- Health Canada has granted PharmAla Biotech a Controlled Drugs & Substances Dealer’s License, allowing the company to sell MDMA and psilocybin to anyone legally permitted to hold them
- Given psychedelics’ multi-billion-dollar tailwind, and the company’s established production capabilities, the license will likely have an accretive effect on revenue
- PharmAla Biotech is a biotechnology company researching, developing and manufacturing MDXX-class molecules, including MDMA
- The psychedelic stock has added a hefty 370 per cent year-over-year, and 135 per cent since inception in 2022
Health Canada has granted PharmAla Biotech (CSE:MDMA) a Controlled Drugs & Substances Dealer’s License, allowing the company to sell MDMA and psilocybin to anyone legally permitted to hold them.
The license allows the company to market directly to strategic parties, pave a path towards increased revenue, and eventually hold and distribute its inventory in house, as opposed to the third parties the company currently uses, as it works to monetize its established psychedelics production infrastructure in the midst of a multi-billion-dollar tailwind.
PharmAla is now the only company in Canada providing clinical-grade MDMA for patient treatments outside of clinical trials, adding to its milestones of being the first public company to synthesize GMP-certified MDMA, and the first to test MDMA’s effect on PTSD in a real-world setting.
On the development front, the company has also completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate, which offers an improved toxicology profile compared with MDMA while providing similar efficacy.
“PharmAla is breaking new ground in the Canadian market. MDMA-assisted therapy is still very new – with PharmAla’s LaNeo MDMA having been used for the first time through the Special Access Program (SAP) in May 2023 – and while the potential benefits are significant, its application must be made in a careful and reasonable way,” Dr. Shane Morris, chief operating officer of PharmAla Biotech, said in a statement.
“Over the past number of months, we have been working with Health Canada officials, and are pleased and grateful that they have both understood and seen the validity of our goals in ensuring supply of regulated, secure, clinical-grade MDMA drug product to patients deemed appropriate by the SAP. This license will assist in that process by allowing PharmAla to educate relevant stakeholders about our products,” he added.
“The granting of this license is an important milestone for our LaNeo MDMA business here in Canada, and absolutely critical for the many potential Special Access Program patients who could benefit significantly from MDMA-assisted therapy,” added Nick Kadysh, PharmAla’s chief executive officer. “This license could drive revenue growth for the company, and allow us to educate potential prescribers on the relevant science behind LaNeo and MDMA therapy. In the long run, we believe that the focus on execution as a regulatory first company, and our unwavering focus on patient outcomes, is what will differentiate us from others in the field.”
PharmAla Biotech is a biotechnology company researching, developing and manufacturing MDXX-class molecules, including MDMA.
PharmAla stock (CSE:MDMA) was up by 46.88 per cent on the news at Thursday’s market close. The stock has added a hefty 370 per cent year-over-year, and 135 per cent since inception in 2022.
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