Psyence BioMed Announces U.S. Strategic Engagement Initiative Focused on GMP Ibogaine Research and Manufacturing
Rhea-AI Summary
Psyence BioMed (Nasdaq: PBM) announced a U.S. strategic engagement initiative focused on GMP ibogaine research and manufacturing. Executives will meet U.S. researchers, institutions, industry leaders, and government stakeholders to discuss regulatory, scientific, and infrastructure needs for pharmaceutical-grade ibogaine suitable for regulated clinical research.
Through its PsyLabs investment, the company operates a GMP-compliant facility in Southern Africa, supporting ethical sourcing, cultivation, extraction, purification, and scalable manufacturing of natural psychedelic compounds, including ibogaine. Psyence BioMed reports growing interest from U.S.-based researchers seeking compliant ibogaine supply for future regulated studies.
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News Market Reaction – PBM
In the May 15 session, PBM declined 2.58%, reflecting a moderate negative market reaction. Argus tracked a peak move of +5.1% during that session. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 23 | Clinical dosing update | Positive | +0.7% | First patient dosed in Phase IIb NPX-5 trial across five Australian sites. |
| Apr 20 | Ibogaine supply positioning | Positive | +48.7% | Highlighted GMP-compliant, vertically integrated ibogaine supply chain and inventory. |
| Apr 17 | U.S. ibogaine policy | Positive | +29.5% | Welcomed U.S. executive action and stressed leadership in GMP ibogaine manufacturing. |
| Apr 08 | Site network expansion | Positive | -0.4% | Expanded Australian clinical network to five sites for NPX-5 Phase IIb trial. |
| Mar 11 | Corporate platform update | Positive | -0.8% | Outlined debt-free status and PsyLabs-backed, vertically integrated GMP platform. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent ibogaine and GMP supply-related announcements have often coincided with strong positive moves, while some NPX-5 clinical and corporate platform updates saw muted or negative reactions, indicating selective enthusiasm for certain catalysts.
Over the last six months, PBM has highlighted progress on two fronts: its NPX-5 psilocybin program and its GMP ibogaine supply platform. On Mar 11, 2026, it emphasized a debt-free, vertically integrated GMP platform and a first export milestone. Through early April, it expanded Australian clinical sites to five and then initiated Phase IIb dosing. Later in April, news positioning PBM as a GMP ibogaine supplier at source and welcoming U.S. action on ibogaine aligned with sharp single-day gains. Today’s U.S. engagement initiative builds directly on that ibogaine and policy narrative.
Key Terms
good manufacturing practice regulatory
gmp regulatory
pharmaceutical-grade technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
NEW YORK, May 15, 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 announced that members of its executive leadership team will travel to the United States in the coming weeks to meet with researchers, institutions, industry leaders, and government stakeholders involved in advancing psychedelic medicine research and policy initiatives.
The visit follows recent U.S. policy developments supporting increased research collaboration, regulatory review pathways, and clinical investigation involving psychedelic compounds, including ibogaine.
As part of the Company’s engagement efforts, Psyence BioMed Chief Executive Officer Jody Aufrichtig recently submitted a formal letter to President Donald J. Trump and U.S. Secretary of Health and Human Services Robert F. Kennedy Jr., applauding the Administration’s leadership in advancing research initiatives involving psychedelic compounds and expanding pathways for scientific collaboration and innovation.
The purpose of the Company’s upcoming U.S. engagement initiative is to educate and inform stakeholders on the complexity, regulatory considerations, and scientific infrastructure required to manufacture pharmaceutical-grade ibogaine under Good Manufacturing Practice (“GMP”) standards suitable for regulated clinical research.
Through its strategic investment in PsyLabs, Psyence BioMed has established active ibogaine operations and manufacturing capabilities in Africa – the natural and original source of ibogaine. The Company believes it is among a limited number of organizations globally capable of producing natural, pharmaceutical-grade ibogaine at scale under pharmaceutical compliant GMP conditions.
PsyLabs operates a GMP-compliant facility in Southern Africa focused on the cultivation, extraction, purification, and manufacturing of highly purified psychedelic compounds from natural sources. Psyence BioMed’s vertically integrated model supports ethical sourcing practices, quality control, analytical testing, and scalable supply chain management designed to support future clinical research demand.
“We believe global interest in ibogaine research continues to accelerate, particularly as policymakers, researchers, and healthcare institutions explore innovative approaches to serious mental health conditions,” said Jody Aufrichtig, Chief Executive Officer of Psyence BioMed. “Our objective during this visit is to contribute constructively to those conversations by sharing our expertise and helping stakeholders better understand the highly specialized process required to produce compliant pharmaceutical-grade ibogaine suitable for regulated research environments.”
The Company noted that following recent U.S. policy announcements, it has experienced increased engagement from U.S.-based researchers and institutions seeking information regarding compliant ibogaine manufacturing capabilities and supply availability for future regulated research initiatives.
Psyence BioMed believes its operational footprint in Africa, vertically integrated infrastructure, and existing GMP inventory position the Company strategically within the emerging global ibogaine supply ecosystem.
Investor and Meeting Inquiries
Researchers, institutions, government stakeholders, and industry organizations interested in arranging a meeting or presentation with Psyence BioMed during the Company’s upcoming U.S. visit are encouraged to contact:
Michael Kydd
Public Affairs Specialist
michael@psyencebiomed.com
Learn more about the company at www.psyencebiomed.com and on LinkedIn.
Contact Information for Psyence Biomedical Ltd.
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Michael Kydd
Investor Relations Advisor
michael@psyencebiomed.com
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.
