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) 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.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) released its fiscal year results for 2021, highlighting innovative developments in psychedelic therapies. The company solidified four exclusive licensing agreements for ketamine treatments, particularly in Parkinson’s disease and ALS. A key achievement was the FDA approval for a Phase 2 clinical trial on ketamine's efficacy for levodopa-induced dyskinesia. Financially, the company reported net losses of $2.66 million with cash reserves of approximately $5.88 million.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has received FDA orphan drug designation for ketamine as a potential treatment for Amyotrophic Lateral Sclerosis (ALS). This significant milestone allows the company to advance to a Phase 2 clinical study in the U.S. CEO Fabio Chianelli emphasized that this validation expedites regulatory and product development plans. With approximately 50,000 ALS patients in the U.S. and a lack of effective treatments, ketamine’s neuroprotective properties could be pivotal. The designation also offers financial incentives and seven years of marketing exclusivity upon regulatory approval.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has filed a provisional patent for a novel ketamine formulation aimed at intradermal administration, expanding its intellectual property portfolio to 19 patents across over 150 countries. The innovative delivery method bypasses skin barriers, potentially enhancing bioavailability and reducing irritation. CEO Fabio Chianelli highlighted the company's commitment to developing prescription-based ketamine products. PharmaTher's pipeline includes FDA-approved studies for treating Parkinson's disease and novel microneedle patches for psychedelic delivery.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced CEO Fabio Chianelli's participation in the Grizzle Psychedelics Con on June 28, 2021, at 12 PM ET. Chianelli expressed enthusiasm for this virtual conference aimed at investors interested in psychedelics, highlighting PharmaTher's promising product pipeline, including an FDA Phase 2 study of ketamine for Parkinson’s disease and a microneedle patch for delivering psychedelics for mental health and pain disorders. The event will also be available for later viewing.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced that CEO Fabio Chianelli will present at the H.C. Wainwright Psychedelics in Psychiatry and Beyond Virtual Conference on June 17, 2021. The presentation will be available on-demand from 7:00 am ET. The company is focused on developing novel uses for psychedelics in treating mental health and neurological disorders, including a Phase 2 FDA study using ketamine for Parkinson's disease and creating microneedle patches for psychedelic delivery. For more details, visit www.PharmaTher.com.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has submitted a pre-Investigational New Drug meeting request to the FDA for its KETABET™ treatment, aimed at addressing major depressive disorder. The company seeks to leverage the FDA's 505(b)(2) pathway and Fast Track designation for KETABET™, which combines ketamine with betaine anhydrous to enhance antidepressant effects while reducing side effects. Additionally, PharmaTher is developing a hydrogel-forming microneedle patch for convenient drug delivery, promising improved patient compliance and therapeutic outcomes.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) is advancing its clinical-stage psychedelics initiatives with three key studies in 2021. The FDA has accepted an IND for a Phase 2 clinical trial using ketamine to treat Parkinson's disease, with patient enrollment expected in Q3-2021 and results in Q4-2021. Additionally, PharmaTher is preparing for a Phase 2 study on KETABET™ for treatment-resistant depression and is finalizing a Phase 2 design for ALS treatments. Upcoming developments include innovative microneedle delivery systems for psychedelics, aimed to enhance efficacy and patient compliance.
PharmaTher Holdings Ltd. and TSRL, Inc. have entered into a Co-Development Agreement to create a microneedle array patch aimed at enhancing delivery methods for both psychedelics and antiviral drugs. This collaboration leverages patented hydrogel-forming technology from Queens University and focuses on improving drug safety, efficacy, and patient compliance. TSRL’s experience in drug development complements PharmaTher’s psychedelic research efforts. Both companies anticipate expedited clinical and commercial development, potentially expanding their market opportunities.