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PharmaTher Holdings Ltd. develops specialty pharmaceutical platforms centered on microneedle drug delivery. Company updates focus on PharmaPatch™ product programs for ketamine, psychedelics, GLP-1 drugs and therapeutic peptides, along with PatchPrint™, its automated tabletop microneedle patch 3D printer designed to support end-to-end patch manufacturing.
Recurring news themes include U.S. patent applications for patch manufacturing and peptide formulations, expansion of the PharmaPatch™ platform into new drug categories, regulatory and policy developments affecting ketamine, psychedelics and peptides, and the company's retained economic participation tied to its previously approved and sold U.S. generic ketamine ANDA.
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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.