TORONTO, March 03, 2025 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is pleased to announce that it has completed its. The Company believes this is the first such shipment of MDMA capsules to cross the American/Canadian border.
“We are incredibly pleased to have delivered our clinical trial materials to Dr. Bershad and Dr. Marder. Unfortunately, the past 2 years since the signing of our contract have highlighted some of the exceptional difficulties in running a clinical exploring a novel indication with a controlled substance. From addressing ethics committee comments and FDA data requests, to waiting for the Research Advisory Panel of California (RAP-C) to approve the trial,” said Nick Kadysh, CEO, PharmAla Biotech. “I know that the UCLA team has had to work mightily to kick this trial off, and we’ve been glad to do our small part. We’re confident that their work will add significantly to the body of scientific evidence around MDMA, and will be in close coordination to support them if needed.
PharmAla’s LaNeo™ MDMA, which remains the only commercially available MDMA drug product approved by the US Food and Drug Administration (USFDA) for clinical trial use, will be used in this case be used for a clinical trial investigating Schizophrenia. The company is taking steps to address what it sees as a significant unmet need for MDMA in the United States for clinical trial use, which it hopes to announce in the near future.
For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.
About PharmAla
PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.
For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: www.PharmAla.ca