Pharmather Holdings Ltd Stock Price, News & Analysis

PharmaTher (OTCQB: PHRRF) is preparing a Pre-Phase 3 (Type B) FDA briefing package to align on a single, well-controlled Phase 3 study for ketamine in levodopa-induced dyskinesia in Parkinson's disease under a 505(b)(2) pathway.

Key clinical inputs: prior Phase I/II showed UDysRS reductions of 51% during Infusion 2, 49% at 3 weeks and 41% at 3 months; ketamine was described as generally safe and well tolerated. Company cites an estimated U.S. treated market of $0.75–$2.2 billion. PharmaTher holds U.S. patent coverage through 2036 (U.S. Patent No. 11,426,366).

Near-term milestones: submit Pre-Phase 3 package in Q4 2025–Q1 2026, finalize Phase 3 protocol in Q1–Q2 2026, and initiate Phase 3 from 1H 2026 onward contingent on FDA alignment and partnering/financing.

PharmaTher (OTCQB: PHRRF) launched KetAImine™, an AI-driven ketamine repurposing and discovery platform within its new Digital Health AI division to accelerate indication discovery, partnering, and 505(b)(2) NDA pathways. The platform combines KetaVault™ proprietary datasets, published evidence, real-world signals, and the company's FDA-approved ketamine ANDA CMC to generate regulator-aligned study concepts, dosing algorithms, and protectable methods of use.

Near-term milestones: a shortlist of 6–8 priority programs in Q4 2025; two lead programs selected in Q1 2026 with planned FDA interactions; at least three collaborations targeted in H1 2026; and IP filings through 2026.

PharmaTher (OTCQB: PHRRF) announced progress on a Phase 3 development program to evaluate ketamine for levodopa-induced dyskinesia (LID) in Parkinson's disease via a 505(b)(2) pathway. Key assets include an FDA-reviewed CMC foundation, Phase I/II clinical data showing UDysRS reductions (51% infusion 2; 49% at 3 weeks; 41% at 3 months) and US patent protection to May 2036. The company targets a potential US$0.75–2.2B treated-market and is pursuing a Pre-Phase 3 FDA meeting (Q4 2025–Q1 2026), pivotal protocol finalization (Q1–Q2 2026) and partnering discussions to support a late-stage trial in 1H 2026, subject to FDA alignment and financing.

PharmaTher Holdings (OTCQB: PHRRF) has announced strategic updates following the sale of its Ketamine Hydrochloride Injection ANDA to a global pharmaceutical company. The company retains ownership of its broader ketamine portfolio, including programs for Parkinson's disease, ALS, and complex regional pain syndrome (CRPS).

The strategic sale provides potential non-dilutive capital tied to U.S. commercial sales and leverages the buyer's established infrastructure for sterile injectables. PharmaTher's next six-month strategy includes pursuing international partnerships, engaging with the FDA for CRPS and Parkinson's disease programs, and exploring pharmaceutical partnerships for its ketamine microneedle patch and wearable pump programs.

PharmaTher Holdings (OTCQB:PHRRF) has entered into a definitive Asset Purchase Agreement to sell its Ketamine Hydrochloride Injection USP ANDA to a global pharmaceutical company specializing in sterile injectables. The transaction includes an upfront cash payment and potential milestone payments that could exceed US$25 million in total consideration.

The deal structure includes profit-sharing arrangements for seven years following the first commercial sale. The undisclosed buyer is an FDA-approved manufacturer with over 40 approved ANDAs in the U.S. This strategic move allows PharmaTher to maintain exposure to the ketamine market while focusing on developing next-generation ketamine programs, including long-acting injectables and novel delivery methods.

PharmaTher (OTCQB: PHRRF) is advancing its ketamine transdermal patch as a non-opioid pain relief solution, building on its recently FDA-approved IV ketamine product, KETARx™. The company is targeting the $50 billion U.S. pain management market, including $13 billion in acute postoperative pain and $30 billion in chronic pain conditions.

The ketamine patch aims to provide controlled, sustained analgesia for both acute and chronic pain, suitable for hospital, outpatient, and home-care settings. PharmaTher plans to pursue the FDA's Commissioner's National Priority Voucher (CNPV) Pilot Program, potentially enabling an accelerated NDA review of just 1-2 months. The development aligns with FDA's priority to address the opioid epidemic, which caused over 80,000 deaths in 2023.

PharmaTher (OTCQB: PHRRF) has provided a significant corporate update following FDA approval of KETARx™, its ketamine-based product for surgical and diagnostic anesthesia. The company is pursuing a dual-track commercialization strategy, targeting either a strategic partnership by Q4-2025 or a self-launch option.

The global ketamine injectable market is projected to grow from $725M (2024) to $3.42B (2034). PharmaTher holds five FDA orphan drug designations for ketamine and plans to submit a New Drug Application (NDA) for Complex Regional Pain Syndrome (CRPS) by Q4-2025, with an expected PDUFA date by Q4-2026. An additional rare disorder NDA is planned for Q1-2026.

The company is focusing exclusively on rare disorders through the FDA's 505(b)(2) pathway, leveraging orphan drug designations for market exclusivity and regulatory incentives.

PharmaTher Holdings (OTCQB: PHRRF) has achieved a significant milestone with FDA approval of KETARx™, their ketamine product for surgical pain management. In a letter to shareholders, CEO Fabio Chianelli announced immediate plans for U.S. commercialization and international expansion.

The company is pursuing a dual strategy: advancing their own commercial launch while engaging in partnership discussions with specialty pharmaceutical companies. Their sales strategy targets hospitals, specialty clinics, and government institutions including the U.S. Department of Defense and Veterans Health Administration.

Beyond surgical applications, PharmaTher is developing ketamine-based treatments for Parkinson's disease, ALS, Complex Regional Pain Syndrome, and various mental health conditions through a ketamine patch and wearable pump system.

PharmaTher Holdings (OTCQB: PHRRF) has received FDA approval for KETARx™, its ketamine product for surgical pain management, marking a significant milestone in the company's development. The approval positions PharmaTher to expand into various therapeutic areas including mental health, neurological disorders, and pain management.

The global ketamine market, currently valued at $750 million, is projected to reach $3.42 billion by 2034, with a CAGR of 16.4%. This growth potential is further validated by SPRAVATO®'s success, which is tracking a $1.6 billion sales run rate with guidance of $3-3.5 billion by 2027-2028.

The approval addresses the ongoing FDA drug shortage list issue for ketamine since February 2018, offering a reliable, high-quality supply source for various therapeutic applications.