Pharmather Holdings Ltd Stock Price, News & Analysis

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.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has appointed Professor Ryan Donnelly as a scientific advisor for its microneedle patch delivery programs, focusing on controlled substances like ketamine and treatments for infectious diseases. Professor Donnelly's research includes a patented hydrogel-forming microneedle patch, which may improve patient outcomes by addressing challenges faced with existing drug delivery methods. The company aims to utilize this technology for FDA-approved treatments and enhance its product pipeline for mental health and pain disorders.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has partnered with Alcami Corporation, a leading U.S.-based CDMO, to manufacture its proprietary ketamine products for FDA Phase 3 clinical trials and global commercialization. The agreement aims to secure clinical and commercial supply by H2-2022, enabling PharmaTher to build a specialty product pipeline for neurological disorders like Parkinson’s and ALS. Alcami's recent $31 million investment will enhance its manufacturing capabilities to support this initiative and unlock partnership opportunities across research labs and pharmaceutical companies globally.

PharmaTher Holdings Ltd. has received its second FDA orphan drug designation for ketamine, this time for treating complex regional pain syndrome (CRPS), a rare chronic pain condition. This designation follows the previous approval for Amyotrophic Lateral Sclerosis (ALS) in August 2021. The company is developing a proprietary ketamine product pipeline focused on rare and near-rare disorders. CEO Fabio Chianelli anticipates initiating a Phase 2 clinical trial for CRPS in 2022. The FDA's orphan drug status offers valuable incentives, including marketing exclusivity and tax credits for drug testing.

PharmaTher Holdings Ltd. has initiated the KET-LID Phase 2 clinical trial to evaluate the safety and efficacy of ketamine for treating levodopa-induced dyskinesia in patients with Parkinson's disease. Patient screening begins in October 2021, with data expected by late-Q4 2021. The study is randomized, double-blind, and active placebo-controlled, focusing on several primary endpoints related to dyskinesia symptoms. If successful, PharmaTher plans to discuss moving to Phase 3 under the 505(b)2 regulatory pathway in 2022.