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.
The CYBN news page on Stock Titan provides an archive of news releases and updates related to Cybin Inc., a Phase 3 clinical-stage neuropsychiatry and pharmaceutical company focused on developing next-generation treatment options for mental health conditions. These news items come directly from the company’s public communications and are also referenced in its Form 6-K filings with the U.S. Securities and Exchange Commission.
Readers can find coverage of Cybin’s clinical development programs, including updates on its lead candidates CYB003, a proprietary deuterated psilocin analog in Phase 3 studies for adjunctive treatment of major depressive disorder, and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. News releases describe milestones such as trial enrollment progress, regulatory approvals to initiate studies in various countries, and participation in healthcare and investor conferences.
The news feed also includes information on Cybin’s capital markets activity, such as registered direct offerings of common shares and pre-funded warrants, the establishment and use of an at-the-market equity program, and the company’s stated intentions for the use of proceeds, including repayment of convertible debentures and funding of its clinical programs. Corporate updates, including plans to transfer its U.S. stock exchange listing from the NYSE American to the Nasdaq Global Market and the associated change in ticker symbol from CYBN to HELP, are documented in detail.
Because Cybin files many of these news releases as exhibits to Form 6-K, the CYBN news page serves as a convenient way to follow the narrative of its clinical progress, financing decisions, and listing changes over time. Investors and researchers can use this archive to review how the company describes its strategy in neuropsychiatry, its geographic operations in Canada, the United States, the United Kingdom, and Ireland, and its stated commitment to rigorous scientific research and regulatory compliance for its investigational compounds.
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.
Cybin Inc. (NYSE American:CYBN) has initiated PARADIGM, a Phase 3 pivotal program evaluating CYB003 for Major Depressive Disorder (MDD) treatment. The program includes two 12-week randomized studies: APPROACH (220 patients across U.S. and Europe) and EMBRACE (starting 1H25), plus a long-term extension study EXTEND. The company reports C$154.3 million cash as of September 30, 2024. CYB003 targets a market of >300 million people worldwide and 21 million in the U.S. Topline results are expected in 2026, with 12-month Phase 2 efficacy data expected in Q4 2024.
Cybin Inc. (NYSE American:CYBN) announced its participation in the 2024 Milken Institute Future of Health Summit. CEO Doug Drysdale will speak on a panel titled 'The Next Frontier in Mental Health Research' on November 13, 2024, in Washington DC.
The discussion will focus on novel approaches to mental health treatments. Drysdale will share updates on Cybin's clinical advancements, including CYB003, their deuterated psilocin program for major depressive disorder entering Phase 3, and CYB004, their deuterated DMT program in Phase 2 for generalized anxiety disorder.
The panel will address mental illness, which affects one in eight people globally, exploring new therapeutic approaches and personalized treatment solutions.
Cybin has been granted U.S. patent 12,122,741 by the USPTO for composition of matter claims related to its CYB005 phenethylamines program. The company is investigating these novel molecules at non-hallucinogenic doses for various Central Nervous System disorders. The development includes exploring non-hallucinogenic neuroplastogens and targeted serotonin 5-HT1A and 5-HT2C receptor agonists. This addition brings Cybin's intellectual property portfolio to over 70 granted patents and more than 220 pending patent applications.
Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN), a clinical-stage neuropsychiatry company, has announced its participation in the Water Tower Research Fireside Chat Series on October 8, 2024, at 3:00 p.m. ET. The event will feature Doug Drysdale, Cybin's CEO, in a discussion hosted by Robert Sassoon, Senior Research Analyst at Water Tower Research.
The fireside chat will cover key topics including:
- Cybin's lead development programs CYB003 and CYB004 and upcoming clinical milestones
- Differentiators in Cybin's development approach compared to other neuropsychiatric developments
- Lessons learned and applied from the FDA's Lykos NDA rejection
Interested parties can register for the webcast through a provided link. An archived version of the webcast will be available on Cybin's investor relations website after the event.
Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) has expanded its clinical team to support the upcoming Phase 3 pivotal program for CYB003 in Major Depressive Disorder (MDD). Key appointments include:
- Dr. Mirza Rahman as Senior VP, Patient Safety & Pharmacovigilance
- Dr. Marcelo Gutierrez as VP, Clinical Pharmacology
- Dr. Atul R. Mahableshwarkar as program lead for CYB003
- Dr. Tom Macek as program lead for CYB004
The strengthened team will support CYB003 pivotal trials, consisting of three studies spanning up to 12 countries. These additions bring expertise in patient safety, pharmacovigilance, clinical pharmacology, and drug development, important for advancing Cybin's proprietary deuterated psilocin program for adjunctive treatment of MDD.