FDA granted a post-complete letter clarification meeting scheduled for December 2, 2024 Company initiated activities to address the deficiencies cited in the CRL TORONTO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the FDA granted a post-complete letter clarification meeting (the “Meeting”)... Read More

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... Read More

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... Read More

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... Read More

Toronto, Ontario--(Newsfile Corp. - August 28, 2024) - PharmaDrug Inc. (CSE: PHRX) (OTC: LMLLF) (" PharmaDrug " or the " Company "), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs, is pleased to announce its strategic plans to advance the clinical development of its patented... Read More

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... Read More

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... Read More

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... Read More

TORONTO, May 10, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced receipt of an Amendment Acknowledgment Letter (“AAL”) for its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine from the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022... Read More

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... Read More

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... 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