Pharmather Holdings Ltd Stock Price, News & Analysis

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.

PharmaTher Holdings (OTCQB: PHRRF) has achieved a significant milestone with the FDA approval of KETARx™, its ketamine product for surgical pain management, on August 8th, 2025. This approval positions PharmaTher strategically in the rapidly growing ketamine market, currently valued at $750 million and projected to reach $3.42 billion by 2034, with a CAGR of 16.4%.

The approval enables PharmaTher to expand ketamine development across various therapeutic areas, including depression, Parkinson's disease, ALS, and Complex Regional Pain Syndrome (CRPS). Notably, ketamine has been on the FDA drug shortage list since February 2018, highlighting the significant market opportunity for a consistent, high-quality supply.

PharmaTher (OTCQB: PHRRF) has announced significant progress in its ketamine commercialization strategy, with the FDA setting an approval goal date of August 9th, 2025. The company confirms it is fully funded through FDA approval and initial U.S. commercial launch, with no plans for new financing before the approval date.

The company has secured U.S.-based manufacturing and is preparing for international expansion in Europe, UK, Canada, Japan, and APAC regions in H2 2025. PharmaTher is targeting a ketamine market projected to reach $3.42 billion by 2034, growing at 16.4% CAGR from its current $750 million valuation. The company is also advancing new ketamine applications for conditions including Parkinson's disease, ALS, and CRPS through pre-INDs and INDs submissions.

PharmaTher Holdings (OTCQB: PHRRF) has secured a crucial U.S. patent (No. 12,128,012) for using ketamine to treat Amyotrophic Lateral Sclerosis (ALS), valid until May 14, 2041. This patent complements their existing FDA Orphan Drug Designation, strengthening their market position in treating this fatal neurodegenerative disorder.

The company is targeting the global ALS treatment market, projected to reach $1.04 billion by 2030. With approximately 5,000 new ALS cases diagnosed annually in the U.S. and 30,000 current patients, PharmaTher is advancing towards Phase 2 clinical trials, with plans for FDA Fast Track designation and Phase 3 studies in 2026.

The combination of patent protection and Orphan Drug status provides PharmaTher with significant advantages, including seven years of market exclusivity, tax credits for clinical trials, and FDA application fee exemptions worth approximately $2.4 million.

PharmaTher Holdings (OTCQB: PHRRF) has expressed strong support for the FDA's new Commissioner's National Priority Voucher (CNPV) program, which could significantly accelerate the development of its ketamine-based therapies. The company, which has an FDA approval goal date of August 9, 2025, for its ketamine product, is developing innovative delivery systems including KETAPATCH™ (a ketamine microneedle patch) and a ketamine on-body wearable pump. PharmaTher holds five FDA orphan drug designations for ketamine treatments in various conditions including ALS, Rett Syndrome, CRPS, Status Epilepticus, and organ transplantation. The CNPV program could reduce FDA review time from 10-12 months to 1-2 months for qualifying applications. The company's ketamine platforms aim to address critical needs in mental health, neurological disorders, and pain management, with potential applications in both civilian and military settings.

PharmaTher Holdings (OTCQB: PHRRF) announced that the FDA has extended its review period for the company's ketamine new drug application. The new approval goal date is set for August 9, 2025, pushed back from the original June 4, 2025 date. The extension is due to the FDA requiring additional time to review information requests, classified as a minor amendment.

The company confirmed it has already addressed all issues from the FDA's previous Complete Response Letter from October 2024. CEO Fabio Chianelli stated that the extension is not expected to significantly impact PharmaTher's operational, business development, and commercialization initiatives for 2025.

[ "FDA classified the amendment as MINOR, suggesting no major concerns", "Company has already addressed all previous issues from October 2024 Complete Response Letter", "Extension not expected to materially impact 2025 business initiatives" ]

PharmaTher (OTCQB: PHRRF) has launched KetaVault™, a groundbreaking portal providing access to comprehensive ketamine research data. This first-of-its-kind platform offers pharmaceutical companies, researchers, and agencies access to PharmaTher's proprietary regulatory, manufacturing, and clinical ketamine data. The launch coincides with the company's anticipated FDA approval for its ketamine product on June 4, 2025. KetaVault™ includes access to: • Regulatory filings and IND applications • Manufacturing and CMC data • Clinical research protocols • Orphan Drug Designations for multiple conditions • Novel delivery systems data The platform aims to expedite clinical trials, regulatory submissions, and commercialization of ketamine-based therapies. PharmaTher also offers partners cGMP-compliant ketamine manufacturing support, positioning itself as an end-to-end solution provider in the ketamine market.