Cybin receives UK approval for second pivotal depression study

TORONTO - Cybin Inc. (NYSE American:CYBN), a $173 million market cap biotech company currently trading at $7.52, has received approval from the UK Medical and Healthcare Products Regulatory Agency (MHRA) to commence EMBRACE, the second pivotal study in its Phase 3 PARADIGM program evaluating CYB003 for major depressive disorder (MDD). According to InvestingPro analysis, the stock appears undervalued based on its Fair Value metrics.

The EMBRACE study is expected to enroll 330 participants suffering from moderate to severe MDD at approximately 60 clinical sites across the United States, Europe, and Australia. Participants will be randomized to receive either CYB003 16 mg, CYB003 8 mg, or placebo, with two doses administered three weeks apart.

CYB003, a proprietary deuterated psilocin analog, previously received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of MDD.

"MHRA approval to initiate the EMBRACE component of our PARADIGM program in the UK marks an important step forward as we advance our lead program," said Doug Drysdale, Chief Executive Officer of Cybin.

The PARADIGM program consists of two 12-week randomized, double-blind, placebo-controlled studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND), with anticipated combined enrollment of approximately 550 participants. Dosing is currently underway in the APPROACH study, and patient rollover has begun into the EXTEND phase. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 7.75, though it’s currently experiencing significant cash burn.

The primary endpoint for EMBRACE will measure change in depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline at six weeks after the first dose.

Cybin is also developing CYB004, a proprietary deuterated N,N-dimethyltryptamine molecule, currently in a Phase 2 study for generalized anxiety disorder.

The information in this article is based on a company press release statement. Analysts maintain a strong buy consensus on Cybin, with price targets ranging from $24.90 to $149.09. Get deeper insights into Cybin’s financial health and access additional ProTips with an InvestingPro subscription.

In other recent news, Cybin Inc. has initiated its Phase 3 CYB003 PARADIGM program for Major Depressive Disorder, involving approximately 550 participants across three studies. The company has also secured strategic partnerships for the U.S.-based manufacturing of CYB003 and expanded its clinical site partnerships. Canaccord Genuity recently updated its financial model for Cybin, maintaining a Buy rating but lowering the price target to $70.00, citing increased research and development expenses. Lucid Capital Markets has initiated coverage on Cybin with a Buy rating and a 12-month price target of $106, highlighting the company’s innovative approach to psychedelic drug formulations.

Additionally, Cybin has been granted a U.S. patent for its CYB004 program, a deuterated DMT designed for treating generalized anxiety disorder, extending exclusivity until 2040. The FDA has prioritized the development of psychedelic drugs, with Cybin’s CYB003 receiving Breakthrough Therapy Designation, potentially accelerating its development timeline. The company’s Phase 2 trials have shown promising results, with a significant percentage of participants achieving remission. Cybin continues to focus on addressing mental health challenges with novel therapeutic solutions, supported by its extensive intellectual property portfolio.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.