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Psyence BioMed Welcomes U.S. Administration’s Latest Action to Accelerate Ibogaine Development

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Psyence BioMed (Nasdaq: PBM), a biopharmaceutical company focused on nature-derived psychedelic compounds, welcomed President Donald J. Trump’s August 18, 2026 announcement supporting accelerated ibogaine development in the U.S. The President cited renewed work with the University of Miami’s 1994 ibogaine IND and highlighted HHS funding, HHS‑VA collaboration, FDA guidance and efforts to expand Right to Try access for veterans.

According to Psyence BioMed, this growing federal commitment aligns with its vertically integrated ibogaine platform, centered on its ownership interest in PsyLabs, which manufactures GMP-compliant ibogaine hydrochloride. The company’s CEO and CFO are in Texas meeting stakeholders to discuss regulatory developments and opportunities for responsible ibogaine clinical development.

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Positive

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Negative

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Market Context

PBM’s low short-interest signal adds positioning context to this policy-linked announcement. The pla...
Analysis

PBM’s low short-interest signal adds positioning context to this policy-linked announcement. The platform record showed no same-day peer headline theme; regulatory milestones, clinical execution, and manufacturing readiness remained the key items to watch.

Key Figures

Original IND application: 1994 Announcement date: August 18, 2026
2 metrics
Original IND application 1994 University of Miami ibogaine application
Announcement date August 18, 2026 Psyence BioMed announcement

Historical Context

5 past events · Latest: May 15 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
May 15 Ibogaine supply initiative Positive -2.6% U.S. strategic engagement initiative focused on GMP ibogaine research and manufacturing
Apr 23 Phase IIb dosing Positive +0.7% First patient dosing initiated in Australian Phase IIb adjustment disorder trial
Apr 20 Ibogaine supply update Positive +48.7% Company highlighted licensed pharmaceutical-grade ibogaine supply and inventory
Apr 17 Ibogaine policy update Positive +29.5% Company welcomed U.S. executive action advancing ibogaine safety and therapeutic research
Apr 08 Clinical site expansion Positive -0.4% Australian clinical network expanded from three to five sites

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive developments produced mostly aligned reactions, but two of five events diverged, including a -2.58% response.

Key Terms

investigational new drug, gmp-compliant, active pharmaceutical ingredients, ibogaine hydrochloride
4 terms
investigational new drug regulatory
"original 1994 ibogaine Investigational New Drug (“IND”) application"
An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.
gmp-compliant technical
"a pharmaceutical manufacturing operation producing GMP-compliant psychedelic active pharmaceutical ingredients"
Good Manufacturing Practice (GMP) compliant means a maker follows established, inspectable rules for producing medicines, medical devices, or other regulated products so each batch is safe, consistent and of expected quality. For investors, GMP compliance lowers the chance of regulatory shutdowns, recalls or delays and increases the likelihood products can be sold; think of it as a verified recipe and checklist that keeps a factory from making faulty batches.
active pharmaceutical ingredients technical
"producing GMP-compliant psychedelic active pharmaceutical ingredients, including ibogaine hydrochloride"
The active pharmaceutical ingredient (API) is the specific chemical or biological substance in a medicine that produces the intended health effect — the ‘engine’ that treats, prevents or diagnoses a condition. Investors watch APIs because they determine a drug’s cost, quality, regulatory approval and patent protection; shortages, manufacturing problems or competition at the API level can directly affect a drug maker’s sales and valuation.
ibogaine hydrochloride medical
"existing inventory of GMP-compliant ibogaine hydrochloride to support clinical development"
A powerful psychoactive chemical derived from a West African plant, ibogaine hydrochloride produces intense, short-term hallucinations and is being studied as a potential treatment for severe substance dependence—often described as a kind of 'reset' for addictive behavior. Investors pay attention because its therapeutic promise comes with significant safety, cardiac and regulatory concerns; clinical results, approvals, or safety reports can quickly affect the valuations and risk profiles of companies developing it.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Company says growing federal commitment to ibogaine aligns directly with the pharmaceutical development and manufacturing platform Psyence BioMed has built

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: 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.


FAQ

What did President Trump announce about ibogaine on August 18, 2026 and how is Psyence BioMed (NASDAQ: PBM) involved?

President Trump highlighted renewed federal efforts to accelerate ibogaine development, including use of the 1994 University of Miami IND. According to Psyence BioMed, this aligns with its ibogaine-focused pharmaceutical platform and positions the company to participate in emerging U.S. clinical and regulatory pathways.

How does Psyence BioMed’s PsyLabs platform support ibogaine development in the United States?

Psyence BioMed holds an ownership interest in PsyLabs, which produces GMP-compliant psychedelic active pharmaceutical ingredients, including ibogaine hydrochloride. According to Psyence BioMed, PsyLabs provides pharmaceutical-grade manufacturing, existing ibogaine inventory and infrastructure to support regulated ibogaine research and clinical development as U.S. pathways evolve.

Why is Psyence BioMed’s leadership meeting stakeholders in Texas following the U.S. ibogaine policy announcement?

Psyence BioMed’s CEO and CFO are in Texas meeting stakeholders in the emerging U.S. ibogaine ecosystem. According to Psyence BioMed, they are discussing regulatory and policy developments, recent progress, and opportunities to advance responsible ibogaine clinical development, with a particular focus on urgent needs such as those of veterans.

What strategic opportunity does the new U.S. federal focus on ibogaine present for Psyence BioMed (PBM)?

The increased federal focus underscores demand for regulated, pharmaceutical-grade ibogaine development. According to Psyence BioMed, its vertically integrated platform and access to GMP ibogaine hydrochloride position the company to actively participate as the United States considers structured pathways for ibogaine research and potential medical use.

How does Psyence BioMed describe the changing regulatory conversation around ibogaine in the United States?

Psyence BioMed notes that ibogaine is moving from the margins of medicine into mainstream policy discussions. According to Psyence BioMed, the White House, HHS, VA, FDA, researchers and states are increasingly focused on how to study ibogaine safely and at pharmaceutical standards.

What role does Psyence BioMed see for itself in future U.S. ibogaine clinical development?

Psyence BioMed states it intends to be an active participant in determining next steps for ibogaine clinical development. According to Psyence BioMed, its manufacturing capabilities, existing GMP ibogaine inventory and regulatory engagement are designed to support rigorous, responsible ibogaine studies in the United States.