Cybin Inc Stock Price, News & Analysis

Cybin (NYSE:CYBN) has secured U.S. patent 12,318,477 for its CYB004 deuterated DMT program, strengthening protection for its novel formulations targeting Generalized Anxiety Disorder (GAD). The patent, extending until 2040, covers DMT and deuterated isotopologues for intramuscular injection. CYB004 is currently in Phase 2 clinical trials, with study completion expected by mid-2025. The company's robust intellectual property portfolio now includes over 90 granted patents and 230+ pending applications. CEO Doug Drysdale emphasized the significance of patent protection for their lead products and highlighted CYB004's potential to provide short-duration, rapid-acting anxiety treatment with patient-friendly intramuscular administration options.

Cybin Inc. (NYSE American:CYBN), a clinical-stage neuropsychiatry company, announces that CEO Doug Drysdale will participate in a Water Tower Research Fireside Chat on May 29, 2025, at 11:00 a.m. ET. The discussion, hosted by Senior Research Analyst Robert Sassoon, will cover several key topics including: the evolution of interventional psychiatry clinics and Cybin's Osmind partnership, updates on the CYB003 Phase 3 program, strategic clinical partnerships, the Thermo Fisher collaboration, upcoming milestones, and insights on FDA developments in psychedelics.

The FDA Commissioner Dr. Martin Makary has identified psychedelic drug development as a top agency priority, emphasizing the need to accelerate research for mental health treatments. This stance particularly benefits Cybin Inc. (CYBN), whose deuterated psilocin program CYB003 has received FDA Breakthrough Therapy Designation for major depressive disorder (MDD) treatment. The company's Phase 2 results showed remarkable efficacy, with 100% response rate and 71% remission rate in participants receiving two 16mg doses. Cybin is currently conducting its Phase 3 PARADIGM program, which includes two 12-week studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND). Additionally, their CYB004 deuterated DMT program is progressing in Phase 2 trials for generalized anxiety disorder, expected to complete by mid-2025.

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.