Welcome back to the Psychedelic Invest week in review. Here are the stories that moved the psychedelic sector during the week of August 11–17, 2025 — from clinical readouts to regulatory shifts and the capital flowing through the space.
NRx Pharmaceuticals (NRXP): FDA grants NRx expanded Fast Track for NRX-100 (IV ketamine) in suicidal depression
NRx Pharmaceuticals said the FDA granted an expanded Fast Track designation (received August 8) for NRX-100, its preservative-free IV ketamine, covering suicidal ideation in patients with depression including bipolar depression. The company said the broader label roughly ten-times the addressable population versus its original 2017 designation, to about 13 million Americans, and argued the agency's unmet-need finding supports eligibility for the Commissioner's National Priority Voucher program as it pursues an NDA.
Source: ir.nrxpharma.com
Cybin Inc. (CYBN): Cybin reports fiscal Q1 2026 results; EMBRACE cleared in Europe/UK, $118.7M cash
Cybin reported results for its fiscal first quarter ended June 30, 2025, with $118.7 million in cash bolstered by a recent $50 million convertible debenture financing. The company highlighted European and UK MHRA approvals for EMBRACE, the second pivotal study of CYB003 (deuterated psilocin) as adjunctive treatment for major depressive disorder, spanning 330 participants across roughly 60 sites. Enrollment completion in the CYB004 (DMT) Phase 2 generalized anxiety disorder study was expected in August 2025.
Source: finance.yahoo.com
atai Life Sciences (ATAI): atai Q2 2025: net loss narrows to $27.7M, cash of $95.9M, Beckley combination advancing
atai Life Sciences cut its Q2 2025 net loss to $27.7 million from $57.4 million a year earlier, while cash, equivalents and short-term securities rose to $95.9 million. With an additional $50 million in committed funding announced in July, management said combined-company resources should fund operations into the second half of 2027 as it advances its planned strategic combination with Beckley Psytech, whose BPL-003 (intranasal 5-MeO-DMT) recently delivered positive Phase 2b treatment-resistant depression data.
Source: ir.atai.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.