$ATAI (+3,77%) and Beckley Psytech Limited have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to BPL-003 (mebufotenine benzoate) nasal spray for adult patients with treatment-resistant depression (TRD). The BTD is awarded to accelerate the development of drugs that target serious or life-threatening conditions and where initial clinical data indicate that the drug may show a significant improvement on one or more clinically relevant endpoints over existing therapies. The award facilitates collaboration with the FDA and has the potential to accelerate development timelines and regulatory reviews.
I am delighted for my portfolio, of course, but above all for the people who may soon be helped.
https://de.marketscreener.com/boerse-nachrichten/atai-life-sciences-n-v-und-beckley-psytech-us-fda-erteilt-bpl-003-den-status-als-breakthrough-th-ce7d5adcd18bf722
