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TORONTO - Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN), a $171.83 million market cap biotech company trading at $7.46, announced Thursday that its Clinical Trial Application has been approved by the Irish Medicines Board to initiate the EMBRACE study in Ireland, Poland, and Greece. This approval follows recent authorization from the UK’s Medicines and Healthcare products Regulatory Agency. According to InvestingPro analysis, the company maintains a strong balance sheet with more cash than debt.
EMBRACE is the second pivotal study in Cybin’s Phase 3 PARADIGM program, which is evaluating CYB003, the company’s proprietary deuterated psilocin analog, for the treatment of Major Depressive Disorder (MDD). The drug has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.
The EMBRACE study aims to enroll 330 participants with moderate to severe MDD across approximately 60 clinical sites in the United States, Europe, the United Kingdom, and Australia. Participants will be randomized to receive either CYB003 16 mg, CYB003 8 mg, or placebo, with two doses administered three weeks apart.
"Securing European approval to commence the EMBRACE component of PARADIGM validates the quality of our Phase 3 clinical development program and reaffirms the strength of our results to date," said Doug Drysdale, Chief Executive Officer of Cybin, according to the press release. While InvestingPro data shows the company is currently burning through cash, its healthy current ratio of 7.75 indicates strong short-term financial stability.
The Phase 3 PARADIGM program consists of three studies: APPROACH and EMBRACE, which are 12-week randomized, double-blind, placebo-controlled studies, and EXTEND, a long-term extension study. APPROACH is currently dosing participants at approximately 45 clinical sites across the U.S.
Data from Cybin’s completed Phase 2 MDD study showed that 71% of participants were in remission and 100% responded to treatment at 12 months after receiving just two 16 mg doses of CYB003.
The primary endpoint of the EMBRACE study will measure change in depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline at six weeks after the first dose.
In other recent news, Cybin Inc. has received approval from the UK Medical and Healthcare Products Regulatory Agency to commence the EMBRACE study, a key component of its Phase 3 PARADIGM program for treating major depressive disorder. This study is expected to enroll 330 participants across the United States, Europe, and Australia. Additionally, Cybin has initiated patient dosing in its Phase 3 CYB003 PARADIGM program, which includes three studies with a combined enrollment of approximately 550 participants. In another development, Cybin has secured a U.S. patent for its CYB004 program, aimed at treating generalized anxiety disorder, extending its exclusivity until 2040. Analyst activity has also been notable, with Canaccord Genuity lowering its price target for Cybin to $70 while maintaining a Buy rating, and Lucid Capital Markets initiating a Buy rating with a $106 price target. These developments highlight Cybin’s ongoing efforts in advancing treatments for mental health conditions.
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