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Optimi-Health

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Optimi Health Submits Phase I Clinical Trial Application Combining The Use Of Proprietary Psilocybin and MDMA Drug Candidates In Healthy Therapists

Optimi Health Corp. (CSE: OPTI | OTCQX: OPTHF | FRA: 8BN), an end-to-end Canadian-based drug manufacturer and formulator licensed by Health Canada to produce and supply natural, GMP-grade psilocybin, synthetic psychedelic substances, and high-quality functional mushrooms, is pleased to announce the submission of its clinical trial application (CTA) for a Phase I combinatorial study that will document the safety of Optimi’s natural psilocybin standardized extract and proprietary 3,4-methylenedioxy-methamphetamine (MDMA) drug candidate in healthy therapist subjects. Yesterday, Optimi announced the successful completion of its novel MDMA drug candidate, OPTI-MHCL, which was tested for purity on-site with a result of >99% over multiple consistent batches…

Pharmather

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PharmaTher Submits FDA Meeting Package to Discuss 505(b)(2) Pathway for New Drug Application of KETARX™ (Ketamine) On-Body Pump System

PharmaTher Holdings Ltd. (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. “We are in a position to meet…

Revive Therapeautics

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Revive Therapeutics Secures MDMA Supply from PharmAla Biotech for MDMA Transdermal Patch Development

Revive Therapeutics Ltd. (OTCQB: RVVTF | CSE: RVV | FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into a supply agreement with PharmAla Biotech Holdings Inc. (“PharmAla”) (CSE: MDMA) to obtain PharmAla’s LaNeo, GMP source of 3,4-Methylenedioxy​methamphetamine (“MDMA”), for the development of Revive’s microneedle patch delivery system. Recently, Revive Therapeutics announced it entered into a research collaboration agreement with PharmaTher Holdings (CSE: PHRM) (OTCQB: PHRRF) to evaluate their microneedle patch technology with MDMA. PharmAla is the first publicly traded company to manufacture…

Lobe Sciences

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Lobe Sciences Congratulates Australia for Becoming the First Nation to Approve the Medicinal Use of Psilocybin and MDMA

Lobe Sciences Ltd. (CSE: LOBE | OTCQB: LOBEF), a North American Biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today congratulated the people of Australia for the decision by the TGA (Therapeutic Goods Administration) to reschedule Psilocybin and MDMA so that trained physicians may prescribe the psychedelics for patients across the country. “This is such an important step by a national government recognizing the value of these compounds in treating certain mental health conditions. As we prepare for a Ph 2 study in Australia in conjunction with iNGENu CRO in Chronic Cluster Headaches,…

PharmAla-Biotech

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PharmAla Named Exclusive MDMA Supplier to Revive Therapeutics

PharmAla Biotech Holdings Inc.(CSE: MDMA) is pleased to announce that it has signed on to act as exclusive supplier of both GMP LaNeo MDMA and Engineering MDMA to Revive Therapeutics (CSE:RVV | OTCQB: RVVTF). On Friday, February 3, Revive Therapeutics announced a licensing agreement with Pharmather Holdings to license their microneedle patch technology with MDMA. “As countries like Australia move to allow the use of MDMA as a therapeutic molecule for the treatment of mental health disorders like PTSD, new drug product forms will be crucial. We’re proud to be able to offer our engineering MDMA to Revive in their…