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Optimi Health - OPTHF STOCK NEWS

Welcome to our dedicated page for Optimi Health news (Ticker: OPTHF), a resource for investors and traders seeking the latest updates and insights on Optimi Health stock.

About Optimi Health Corp.

Optimi Health Corp. (CSE: OPTI, OTCQX: OPTHF, FSE: 8BN) is a Canadian-based manufacturer licensed by Health Canada to produce and supply GMP-certified psilocybin and MDMA for clinical research and therapeutic applications. Specializing in natural, pharmaceutical-grade psychedelic substances, Optimi is dedicated to advancing mental health treatments through innovative, scalable, and compliant production processes. The company operates two state-of-the-art facilities in Princeton, British Columbia, covering 20,000 square feet, purpose-built to meet strict Good Manufacturing Practice (GMP) and Good Agricultural and Collection Practice (GACP) standards.

Core Business and Operations

Optimi Health focuses on the production of controlled substances such as botanical psilocybin and MDMA, targeting the growing demand for psychedelic-assisted therapies. The company’s operations span cultivation, formulation, and analytical testing, ensuring end-to-end control over the quality and consistency of its products. With both a Controlled Drugs and Substances Dealer’s Licence and a Drug Establishment Licence (DEL) from Health Canada, Optimi is uniquely positioned to supply researchers, drug developers, and authorized healthcare providers in regulated markets worldwide.

Product Offerings and Applications

Optimi’s product portfolio includes GMP-certified psilocybin extract capsules and MDMA capsules, designed for use in clinical trials, therapeutic settings, and real-world evidence collection. These products target critical mental health conditions such as post-traumatic stress disorder (PTSD), treatment-resistant depression, and addiction. The company's natural psilocybin extract has been validated in groundbreaking studies, including culturally significant trials integrating indigenous knowledge systems.

Regulatory Compliance and Global Reach

Optimi’s commitment to regulatory excellence is evident in its compliance with Health Canada’s stringent GMP standards. The company’s DEL enables it to manufacture and export controlled substances to regulated jurisdictions globally, including Australia, New Zealand, Israel, and Canada. Optimi has played a pivotal role in advancing psychedelic medicine by supporting clinical trials and therapeutic programs in collaboration with organizations like Mind Medicine Australia and the Mātai Medical Research Institute.

Competitive Advantages

  • Vertically Integrated Operations: Optimi’s in-house cultivation, formulation, and manufacturing capabilities ensure unparalleled quality and scalability.
  • Regulatory Leadership: As the only Canadian psychedelics manufacturer with both a Controlled Drugs and Substances Dealer’s Licence and a DEL, Optimi sets the standard for compliance and reliability.
  • Global Partnerships: Collaborations with leading organizations enhance Optimi’s ability to deliver innovative solutions for mental health care.
  • Cost-Effective Production: Optimi’s efficient manufacturing processes make its products accessible to a broader range of patients and healthcare providers.

Industry Significance

Operating within the rapidly evolving psychedelics industry, Optimi Health addresses a critical need for effective mental health treatments. The company’s contributions to clinical research and its focus on GMP-certified production position it as a trusted partner in the global effort to integrate psychedelic therapies into mainstream healthcare.

Commitment to Quality and Innovation

Optimi Health’s mission is to be the most trusted supplier of safe, natural psychedelic drug candidates. By combining rigorous compliance with innovative research, the company is paving the way for transformative mental health solutions that meet the highest standards of quality and efficacy.

Rhea-AI Summary
Optimi Health Corp. is hosting a webinar titled 'Know Your Drug Candidate: Safeguarding Quality in Psychedelic Therapy' to provide insights into the safety and quality standards of their psychedelic drug candidates. The company is the only end-to-end, publicly listed psychedelics company currently offering its drug candidates at scale to address accessibility through lower costs. The FDA is expected to decide on the acceptance of the New Drug Application for MDMA-Assisted Therapy for PTSD by February 12, 2024, which has the potential to reshape the industry landscape.
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Optimi Health Corp. has been granted an amendment to its Health Canada Controlled Drugs and Substances Licence, allowing substantial increases in the quantities of MDMA, MDA, and 2CB. This strategic licensing plan positions the company as an industry-leading psychedelics drug manufacturer, preparing for potential approval of MDMA by the U.S. Food and Drug Administration in 2024. The company's 2024 strategic licensing plan includes approvals for a Drug Master File (DMF) and Drug Establishment Licence (DEL) to ensure regulatory compliance and transparency.
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Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) proudly announces the granting of its Precursor Licence for 3,4-Methylenedioxyphenyl-2-propanone ('MDP2P') by Health Canada, allowing the company to import MDP2P for formulating and verifying MDMA drug candidates. This achievement positions Optimi to produce MDMA at reduced costs, aligning with market demand and the recent NDA submission by MAPS PBC to the FDA. The successful encapsulation of MDMA into 40mg and 60mg dosage formats further solidifies Optimi's strategic position as a premier provider of encapsulated MDMA in 2024 and beyond.
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Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) announced a supply agreement with Sunshine Earth Labs Ltd., a fellow biosciences company, to provide GMP quality-controlled substances for medicinal and research purposes. The partnership leverages the strengths of two reputable companies in the psychedelics industry, reinforcing British Columbia's standing as a hub for innovative advancements.
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Optimi Health Corp. (OPTI) has successfully harvested eight new natural Psilocybin genetics, solidifying its position as a leading psychedelic research and formulation company. The company is advancing its full spectrum, GMP extract quality program and has confirmed the product's potency and quality attributes for the duration of clinical trials. Optimi is also making GMP Psilocybin API available for encapsulation into standardized dosages or sale to other groups, expanding its reach and impact within the psychedelic research community.
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Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) announces the successful resolution of a dispute related to a supply agreement, emphasizing commitment to positive relationships and business integrity in the psychedelics sector.
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Optimi Health Corp. appoints Dr. Preston A. Chase as Chief Science Officer, bringing extensive experience in R&D and commercialization of innovative products. Dr. Chase will lead the scientific team to advance research capabilities and develop safe, effective psychedelics drug candidates.
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Optimi Health Corp. has secured a non-dilutive Debt Financing Agreement and General Security Agreement for CAD$1,000,000. The loan is secured against the company's assets and will bear interest at a rate of 7.5% per annum. The loan is repayable on April 30, 2025, and the company has the option to repay it earlier with a prepayment fee. As part of the agreement, the company has granted 100,000 common share purchase warrants.
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Optimi Health Corp. sees positive outcomes from the MAPS Phase 3 MDMA-Assisted Therapy Clinical Trial for PTSD treatment
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Optimi Health Corp. receives approval from Health Canada to supply Canada's Special Access Program with psychedelic substances.
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FAQ

What is the current stock price of Optimi Health (OPTHF)?

The current stock price of Optimi Health (OPTHF) is $0.12985 as of March 3, 2025.

What is the market cap of Optimi Health (OPTHF)?

The market cap of Optimi Health (OPTHF) is approximately 14.3M.

What does Optimi Health specialize in?

Optimi Health specializes in the production of GMP-certified psilocybin and MDMA for clinical research and therapeutic applications.

What licenses does Optimi Health hold?

Optimi Health holds a Controlled Drugs and Substances Dealer’s Licence and a Drug Establishment Licence (DEL) from Health Canada.

Who are Optimi Health's customers?

Optimi Health supplies researchers, drug developers, and authorized healthcare providers in regulated markets worldwide.

What mental health conditions does Optimi's product address?

Optimi’s products target PTSD, treatment-resistant depression, and addiction, among other mental health conditions.

What makes Optimi Health unique in the psychedelics industry?

Optimi Health’s vertically integrated operations, regulatory leadership, and focus on natural, GMP-certified products set it apart in the psychedelics industry.

Where are Optimi Health’s facilities located?

Optimi operates two state-of-the-art facilities in Princeton, British Columbia, totaling 20,000 square feet.

What markets does Optimi Health serve?

Optimi Health serves regulated markets globally, including Australia, New Zealand, Israel, and Canada.

What partnerships does Optimi Health have?

Optimi collaborates with organizations like Mind Medicine Australia and the Mātai Medical Research Institute to advance psychedelic medicine.
Optimi Health

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