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Home » Numinus Wellness Inc. congratulates Lykos Therapeutics on FDA acceptance of new drug application for MDMA-assisted therapy for PTSD
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Numinus Wellness Inc. congratulates Lykos Therapeutics on FDA acceptance of new drug application for MDMA-assisted therapy for PTSD

perbinderBy perbinderFebruary 14, 2024No Comments6 Mins Read
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Numinus welcomes psychedelic pioneer rick doblinPh.D., as strategic advisor

Updates Markets Following Completion of Previously Announced Acquisition Transaction

/This news release is intended for distribution in Canada It is intended for distribution only and is not intended for distribution. America newswire service or distribution in US./

vancouver british columbia, February 14, 2024 /CNW/ – Numinus Wellness Inc. (“Numinus” or “company“) (TSX: NUMI) is a mental health care company advancing traditional and innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted therapies, and is a leader in this research. Congratulations to the Multidisciplinary Association for Psychedelic Studies (“MAPS”). This allows Lykos Therapeutics (formerly MAPS Public Benefit Corporation) to submit its first new drug application to the USFDA upon acceptance of a new drug application to the US Food and Drug Administration (“FDA”) for MDMA (Midomafetamine Capsules). I got it. Combined with psychological interventions for patients with PTSD, FDA grants priority review to applications and mandates the Prescription Drug User Fee Act (“PDUFA”) authority to take action within six months. The day is August 11, 2024It is set.

Numinus Wellness Inc. Logo (CNW Group/Numinus Wellness Inc.)Numinus Wellness Inc. Logo (CNW Group/Numinus Wellness Inc.)

Numinus Wellness Inc. Logo (CNW Group/Numinus Wellness Inc.)

“This is an exciting development and, if approved, would be the first MDMA-assisted therapy available in the United States to the millions of Americans suffering from PTSD,” he said. Peyton Nykvest, Founder and CEO of Numinus. “We have arrived here as a result of more than 20 years of clinical research initiated by MAPS, the nonprofit organization that founded Lykos, and through our participation in clinical research at the Cedar Clinical Research facility, we are partnering with MAPS. We are proud to collaborate. Numinus is dedicated to building the infrastructure that will allow us to administer MDMA-AT, if FDA-approved, in a sustainable and sustainable manner while ensuring the highest quality results for our clients. We have been at the forefront of this effort through training and delivery of scalable services, and we plan to expand these efforts in the near term to continue meeting the needs of the more than 14 million people diagnosed with PTSD. We would like to actively support this. US. ”

“Psychotherapy is part of the proposed treatments, and our network of clinics, physician training programs and protocols developed in conjunction with our clinical research programs allow us to offer MDMA-assisted therapy as soon as regulatory authorities allow it.” I would like to do so.” added michael tan, President and COO of Numinus. “It is important to note that our Canadian clinics are currently treating patients with MDMA-assisted therapy to a limited extent under current regulatory exceptions. Our combination of experience and infrastructure This positions us to be a leading provider of psychedelic-assisted therapies.” ”

strategic advisor

Numinus also proudly announced: rick doblinPh.D., Founder and President of MAPS, will participate independently as an unpaid, non-exclusive strategic advisor to Numinus, leading the enhancement of Numinus’ therapeutic and training assets related to MDMA-assisted therapies, and Helps facilitate empirical validation. Mr. Numinus and his Dr. Doblin share a common commitment to inclusivity and ensuring access to a wide range of treatments by making quality care available to everyone seeking innovative treatments. We share goals. This appointment strengthens the company’s commitment to training programs that support the efficacy and safety of MDMA-assisted therapy for PTSD.

“It is an honor to welcome Dr. rick doblin Appointed to Numinus as an unpaid strategic advisor. His extensive experience and commitment to advancing psychedelic-assisted therapies align with Numinus’ mission to provide innovative and accessible care to people around the world. ” Peyton Nykvest.

“My hope as an unpaid, non-exclusive Numinus Strategic Advisor is to accelerate our joint mission to expand access to psychedelic-assisted therapies. Contribute to the evolution of MDMA-related training and care programs. , we look forward to ultimately advancing standards.”We value your consideration in this area of ​​transformation. ” said the doctor. rick doblin.

Latest information on purchased trades market

Numinus also today provided the company with an update on its previously announced gross proceeds acquisition transaction. 6 million dollars (“Offerings”). MAPS continues to be a key collaborator with Numinus in experiential training and other mission-critical areas of our business. rick doblin As a strategic advisor to Numinus, MAPS cannot participate in this offering. Integrated VC is also not participating in this offering.This recruitment is scheduled to end approximately on February 16, 2024.

About Numinus

Numinus Wellness Inc. (TSX: NUMI) helps people heal and stay healthy through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model, which includes psychedelic research and clinic care, is at the forefront of a transformation aimed at healing rather than managing symptoms such as depression, anxiety, trauma, pain, and drug use. At Numinus, we are leading the way in integrating psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more about www.numinus.com and follow us linkedin, Facebook, twitterand Instagram.

Forward-looking statements

Statements regarding anticipated future events and other information contained in this press release constitute forward-looking statements. Forward-looking statements often, but not always, refer to words such as “seeks,” “anticipates,” “believes,” “plans,” “estimates,” “anticipates,” “intends” and similar words. and forward-looking statements. An event “may occur,” “will occur,” “should occur,” “could occur,” or “might occur,” or any other similar expression. Forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements, including regulatory restrictions on the use of MDMA. there is. Safety and efficacy of MDMA-assisted therapy. Acceptance, dissemination, and commercialization of MDMA-assisted therapy. the effectiveness of any advice provided by, or any future collaborations related to, the Strategic Advisors, if any; our dependence on obtaining regulatory approvals and the possibility that the offering will not close on time or at all because conditions to closing are not satisfied on a timely basis or because the underwriters exercise termination rights; Numinus’ ability to maintain or increase its revenues; Numinus’ ability to achieve or maintain profitability; the Company’s need for additional financing and the effect of financial market conditions and other factors on the availability of capital;and other risks described in the Annual Information Form dated. November 29, 2023 Available on SEDAR www.sedarplus.ca. Forward-looking statements are based on management’s estimates and opinions at the date the statements are made. Numinus undertakes no obligation to update any forward-looking statements, even if circumstances or management’s estimates or opinions should change, except as required by applicable law. Investors should not place undue reliance on forward-looking statements.

Source Numinus Wellness Inc.

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View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2024/14/c4699.html





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