Pharmather Holdings Ltd Stock Price, News & Analysis

PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced an update regarding its KETARX™ (ketamine) treatment for levodopa-induced dyskinesia in Parkinson's disease, following a Type C meeting with the FDA. The FDA supported the company's regulatory approach and indicated that a single confirmatory trial could suffice for marketing approval under specific conditions. PharmaTher will adjust its clinical development plans according to the FDA's feedback and aims to pursue FDA Fast Track designation. Recent Phase I/II results showed ketamine was safe and well-tolerated, with significant reductions in dyskinesias for all subjects treated.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has submitted its Type B meeting package to the FDA to discuss requirements for the KETARX™ On-Body Pump System. The meeting is scheduled for March 23, 2023. PharmaTher aims to submit a New Drug Application (NDA) by the end of 2023, using its clinical and non-clinical data. The company intends to seek FDA approval for the device to enhance general anesthesia and sedation procedures. The KETARX™ system may provide improved administration of ketamine while potentially extending its use in mental health and pain disorders. However, no assurance of expedited approval is provided.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has received its 5th FDA orphan drug designation for KETARX™ (racemic ketamine) to treat Rett Syndrome, a rare neurological disorder that primarily affects girls. This designation paves the way for proposed Phase 3 clinical trials. The company has previously received orphan designations for conditions including Ischemia-reperfusion injury and Status Epilepticus. Currently, no FDA-approved treatments exist for Rett Syndrome, impacting 1 in 10,000 female births. KETARX™ shows potential in treating this condition, validated through prior research and ongoing clinical trials.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has submitted a meeting package to the FDA to advance its ketamine product, KETARX™, into Phase 3 development for treating levodopa-induced dyskinesia in Parkinson's disease. The company aims to utilize the 505(b)(2) pathway for a new drug application. Notably, KETARX™ has shown promising results in prior studies, with 100% of subjects experiencing reduced dyskinesias. The FDA is expected to respond by March 20, 2023. Additionally, PharmaTher is seeking Fast Track Designation, which could expedite KETARX™'s development process, benefiting patients with this debilitating condition affecting over 10 million globally.

PharmaTher Holdings Ltd. has applied for Orphan Drug Designation from the FDA for ketamine to treat Rett Syndrome, a rare neurological disorder. This follows a completed Phase 2 clinical trial, with unpublished results expected to support a future Phase 3 study. The company holds four existing orphan drug designations for ketamine, including conditions such as Status Epilepticus and Amyotrophic Lateral Sclerosis. If approved, ketamine would qualify for marketing exclusivity, tax credits, and other benefits. Rett syndrome affects 1 in 10,000 female births with no current FDA-approved treatments.

PharmaTher Holdings Ltd. aims to commercialize KETARX™ (racemic ketamine) for mental health, neurological, and pain disorders. The company is seeking FDA approvals via the ANDA and 505(b)(2) pathways by H2-2023. Key development initiatives include Phase 3 studies for Parkinson’s disease and Phase 2 studies for amyotrophic lateral sclerosis (ALS) and microneedle patch delivery. PharmaTher has received four FDA orphan drug designations, enhancing its market potential. The projected revenue from KETARX™ could reach up to USD $40 million based on one million unit sales at an average price of USD $25-40.