Psyence BioMed supports President Trump's announcement accelerating ibogaine's development as a medical treatment in the U.S.
Quiver AI Summary
Psyence BioMed Ltd. has expressed support for President Trump's recent announcement on advancing ibogaine as a potential medical treatment, following the University of Miami's submission of its 1994 ibogaine Investigational New Drug application to the U.S. government. The President's statement emphasized ongoing initiatives and funding to propel research into ibogaine and encouraged more institutions to participate in development efforts. Psyence BioMed’s CEO, Jody Aufrichtig, indicated that the company is poised to contribute to this momentum, particularly for veterans, and is engaged with stakeholders in Texas to discuss advancing ibogaine’s regulated clinical development. Psyence is building a manufacturing platform through PsyLabs to support this initiative, highlighting a shift towards recognizing ibogaine's potential in mainstream medicine.
Potential Positives
- Psyence BioMed received a public endorsement from President Donald J. Trump, emphasizing the potential for accelerated development of ibogaine as a medical treatment in the U.S.
- The company's leadership is actively engaging with stakeholders in Texas to discuss the evolving regulatory environment and advance ibogaine research, demonstrating proactive involvement in a growing market.
- Psyence BioMed's vertical integration and ownership of PsyLabs provides them with a robust manufacturing platform for pharmaceuticals, positioning them advantageously as the U.S. seeks to establish regulated pathways for ibogaine development.
Potential Negatives
- The press release heavily relies on an announcement made by President Trump, which may not convey a strong independent business message and could subject the company to political fluctuations.
- There are numerous speculative elements in the release regarding regulatory pathways and research opportunities for ibogaine, which could lead to uncertainty if those outcomes are not achieved.
- The company notes the lack of completed clinical trials for its products, indicating potential limitations in demonstrating efficacy and safety, which could hinder investor confidence and market acceptance.
FAQ
What is Psyence BioMed's focus in biopharmaceuticals?
Psyence BioMed specializes in developing nature-derived psychedelic compounds for clinical research and therapeutic applications.
What recent announcement did President Trump make regarding ibogaine?
President Trump announced support for accelerating ibogaine's development as a medical treatment, following the submission of a 1994 IND application by the University of Miami.
How is Psyence BioMed involved in ibogaine research?
Psyence BioMed is actively participating in ibogaine's development and holds manufacturing capabilities through its ownership interest in PsyLabs.
What is PsyLabs' role in Psyence BioMed's plans?
PsyLabs provides GMP-compliant manufacturing capabilities for psychedelic active pharmaceutical ingredients, including ibogaine hydrochloride, supporting clinical development efforts.
What is the current regulatory environment for ibogaine in the U.S.?
The regulatory environment is evolving, with increased engagement from government agencies interested in safely developing ibogaine as a pharmaceutical treatment.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
NEW YORK, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Psyence BioMed Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company focused on the development and supply of nature-derived psychedelic compounds for clinical research and therapeutic applications, today welcomed President Donald J. Trump’s latest announcement supporting the accelerated development of ibogaine as a potential medical treatment in the United States.
President Trump announced today that the University of Miami has provided the U.S. Federal Government with its original 1994 ibogaine Investigational New Drug (“IND”) application, which he said could help accelerate ibogaine’s development as a medical treatment in the United States.
The President also highlighted progress since his April Executive Order, including HHS research funding, HHS-VA collaboration, FDA guidance and efforts to expand Right to Try access for veterans.
President Trump concluded his statement with a call for additional companies and institutions to participate in the effort.
“This is what Psyence BioMed was built for,” said Jody Aufrichtig, Chief Executive Officer of Psyence BioMed. “The President has made clear that the United States wants serious companies and institutions to step forward and help advance ibogaine. We are ready to answer that call.”
Aufrichtig and Psyence BioMed Chief Financial Officer Warwick Corden-Lloyd are currently in Texas meeting with stakeholders and other leaders in the emerging U.S. ibogaine ecosystem to discuss recent progress, the evolving regulatory and policy environment, and opportunities to advance the responsible clinical development of ibogaine in the United States.
“The timing of the President’s announcement is particularly meaningful as Warwick and I are here in Texas engaging directly with stakeholders who are working to turn this growing momentum into tangible progress,” Aufrichtig added. “There is a real sense of urgency around this work, particularly for veterans, and Psyence BioMed intends to be an active participant in determining what comes next.”
Psyence BioMed has been building a vertically integrated pharmaceutical platform designed to support the regulated clinical development of ibogaine. The Company holds an ownership interest in PsyLabs, a pharmaceutical manufacturing operation producing GMP-compliant psychedelic active pharmaceutical ingredients, including ibogaine hydrochloride. Through PsyLabs, Psyence BioMed has access to pharmaceutical-grade manufacturing capabilities and an existing inventory of GMP-compliant ibogaine hydrochloride to support clinical development.
PsyLabs is a core component of Psyence BioMed’s ibogaine strategy, providing manufacturing infrastructure and pharmaceutical expertise as the United States moves toward establishing regulated pathways for ibogaine research and development.
“The conversation around ibogaine has changed dramatically,” Aufrichtig continued. “This is no longer a discussion taking place at the margins of medicine. The White House, HHS, the VA, FDA, researchers and states are increasingly asking how ibogaine can be studied safely, responsibly and at the standards expected of a pharmaceutical medicine. Those are exactly the questions we have been preparing to help answer.”
Psyence BioMed believes the Administration’s latest action reinforces the growing momentum toward regulated ibogaine development in the United States and the need for pharmaceutical-grade manufacturing, rigorous clinical development and close regulatory engagement.
Learn more about the company at www.psyencebiomed.com and on LinkedIn.
Contact Information for Psyence Biomedical Ltd.
Email: [email protected]
Media Inquiries: [email protected]
General Information: [email protected]
Phone: +1 416-477-1708
Investor Contact:
Michael Kydd
Investor Relations Advisor
[email protected]
About Psyence BioMed
Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics and the manufacturing of pharmaceutical-grade drug candidates. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin and ibogaine-based psychedelic medicine to be listed on Nasdaq. We are dedicated to addressing unmet mental health needs. We are committed to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders.
About PsyLabs
PsyLabs is a psychedelic Active Pharmaceutical Ingredient (API) development company, federally licensed to cultivate, extract, and export psilocybin mushrooms and other psychedelic compounds including psilocin, mescaline, ibogaine, and dimethyltryptamine (DMT) to legal medical and research markets. The company has successfully exported psilocybin products to Canada, the UK, Portugal, and Slovenia, and supplies purified extracts to its UK-based CMO partner.
PsyLabs operates from an ISO 22000 and GMP-compliant facility, ensuring the highest standards of safety and traceability. With a focus on natural compound purification, regulatory support, and global distribution, PsyLabs is expanding its product pipeline to include ibogaine and other next-generation psychedelics. www.psylabs.life
Forward Looking Statements
This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations, and intentions with respect to future operations, products and services; and other statements identified by words such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “believe,” “intend,” “plan,” “projection,” “outlook” or words of similar meaning.
Forward-looking statements in this communication include statements regarding the possible issuance, timing, scope and effect of any U.S. executive action or other governmental measures relating to ibogaine; the potential for such measures to support or accelerate regulated scientific and clinical research into ibogaine; the therapeutic potential of ibogaine and the development of future regulatory pathways for ibogaine-based products; Psyence BioMed’s ability to support global clinical research and future therapeutic development through its investment in PsyLabs and its GMP-compliant manufacturing capabilities; the Company’s ability to develop, maintain and scale an ethically sourced, sustainable and traceable ibogaine supply chain; and the Company’s expected role in supporting future research, development and commercialization activities relating to ibogaine. These forward-looking statements are based on a number of assumptions, including assumptions regarding the development of governmental policy relating to ibogaine, the continuation or expansion of interest in regulated psychedelic research, the availability of lawful research and development pathways, the Company’s ability to maintain required licenses, permits, supply arrangements, third-party relationships and manufacturing capabilities, and the Company’s ability to operate its sourcing and production activities in compliance with applicable legal, regulatory, ethical and environmental standards. There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.
These risks and uncertainties include, among others, the risk that: (i) any anticipated executive order or other governmental action is not issued, is delayed, or differs from current expectations; (ii) that any such action does not result in expanded research opportunities, clearer regulatory pathways, or any benefit to the Company; (iii) changes in laws, regulations or enforcement priorities in the United States, Southern Africa or other applicable jurisdictions; (iv) the continuing status of ibogaine as a controlled substance in relevant jurisdictions; (v) risks relating to clinical development, regulatory review and approval; (vi) competition and market adoption risks; (vii) and the Company’s ability to maintain compliance with Nasdaq continued listing standards. Additionally, there can be no assurance that the anticipated executive order will be issued, or, if issued, that it will have any particular scope, timing or effect on the Company, its operations, product candidates or applicable regulatory pathways. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the Company’s final prospectus (File No. 333-298285) filed with the Securities and Exchange Commission (the “SEC”) on November 3, 2025 and other documents filed by Psyence BioMed from time to time with the SEC.
These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, Psyence BioMed does not intend to update these forward-looking statements.
The Company does not make any medical, treatment or health benefit claims about its proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, ibogaine, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by authorized clinical research. There is no assurance that the use of psilocybin, psilocybin analogues, ibogaine, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of the proposed products. Any references to ibogaine stock, inventory, doses or similar references constitute the Company’s best estimates only, as such quantities may vary for several reasons. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company has verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
For purposes of this release, references to “GMP-compliant” mean that the relevant product is produced in a facility designed, operated and controlled in accordance with applicable Good Manufacturing Practice standards. Such references do not, in themselves, constitute a representation that the product, process or facility has been formally certified, approved or endorsed by any particular regulatory authority unless expressly stated. In addition, references to “at Source,” or similar expressions refer to supply activities conducted at the cultivation source in Africa. Such references are intended solely to describe the geographic origin and source-location of cultivation and supply activities, and do not, in themselves, constitute a representation regarding regulatory approval, pharmaceutical certification, product registration, or endorsement by any regulatory authority unless expressly stated.