Pharmather Holdings Ltd Stock Price, News & Analysis

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.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has formed a collaboration with MediSynergics, LLC to develop patented ketamine derivatives aimed at treating pain and CNS disorders. Initial research shows these derivatives could potentially offer better efficacy and fewer side effects than traditional ketamine, making them suitable alternatives to opioids. The partnership also aims to explore next-generation psychedelics like psilocybin and DMT. PharmaTher is currently in a Phase 2 FDA study using ketamine to treat Parkinson's disease and is developing a microneedle patch for psychedelic delivery.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has filed an application with the FDA for Orphan Drug Designation for ketamine to treat amyotrophic lateral sclerosis (ALS). ALS, affecting around 50,000 in the U.S. and Europe, currently has no cure and a limited life expectancy post-diagnosis. Ketamine's promising preclinical research indicates it may preserve muscle function and increase life expectancy in ALS patients. If approved, ketamine could achieve over USD $1 billion in peak sales, offering significant incentives and marketing exclusivity to PharmaTher.