Gold prices remain near record highs; Fed cut bets prompt weekly gains
NEW YORK - Cybin Inc. (NYSE American:CYBN), a clinical-stage biotech company with a market capitalization of $159 million, has completed enrollment in its Phase 2 clinical trial evaluating CYB004, a proprietary deuterated dimethyltryptamine (DMT) program, for the treatment of Generalized Anxiety Disorder (GAD), the company announced Monday. The stock, which has seen a 24% decline year-to-date according to InvestingPro data, currently trades at $6.73.
The study has enrolled 36 participants to assess the safety and efficacy of CYB004 at 12 weeks after the first dose. Participants were randomized into two groups in a 2:1 ratio, with one group receiving two intramuscular administrations of CYB004 at a 20mg dose predicted to be therapeutic, and the second group receiving a lower 2mg dose predicted to be sub-therapeutic.
The primary endpoint is the change in Hamilton Anxiety Rating Scale score from baseline at six weeks following the first administration. Secondary endpoints include changes in the same scale through the 12-week double-blind period.
"Improved treatments are greatly needed, as anxiety disorders affect more than 300 million people worldwide," said Eric So, Interim Chief Executive Officer of Cybin. "GAD is the most common anxiety disorder seen in primary care, with roughly 6.8 million people living with GAD in the United States alone."
According to the company statement, approximately half of GAD patients do not respond to currently approved treatments with selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors.
Cybin reaffirmed that top-line data from the study is expected in the first quarter of 2026.
The company is also developing CYB003, a proprietary deuterated psilocin analog, currently in Phase 3 studies for the adjunctive treatment of major depressive disorder. This program has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.
The information in this article is based on a company press release statement.
In other recent news, Cybin Inc. has announced several developments in its clinical trials and received regulatory approvals. The company has initiated patient dosing for its Phase 3 CYB003 PARADIGM program targeting Major Depressive Disorder (MDD), with the program consisting of three studies—APPROACH, EMBRACE, and EXTEND—aiming to enroll about 550 participants. Cybin has also received approval from the Irish Medicines Board to begin the EMBRACE study in Ireland, Poland, and Greece, following a similar approval from the UK’s Medicines and Healthcare products Regulatory Agency. This study is part of the larger Phase 3 PARADIGM program evaluating CYB003 for MDD, which has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration.
Additionally, H.C. Wainwright has reiterated its Buy rating on Cybin stock with a price target of $150, citing multiple upcoming catalysts, including the completion of enrollment in the CYB004 Phase 2 trial for generalized anxiety disorder. Meanwhile, Canaccord Genuity has updated its financial model for Cybin, lowering the stock price target to $70 while maintaining a Buy rating. The firm projects a 40% probability of approval for CYB003 as an adjunct treatment for MDD, with a potential launch in fiscal year 2029. Cybin’s ongoing efforts and recent approvals reflect its commitment to advancing its psychedelic medicine pipeline.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.