Welcome to our dedicated page for Cybin news (Ticker: CYBN), a resource for investors and traders seeking the latest updates and insights on Cybin stock.
Cybin Inc. (CYBN) is a clinical-stage biopharmaceutical leader advancing novel psychedelic-based therapies for mental health conditions. This dedicated news hub provides investors and researchers with essential updates on the company's progress in developing innovative treatment solutions.
Access timely reports on clinical trial milestones, regulatory developments, and strategic partnerships that shape Cybin's research pipeline. Our curated collection includes official press releases detailing advancements in deuterated compound research, intellectual property achievements, and collaborative neuroscience initiatives.
Key updates cover FDA designations, preclinical study results, and patent filings that demonstrate Cybin's scientific rigor in psychedelic therapeutics development. The resource serves as a centralized tracking point for material events influencing the company's position in mental health innovation.
Bookmark this page for structured access to verified information about Cybin's therapeutic candidates and operational developments. Check regularly for objective updates on progress within the regulated biopharmaceutical research landscape.
Cybin (NYSE American:CYBN) has expanded its strategic clinical site partnerships to 18 locations for its multinational Phase 3 program evaluating CYB003 for Major Depressive Disorder (MDD) treatment. The APPROACH study, their first pivotal Phase 3 trial, is expected to include approximately 45 clinical sites.
Recent Phase 2 data demonstrated remarkable efficacy, with 71% of MDD patients achieving remission from depression symptoms for 12 months after receiving two 16mg doses of CYB003 administered three weeks apart. The company's second Phase 3 study, EMBRACE, is scheduled to begin mid-2025.
The Strategic Partnership Agreements (SPAs) aim to enhance operational efficiency and improve site performance and patient recruitment. Notable participants include Dr. Kimball A. Johnson from CenExel iResearch Atlanta, the principal investigator from the successful Phase 1/2a CYB003 trial, and Paul Thielking from Cedar Clinical Research.
Cybin Inc. (NYSE American:CYBN) has announced a strategic partnership with Osmind to advance its commercial preparation for clinical-stage psychiatry programs. Osmind's network of over 800 U.S. psychiatry clinics will support the operational infrastructure for Cybin's interventional treatments.
The partnership will focus on key areas including pharmacy, fulfillment, patient access, and reimbursement for Cybin's lead programs: CYB003 in Phase 3 for major depressive disorder and CYB004 in Phase 2 for generalized anxiety disorder.
The collaboration addresses significant market opportunities, with the global major depressive disorder market projected to grow from $5.15 billion in 2024 to $11.09 billion by 2033. Currently, about two-thirds of MDD patients don't find relief with initial antidepressant treatment, while approximately 50% of GAD patients are unresponsive to first-line SSRI and SNRI treatments.
Cybin Inc. (NYSE American:CYBN) reported its Q3 FY2025 financial results and business updates. The company has launched PARADIGM, a multinational Phase 3 program evaluating CYB003 for major depressive disorder (MDD) treatment, comprising two 12-week studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND), targeting approximately 550 patients.
Key financial highlights include cash position of C$136.3 million as of December 31, 2024, with access to over C$203.6 million including warrant exercises. The company reported a net loss of C$10.5 million for Q3, compared to C$30.3 million in the previous year. Operating expenses were C$28.0 million.
The company also announced a new at-the-market equity program of up to US$100 million for working capital and growth initiatives. Phase 2 clinical data for CYB003 showed promising results, with 100% response rate and 71% remission rate in participants receiving two 16mg doses.
Cybin Inc. (NYSE American:CYBN) has launched its first strategic partnership agreement (SPA) with Segal Trials to advance its multinational pivotal Phase 3 program evaluating CYB003 for Major Depressive Disorder (MDD) treatment. The program aims to enroll approximately 550 patients across 40+ clinical sites in the US and Europe.
Segal Trials, operating six research sites in South Florida, brings extensive experience in psychiatry, neurology, addiction, and psychedelics research. The partnership strategy aims to enhance trial operations efficiency and site performance through collaboration.
Recent Phase 2 data showed remarkable results, with 71% of patients achieving remission from depression symptoms for 12 months after receiving two 16mg doses of CYB003 administered three weeks apart.
Cybin Inc. (NYSE American:CYBN) has reported significant achievements in 2024 and outlined key milestones for 2025. The company announced positive Phase 2 results for CYB003 in treating Major Depressive Disorder (MDD), showing 100% response rate and 71% remission rate with two 16mg doses at 12 months. The FDA granted Breakthrough Therapy Designation for CYB003, expediting its development process.
Cybin initiated PARADIGM, a multinational Phase 3 program for CYB003, comprising two studies: APPROACH (220 participants) and EMBRACE (330 participants), plus a long-term extension study EXTEND. The company also launched a Phase 2 proof-of-concept study for CYB004 in Generalized Anxiety Disorder (GAD), with results expected in Q1 2025.
The company expanded its patent portfolio with new U.S. patents for CYB003 and CYB005 programs, bringing the total to over 70 granted patents with 220+ pending.
Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN), a clinical-stage breakthrough neuropsychiatry company focused on developing innovative mental healthcare treatments, has announced its participation in the Lytham Partners 2025 Investor Healthcare Summit.
The company's CEO, Doug Drysdale, will engage in a fireside chat during the virtual event on January 13, 2025, at 11:30 a.m. ET. The session will be available through a live webcast, and an archived version will be accessible on the company's investor relations website under the Events & Presentations section.
Cybin announced two poster presentations at the 2024 American College of Neuropsychopharmacology Annual Meeting, showcasing significant clinical data from their mental health treatment programs. The first presentation highlights 12-month efficacy results from their Phase 2 study of CYB003 (deuterated psilocin) in Major Depressive Disorder, demonstrating 100% response rate and 71% remission rate with two 16mg doses.
The second presentation focuses on a Phase 1b study examining drug interactions between DMT and SSRIs in MDD patients, suggesting patients may not need to stop antidepressant treatment before psychedelic therapy. The company also noted progress in their CYB004 deuterated DMT program, currently in Phase 2 trials for Generalized Anxiety Disorder.
Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) has announced its participation in the Water Tower Research Fireside Chat Series scheduled for December 11, 2024, at 11:00 a.m. ET. CEO Doug Drysdale and Chief Medical Officer Amir Inamdar will join the discussion hosted by Robert Sassoon, Senior Research Analyst at Water Tower Research.
The chat will focus on two main topics: the 12-month efficacy data from CYB003's Phase II study for major depressive disorder treatment, and details about the company's Phase III PARADIGM™ program, including its design, enrollment process, and milestone targets. The event will be accessible via webcast, with archived recordings available on Cybin's investor relations website.
Cybin Inc. (NYSE American:CYBN) reported groundbreaking 12-month efficacy data from its Phase 2 study of CYB003 for major depressive disorder (MDD). After two 16mg doses administered three weeks apart, 100% of participants were responsive to treatment, with 71% in remission at 12 months. The study showed a ~23-point reduction in MADRS depression scores from baseline. The 16mg dosing group demonstrated superior results compared to the 12mg group, which showed 60% response and 50% remission rates. CYB003, which received FDA Breakthrough Therapy Designation, maintained an excellent safety profile with no new adverse events reported during the 12-month follow-up.
Cybin Inc. (NYSE American:CYBN) has announced a conference call and webcast scheduled for November 18, 2024, at 8:00 a.m. ET. The presentation will feature 12-month efficacy and safety data from the company's Phase 2 study of CYB003 in Major Depressive Disorder, along with details about the recently initiated Phase 3 PARADIGM program. The event will be led by CEO Doug Drysdale and CMO Amir Inamdar, followed by a Q&A session for investors.
