaTher Holdings Ltd. has received a US patent for novel applications of ketamine aimed at treating Parkinson’s disease and motor disorders. Positive results from a Phase 1/2 clinical study showed that 100% of participants experienced a reduction in levodopa-induced dyskinesia, with a significant 51% reduction observed after the second infusion. The company plans to conduct a Phase 3 study to pursue FDA approval for KETARX™, its ketamine product, under the 505(b)(2) pathway. The growing market for Parkinson’s treatments is projected to reach $7.5 billion by 2025.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) reported a total of $12.12 million in cash and investments as of May 31, 2022, fully funding its ketamine-based development programs for mental health and pain disorders.
The company aims for FDA approval of its ketamine injection and infusion products by 2H-2023. Key milestones include results from a Phase 2 clinical trial for ALS and potential Phase 3 trials for Parkinson’s disease. The firm is also pursuing partnerships for its innovative delivery systems.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) shared results from a Phase 1/2 clinical study of ketamine for treating levodopa-induced dyskinesia in Parkinson's disease at the MDS International Congress. The study showed that 100% of participants experienced a reduction in dyskinesias, with UDysRS scores decreasing by 51% at infusion, 49% at three weeks, and 41% at three months. The company plans a Phase 3 study to seek FDA approval under the 505(b)(2) pathway. Additionally, a patent for ketamine's potential use in Parkinson's treatment has been allowed by the USPTO.
PharmaTher Holdings Ltd. announced positive results from its IND-enabling pharmacokinetic study of the KETARX™ Ketamine Patch, demonstrating successful delivery of ketamine over 40 hours. The study, conducted under Good Laboratory Practice compliance, showed that the patch was well tolerated and allowed for increased dosage flexibility. PharmaTher plans to initiate phase 2 and 3 clinical studies by the end of Q4-2022 targeting mental health, PTSD, and pain management, following the FDA's 505(b)(2) regulatory pathway for approval.
FAQ
What is the current stock price of Pharmather Holdings (PHRRF)?
What is the market cap of Pharmather Holdings (PHRRF)?
