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. (symbol: CYBN) is a pioneering biopharmaceutical company dedicated to addressing mental health challenges through innovative therapeutics. Specializing in psychedelic-based therapies, Cybin focuses on developing novel compounds, delivery mechanisms, and protocols aimed at treating a range of psychiatric and neurological conditions.
Cybin's core business revolves around advancing clinical-stage programs designed to harness the potential of psychedelics. The company is engaged in creating safe and effective treatments for conditions such as depression, anxiety, and post-traumatic stress disorder (PTSD). Their research and development efforts highlight the transformative potential of these therapies in modern medicine.
Recently, Cybin has achieved significant milestones, including progress in their proprietary drug delivery technologies. These advancements aim to improve the administration and efficacy of psychedelic compounds, ensuring patients receive the maximum therapeutic benefit. Their innovative approach extends to developing new chemical entities (NCEs) that hold promise in the field of mental health treatment.
Financially, Cybin remains robust and committed to its growth strategy. The company has secured strategic partnerships and collaborations that bolster its research initiatives and clinical trials. These alliances are crucial in accelerating the development and commercialization of their therapeutic solutions.
Cybin's product pipeline is impressive, featuring multiple candidates in various stages of development. These include CYB001, a formulation targeting major depressive disorder, and CYB003, designed for anxiety disorders. Each product undergoes rigorous testing to ensure safety and effectiveness.
In summary, Cybin Inc. is at the forefront of revolutionizing mental health treatment through psychedelic-based therapies. Their dedication to advancing science and addressing unmet medical needs positions them as a significant player in the biopharmaceutical industry.
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.
Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN), a clinical-stage breakthrough neuropsychiatry company, has announced its participation in the TD Cowen 4th Annual Novel Mechanisms in Neuropsychiatry Summit. The virtual event will take place on September 26, 2024.
Amir Inamdar, Cybin's Chief Medical Officer, will be part of a panel discussion titled 'Advancement in Psychedelic Therapies for Neuropsychiatry'. The panel will be webcast live on Thursday, September 26, 2024, at 10:00 a.m. ET.
Interested parties can access the webcast through a provided link. An archived version of the webcast will also be available on Cybin's investor relations website under the Events & Presentations page.
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