PharmaTher Highlights Strategic Ketamine Opportunity Following New U.S. Executive Order on Psychedelic Treatments for Serious Mental Illness
Rhea-AI Summary
PharmaTher (OTCQB: PHRRF) says a U.S. executive order on accelerating treatments for serious mental illness (April 18, 2026) could create a more supportive regulatory backdrop for its ketamine programs. The company highlights its KetaVault partnership portal, a completed IND‑enabling PK/tolerability study for a ketamine microneedle patch, retained ketamine programs, and ongoing upside from a prior FDA‑approved ketamine ANDA sale that may generate more than US$25 million over time, subject to commercial performance.
Positive
- Potential >US$25M in milestone/profit payments from prior ANDA sale
- Completed IND‑enabling PK/tolerability study for ketamine microneedle patch
- KetaVault portal enables data licensing and partnership acceleration
Negative
- ANDA payments are contingent on commercial performance, not guaranteed
- Policy tailwind is non‑binding and may not speed approvals
News Market Reaction – PHRRF
In the Apr 21 session, PHRRF gained 3.61%, reflecting a moderate positive market reaction.
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Company believes supportive U.S. policy momentum may strengthen the strategic value of its ketamine patch, KetaVault™ platform, retained ketamine programs, and prior FDA-approved ketamine ANDA transaction
Toronto, Ontario--(Newsfile Corp. - April 21, 2026) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) ("PharmaTher" or the "Company"), a specialty pharmaceutical company, today announced that it believes the recent U.S. executive order, "Accelerating Medical Treatments for Serious Mental Illness," signed on April 18, 2026, may help create a more supportive political and regulatory backdrop for innovative ketamine-based programs, particularly where severe unmet need, depression, suicidality, and other difficult-to-treat mental health conditions are involved.
"We believe the recent U.S. executive order is another signal that policymakers are placing greater urgency on advancing new treatment options for serious mental illness," said Fabio Chianelli, Chief Executive Officer of PharmaTher. "We believe this evolving regulatory environment strengthens the strategic value of our ketamine portfolio, including our microneedle patch program, KetaVault™ partnership portal, retained specialty ketamine programs, and our ongoing economic exposure from the prior sale of our FDA-approved ketamine ANDA."
Supportive U.S. Policy Momentum for Serious Mental Illness
The executive order is focused on psychedelic drugs for serious mental illness and emphasizes accelerated research, clinical trial participation, data sharing, and real-world evidence generation, including collaboration among HHS, FDA, the Department of Veterans Affairs, and the private sector. PharmaTher believes the broader direction of U.S. policy reflects growing support for accelerating the development of important therapies for patients with severe and treatment-resistant mental health conditions. These measures could contribute to a more supportive backdrop for advancing differentiated ketamine programs, particularly in areas involving severe unmet need, mental health, and veteran-focused treatment opportunities.
Re-Emphasizing the Ketamine Patch Opportunity
PharmaTher believes its ketamine microneedle patch program could represent an important differentiated opportunity within this evolving environment. The Company has previously reported completion of an IND-enabling pharmacokinetic and tolerability study for its ketamine patch and has described the program as part of its broader effort to develop patient-friendly ketamine delivery options across mental health, neurological, and pain disorders. PharmaTher believes a patch-based approach could offer strategic lifecycle value through controlled and sustained delivery, reduced treatment burden, and broader commercial flexibility.
Figure 1. Representative image of PharmaTher's PharmaPatch™ ketamine microneedle patch and close-up of the microneedle array.
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https://images.newsfilecorp.com/files/11479/293536_996791f8f45d9be3_001full.jpg
FDA-Approved Ketamine Foundation Provides Ongoing Upside
In addition to its proprietary development programs, PharmaTher believes its prior FDA approval for its generic ketamine (ANDA #217858) remains strategically important. The Company previously sold its U.S. ketamine ANDA to a sterile-injectables pharmaceutical company and disclosed that the transaction could generate more than US
Broader Ketamine Portfolio Remains in Place
PharmaTher has stated that the ANDA sale did not include its broader ketamine portfolio and that the Company continues to own its ketamine-based programs for Parkinson's disease, amyotrophic lateral sclerosis, and complex regional pain syndrome, as well as its ketamine microneedle patch program. While these neurological and pain programs are separate from the executive order's specific focus on serious mental illness, PharmaTher believes they remain important long-term assets within its broader ketamine strategy and could continue to benefit from increasing strategic and commercial interest in differentiated ketamine development.
KetaVault™ Strengthens PharmaTher's Partnership and Platform Value
PharmaTher believes KetaVault™ strengthens its ketamine platform by offering a proprietary portal to proprietary ketamine data (including INDs, CMC, and clinical data) for pharmaceutical, biotech, academic, and government entities. This portal could accelerate partnerships and commercial planning across mental health, neurology, pain, and other ketamine opportunities. With increasing policy focus on serious mental illness, PharmaTher believes its differentiated delivery technology, retained ketamine rights, regulatory experience, and partnership-enabling platforms such as KetaVault™ position it well to advance its ketamine programs through internal development, strategic collaborations, and regulatory engagement.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty pharmaceutical company focused on developing, acquiring, and commercializing pharmaceutical products and enabling technologies. For more information, visit PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. Forward-looking statements in this release include, but are not limited to, statements regarding: the potential impact, significance, interpretation, or timing of the recent U.S. executive order and related governmental or regulatory developments concerning serious mental illness; the extent to which such developments may create a supportive political, regulatory, clinical, or commercial backdrop for ketamine-based programs; the future development, regulatory pathway, differentiation, strategic value, and commercial potential of PharmaTher's ketamine microneedle patch program and other proprietary ketamine delivery technologies; the strategic value and potential utility of KetaVault™ as a platform to support partnering, development, and commercialization opportunities; the Company's ability to enter into strategic collaborations or other transactions relating to its ketamine programs, technologies, or data assets; the Company's ability to derive economic benefit from the prior sale of its U.S. ketamine ANDA, including potential milestone and profit-sharing payments; the continued development, value, and strategic relevance of the Company's ketamine-based programs for Parkinson's disease, amyotrophic lateral sclerosis, complex regional pain syndrome, mental health, and other indications; and the Company's ability to advance its ketamine-based programs through internal development, strategic collaborations, regulatory engagement, and other strategic initiatives. Forward-looking statements are often identified by words such as "believe," "expect," "plan," "intend," "may," "could," "would," "should," "anticipate," "potential," "opportunity," and similar expressions. These statements are based on management's current expectations, assumptions, and beliefs as of the date of this news release and are subject to known and unknown risks, uncertainties, and other factors that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: uncertainties relating to the interpretation, implementation, and effect of executive, governmental, or regulatory actions; the risk that any political or regulatory developments may not result in any direct benefit to ketamine-based products or programs; risks relating to research and development, clinical progress, regulatory review, manufacturing and supply, intellectual property protection, data access, market acceptance, competition, financing requirements, and general economic, industry, and capital markets conditions; the ability to secure and maintain strategic partnerships or other transactions; and the ability to realize any economic benefit from the prior ANDA transaction. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, PharmaTher undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Additional risk factors are described in the Company's MD&A for the three and six months ended November 30, 2025, dated January 29, 2026, available on SEDAR+.
This news release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful.
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