December 4, 2024 – [Phoenixville, PA] – Facet Life Sciences, a leader in US regulatory strategy and product development solutions for the life sciences industry, has been named as the US regulatory partner for Cybin Inc. (“Cybin”), a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative treatment options to address the large unmet need for people who suffer from mental health conditions. This collaboration will support Cybin’s pioneering work in next generation therapeutics, particularly for conditions like Major Depressive Disorder, Generalized Anxiety Disorder, and Central Nervous System disorders.
Facet Life Sciences will leverage its extensive expertise in US regulatory submissions to guide Cybin’s development programs to and through the U.S. Food and Drug Administration (“FDA”) review and approval process. Cybin’s work involves novel, proprietary molecules which are in advanced clinical development. Facet Life Sciences’ role will encompass strategic nonclinical, CMC, clinical, and procedural regulatory development guidance, tactical regulatory, medical writing support and submission management for Cybin’s key therapies, including CYB003, Cybin’s proprietary deuterated psilocin program in Phase 3 development for the potential adjunctive treatment of major depressive disorder which received FDA Breakthrough Therapy Designation earlier this year.
“We are excited to collaborate with Cybin as their regulatory partner, supporting their mission to redefine mental health treatment through innovation,” said Ken VanLuvanee, Founder and CEO, Facet Life Sciences. “Cybin’s approach aligns with our mission to help advance groundbreaking therapeutics while meeting the highest regulatory standards, including our desire to bring efficacious and safe therapeutics to patients suffering with various neuropsychiatric diseases.”
About Facet Life Sciences
Facet Life Sciences provides integrated clinical, non-clinical, manufacturing, regulatory, statistics, marketing, and commercialization services to help small and mid-sized companies achieve success. Facet’s team of experts have hundreds of years of combined experience making them uniquely equipped to guide companies from the bench through development, approval, and to patients in need.
About Cybin
Cybin is a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next generation treatment options to address the large unmet need for people who suffer from mental health conditions.
Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. To learn more about Cybin, visit www.cybin.com.
For media inquiries, contact:
- Facet Life Sciences: info@facetls.com
- Cybin: media@cybin.com