Cybin Applauds FDA Commissioner Dr. Martin Makary’s Call to Accelerate and Prioritize Research on Psychedelic Therapeutics
– U.S. Food and Drug Administration (“FDA”) Commissioner identifies psychedelic drug development as a top agency priority in an effort to address unmet needs in mental health – – Calls for FDA to be open to innovative treatments that show promise, even when they challenge traditional understanding
Cybin Engages Thermo Fisher Scientific to Provide U.S.-Based Manufacturing for its CYB003 Program for the Adjunctive Treatment of Major Depressive Disorder
– Thermo Fisher Scientific, the world leader in serving science, is providing Phase 3 capsule clinical supply and will support future commercial manufacturing efforts for CYB003 – – Production of both drug substance and drug product will be performed at Thermo Fisher’s U.S.
Cybin to Participate in the Alliance Global Partners Healthcare Company Showcase
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“ Cybin ” or the “ Company ”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, is pleased to announce
Cybin Announces Additional U.S. Patent Supporting its CYB003 Breakthrough Therapy Program in Phase 3 Development for Major Depressive Disorder
– Newly issued patent includes pharmaceutical compositions and oral dosage forms within the CYB003 program with expected exclusivity until 2041 – – Cybin’s growing intellectual property portfolio comprises more than 80 granted patents and over 230 pending applications – – Patient dosing continues
Cybin to Participate at the 28th Annual Milken Institute Global Conference
– Doug Drysdale, CEO, to appear on panel entitled “The Global Landscape and Opportunities for Medical Breakthroughs,” on May 5, 2025 – TORONTO–(BUSINESS WIRE)– Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“ Cybin ” or the “ Company ”), a clinical-stage breakthrough neuropsychiatry company
Cybin Announces Additional Strategic Clinical Site Partnerships to Support PARADIGM, a Multinational Phase 3 Program Evaluating CYB003
– Strategic Partnership Agreements promote collaboration and aligned incentives across sites, enhancing operational efficiency and improving site performance and patient recruitment – – Phase 2 data confirmed that two 16 mg doses of CYB003 administered three weeks apart provides remission from
Cybin Partners with Osmind to Accelerate Commercial Preparation for its Clinical-Stage Psychiatry Programs
– Cybin will leverage Osmind’s 800-clinic network, point-of-care software, and real-world data to support the commercial preparation for its clinical-stage pipeline – – Osmind is a leading service provider to psychiatry practices in the U.S. focused on advancing psychiatry through technology and
Cybin Reports Third Quarter Fiscal Year 2025 Financial Results and Recent Business Highlights
– Launched strategic clinical site partnerships to accelerate PARADIGM, a multinational pivotal Phase 3 program evaluating CYB003 for the adjunctive treatment of major depressive disorder (“MDD”) – – PARADIGM comprises two 12-week randomized, double-blind, placebo-controlled studies (APPROACH™ and
Cybin Launches Strategic Clinical Site Partnerships to Support PARADIGM, a Multinational Pivotal Phase 3 Program Evaluating CYB003 for the Adjunctive Treatment of Major Depressive Disorder
– Strategic Partnership Agreements will facilitate collaboration among sites, cultivate long term partnerships, enhance efficiency in trial operations, and improve overall site performance – – First program member is Segal Trials, a preferred provider for leading pharmaceutical companies globally
Cybin Highlights 2024 Accomplishments and Upcoming Milestones for 2025
– Announced positive Phase 2 Data for CYB003, Demonstrating Breakthrough 12-Month Efficacy in Treating Major Depressive Disorder (“MDD”) – – Initiated PARADIGM: A Multinational Pivotal Phase 3 Program Evaluating CYB003 for the Adjunctive Treatment of MDD – – Received U.S.