Pharmather Holdings Ltd Stock Price, News & Analysis

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.

PharmaTher (OTCQB: PHRRF) announced a Notice of Allowance from the USPTO for its patent on ketamine's use in treating motor disorders, including Parkinson’s Disease. This patent enhances their intellectual property and commercial prospects. The company plans to advance to a Phase 3 clinical study following successful results from a dose-finding study for levodopa-induced dyskinesia, showing 100% efficacy in reducing dyskinesias. The global Parkinson’s market is projected to grow to $7.5 billion by 2025, presenting significant financial potential for PharmaTher's ketamine treatment.

PharmaTher Holdings Ltd. has successfully completed a study on its patented microneedle patch, PHARMAPATCH™, for delivering ketamine and KETABET™. This breakthrough aims to mitigate side effects linked to traditional ketamine delivery methods. The patch showed promising results in animal studies, achieving sustained plasma concentrations of ketamine. The company plans to initiate Phase 2 clinical studies for treatment-resistant depression and chronic pain, and is currently preparing for upcoming GLP pre-clinical studies. PHARMAPATCH™ offers a de-risked, transdermal solution for patients.

PharmaTher Holdings Ltd. announced positive findings from an observational study on KETABET™, a drug combining FDA-approved ketamine and betaine anhydrous. The study revealed a significant 66% reduction in side effects like depersonalization and derealization associated with ketamine treatment for depression. The company plans to launch a Phase 2 clinical study using KETABET™ integrated into a microneedle patch, aiming to improve treatment compliance for various mental health disorders. Patent protection for KETABET™ is secured in multiple countries, expiring in 2036.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has partnered with CC Biotechnology Corporation to develop a wearable ketamine delivery device. This innovation aims to transition ketamine administration from traditional intravenous and intramuscular methods to a subcutaneous format, enhancing patient comfort and treatment adherence for mental health, neurological, and pain disorders. Clinical studies for the new device are expected to begin in Q1-2023. The partnership seeks to establish PharmaTher as a leader in specialty ketamine products, complementing its existing portfolio of injectable and microneedle patch solutions.

PharmaTher Holdings Ltd. announced the granting of US Patent No: 11,286,230 for a continuous-flow process technology for producing ketamine. This patent enhances PharmaTher's intellectual property portfolio, which includes novel uses and delivery systems for ketamine to address unmet medical needs in mental health and pain disorders. The company plans to develop its own Ketamine Injection and Infusion product, aiming for FDA submission in Q4-2022. This patent addresses inefficiencies in traditional ketamine production, improving yield and purity.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) reported a total of nearly $12 million in cash and investments as of February 28, 2022, ensuring full funding for ongoing development programs focused on ketamine products targeting mental health and pain disorders. Key highlights include progress towards FDA approval for KETARX™, a ketamine injection product, and successful clinical studies evaluating its microneedle patch and other formulations. The Company aims to lead in advancing ketamine therapeutics and plans to submit regulatory applications by the end of 2022.

PharmaTher Holdings Ltd. announced its plan to file ANDA and 505(b)(2) submissions with the FDA for innovative ketamine formulations aimed at mental health and neurological disorders. The company secured an exclusive license agreement with Gesval S.A. for a patented continuous-flow technology to enhance ketamine production efficiency. The company aims to launch its Ketamine Injection product and address various medical needs, including future pivotal studies for Parkinson's and ALS. Notably, PharmaTher's strategy includes partnerships for secure cGMP ketamine supply and novel dosage forms.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced positive topline results from its ketamine study for treating levodopa-induced dyskinesia in Parkinson's disease. The study found that 100% of patients treated showed a reduction in dyskinesias, and ketamine was well tolerated with no serious adverse events reported. These results support the preparation for a Phase 3 clinical study aimed at FDA approval of KETARX™ under the 505(b)(2) pathway. The global market for Parkinson's disease is projected to grow significantly, indicating potential commercial opportunities.