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TORONTO - Cybin Inc. (NYSE American:CYBN), a $182 million market cap biotech company, has initiated patient dosing in its Phase 3 CYB003 PARADIGM program for Major Depressive Disorder (MDD), the company announced in a press release statement. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt, though it’s rapidly deploying capital for clinical development.
The Phase 3 program consists of three studies—APPROACH, EMBRACE, and EXTEND—with expected combined enrollment of approximately 550 participants.
Cybin has expanded its clinical site partnership program to support the Phase 3 trials and formed strategic partnerships with Thermo Fisher Scientific for U.S.-based manufacturing of CYB003 and with Osmind to leverage its 800-clinic network for commercial preparation.
The company has also strengthened its intellectual property portfolio with two additional U.S. patents supporting its lead programs. U.S. patent 12,291,499 covers pharmaceutical compositions within the CYB003 program with expected exclusivity until 2041, while U.S. patent 12,318,477 includes claims to novel formulations of DMT and deuterated isotopologues for intramuscular injection, including CYB004, with expected exclusivity until 2040.
Cybin CEO Doug Drysdale noted that recent regulatory signals from U.S. agencies could potentially expedite approval pathways for the company’s clinical programs. FDA Commissioner Dr. Marty Makary has stated that psychedelic-drug review is a top priority, promising "expeditious and rapid review of clinical data."
The company is also developing CYB004, a proprietary deuterated N,N-dimethyltryptamine molecule, currently in Phase 2 studies for generalized anxiety disorder.
Drysdale is scheduled to participate in a panel discussion on regulatory landscape and commercialization at the Psychedelic Science 2025 Conference on June 19 in Denver, Colorado. Investors should note that Cybin’s next earnings report is scheduled for June 26, with analysts maintaining a strong buy consensus on the stock. For detailed financial analysis and additional insights, consider exploring InvestingPro, which offers 8 more key tips about Cybin’s financial position and growth prospects.
In other recent news, Cybin Inc. has been active with several significant developments. The company announced the granting of a U.S. patent for its CYB003 program, a treatment for Major Depressive Disorder (MDD), which extends market exclusivity until 2041. Additionally, Cybin has secured another U.S. patent for its CYB004 program, aimed at treating generalized anxiety disorder, with exclusivity expected until 2040. The company is currently conducting a Phase 2 study for CYB004 and a Phase 3 study for CYB003, with promising early results reported.
Cybin has also partnered with Thermo Fisher Scientific to support the Phase 3 clinical supply and potential future commercial manufacturing of CYB003. This collaboration aims to leverage Thermo Fisher’s manufacturing expertise to accelerate the drug’s development. In another development, Lucid Capital Markets initiated coverage on Cybin with a Buy rating, citing the company’s innovative approach to psychedelic drug formulations and its extensive intellectual property portfolio. The U.S. Food and Drug Administration has also prioritized psychedelic drug research, with Cybin’s CYB003 receiving Breakthrough Therapy Designation for MDD treatment.
These recent developments highlight Cybin’s ongoing efforts to advance its clinical programs and expand its intellectual property portfolio in the field of mental health treatment.
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