FILAMENT HEALTH ANNOUNCES FIRST-EVER COMPASSIONATE USE APPROVAL FOR PSILOCYBIN IN THE EUROPEAN UNION
VANCOUVER, BC, /CNW/ - Filament Health Corp. (OTC:FLHLF) (" Filament" or the " Company"), a clinical‐stage natural psychedelic drug development company, today announced the first-ever approval for compassionate use of psilocybin in the European Union (EU). The Company's botanical psilocybin drug candidate, PEX010, has been authorized for administration to a patient suffering from treatment-resistant depression (TRD) in Germany.
The approval was granted under Germany's compassionate use framework and marks the first time psilocybin will be prescribed outside of a clinical trial in the EU. The treatment will be conducted by Dr. Gerhard Gründer at the Central Institute of Mental Health, Department of Molecular Neuroimaging.
"This is a landmark moment for the field of psychedelic medicine in the European Union. Treatment-resistant depression affects up to 30% of individuals diagnosed with major depressive disorder and remains one of the most difficult psychiatric conditions to treat. Psilocybin has demonstrated significant promise as a novel therapeutic option, and this approval marks an important step toward expanding access for those in urgent need," said Dr. Gerhard Gründer. "I am honoured to play a role in expanding European access to psilocybin and grateful to the team at Filament Health for their support."
"The approval of PEX010 for this milestone moment in European psilocybin access reinforces Filament's position as the world's leading supplier of GMP-quality psychedelic drug candidates," said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. "We're incredibly proud that our drug product will be the first psilocybin to be administered under compassionate use in the EU. It's a validation of Filament's ongoing efforts to make safe, standardized psychedelic medicines available to those who need them most."
ABOUT FILAMENT HEALTH (OTC:FLHLF)
Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.
Learn more at www.filament.health and on X, Instagram, and LinkedIn.
FORWARD LOOKING INFORMATION
Certain statements and information contained in this press release and the documents referred to herein may constitute "forward‐looking statements" and "forward‐looking information," respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, "expect", "anticipate", "continue", "estimate", "may", "will", "should", "believe", "intends", "forecast", "plans", "guidance" and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements. Forward‐looking statements regarding the Company are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information, including the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward‐ looking statements and forward‐looking information. Filament will not update any forward‐looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws.
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