Psychedelic: Filament reports compassionate use approval for psilocybin

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on a compassionate use approval, an international patent filing and study results.

FILAMENT REPORTS COMPASSIONATE USE APPROVAL FOR PSILOCYBIN: Filament Health (FLHLF) announced Thursday an approval for compassionate use of psilocybin in the European Union. The company’s botanical psilocybin drug candidate, PEX010, has been authorized for administration to a patient suffering from treatment-resistant depression in Germany. The approval was granted under Germany’s compassionate use framework. The treatment will be conducted by Dr. Gerhard Gründer at the Central Institute of Mental Health, Department of Molecular Neuroimaging.

“The approval of PEX010 for this milestone moment in European psilocybin access reinforces Filament’s position as the world’s leading supplier of GMP-quality psychedelic drug candidates,” said Benjamin Lightburn, CEO. “We’re incredibly proud that our drug product will be the first psilocybin to be administered under compassionate use in the EU. It’s a validation of Filament’s ongoing efforts to make safe, standardized psychedelic medicines available to those who need them most.”

CLEARMIND FILES INTERNATIONAL PATENT APPLICATION: Clearmind Medicine (CMND) announced Wednesday the(SPRC).

“Our goal is to bring meaningful innovation to areas with high unmet medical need,” said Adi Zuloff-Shani, CEO. “This patent filing reflects our commitment to developing novel, science-backed treatments that can potentially improve the lives of millions struggling with obesity and fatty liver disease.”

RECOGNIFY REPORTS PHASE 2B TRIAL DID NOT MEET PRIMARY ENDPOINT: Recognify Life Sciences, a strategic investment of atai Life Sciences (ATAI), announced Friday that its randomized, double-blind, placebo-controlled Phase 2b clinical trial evaluating inidascamine in patients with cognitive impairment associated with schizophrenia did not meet its primary endpoint. While the study did not achieve statistical significance on its primary endpoint of improvement on the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery neurocognitive composite score at Week 6, inidascamine demonstrated a modest but consistent numerical improvement across the overall MCCB neurocognitive composite and multiple individual subdomains, including Symbol Coding, Speed of Processing and Verbal Learning. Directionally positive effects were also observed on the Virtual Reality Functional Capacity Assessment Tool, a measure of real-world functional cognitive capacity. Inidascamine was well-tolerated, with a favorable safety profile consistent with previous studies. Importantly, no evidence of sedation, weight gain, or extrapyramidal symptoms was observed, which are side effects commonly associated with treatments used in people living with schizophrenia.

Srinivas Rao, CEO of atai Life Sciences, said, “CIAS remains a challenging therapeutic area with a significant unmet need. While we believe these results support the continued development of inidascamine by Recognify for CIAS as well as its potential application in other indications, as previously communicated, we intend to allocate atai’s resources on our wholly owned pipeline of transformative psychedelic product candidates focused on affective disorders.”

Following the report, Canaccord lowered the firm’s price target on Atai to $11 from $12 and kept a Buy rating on the shares. The firm noted they announced that inidascamine, a non-psychedelic, did not meet its primary endpoint in a Phase 2b trial for cognitive impairment associated with schizophrenia, but showed some numerical improvements on cognitive and functional scores. Canaccord believes the weakness presents a solid opportunity to buy the shares on a more streamlined focus.

Meanwhile, Oppenheimer initiated coverage of Atai with an Outperform rating and $14 price target. The firm says Atai is leading the psychedelic revolution within neuropsychiatry. The market opportunity is underappreciated considering 10M patients could benefit from alternative approaches and Atai’s Phase 2b data for BPL-003 solidify a “transformational approach,” the analyst said.

Additionally, H.C. Wainwright raised the firm’s price target on Atai to $15 from $10 and kept a Buy rating on the shares. The firm remains bullish on Atai despite the Phase 2b trial evaluating inidascamine missing the primary endpoint. In a follow-up call, management reiterated the company focus on the company’s wholly-owned psychedelics pipeline, including BPL-003, which has continued to exceed expectations, the analyst said. H.C. Wainwright cited Atai’s focus on its “most promising near-term asset” for the target increase.

COMPASS PATHWAYS Q2 EARNINGS: On Thursday, Compass Pathways (CMPS) reported second quarter loss per share of (41c), which compared to a loss per share of (56c) for the same period last year. Cash and cash equivalents were $221.9M as of June 30, compared with $165.1M as of December 31, 2024. Full year 2025 net cash used in operating activities is expected to be in the range of $120M to $145M. The cash position at June 30 is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2027.

“With the recent positive 6-week primary endpoint from our first COMP360 Phase 3 study and the prior positive Phase 2b study, we have now delivered clinically meaningful and highly statistically significant top-line results after a single dose of COMP360 in two late-stage studies in treatment-resistant depression, a considerable achievement in psychiatry,” said Kabir Nath, CEO. “As we look forward to the 006 data, our second phase 3 study, we are excited to see the efficacy of two fixed doses with the 6-week primary endpoint measurement only three weeks after the second dose. Given our recent positive phase 3 data, we are highly focused on solidifying our commercialization efforts and exploring pathways to get this potential paradigm changing treatment option to patients as quickly as possible.”

PSYENCE BIOMED REPORTS HIGH-PURITY IBOGAINE PRODUCTION: Psyence Biomedical (PBM) announced that its strategic partner, PsyLabs has produced a GMP-aligned Ibogaine Total Alkaloid extract. The high-purity extract met all microbial safety standards for food-grade consumption, as verified by an accredited third-party laboratory. In 2024, Psyence BioMed acquired an equity stake in PsyLabs and continued that investment in 2025.

“This is a groundbreaking moment for our entire team on the ground who have put countless hours and effort into ensuring our naturally derived, sustainable input materials are extracted with the same caution, mindfulness, and care, all covering the GMP manufacturing processes,” said Cody Robyn Futeran, Head of Extraction Innovations and Business Development at PsyLabs. “I’m extremely proud of our team for receiving such outstanding results showing PsyLabs’ readiness to fulfil orders of safe-for-consumption medications across the world.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Bright Minds (DRUG), Cybin (CYBN), Enveric Biosciences (ENVB), GH Research (GHRS), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), MindMed (MNMD), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), Seelos Therapeutics (SEEL) and Silo Pharma (SILO).