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. operates commercially as Helus Pharma and reports developments as a clinical-stage pharmaceutical company developing proprietary novel serotonergic agonists for depression, anxiety, and other mental health conditions. Company updates commonly address HLP003 in major depressive disorder, HLP004 in generalized anxiety disorder, investigational 5-HT receptor-focused compounds, clinical-research collaborations, regulatory-policy commentary, and scientific or medical leadership additions.
News about the company also covers public-company finance and corporate structure, including common-share offerings, pre-funded warrants, at-the-market equity programs, exchange-listing changes, conference presentations, quarterly financial results, and governance transitions tied to its development-stage pharmaceutical operations.
Cybin (NYSE:CYBN) has partnered with Thermo Fisher Scientific for Phase 3 clinical supply and potential commercial manufacturing of CYB003, its deuterated psilocin program for Major Depressive Disorder (MDD) treatment. The manufacturing operations will be based in the U.S., with drug substance production in Florence, South Carolina, and capsule production in Cincinnati, Ohio.
CYB003 received FDA Breakthrough Therapy Designation in March 2024, enabling expedited review and faster development. The program's Phase 2 results showed impressive efficacy with a 100% response rate and 71% remission rate among participants receiving two 16mg doses at 12 months. The company launched PARADIGM™, its multinational Phase 3 program, in November 2024 to evaluate CYB003 in a broader MDD patient population.
Cybin Inc. (NYSE American:CYBN), a clinical-stage neuropsychiatry company, announces its participation in the upcoming Alliance Global Partners Healthcare Company Showcase. CEO Doug Drysdale will engage in a fireside chat during this virtual event on May 21, 2025, at 1:40 p.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 The presentation will be accessible via live webcast, with an archived version available on Cybin's investor relations website under the Events & Presentations section.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:CYBN) has secured a new U.S. patent (12,291,499) for its CYB003 program, which is currently in Phase 3 development for Major Depressive Disorder (MDD). The patent, providing exclusivity until 2041, covers pharmaceutical compositions and oral dosage forms within the company's proprietary deuterated psilocin analog program.
The company's intellectual property portfolio now includes over 80 granted patents and 230+ pending applications. Cybin is actively conducting two Phase 3 studies: the ongoing APPROACH study for CYB003 as an adjunctive treatment for MDD, and the upcoming EMBRACE study, scheduled to begin in mid-2025.
Cybin Inc. (NYSE American:CYBN) announced that CEO Doug Drysdale will participate in the 28th Annual Milken Institute Global Conference, speaking on a panel titled "The Global Landscape and Opportunities for Medical Breakthroughs." The panel discussion will take place on May 5, 2025, at 2:30 p.m. PDT at the Beverly Hilton in Los Angeles.
The conference runs from May 4-7, 2025. Drysdale emphasized the company's role in advancing medical innovation and developing precise treatment regimens. The panel discussion will be available via live webcast and archived on Cybin's investor relations website.
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.