From the clinic to the capital markets, here is Psychedelic Invest's roundup of the key headlines for the week of February 23 – March 1, 2026.
Reunion Neuroscience: FDA grants Breakthrough Therapy Designation to Reunion's luvesilocin (RE104) for postpartum depression
Privately held Reunion Neuroscience said the FDA granted Breakthrough Therapy Designation to luvesilocin (formerly RE104), a subcutaneous prodrug of the psilocybin-like compound 4-OH-DiPT, for postpartum depression. The designation followed Phase 2 RECONNECT data in which 70% of patients on the 30 mg dose reached remission by Day 7, sustained through Day 28. Reunion expects to begin a pivotal Phase 3 PPD trial in 2026, adding another psychedelic-derived asset to the FDA's expedited-review roster.
Source: globenewswire.com
PharmAla Biotech Holdings Inc. (MDMA): PharmAla to supply Amsterdam UMC with LaNeo MDMA and develop single-capsule stability data
PharmAla Biotech signed a binding agreement to supply LaNeo 40 mg MDMA capsules to Amsterdam University Medical Center for a planned clinical trial, bundled with a three-year stability-testing program for its single-capsule format. The company said the new stability data will support commercial-grade blister packaging for its LaNeo MDMA line. The deal extends PharmAla's footprint as a clinical-grade MDMA supplier into European research.
Source: globenewswire.com
Incannex Healthcare Inc. (IXHL): Incannex announces 1-for-30 reverse stock split to maintain Nasdaq listing
Incannex Healthcare, whose psychedelic program PSX-001 is an oral synthetic psilocybin in Phase 2 for generalized anxiety disorder, announced a 1-for-30 reverse stock split effective February 26 to regain Nasdaq minimum-price compliance. The split reduced shares outstanding from roughly 358 million to about 12 million. The move reflected continued financing and listing pressure on small-cap psychedelic developers.
Source: globenewswire.com
AtaiBeckley Inc. (ATAI): AtaiBeckley reports positive Phase 2a topline for EMP-01 (oral R-MDMA) in social anxiety disorder
AtaiBeckley announced topline results from an exploratory, placebo-controlled Phase 2a study of EMP-01, its oral R-MDMA candidate, in 71 adults with moderate-to-severe social anxiety disorder. The study met its primary safety objective and showed a placebo-adjusted 11.85-point reduction on the Liebowitz Social Anxiety Scale at Day 43 (p=0.036, one-tailed), with 49% CGI-I responders versus 15% on placebo, achieved without adjunctive psychotherapy. The data support continued development of oral R-MDMA and add to AtaiBeckley's multi-asset psychedelic pipeline.
Source: ir.ataibeckley.com
Definium Therapeutics, Inc. (DFTX): Definium reports full-year 2025 results with $411.6M cash and three 2026 Phase 3 readouts on track
In its first annual report under the new name, Definium Therapeutics reported $411.6 million in cash and investments as of year-end 2025, a runway it said funds operations into 2028. The company confirmed its Emerge Phase 3 MDD trial is fully enrolled (topline expected late Q2 2026), Voyage (GAD) is roughly 80% enrolled (early Q3 2026), and Panorama (GAD) enrollment is on track for a 2H 2026 readout. Management framed 2026 as a pivotal year with three Phase 3 topline readouts for its optimized-LSD lead DT120.
Source: finance.yahoo.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.