Another week, another round of developments across psychedelic medicine. Below is our recap of what mattered to investors for the week of September 22–28, 2025.
atai Life Sciences / Beckley Psytech (ATAI): atai and Beckley report positive Phase 2a two-dose BPL-003 data in treatment-resistant depression
The partners reported positive results from an open-label Phase 2a study of a two-dose induction regimen of BPL-003 (intranasal mebufotenin/5-MeO-DMT) in treatment-resistant depression. Among 12 evaluable patients, a second dose drove a mean MADRS reduction of 19.0 points, with remission rising from 25% to 50% at Week 8 and effects sustained through Week 12. The data support a planned Phase 3 program expected to begin in the first half of 2026.
Source: globenewswire.com
NRx Pharmaceuticals, Inc. (NRXP): FDA approves NRx suitability petition for preservative-free ketamine strength
NRx Pharmaceuticals said the FDA granted its suitability petition for the proposed strength of its single-patient, preservative-free ketamine product (marketed as KETAFREE). The approval clears a procedural step supporting NRx's planned NDA for NRX-100 (IV ketamine) in suicidal depression, a program that holds Fast Track designation. It advances the company's path toward a potential 2026 regulatory decision.
Source: globenewswire.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.