Cybin Inc Stock Price, News & Analysis

Cybin (NYSE American:CYBN) has provided updates on its neuropsychiatry platform and clinical milestones. The company has completed enrollment of 36 participants in its Phase 2 study of CYB004 (deuterated DMT) for Generalized Anxiety Disorder, with topline data expected in Q1 2026.

The company is advancing CYB003, its deuterated psilocin analog, in Phase 3 studies for major depressive disorder (MDD). The APPROACH study aims to enroll 220 patients across 45 U.S. clinical sites, while the EMBRACE study targeting 330 participants is set to begin in Q4 2025.

Cybin boasts a robust intellectual property portfolio with 100+ granted patents and 250+ pending applications. The company has partnered with Thermo Fisher Scientific for U.S.-based commercial-scale manufacturing and Osmind for commercial preparation across 800+ psychiatry clinics.

Cybin (NYSE American:CYBN), a clinical-stage neuropsychiatry company, announced its participation in TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit. The company's Chief Medical Officer Amir Inamdar and Chief Business Officer George Tziras will engage in a fireside chat on September 17, 2025, at 9:20 a.m. ET.

The presentation will be accessible through a webcast, with a replay available on Cybin's investor relations website under the Events & Presentations section.

Cybin (NYSE American:CYBN) has completed enrollment for its Phase 2 clinical trial evaluating CYB004, a proprietary deuterated DMT program, for treating Generalized Anxiety Disorder (GAD). The study has enrolled 36 participants to evaluate safety and efficacy over a 12-week period.

The company expects to release top-line data in Q1 2026. CYB004 aims to address a significant unmet need, as GAD affects 6.8 million people in the US alone, with approximately 50% not responding to current approved treatments. The drug offers convenient intramuscular dosing and is supported by robust patent protection.

Cybin (NYSE American:CYBN), a clinical-stage neuropsychiatry company, has announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference. George Tziras, the Company's Chief Business Officer, will engage in a fireside chat on September 8, 2025, at 11:00 a.m. ET.

The presentation will be accessible via webcast, with a replay available on Cybin's investor relations website under the Events & Presentations section.

Cybin (NYSE American:CYBN), a clinical-stage neuropsychiatry company, announced its participation in the upcoming Cantor Global Healthcare Conference. The company's Chief Medical Officer, Dr. Amir Inamdar, will engage in a fireside chat scheduled for September 5, 2025, at 10:20 a.m. ET.

The presentation will be accessible via live webcast, with an archived version available on Cybin's investor relations website under the Events & Presentations section.

Cybin (NYSE American:CYBN) announced significant leadership changes as CEO Doug Drysdale steps down effective September 2, 2025. The company's Co-Founder and President, Eric So, has been appointed as Interim Chief Executive Officer by the Board of Directors.

So, who brings over 20 years of experience as an owner, operator, and investor, will focus on advancing Cybin's clinical pipeline, particularly the development of CYB003 and CYB004. The Board has established a committee to conduct a search for a permanent CEO who will lead the company through its commercialization phase.

The transition comes as Cybin continues its mission to transform mental healthcare through innovative neuropsychiatry treatments, supported by its clinical progress, regulatory recognition, and strategic partnerships.

Cybin (NYSE:CYBN) has received Australian approval for EMBRACE, its second pivotal Phase 3 study evaluating CYB003 for Major Depressive Disorder (MDD) treatment. The study will enroll 330 participants across approximately 60 clinical sites in the US, Europe, and Australia.

The EMBRACE study is part of the larger PARADIGM program and follows recent approvals in Ireland, Poland, Greece, and the UK. The trial will feature three arms: high dose (16mg), mid-dose (8mg), and placebo, with participants receiving two doses three weeks apart. Previous Phase 2 results showed impressive outcomes, with 71% of participants achieving remission and 100% responding to treatment at 12 months after two 16mg doses.

CYB003, which has received FDA Breakthrough Therapy Designation, will be studied in patients with moderate to severe MDD who show inadequate response to current antidepressants.

Cybin (NYSE American: CYBN), a clinical-stage neuropsychiatry company, held its annual meeting of shareholders on August 18, 2025. The meeting saw participation from 90 shareholders representing 48.92% of total outstanding shares. Key outcomes include:

Shareholders approved Zeifmans LLP as the company's auditor with 99.485% support, set the board size at six directors with 92.95% approval, and elected six directors to the board. Notable director election results included Theresa Firestone (86.161%), Grant Froese (86.179%), and Eric Hoskins (61.326%). George Tziras did not seek re-election to the board.

Cybin (NYSE American:CYBN) reported significant progress in its Q1 FY2026 and key milestones for its neuropsychiatry programs. The company received European and UK MHRA approval for EMBRACE, its second Phase 3 study of CYB003 for Major Depressive Disorder (MDD), which will enroll 330 participants across 60 clinical sites globally.

The company secured US$50 million in convertible debentures and reported cash reserves of US$118.7 million as of June 30, 2025. The PARADIGM program, including APPROACH and EMBRACE studies, will evaluate CYB003 in approximately 550 participants. Additionally, Cybin expects to complete patient enrollment for its CYB004 Phase 2 study in General Anxiety Disorder in August 2025.