Catching you up on the week of October 13–19, 2025: the trial milestones, regulatory moves, and business developments shaping psychedelic medicine right now.
atai Life Sciences / Beckley Psytech (ATAI): FDA grants Breakthrough Therapy designation to BPL-003 for treatment-resistant depression
The FDA awarded Breakthrough Therapy designation to BPL-003, Beckley Psytech's intranasal mebufotenin (5-MeO-DMT) benzoate, for treatment-resistant depression. The designation grants expedited development and closer FDA guidance, following positive Phase 2b data reported in July. It reinforced BPL-003 as a lead asset heading into the atai-Beckley combination.
Source: globenewswire.com
atai Life Sciences N.V. (ATAI): atai prices roughly $149.5 million underwritten stock offering
atai priced an underwritten offering of common shares at $5.48 each, drawing new institutional investors including Janus Henderson, Foresite Capital, Deep Track Capital and HBM Partners alongside existing backers. With the underwriters' option exercised, the deal totaled about 27.3 million shares for approximately $149.5 million in gross proceeds. The capital bolsters atai's balance sheet ahead of its Beckley Psytech merger and Phase 3 plans.
Source: theglobeandmail.com
That's the recap. Follow the Psychedelic Invest Index for how the sector is trading, and check back next week for the next edition.