Latest news with #CybinInc
National Post
07-08-2025
- Business
- National Post
Cybin Receives European Approval for EMBRACE, a Multinational Phase 3 Study Evaluating CYB003 for the Adjunctive Treatment of Major Depressive Disorder
Article content Article content Article content the United States, Europe, the United Kingdom, and Australia – Article content – European CTA approval to initiate the EMBRACE study in Ireland, Poland, and Greece has been received – Article content – Recently received Medicines and Healthcare products Regulatory Agency ('MHRA') approval to commence EMBRACE in the United Kingdom – Article content – Data from completed Phase 2 MDD study showed that 71% of participants were in remission and 100% of participants responded to treatment at 12 months after just two 16 mg doses of CYB003 – Article content TORONTO — Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (' Cybin ' or the ' Company '), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative next-generation treatment options, today announced that its Clinical Trial Application ('CTA') has been approved by the Irish Medicines Board, acting as the reference Member state, to initiate the EMBRACE ™ study in Ireland, Poland, and Greece. EMBRACE is the second pivotal study in PARADIGM ®, the Company's Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog. The Company also recently announced approval from the Medical and Healthcare products Regulatory Agency ('MHRA') to commence EMBRACE in the United Kingdom. Article content CYB003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration ('FDA') for the adjunctive treatment of Major Depressive Disorder ('MDD'). Article content 'Securing European approval to commence the EMBRACE component of PARADIGM – especially on the heels of the recent UK MHRA approval – 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. 'We appreciate the trust placed in us by the European Regulatory Agencies and are eager to leverage Europe's well-established clinical trial infrastructure. The EMBRACE study aims to enroll 330 participants who live with moderate to severe MDD and whose symptoms are inadequately controlled with antidepressant treatments. With this additional approval, which enables us to enroll participants in Ireland, Poland, and Greece, we are pleased to expand the reach for this critical research. The rise in mental health disorders knows no borders, and we are committed to an international research base to develop new and more effective treatments for MDD patients everywhere.' Article content Study Design: Article content EMBRACE will enroll 330 patients with moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but are responding inadequately. Study participants will be randomized 1:1:1 to receive either CYB003 16 mg, CYB003 8 mg, or inactive placebo. Each study arm will evaluate two doses, administered three weeks apart. The primary endpoint will be change in depressive symptoms as measured by change in MADRS from baseline at six weeks after the first dose. Article content The Phase 3 PARADIGM™ program is expected to enroll a total of 550 participants across three studies: two 12-week randomized, double-blind, placebo-controlled studies, APPROACH™ and EMBRACE, and a long-term extension study, EXTEND. The first Phase 3 trial, APPROACH, is currently dosing and is taking place at approximately 45 clinical sites across the U.S, and patient rollover into EXTEND is ongoing. The second Phase 3 trial, EMBRACE, is expected to enroll participants at approximately 60 clinical sites across the U.S., Europe, and Australia. Participants from APPROACH and EMBRACE will have the opportunity to roll over into EXTEND after completing the 12-week, double-blind, placebo-controlled treatment periods. Article content About Cybin Article content Cybin is a late-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. Article content With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Article content Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. Article content Cautionary Notes and Forward-Looking Statements Article content Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, 'forward-looking statements') and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as 'may', 'should', 'could', 'potential', 'possible', 'intend', 'estimate', 'plan', 'anticipate', 'expect', 'believe' or 'continue', or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company's plans to enroll participants and add additional clinical sites for the PARADIGM program; the Company's plan to enroll 330 participants at 60 clinical sites across the United States, Europe, United Kingdom and Australia for the EMBRACE study; and the Company's plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. APPROACH and EMBRACE are registered trademarks of Cybin IRL Limited, a subsidiary of Cybin. Article content These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the year ended March 31, 2025 and the Company's annual information form for the year ended March 31, 2025, which are available under the Company's profile on SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Article content Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations. Article content Article content Article content Article content Contacts Article content Investor & Media: Article content Article content Gabriel Fahel Article content Article content Chief Legal Officer Article content Article content Cybin Inc. Article content Article content Article content Article content
Montreal Gazette
06-08-2025
- Business
- Montreal Gazette
Cybin to Participate in the Canaccord Genuity 45th Annual Growth Conference
Cybin to Participate in the Canaccord Genuity 45th Annual Growth Conference Investor & Media Contact: Gabriel Fahel Chief Legal Officer Cybin Inc. 1-866-292-4601 irteam@ – or – media@ Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) ("Cybin" or the "Company"), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, is pleased to announce that Doug Drysdale, Cybin's Chief Executive Officer, will participate in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference, on August 12, 2025 in Boston, MA. Mr. Drysdale's fireside chat will be webcast live on Tuesday, August 12, 2025, at 2:30 p.m. ET. To listen to the event, please click here to access the webcast. The archived webcast will also be available on the Company's investor relations website on the Events & Presentations page. About Cybin Cybin is a late-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. Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. This story was originally published
Associated Press
11-06-2025
- Business
- Associated Press
Cybin to Participate in the 2025 Psychedelic Science Conference
TORONTO--(BUSINESS WIRE)--Jun 11, 2025-- Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (' Cybin ' or the ' Company '), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, is pleased to announce that Doug Drysdale, Cybin's Chief Executive Officer, will be speaking at the Psychedelic Science 2025 Conference taking place June 16-20, 2025 in Denver, Colorado. The details are as follows: Panel Title: The Home Stretch: Pivotal Trials and Preparing for Launch Date and Time: Thursday, June 19, 2025 at 9:30 a.m. MDT (11:30 a.m. EDT) 'This annual gathering of global experts is a unique opportunity to share perspectives and engage with others on the forefront of achieving the potential of psychedelic therapeutics,' said Doug Drysdale, Chief Executive Officer of Cybin. 'Cybin is fully committed to advancing our ongoing clinical work and delivering innovative alternatives to the current standard of care to address the large unmet medical need in treating mental health disorders. Recognition of this potential within medical circles has never been greater, and I am pleased to be part of the panel that is focused on these crucial next steps along the regulatory pathway.' About Cybin Cybin is a late-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. Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. View source version on CONTACT: Investor & Media Contact: Gabriel Fahel Chief Legal Officer Cybin Inc. 1-866-292-4601 [email protected]– or –[email protected] KEYWORD: UNITED STATES NORTH AMERICA CANADA COLORADO INDUSTRY KEYWORD: BIOTECHNOLOGY NEUROLOGY MENTAL HEALTH HEALTH CLINICAL TRIALS SOURCE: Cybin Inc. Copyright Business Wire 2025. PUB: 06/11/2025 07:30 AM/DISC: 06/11/2025 07:28 AM
Business Wire
11-06-2025
- Business
- Business Wire
Cybin to Participate in the 2025 Psychedelic Science Conference
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (' Cybin ' or the ' Company '), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, is pleased to announce that Doug Drysdale, Cybin's Chief Executive Officer, will be speaking at the Psychedelic Science 2025 Conference taking place June 16-20, 2025 in Denver, Colorado. The details are as follows: Panel Title: The Home Stretch: Pivotal Trials and Preparing for Launch Date and Time: Thursday, June 19, 2025 at 9:30 a.m. MDT (11:30 a.m. EDT) 'This annual gathering of global experts is a unique opportunity to share perspectives and engage with others on the forefront of achieving the potential of psychedelic therapeutics,' said Doug Drysdale, Chief Executive Officer of Cybin. 'Cybin is fully committed to advancing our ongoing clinical work and delivering innovative alternatives to the current standard of care to address the large unmet medical need in treating mental health disorders. Recognition of this potential within medical circles has never been greater, and I am pleased to be part of the panel that is focused on these crucial next steps along the regulatory pathway.' About Cybin Cybin is a late-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. Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram.
Yahoo
03-06-2025
- Business
- Yahoo
Cybin Announces Additional U.S. Patent Supporting its CYB004 Program in Phase 2 Development for Generalized Anxiety Disorder
- Newly issued patent includes claims to novel formulations of N,N-dimethyltryptamine ("DMT") and deuterated isotopologues for intramuscular injection, including CYB004, with expected exclusivity until 2040 - - Cybin's growing intellectual property portfolio comprises more than 90 granted patents and over 230 pending applications - TORONTO, June 03, 2025--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) ("Cybin" or the "Company"), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today announced that the United States Patent and Trademark Office has granted U.S. patent 12,318,477 in support of its CYB004 deuterated DMT program in development for the treatment of generalized anxiety disorder ("GAD"). The patent, which is expected to provide exclusivity until 2040, includes claims to novel formulations of DMT and deuterated isotopologues for intramuscular ("IM") injection, including CYB004. "Patents are extremely valuable assets, and protection for our lead product candidates is a top priority for us," said Doug Drysdale, Chief Executive Officer of Cybin. "We believe that our CYB004 program has the potential to deliver short-duration, rapid-acting treatment for anxiety disorders and offer more patient-friendly dosing methods such as IM administration. The issuance of this additional patent in support of CYB004 adds further validation of this important program. Dosing is currently underway in our Phase 2 study evaluating CYB004 in generalized anxiety disorder, and we expect the study to complete around mid-year. I'm proud that Cybin has amassed one of the strongest IP portfolios in the sector with more than 90 granted patents and over 230 pending applications." About Cybin Cybin is a late-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. With industry leading proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin program, in Phase 3 development for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine program in a Phase 2 study for generalized anxiety disorder. The company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. Cautionary Notes and Forward-Looking Statements Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as "may", "should", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe" or "continue", or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company's expectations respecting the patent exclusivity period; plans to complete the Phase 2 GAD study around mid-year 2025; and the Company's plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the spread of a pandemic on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in each of the Company's management's discussion and analysis for the three and nine month periods ended December 31, 2024 and the Company's annual information form for the year ended March 31, 2024, which are available under the Company's profile on SEDAR+ and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations. Neither the Cboe Canada nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein. View source version on Contacts Investor & Media Contact: Gabriel FahelChief Legal OfficerCybin Inc.1-866-292-4601irteam@ – or – media@ Sign in to access your portfolio
