ENVB News & Events

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on study results, an analyst initiation and a supply agreement.ATAIBECKLEY REPORTS PHASE 2A EMP-01 RESULTS:AtaiBeckleyannounced Thursday topline results from its exploratory, double-blind, placebo-controlled, first-in-patientin adults with Social Anxiety Disorder. The study met its primary safety objective and generated encouraging secondary and exploratory efficacy signals in a highly severe, difficult-to-treat population. The multi-center study enrolled 71 adults with moderate-to-severe SAD across 7 clinical sites in the UK. Participants were randomized to receive two in-clinic administrations of EMP-01 or placebo, given 28 days apart, with no adjunctive psychotherapy. 70 participants received at least one dose of study drug, and 69 completed the Day 43 efficacy assessments, indicating high patient acceptability and retention. All clinician-rated assessments were conducted by blinded central raters.Both treatment arms reflected a severely affected patient population, with all other baseline characteristics well-balanced across groups- including demographics, comorbidities, prior SSRI/SNRI exposure, and CGI-Severity. The primary endpoint was safety and tolerability through Day 43 and the secondary endpoint was change in social anxiety symptoms from baseline to Day 43, using the Liebowitz Social Anxiety Scale. The LSAS is a 24-item clinician-rated scale that evaluates both fear responses and real-world avoidance behaviors across social and performance situations. An additional exploratory endpoint included changes on the Clinician-Rated Global Impression-Improvement scale, a 7-point scale used to measure changes in a patient's overall condition compared to baseline. With respect to the trial's primary objective, EMP-01 demonstrated a favorable and manageable safety and tolerability profile. No serious adverse events and no treatment-emergent suicidal behaviour or intent were observed. Most adverse events were mild or moderate and resolved without intervention.Secondary and exploratory efficacy endpoints showed encouraging signals. EMP-01 produced a numerically greater symptom reduction than placebo, as measured by LSAS, at Day 43 relative to baseline. Although the study was not powered for statistical significance, the placebo-adjusted least squares mean reduction for EMP-01 of 11.85 points on the LSAS at Day 43 is consistent with a clinically meaningful improvement and a moderate treatment effect size. The relatively early reduction in symptoms, as measured by LSAS, at the 6-week study endpoint, after two doses of EMP-01, was comparable in magnitude in a cross-trial comparison to that typically reported after 8 - 12 weeks of daily SSRI/SNRI therapy in registration trials. On the CGI-I scale, which reflects a global impression of overall patient improvement, 49% of patients receiving EMP-01 were rated as "very much improved" or "much improved" compared to 15% in the placebo group. This 34-percentage-point difference corresponds to a Number Needed to Treat of 2.95, indicating a clinically meaningful level of global improvement in the EMP-01 group.The LSAS comprises two subscales - Fear and Avoidance - which often show different timelines of improvement in SAD pharmacotherapy trials, with Fear typically improving first. In this study, EMP-01 produced simultaneous gains across both domains. By Day 43, LSAS Fear improved by -13.7 points vs. -8.1 on placebo, and LSAS Avoidance improved by -15.1 points vs. -8.5 on placebo. Because avoidance behaviors typically change gradually and often require prolonged real-world exposure, the early, parallel improvements in both Fear and Avoidance - after two dosing sessions and without psychotherapy - suggest that EMP-01 could influence both the emotional and behavioral dimensions of social anxiety disorder.Professor Murray Stein, Distinguished Professor of Psychiatry and Public Health at the University of California San Diego, and consultant to AtaiBeckley, said, "The initial findings from this trial of R-MDMA are remarkable. Social Anxiety Disorder is a serious, often chronic and disabling condition affecting millions of Americans, and there have been no therapeutic advances in its pharmacological treatment in over 20 years. While preliminary, this study suggests that EMP-01 has the potential to make a tremendous impact on the lives of patients and their families. I hope future trials will be conducted to confirm these very exciting findings."DEFINIUM INITIATED WITH AN OUTPERFORM:Wolfe Research initiated coverage of Definium TherapeuticswithThe firm launched coverage of the neuroscience biotech sector with a "portfolio of high conviction names across multiple therapeutic areas." Wolfe names Definium its top pick for psychedelics, which is one of its favorite central nervous system areas. It sees the stock moving up in 2026.PHARMALA TO SUPPLY LANEO MDMA TO AMSTERDAM UMC:PharmAla Biotech Holdingsannounced Monday that it haswith Amsterdam University Medical Center in the Netherlands for the provision of LaNeo 40mg MDMA capsules for use in a proposed clinical trial. Under the terms of the agreement, PharmAla will supply its LaNeo 40mg capsule dosage, repackaged in a new single-capsule packaging format. The agreement also includes a three-year stability testing program for the single-capsule dosage form, which will generate new stability data that PharmAla expects to leverage in the development of commercial-grade blister packaging for its LaNeo MDMA product line."We are delighted to be working with Amsterdam UMC, one of Europe's leading academic medical centres," said CEO Nicholas Kadysh. "This agreement is significant not only because it expands our European clinical footprint, but because the stability testing program included in the contract will generate single-capsule stability data that we intend to use as the foundation for developing blister packaging for LaNeo MDMA. This is an important step towards a truly commercial-grade product."Additionally on Thursday, PharmAla announced that it has executed an agreement with Spaulding Rehabilitation, a member of the Mass General Brigham healthcare system, for the provision of MDMA for use in a clinical trial investigating MDMA-assisted therapy for the treatment of fibromyalgia. Under the agreement, PharmAla will provide its LaNeo MDMA at no charge to Spaulding Rehabilitation for use in a study entitled "Hyperscan Neuroimaging to Reveal the Brain Mechanisms Supporting Analgesia Following MDMA-Assisted Therapy in Fibromyalgia," in exchange for a license to the study results. The study will be conducted under the direction of Principal Investigator Vitaly Napadow, PhD. As part of this collaboration, Spaulding will deliver comprehensive study results to PharmAla within 90 days of the study's completion. PharmAla will have the ability to leverage these findings for a broad range of public applications, including potential regulatory submissions, while Spaulding retains the right of first publication in a peer-reviewed journal. Intellectual property arising from the study will be held by the respective parties best positioned to advance its potential, with PharmAla retaining rights to innovations directly related to the study drug, and Spaulding retaining rights to discoveries made independently by its research team."This agreement marks an important expansion of the clinical research into LaNeo MDMA beyond PTSD and into new therapeutic indications," said Kadysh. "Fibromyalgia affects millions of patients worldwide, and current treatment options are limited. We are excited to support this groundbreaking research into the potential analgesic mechanisms of MDMA-assisted therapy, and we look forward to the important data that will emerge from this study."ENVERIC REPORTS WITHDRAWAL OF PATENT PETITION:Enveric Biosciencesannounced Wednesday that the previously announcedagainst Enveric's issued U.S. Patent No. 12,138,276 has been withdrawn. This action follows Enveric's filing of a Request for Discretionary Denial of the petition. As a result of this action, there are no remaining challenges currently pending against Enveric's patent. Enveric's '276 patent, entitled, "Halogenated psilocybin derivatives and methods of using," includes claims that appear relevant to the bretisilocin molecule currently in clinical trials. On November 20, counsel for AbbViefiled a request to the USPTO asking to withdraw the petition Gilgamesh had filed. The PTAB granted the request, and the petition is now withdrawn."Enveric is gratified by this turn of events, which we believe demonstrates our willingness to fully defend the intellectual property that protects our valuable discoveries," said Joseph Tucker, CEO. "The fact that the PGR petition was filed in the first place underscored the breadth of our intellectual property footprint in the field, embodied by the numerous discoveries pertaining to next-generation, small-molecule psychedelics and potential non-hallucinatory neuroplastogenic therapeutics targeting psychiatric and neurological disorders. We believe that our patent portfolio will continue to generate value for our shareholders and support our efforts towards developing novel therapeutics to benefit patients with mental health conditions."HELUS PHARMA APPOINTS LEWIS-HALL TO BOARD:On Tuesday, Helus Pharmaannounced theLewis-Hall will also serve as chair of the company's scientific advisory committee. Lewis-Hall began her medical career as a practicing psychiatrist and later held senior leadership roles across the biopharmaceutical industry, including serving for more than a decade on Pfizer'sexecutive leadership team as Chief Medical Officer"Dr. Lewis-Hall is a highly respected physician and leader whose career has been defined by bringing complex, innovative therapies from development to patients around the world, particularly in areas of serious and underserved mental health need," said Michael Cola, CEO. "Her deep experience in clinical strategy, regulatory engagement, and global commercialization will be invaluable as we advance our novel serotonergic agonist programs for psychiatric disorders and continue building a company grounded in scientific rigor, patient impact, and responsible scale. We are honored to welcome her to our Board and as Chair overseeing the Scientific Advisory Committee."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Algernon Health, BetterLife, Bright Minds, Clearmind, Compass Pathways, Filament Health, GH Research, Incannex, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmaTher, Psyence BioMed, Psyence Group, Relmada Therapeutics, Revive Therapeuticsand Silo Pharma.

Enveric Biosciences announced that the previously announced post-grant review petition filed by Gilgamesh Pharmaceuticals against Enveric's issued U.S. Patent No. 12,138,276 has been withdrawn. This action follows Enveric's filing of a request for discretionary denial of the petition. As a result of this action, there are no remaining challenges currently pending against Enveric's patent. Enveric's '276 patent, entitled, "Halogenated psilocybin derivatives and methods of using," includes claims that appear relevant to the bretisilocin molecule currently in clinical trials.

Enveric Biosciences announced new mechanistic data demonstrating that its lead candidate, EB-003, activates both Gq- and ss-arrestin-mediated signaling downstream of the 5-HT2A receptor. Multiple independent, peer-reviewed studies have previously shown that selective activation of 5-HT2A receptor, by either Gq-biased or ss-arrestin-biased agonists, can independently produce antidepressant- and anxiolytic-like effects in preclinical models, suggesting that therapeutic benefit can arise from activation of either pathway. The new data was generated using proprietary bioluminescence resonance energy transfer assays. Enveric developed and validated in-house BRET assays to characterize EB-003's intracellular signaling profile because commercial assays capable of reliably measuring pathway-specific 5-HT2A signaling were not available. The data demonstrate biologically relevant engagement of both Gq and ss-arrestin pathways. Enveric's new data also indicate that EB-003 exhibits a modest preference toward ss-arrestin over Gq signaling relative to serotonin, the native ligand of the receptor. Ongoing research is exploring the mechanistic significance of this apparent bias. Importantly, both pathways appear to be engaged at levels consistent with biological relevance. A recently published study in Nature employing BRET assays and complementary techniques provides additional mechanistic clarity regarding signaling downstream of 5-HT2A. The study reports that Gi signaling downstream of 5-HT2A was required for hallucinogenic effects in the experimental models evaluated, while Gq signaling mediated antidepressant- and anxiolytic-like benefits in preclinical systems. These findings indicate that therapeutic benefit and hallucinations may arise from distinct intracellular pathways. The company continues to advance EB-003 through IND-enabling studies.

Enveric Biosciences files to sell 328,802 shares of common stock for holders