Pharmather Holdings Ltd Stock Price, News & Analysis

PharmaTher (OTCQB: PHRRF) announced a strategic initiative to apply its PharmaPatch™ microneedle patch platform to GLP-1 therapies for obesity on January 14, 2026. The company cites prior pre-IND work and published research on ketamine and psychedelic patches to support controlled, sustained delivery and flexible dosing.

PharmaTher aims to develop a needle-free, at-home microneedle patch with potential delivery of up to one month from a single application, will pursue feasibility and preclinical studies, and expects to file a patent application later this month. The release highlights a cited U.S. obesity market forecast of $11.2B in 2024 rising to $48.5B by 2030.

PharmaTher (OTCQB: PHRRF) published a January 2, 2026 letter from CEO Fabio Chianelli outlining 2025 milestones and 2026 priorities. Key 2025 achievements included FDA approval of Ketamine ANDA #217858, the sale and December 2025 closing of that ANDA under a deal with upfronts, sales milestones and profit‑sharing potentially exceeding US$25 million, and reduced cash burn entering 2026.

For 2026 the company plans to: realize economics from the ANDA sale, pursue ex‑U.S. ketamine commercialization and partnerships (Parkinson's and drug delivery), evaluate a long‑acting injectable program via an Oakwood agreement, and crystallize value from its 49% equity interest in Sairiyo Therapeutics.

PharmaTher (OTCQB: PHRRF) closed the sale of its Ketamine Hydrochloride Injection ANDA #217858 to a sterile-injectables company on December 2, 2025, receiving a confidential upfront cash payment and remaining eligible for milestone and seven-year profit-sharing payments.

The transaction could generate more than US$25 million over time, subject to commercial performance, and frees PharmaTher to focus on its patented long-acting injectable (LAI) ketamine program with Oakwood Laboratories via an exclusive evaluation and option-to-license agreement.

PharmaTher (OTCQB: PHRRF) entered an Exclusive Evaluation and Option-to-License Agreement with Oakwood Laboratories to evaluate and potentially license a patented long-acting injectable (LAI) ketamine program on a 12-month exclusive evaluation term dated November 17, 2025.

The LAI program uses Oakwood's sustained-release microsphere platform for subcutaneous or intramuscular dosing, targets treatment-resistant depression (TRD), major depressive disorders and Parkinson's disease-related LID, and is planned to pursue a 505(b)(2) regulatory pathway. Management cites SPRAVATO® as a $1.64B TTM market reference and notes projected annual sales of $3.0–$3.5B by 2027–2028 for that market.

Near-term actions include finalizing CMC, engaging FDA on development strategy, and preparing for clinical studies to advance the program toward an option exercise and potential global license.

PharmaTher (OTCQB: PHRRF) applauds the FDA's October 16, 2025 selection of ketamine under the Commissioner's National Priority Voucher (CNPV) pilot and says this elevates on‑shore ketamine as a national priority. PharmaTher highlights a reduced regulatory decision window (~1–2 months for complete files), resolution of prior U.S. shortages (Feb 2018–Aug 2025), and potential demand tailwinds for domestic suppliers.

The company cites its previously announced ANDA sale with up to US$25 million in potential payment milestones plus multi‑year profit sharing, retention of non‑generic ketamine rights (505(b)(2) programs including LID‑PD), and a reported U.S. market opportunity of ~US$0.75–$2.2B for LID‑Parkinson's.

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.