Pharmather Holdings Ltd Stock Price, News & Analysis

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.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has appointed Dr. Thomas Laughren as a Regulatory Affairs Advisor to assist in regulatory matters concerning KETABET™, a novel formulation combining FDA-approved ketamine and betaine for treating neuropsychiatric disorders. Dr. Laughren, with 29 years of experience at the FDA, will help finalize the IND application for a Phase 2 study on KETABET™ targeting depression. The treatment aims to mitigate major depressive disorder symptoms in over 300 million people globally, potentially enhancing ketamine's efficacy while reducing its side effects.

PharmaTher Holdings Ltd. has successfully closed a private placement with institutional investors, raising CAD$10 million. The Company issued 15,625,000 common shares and warrants at CAD$0.64 per share, with each warrant allowing the purchase of one share at CAD$0.80 over five years. Proceeds will fund the development of its microneedle patch program and proprietary ketamine product. The placement agent, H.C. Wainwright & Co., received an 8% commission and warrants. Securities are restricted in the U.S. and not registered under U.S. laws.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) is now part of the North American Psychedelics Index, included in the Horizons Psychedelic Stock Index ETF (NEO: PSYK). This Index focuses on public companies in the psychedelics sector and aims to reflect the industry's evolution. CEO Fabio Chianelli stated that this inclusion enhances investor awareness and boosts confidence in PharmaTher's business model, which emphasizes research and development of ketamine treatments for mental health and neurological disorders. The Index is regularly rebalanced quarterly.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced significant advancements in its clinical pipeline, including a Phase 2 study using ketamine for Parkinson's disease, with 10 U.S. clinical sites selected. The IND for KETABET™, aimed at treating depression, is set for submission in October 2021. Additionally, the company completed its Phase 2 protocol for ALS treatment and is developing microneedle patches for psychedelics. With FDA approvals and a focus on commercialization in 2022, PharmaTher is positioned as a leader in psychedelic therapies.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. CEO Fabio Chianelli will present updates on the company’s FDA Phase 2 clinical studies involving ketamine for conditions like Parkinson’s disease and treatment-resistant depression. The firm is also developing microneedle patches for psychedelic delivery. This presentation will be available to registered attendees for on-demand viewing starting 7:00 AM EST on September 13.