PBM

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on study results, FDA alignment and a DSMB recommendation. Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential HELUS PHARMA REPORTS PHASE 2 HLP004 RESULTS: Helus Pharma (HELP) announced Thursday topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening. All study participants were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment. Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points in the HAM-A from baseline at six weeks. The study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy. At six months, the pooled study population showed 67% responders and 39% remitters. Participants randomized to both 20 mg and 2mg dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59% meeting the criteria for response and 32% for remission in the 20mg arm and a 30% responder and remitter rate in the 2mg arm at week 6. The study also found a short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours, fitting within the treatment paradigm of existing interventional psychiatry clinics. Additionally, results show a favorable tolerability p...

NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced the voting results from its Annual and Special Meeting of Shareholders (the “Meeting”), held at 9:00 a.m. Eastern Time on February 12, 2026. Shareholders voted in favour of all matters of business presented at the Meeting, including the election of directors, the appointment of auditors and the approval of share consolidation authority for the board of directors (the “Board”). All director nominees listed in the Company’s management information circular dated January 2, 2026 were duly elected as directors of the Company to hold office until the next annual meeting of shareholders or until their successors are elected or appointed. Shareholders approved the appointment of MNP LLP as the Company’s auditors for the ensuing year and authorized the Board to fix the auditors’ remuneration. Shareholders further approved a special resolution authorizing the Board, in its sole discretion, to implement one or more consolidations of the Company’s issued and outstanding common shares, at a ratio of up to 250:1, with such consolidation(s) to be implemented, if at all, at a time and ratio to be determined by the Board. The Company will provide additional disclosure if and when the Board determines to implement any share consolidation, including the final consolidation ratio and effective date, subject to applicable regulatory and exchange approvals. Further details regarding the matters voted on at the Meeting are set out in the Company’s management information circular, which is available under the Company’s profile on EDGAR. About Psyence BioMed Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin and ibogaine-based psychedelic medicine to be listed on Nasdaq. We are dedicated to addressing unmet mental health needs. We are committed to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders. Lea...