Psychedelic: AtaiBeckley reports publication of BPL-003 study results

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on a publication of study results, a clinical site network expansion and a labeling alignment.

ATAIBECKLEY REPORTS PUBLICATION OF BPL-003 STUDY RESULTS: AtaiBeckley (ATAI) announced Wednesday peer-reviewed Phase 2a results in CNS Drugs, demonstrating that a single intranasal dose of BPL-003, which holds FDA Breakthrough Therapy Designation, achieved rapid and sustained reductions in MADRS scores from baseline in participants with treatment-resistant depression who remained on stable SSRI therapy throughout the study. A 66.7% antidepressant response rate was observed at Day 2 in both the 10 mg and 12 mg cohorts, with 83% of participants in the 10 mg cohort and 66.7% of participants in the 12 mg cohort maintaining a response at Week 12. BPL-003 was generally well tolerated with no serious adverse events reported, and participants achieved a mean discharge approximately 100 minutes post-dose.

Srinivas Rao, CEO said, “A 66.7% Day‑2 response rate with a single intranasal dose of BPL‑003, maintained through Week 12 in the 10 mg cohort, represents a compelling clinical signal in patients who remained on their baseline SSRI therapy. Combined with our statistically significant double-blind, randomized Phase 2b results in 193 participants and our recent FDA End‑of‑Phase 2 alignment, these Phase 2a data reinforce the potential of BPL‑003 to transform the treatment paradigm for TRD as we prepare to initiate Phase 3 in Q2 2026.”

PSYENCE BIOMED EXPANDS AUSTRALIAN CLINICAL SITE NETWORK: Psyence Biomedical (PBM) announced Wednesday the expansion of its clinical site network in Australia from three to five sites supporting its ongoing clinical activities. The expansion includes the addition of Ramsay Health Care and NeuroCentrix. The company believes that their inclusion strengthens the company’s clinical program and enhances its ability to support ongoing clinical activities with high-quality, experienced site partners. The ongoing Phase IIb clinical trial, conducted by Southern Star Research, is evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer in a palliative care setting. The study is currently operating across three established sites: Empax Centre in Perth, the Mind Medicine Australia Clinic in Melbourne, and Paratus Clinical Research in Melbourne, where initial patient dosing began in late 2025. Building on this foundation, the addition of Ramsay Health Care and NeuroCentrix expands the program to five sites, which is expected to strengthen recruitment, accelerate enrollment, and advance an ongoing, multi-site Phase IIb natural psilocybin trial in a palliative oncology population. In support of this clinical activity, Psyence BioMed is supplying its fully GMP-compliant, pharmaceutical-grade psilocybin product, NPX-5, manufactured at PsyLabs’ GMP-controlled production facility.

“This expansion marks an important step forward in scaling the clinical infrastructure required to advance NPX-5 and support ongoing patient dosing,” said Jody Aufrichtig, CEO. “By adding high-quality clinical partners such as Ramsay Health Care and NeuroCentrix, we are strengthening our ability to execute efficiently, accelerate enrollment, and generate meaningful clinical data. As patients continue to be dosed with NPX-5, our focus remains on advancing the program through a disciplined, regulatory-aligned pathway.”

NRX ANNOUNCES FDA LABELING ALIGNMENT FOR KETAMINE PRODUCT: NRx Pharmaceuticals (NRXP) announced Monday that it had received a letter from the Labeling Program of the FDA Office of Generic Drugs whose only comments were limited to minor formatting changes to the proposed label for the company’s preservative-free ketamine product. The company expects to submit the final label this month. The determination is deemed preliminary until final supervisory review of NRx’s Abbreviated New Drug Application with anticipated approval in Summer 2026.

“We deeply appreciate the FDA’s timely review of the proposed labeling for our generic drug application and look forward to an ongoing collaborative relationship,” said Jonathan Javitt, CEO.

SILO RECEIVES EUROPEAN PATENT ALLOWANCE: Silo Pharma (SILO) announced Monday that the European Patent Office has issued a communication indicating its intent to grant a patent for the patent application titled “Prophylactic Efficacy of Serotonin 4 Receptor Agonists Against Stress” that the company has on exclusive license from Columbia University. The allowed claims cover methods of preventing stress-induced fear and depressive-like behavior and associated affective disorders using selected serotonin receptor agonists, a differentiated approach targeting pathways associated with stress resilience rather than just symptom management.

“This is a high-value milestone that strengthens our global intellectual property position and underscores the potential of our 5-HT4 program,” said Eric Weisblum, CEO. “We believe this approach represents a compelling shift toward proactive treatment of stress-related disorders, which remain a massive and underserved market.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), BetterLife (BETRF), Bright Minds (DRUG), Clearmind (CMND), Compass Pathways (CMPS), Definium Therapeutics (DFTX), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Helus Pharma (HELP), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmAla Biotech (MDXXF), PharmaTher (PHRRF), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), and Revive Therapeutics (RVVTF).