PharmaTherCSE: PHRM
Canadian specialty pharmaceutical company focused on ketamine-based therapies for psychiatric and neurological conditions. KETARX™ (racemic ketamine IV) received FDA approval in August 2025, making PharmaTher one of the first Canadian companies to achieve US regulatory approval for a ketamine product. Also developing KETABET, a proprietary combination of ketamine and betaine.
Development Programmes
2KETARx (Generic Ketamine Injection)
KetamineSurgical / post-operative pain management
Programme Tracker
Chronic Pain
FDA ANDA #217858 approved August 8, 2025; U.S. commercialisation rights sold December 2025 (upfronts + milestones potentially exceeding $25M)
Milestones
Regulatory approved
CompletedActual: Aug 8, 2025
FDA approved ANDA #217858 — KETARx generic ketamine injection for surgical pain management
Why it matters: KETARx became the first ketamine product specifically indicated for surgical pain management under an ANDA pathway. Following two prior complete response letters (April and October 2024), approval validates PharmaTher's manufacturing quality fixes. U.S. commercialisation rights sold in December 2025 for potential $25M+ in milestone payments.
Licensing deal
CompletedActual: Dec 1, 2025
U.S. commercialisation rights for KETARx sold; deal includes upfronts, sales milestones, profit-sharing potentially exceeding $25M
Why it matters: Monetising the ANDA approval through a licensing/commercialisation deal is the standard exit for smaller companies that win generic approvals. The $25M+ deal provides runway to advance the Parkinson's ketamine programme.
Recorded Events
Dec 1, 2025: Licensing deal
Aug 8, 2025: Regulatory approved
Ketamine (IV) — Levodopa-Induced Dyskinesia
KetamineParkinson's disease (levodopa-induced dyskinesia)
Programme Tracker
Neurocognitive Disorders
Phase 2 complete (suspended before planned March 2024 completion); positive results — subanesthetic IV ketamine reduced LID; advancing toward Phase 3, seeking partnership
Milestones
Phase II topline
CompletedActual: Jan 1, 2024
Phase 2 (NCT04912115) topline: subanesthetic IV ketamine reduced levodopa-induced dyskinesia; well tolerated; proceeding toward Phase 3
Why it matters: Levodopa-induced dyskinesia (LID) is a major quality-of-life issue for Parkinson's patients on long-term levodopa therapy, affecting ~50% after 5 years. There is only one approved treatment (amantadine/Gocovri). Positive Phase 2 data from a randomised, double-blind trial positions ketamine as a potential Phase 3 candidate with a large patient population.
Watch next: Phase 3 partnership announcement and trial initiation
Recorded Events
Jan 1, 2024: Phase II topline
Quick Facts
- Type
- Public Biotech
- Founded
- 2019
- Ticker
- CSE: PHRM
- Lead Stage
- Approved
- Website
- Visit