Articles from PharmaTher Holdings Ltd.

TORONTO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, is pleased to announce today that the U.S. Food and Drug Administration (FDA) has approved the Company’s ketamine product, herein referred to as KETARx™, on August 8th, 2025, for its indicated uses in surgical pain management. This FDA approval signifies a momentous achievement for PharmaTher and strategically positions the Company to contribute to the psychedelic pharmaceutical revolution by leveraging its commercial and clinical initiatives with ketamine towards mental health, neurological, and pain disorders.

TORONTO, July 02, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on the development and commercialization of ketamine-based pharmaceuticals, is pleased to provide a corporate update to its shareholders, outlining a clear strategy to become the global leader in unlocking the pharmaceutical potential of ketamine. The Company has reached a pivotal stage in its growth, marked by a defined regulatory timeline and a strategic plan for commercial and international expansion for its ketamine-based products.

TORONTO, June 24, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) ("PharmaTher" or the "Company"), a company focused on unlocking the pharmaceutical potential of ketamine, is pleased to announce that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 12,128,012, expiring May 14, 2041, for the use of ketamine in the treatment of Amyotrophic Lateral Sclerosis (ALS).

Provides Accelerated Path to Market for PharmaTher’s Ketamine-based Proprietary Delivery Systems & Orphan Drug Designations, and Leveraging its Ketamine Product, having an FDA Approval Goal Date on August 9, 2025

TORONTO, May 16, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) ("PharmaTher" or the "Company"), a specialty pharmaceutical company focused on ketamine for unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has extended the approval goal date for the review of its new drug application for ketamine. The new approval goal date is August 9, 2025, revised from the previous date of June 4, 2025. The extension allows the FDA additional time to review additional information requests, which the FDA has classified as a MINOR amendment. Importantly, this is not a Complete Response Letter. PharmaTher confirms it has previously addressed all issues raised in the FDA's Complete Response Letter dated October 22, 2024.

KetaVault™ to Provide Partners Unprecedented Access to PharmaTher's Extensive Regulatory, Manufacturing, and Clinical Ketamine Data, Aiming to Expedite New Therapies and Market Entry

The Assigned FDA Approval Goal Date is June 4, 2025

PharmaTher expects to submit the MINOR AMENDMENT to the CRL by end-February 2025 and expects a new approval date for a Q2-2025 FDA approval of ketamine

TORONTO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on the development and commercialization of ketamine, announced today that Fabio Chianelli, the Company’s Chairman and Chief Executive Officer, has issued the following letter to shareholders.

FDA provided preliminary responses to questions contained in the clarification only post-CRL meeting scheduled for December 2, 2024

FDA granted a post-complete letter clarification meeting scheduled for December 2, 2024

TORONTO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the Company requested a post-complete letter clarification meeting (the “Meeting”) in response to the FDA issuing a complete response letter (CRL), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024.

TORONTO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024.

TORONTO, Sept. 04, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced an update for its New Drug Application for Ketamine from the U.S. Food and Drug Administration (the “FDA”) with an assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. On September 3, 2024, the FDA communicated with the Company that the review is ongoing and no additional information is needed, but is subject to change. The Company will continue to provide updates as they occur.

TORONTO, Aug. 21, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, announces that 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), announced today that an independent screening of drugs for monkeypox (“Mpox”) highlighted cepharanthine’s potential to bind to the virus’s proteins. The letter to the editor titled, "Highly accurate protein structure prediction and drug screen of monkeypox virus proteome", is non peer reviewed and published in Journal of Infection and can be found here.

TORONTO, Aug. 19, 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 received approval by the Australian Human Research Ethics Committee to initiate a first-in-human Phase 1 clinical study (the “Study”) investigating a patented reformulated enteric coated version of oral cepharanthine (“PD-001”) as a potential treatment for Medical Countermeasures and cancer. PD-001 was previously awarded a $3.4 million contract from the Defense Threat Reduction Agency (DTRA) for the Ebola virus.

TORONTO, May 15, 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 submitted to the Australian Human Research Ethics Committee for review and potential approval to initiate a Phase 1 clinical study (the “Study”) of Sairiyo’s patented reformulated enteric coated version of orally bioavailable cepharanthine (“PD-001”) as a potential treatment for infectious diseases and oncology.

The FDA Assigned Goal Date is October 29, 2024

TORONTO, May 01, 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 completed its clinical and regulatory package to evaluate Sairiyo’s patented reformulated enteric coated version of orally bioavailable cepharanthine (“PD-001”) as a potential treatment for infectious diseases and oncology in a Phase1 clinical study in Australia.

TORONTO, April 18, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “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 of 2022 (“GDUFA”) goal date of April 29, 2024. The CRL is similar to the review letter FDA provided on possible deficiencies identified by Quality, as announced on February 12, 2024, and no additional deficiencies were mentioned in the CRL. As such, the Company has completed the necessary tests and responses to address the FDA’s comments and will submit them to the FDA for their review and response to a new GDUFA goal date. The Company will provide updates as they occur.

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, 2024. As announced by the Company on February 12, 2024, the ANDA is under priority review by the FDA and has been provided with preliminary thoughts on possible deficiencies identified by the Quality reviewers. The Company has completed the necessary tests and responses to address the FDA’s comments. The Company aims to submit its responses to the FDA by the end of this week. There can be no assurance the GDUFA goal date will be met. Should the goal date not be met, the FDA would provide a Complete Response Letter to the Company to address the responses, provide additional feedback, if any, and assign an appropriate goal date. The Company is prepared to address potential FDA requests and concerns immediately and will update shareholders as they occur.

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 development plan to evaluate Sairiyo’s patented reformulated enteric coated version of orally bioavailable cepharanthine (“PD-001”) as a potential treatment for oncology and infectious diseases in a Phase1 clinical study in Australia. PD-001 is protected by US Patent US10576077, with a patent expiration date of March 23, 2036.

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. The ANDA continues to be under review by the FDA and has provided preliminary thoughts on possible deficiencies identified by Quality. The Company aims to respond to satisfy the preliminary thoughts on possible deficiencies before the goal date. The Company received a waiver from the FDA for bioequivalence studies and has not identified any deficiencies. There can be no assurance the goal date will be met. The FDA may assign an appropriate goal date. The Company will provide updates as they occur.

Assigned FDA approval goal date of April 29, 2024, is still on track

FDA assigns GDUFA goal date of April 29, 2024

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™ approval and commercial launch in the U.S. in Q2-2024, followed by the pursuit of international approvals to support the growing global demand for ketamine.

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 Biomedical Innovation (“Terasaki”).

Expected FDA approval for KETARX™ (racemic ketamine) via the ANDA pathway in Q1-2024 and commercial launch in Q2-2024

Expected FDA approval for KETARX™ (racemic ketamine) via the ANDA pathway in Q1-2024 and commercial launch in Q2-2024

Company funded to meet upcoming milestones over the next 24 months

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”).

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”).

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 KETARX™ On-Body Pump System (subcutaneous racemic ketamine) and submission of a New Drug Application (“NDA”) under the 505(b)(2) pathway. PharmaTher aims to leverage its own CMC information, clinical data and available non-clinical and clinical data to submit an NDA by the end of 2023. The meeting date with the FDA is set for March 23, 2023.

PharmaTher’s 5th FDA orphan drug designation for KETARX™ (ketamine)

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”). This Type C meeting allows the Company to discuss with the FDA its plans for a Phase 3 clinical study to support the submission of a new drug application under the 505(b)(2) regulatory pathway for KETARX™ in treating LID-PD. In addition, the Company has requested guidance from the FDA to obtain Fast Track Designation for KETARX™. The Type C meeting is via written responses. The goal date for the FDA in providing its written responses is March 20, 2023.

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 clinical trial (NCT03633058) for Rett syndrome. Unpublished results from this study will be evaluated to support a potential Phase 3 clinical study and FDA agreement on a regulatory plan for approval which the Company may pursue.

Company aims to commercialize wholly-owned KETARX™ (racemic ketamine) for mental health, neurological and pain disorders

PharmaTher’s 4th FDA orphan drug designation for ketamine

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

TORONTO, Nov. 01, 2022 (GLOBE NEWSWIRE) -- 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”) in the development and commercialization for the intellectual property of ketamine in the treatment Rett Syndrome, a rare genetic neurological disorder. Ketamine has been subject to a Phase 2 clinical trial (NCT03633058) for Rett syndrome and unpublished results will be evaluated to support a defined clinical and regulatory plan for FDA feedback.

Grant of US patent strengthens the PharmaTher’s intellectual property portfolio covering novel uses and delivery forms of ketamine

Nearly $12 million in cash and investment