Filament Health / German health authorities (FH) — Germany's federal drug regulator (BfArM) authorized a compassionate-use program allowing adults with treatment-resistant depression to receive psilocybin, the first time a psychedelic has been made available under expanded-access rules in the EU.
The botanical psilocybin drug candidate PEX010 is supplied by Canada's Filament Health, initially through two centers, the Central Institute of Mental Health and OVID Clinic Berlin, with capacity for roughly 50 patients in the first year. For investors, the program gives Filament an early European supply foothold and signals growing regulator willingness to permit supervised psilocybin access outside formal trials.
Source: psychedelicalpha.com
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