TORONTO, April 18, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (t he “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced receipt of a Complete Response Letter (“CRL”) for its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments... Read More

TORONTO, April 16, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, provides an update of its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of April 29,... Read More

TORONTO, Feb. 21, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, announced today Sairiyo Therapeutics Inc. (“Sairiyo”), a company that is forty-nine percent (49%) owned by PharmaTher and fifty-one percent (51%) owned by PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) (“PharmaDrug”), has initiated its regulatory and clinical... Read More

TORONTO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, provides an update of its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of April 29, 2024.... Read More

TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, is pleased to provide an update for the Company’s lead drug, ketamine (“KETARX™”), as a potential treatment for anesthesia, sedation, pain, mental health, and neurological indications. On September 27, 2023, the Company announced that the U.S. Food and Drug... Read More

FDA assigns GDUFA goal date of April 29, 2024 Milestone builds upon PharmaTher’s commitment toward unlocking the potential of ketamine for unmet medical needs TORONTO, Sept. 27, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (“FDA”) has accepted the... Read More

TORONTO, Sept. 06, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has submitted a priority original Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”) for expedited review of its ANDA. The Company anticipates KETARX™... Read More

TORONTO, July 18, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce that it has successfully completed a research study evaluating PharmaPatch™, a proprietary microneedle patch, in delivering N,N-dimethyltryptamine (“DMT”). The research study was conducted with Terasaki Institute for... Read More

TORONTO, June 27, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has filed a Pre-Submission Facility Correspondence in advance of its Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”) to support expedited review of... Read More

TORONTO, June 20, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has entered into a collaboration agreement with Vitruvias Therapeutics, Inc. (“Vitruvias”), a leading U.S. based specialty generic pharmaceutical company, for the commercialization of the Company’s KETARX™ (racemic... Read More

Company funded to meet upcoming milestones over the next 24 months Expected FDA approval for KETARX™ (racemic ketamine) via the ANDA pathway in Q1-2024 and international approvals after that Company advancing PharmaPatch™ (microneedle patch) for psychedelics and infectious diseases Streamlined clinical development programs to focus on near-term investment and revenue opportunities with KETARX™ and PharmaPatch™ TORONTO, June... Read More

TORONTO, May 02, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced the submission of a Fast Track Application to the U.S. Food and Drug Administration (“FDA”) for KETARX™ (ketamine) for the treatment for levodopa-induced dyskinesia in Parkinson’s disease (“LID-PD”). Fast Track designation aims to expedite the... Read More

TORONTO, March 29, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced an update on the Type C meeting with the U.S. Food and Drug Administration (“FDA”) for advancing KETARX™ (ketamine) towards Phase 3 clinical development as a treatment for levodopa-induced dyskinesia in Parkinson’s disease (“LID-PD”). The FDA... Read More

TORONTO, Feb. 07, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in advancing specialty ketamine pharmaceuticals, today submitted its Type B meeting package with the U.S. Food and Drug Administration (“FDA”) to discuss the remaining requirements for the... Read More

PharmaTher’s 5 th FDA orphan drug designation for KETARX™ (ketamine) Phase 2 clinical study results to support proposed Phase 3 development of KETARX™ (ketamine) to treat Rett Syndrome for FDA approval via the 505(b)(2) regulatory pathway TORONTO, Feb. 02, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, today... Read More

TORONTO, Feb. 01, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in advancing specialty ketamine pharmaceuticals, today submitted its meeting package with the U.S. Food and Drug Administration (“FDA”) to discuss advancing KETARX™ (racemic ketamine) into Phase 3 development as a treatment for levodopa-induced dyskinesia in Parkinson’s disease (“LID-PD”).... Read More

TORONTO, Jan. 18, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that it has applied with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for ketamine to treat Rett Syndrome, a rare genetic neurological disorder. Ketamine has been subject to a Phase 2... Read More

Company aims to commercialize wholly-owned KETARX™ (racemic ketamine) for mental health, neurological and pain disorders Company aims to seek FDA approvals for KETARX™ via the ANDA and 505(b)(2) regulatory pathways in H2-2023 Company aims to advance clinical development programs of KETARX™, including (i) Phase 3 clinical study for Parkinson’s disease; (ii) Phase 2 clinical study with microneedle patch; and (iii) Phase 2... Read More

TORONTO, Dec. 15, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for ketamine in the prevention of ischemia-reperfusion injury from organ transplantation. The Company currently holds four orphan drug designations... Read More

Seeking guidance from FDA to proceed towards a Phase 3 clinical study of KETARX™ (ketamine) for Parkinson’s disease under the 505(b)(2) regulatory pathway Ketamine was safe, well-tolerated with 100% of patients treated with ketamine demonstrating reduction in dyskinesias as measured by the Unified Dyskinesia Rating Scale (UDysRS) UDysRS showed a 51% reduction from baseline during Infusion 2 (p=0.003), 49% at 3-week (p=0.006)... Read More

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on developing and commercializing novel uses and delivery forms of ketamine to treat mental health, neurological and pain disorders, is pleased to announce that the Company has entered into an evaluation and exclusive option agreement (the “Agreement”) with Case Western Reserve University (“CWRU”)... Read More

Grant of US patent strengthens the PharmaTher’s intellectual property portfolio covering novel uses and delivery forms of ketamine Announced positive efficacy and safety data from Phase 1/2 clinical study of ketamine in the treatment of levodopa-induced dyskinesia in Parkinson’s disease patients, with 100% of patients treated with ketamine demonstrating a reduction in dyskinesias as measured by the Unified Dyskinesia Rating... Read More

Nearly $12 million in cash and investment Fully funded for the Company’s development programs, including ketamine injection and infusion products, ketamine microneedle patch and ketamine wearable pump device for mental health, neurological, and pain disorders Seeking FDA approval for the Company’s ketamine injection and infusion products for anesthesia and procedural sedation in 2023 PharmaTher Holdings Ltd. (the “Company”... Read More

Ketamine was safe, well-tolerated with 100% of patients treated with ketamine demonstrating reduction in dyskinesias as measured by the Unified Dyskinesia Rating Scale (UDysRS) UDysRS showed a 51% reduction from baseline during Infusion 2 (p=0.003), 49% at 3-week (p=0.006) and 41% at 3-month (p=0.011) post-ketamine Planning a Phase 3 clinical study to allow for FDA approval of KETARX™ (ketamine) for Parkinson’s disease under... Read More

KETARX™ Ketamine Patch demonstrated extended delivery of ketamine over 40 hours KETARX™ Ketamine Patch offers flexible dosing through increased size, drug load or concentration of ketamine to better align with intramuscular and intravenous administration Initiating clinical studies by the end of Q4-2022 to support phase 2 and... Read More

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, announced today that the United States Patent and Trademark Office (“USPTO”) has provided a Notice of Allowance for patent application No. 15/574,346, titled “Compositions and Methods for Treating Motor Disorders”, which includes claims intended to cover ketamine in the potential treatment of... Read More

Successfully delivered ketamine and KETABET™ (ketamine and betaine) via microneedle patch, unlocking the potential for desired dosage forms and pharmacokinetic profiles Pursuing Phase 2 clinical studies in treatment-resistant depression and pain indications in Q4-2022 PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce... Read More

KETABET™ (Ketamine and Betaine) shown effectiveness as measured by the Clinician Administered Dissociative States Scale Study results are adequate to give an effect size in powering a placebo-controlled clinical study PharmaTher planning a Phase 2 clinical study to incorporate KETABET™ in its proprietary microneedle patch for depression PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a... Read More

Wearable ketamine delivery device complements PharmaTher’s ketamine product portfolio, including injectable, intravenous, and microneedle patch PharmaTher aims to become a leader in specialty ketamine products for mental health, neurological and pain disorders PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB:... Read More

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that the United States Patent and Trademark Office granted US Patent No: 11,286,230, titled “Ketamine Flow Synthesis” (the “Patent”), which refers to a continuous-flow process technology for the preparation of ketamine and ketamine analogs. The Company gained exclusive... Read More

Nearly $12 million in cash and investment Fully funded for the Company’s development programs, including ketamine injection and infusion product, ketamine microneedle patch and ketamine wearable pump device for mental health, neurological, and pain disorders Seeking FDA approval for KETARX™ (ketamine injection and infusion product) for anesthesia and procedural sedation PharmaTher Holdings Ltd. (the “Company” or... Read More

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that PharmaTher has entered into an exclusive worldwide license agreement with Gesval S.A., a public limited company incorporated by the University of Liège, Belgium, for the development and commercialization of a patented continuous-flow process technology for the... Read More

100% of patients treated with ketamine demonstrated reduction in dyskinesias as measured by the Unified Dyskinesia Rating Scale Ketamine was well tolerated with no serious adverse events reported Study results are adequate to give an effect size in powering a Phase 3 clinical study PharmaTher planning a Phase 3 clinical study to allow for FDA approval of KETARX™ (ketamine) for Parkinson’s disease under the 505(b)(2)... Read More

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that the United States Patent and Trademark Office granted to the Company U.S. Patent No. 11,213,495, titled "Method and Composition for Decreasing the Psychotomimetic Side Effect and Addictive Disorder of Ketamine.” The patent refers to the combination formulation of... Read More

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine prescription-based products, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted an investigator-initiated investigational new drug ("IND") application to proceed with a Phase 2 clinical trial (the “Study”) evaluating ketamine in the... Read More

Second published study to demonstrate the potential therapeutic utility and mechanism of action of KETABET™ (patented combination of ketamine and betaine) in models of depression Repeated use of KETABET™ exhibits potential protective and reversing effects on ketamine-elicited psychotomimetic behaviors and cognitive impairments Supports clinical initiatives as a potential next generation ketamine treatment for mental health... Read More

Focused on becoming a leader in the development and commercialization of specialty ketamine prescription-based products Expected milestones for 2022 include initiating Phase 3 clinical study for ketamine to treat Parkinson’s disease (KETLID) ; completing Phase 2 clinical study for ketamine to treat ALS (KETALS) ; completing observational study with ketamine and betaine for depression and pain (KETABET) ; initiating Phase 2... Read More

PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine products, and LTS LOHMANN Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company, today announced they have entered into a process development agreement for the clinical trial scale up of PharmaTher’s proprietary Ketamine microneedle patch product. In... Read More

Delivering LSD via microneedle patch unlocks potential for desired dosage forms and pharmacokinetic profiles for improved safety and effectiveness Pursuing Phase 2 clinical studies in 2022 with LSD and notable psychedelics PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has successfully completed its first... Read More

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that the Japan Patent Office has issued Japanese Patent No. 6967532 for KETABET™, a combination formulation of FDA-approved ketamine and betaine anhydrous, which has shown in research to enhance the antidepressant effect while having the potential to reduce the known... Read More

Adds to PharmaTher’s existing FDA orphan drug portfolio with amyotrophic lateral sclerosis and complex regional pain syndrome Strengthens commitment to treat rare disorders and life-threatening conditions with ketamine PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has applied with the U.S. Food and Drug... Read More

Delivering psilocybin via microneedle patch unlocks potential for desired dosage forms and pharmacokinetic profiles for improved safety and effectiveness. Completing microneedle patch research programs with other psychedelics before year-end. Pursuing Phase 2 clinical studies in 2022 with psilocybin and notable psychedelics. PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage... Read More

Focusing on partnership model for MicroDose-MN ™ and MacroDose-MN ™ patches to deliver psychedelics. Creating value and intellectual property protection for psychedelic programs. Providing pathways for partners to enter FDA Phase 1 and 2 clinical studies in 2022 with psychedelics. PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to... Read More

Completing IND-enabling studies with novel microneedle patch for ketamine, psilocybin, MDMA, LSD, and DMT. Expanding research in evaluating ibogaine and mescaline. Aiming for FDA Phase 1 and 2 clinical studies in Q2-2022. Discussing partnership opportunities for delivering psychedelics with MicroDose-MN ™ and MacroDose-MN ™ patches. PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a... Read More

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today released its business update and financial results for the three months ended August 31, 2021. All amounts are stated in Canadian dollars unless otherwise indicated. “To date, we have made tremendous progress across all drug programs including the initiation of our FDA Phase 2 clinical... Read More

Focus on expanding the delivery of controlled-substances in a microneedle patch. Evaluating potential uses of a microneedle patch for infectious diseases. Strengthening capabilities in the manufacturing of microneedle patches for FDA clinical studies and commercialization. PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce... Read More