Pharmather Holdings Ltd Stock Price, News & Analysis

PharmaTher Holdings Ltd. announced that the FDA granted Orphan Drug Designation for its ketamine product to treat Status Epilepticus (SE), a severe neurological condition requiring emergency treatment. This marks the third orphan designation for ketamine, adding to its portfolio for treating amyotrophic lateral sclerosis and complex regional pain syndrome. SE affects approximately 120,000-180,000 individuals annually in the U.S., with a mortality rate of 17%. Orphan status grants benefits including seven years of marketing exclusivity and potential tax credits.

PharmaTher Holdings Ltd. announced that the FDA has accepted its IND application to initiate a Phase 2 clinical trial for ketamine in treating Amyotrophic Lateral Sclerosis (ALS). Conducted at the University of Missouri and led by Dr. Richard Barohn, this trial will include 36 participants and evaluate ketamine's safety and efficacy over 24 weeks. Following positive results, the company plans to meet with the FDA to discuss progression to Phase 3 trials. With ALS affecting around 50,000 individuals annually in the U.S. and Europe, ketamine may offer a new therapeutic avenue for this challenging condition.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced the publication of a study validating the efficacy of KETABET™, a combination of ketamine and betaine, in mitigating adverse psychiatric effects from ketamine in treating depression and chronic pain. The study, published in Biomedicine & Pharmacotherapy, suggests that betaine can protect against cognitive deficits associated with repeated ketamine use. With patent protection until 2036, PharmaTher aims to advance KETABET™ into Phase 2 clinical studies in H2-2022.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) focuses on specialty ketamine-based products. In 2022, it plans to initiate Phase 3 clinical studies for treating Parkinson's disease (KETLID), complete Phase 2 studies for ALS (KETALS), and develop a ketamine microneedle patch (KETAPATCH). Additionally, the company anticipates FDA approval for its Ketamine Hydrochloride Injection (KETARX). Key partnerships and exclusive licenses with universities strengthen its treatment pipeline, aiming to enhance therapeutic options for mental health and neurological disorders.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has entered a process development agreement with LTS LOHMANN Therapie-Systeme AG for the clinical trial scale-up of its proprietary Ketamine microneedle patch. The partnership aims to advance the development and non-commercial manufacturing of this innovative drug delivery system, targeting neuropsychiatric and pain disorders. The microneedle patch, developed with Queen’s University of Belfast, promises efficient delivery of ketamine and will support upcoming FDA and EMA submissions. PharmaTher plans to initiate Phase 1/2 clinical studies in 2022.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has announced the successful completion of its first research study on MicroDose-MN™, a microneedle patch for intradermal delivery of psychedelics, specifically LSD. The study supports filing an IND application with the FDA for Phase 2 clinical studies in 2022. The MicroDose-MN™ patch aims to provide flexible dosing and controlled release while allowing patients to self-administer their medication safely. Additionally, the company is evaluating the patch for MDMA and DMT, with results expected by year-end 2021.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced that the Japan Patent Office granted Patent No. 6967532 for KETABET™, a combination of FDA-approved ketamine and betaine anhydrous. This patent, valid until 2036, enhances the company's global patent portfolio and suggests KETABET™ could address multiple mental health disorders while reducing ketamine's side effects. The microneedle patch delivery system is designed to improve drug delivery for various conditions, potentially increasing market opportunities in Japan and beyond.

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.