Company preparing FDA meeting package to align on a single, well-controlled Phase 3 study under 505(b)(2); Pharma partner discussions ongoing
Toronto, Ontario--(Newsfile Corp. - October 16, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine, today announced that it has begun preparing its U.S. Food and Drug Administration ("FDA") briefing materials to discuss a Phase 3 program for ketamine in levodopa-induced dyskinesia in Parkinson's disease ("LID-PD") and that prospective pharma partners are currently evaluating potential collaboration structures for the registrational program and commercialization.
Key Updates
PharmaTher is preparing a Pre-Phase 3 (Type B) FDA package to confirm the registrational study design—including primary and key secondary endpoints—along with the safety monitoring plan and other requirements for a 505(b)(2) NDA in LID-PD, consistent with prior Agency feedback that a single, well-controlled trial may be sufficient in appropriate settings. The planned Phase 3 is designed to be de-risked by leveraging the 505(b)(2) pathway and existing clinical evidence, PharmaTher's FDA-reviewed CMC foundation, and intellectual-property coverage through 2036 (U.S. Patent No. 11,426,366). Prior Phase I/II work showed reductions in dyskinesias on the UDysRS at multiple time points (51% during Infusion 2; 49% at 3 weeks; 41% at 3 months), with ketamine generally safe and well tolerated; these data will inform the Phase 3 design. In parallel, the Company is in discussions with potential partners covering potential co-development and licensing.
Market Opportunity
As previously communicated, PharmaTher estimates a U.S. treated market opportunity of approximately US$0.75-$2.2 billion for an effective LID-PD therapy, informed by PD prevalence, LID incidence among levodopa-treated patients, and plausible treatment penetration and pricing assumptions.
Planned Near-Term Milestones
About the Phase 3 Strategy
PharmaTher's Phase 3 strategy seeks FDA agreement that a single, well-controlled Phase 3 study conducted under the 505(b)(2) pathway could support an NDA, with an appropriate safety monitoring plan and treatment duration suited to a chronic condition. The planned efficacy approach will center on dyskinesia severity and impact—such as the Unified Dyskinesia Rating Scale (UDysRS)—while pain and mood will be assessed as exploratory domains given their relevance in Parkinson's disease and ketamine's potential influence. On the CMC front, the Company intends to leverage validated analytical methods, specifications, and stability programs derived from its FDA-reviewed manufacturing foundation to streamline Phase 3 drug supply and reduce time and risk on the path to NDA submission.
About PharmaTher
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine. 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 have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary and Forward-Looking Statements
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. There can be no assurance that the Company will proceed with the clinical development and that the FDA will support any potential request for an expedited path to approval. These risks include, among others, the commercial performance of the ANDA product, FDA acceptance of the regulatory plan, clinical development, CMC package, regulatory approvals, market acceptance and opportunities, competition, market size, the Company programs being partnered. Readers are cautioned not to place undue reliance on forward-looking statements. PharmaTher disclaims any obligation to update or revise forward-looking statements except as required by law. In addition, this press release contains cautionary and forward-looking statements and information within the meaning of applicable Canadian securities legislation. These relate to future events or future performance. The use of any of the words "aim", "anticipate", "before", "believe", "closer", "confident", "could", "eligible", "enable", "ensure", "estimated", "expect", "intend", "lead", "leverage", "makes", "may", "mitigate", "plan", "position", "potential", "prior", "promise", "projected", "proposed", "provide", "purpose", "ready", "significant", "strong", "toward", "will", "would", and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in the Company's management's discussion and analysis for the year ended May 31, 2025, dated September 26, 2025, which is available on the Company's profile at www.sedarplus.ca.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/270646
Key Updates
PharmaTher is preparing a Pre-Phase 3 (Type B) FDA package to confirm the registrational study design—including primary and key secondary endpoints—along with the safety monitoring plan and other requirements for a 505(b)(2) NDA in LID-PD, consistent with prior Agency feedback that a single, well-controlled trial may be sufficient in appropriate settings. The planned Phase 3 is designed to be de-risked by leveraging the 505(b)(2) pathway and existing clinical evidence, PharmaTher's FDA-reviewed CMC foundation, and intellectual-property coverage through 2036 (U.S. Patent No. 11,426,366). Prior Phase I/II work showed reductions in dyskinesias on the UDysRS at multiple time points (51% during Infusion 2; 49% at 3 weeks; 41% at 3 months), with ketamine generally safe and well tolerated; these data will inform the Phase 3 design. In parallel, the Company is in discussions with potential partners covering potential co-development and licensing.
Market Opportunity
As previously communicated, PharmaTher estimates a U.S. treated market opportunity of approximately US$0.75-$2.2 billion for an effective LID-PD therapy, informed by PD prevalence, LID incidence among levodopa-treated patients, and plausible treatment penetration and pricing assumptions.
Planned Near-Term Milestones
- Q4 2025 — Q1 2026: Submit Pre-Phase 3 meeting request and briefing package; hold FDA meeting and receive minutes.
- Q1 — Q2 2026: Finalize Phase 3 protocol (primary and key secondary endpoints, inclusion/exclusion, statistical plan) per FDA feedback.
- 1H 2026 onward: Initiate Phase 3 activities, contingent on FDA alignment and partnering/financing.
About the Phase 3 Strategy
PharmaTher's Phase 3 strategy seeks FDA agreement that a single, well-controlled Phase 3 study conducted under the 505(b)(2) pathway could support an NDA, with an appropriate safety monitoring plan and treatment duration suited to a chronic condition. The planned efficacy approach will center on dyskinesia severity and impact—such as the Unified Dyskinesia Rating Scale (UDysRS)—while pain and mood will be assessed as exploratory domains given their relevance in Parkinson's disease and ketamine's potential influence. On the CMC front, the Company intends to leverage validated analytical methods, specifications, and stability programs derived from its FDA-reviewed manufacturing foundation to streamline Phase 3 drug supply and reduce time and risk on the path to NDA submission.
About PharmaTher
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine. 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 have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary and Forward-Looking Statements
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. There can be no assurance that the Company will proceed with the clinical development and that the FDA will support any potential request for an expedited path to approval. These risks include, among others, the commercial performance of the ANDA product, FDA acceptance of the regulatory plan, clinical development, CMC package, regulatory approvals, market acceptance and opportunities, competition, market size, the Company programs being partnered. Readers are cautioned not to place undue reliance on forward-looking statements. PharmaTher disclaims any obligation to update or revise forward-looking statements except as required by law. In addition, this press release contains cautionary and forward-looking statements and information within the meaning of applicable Canadian securities legislation. These relate to future events or future performance. The use of any of the words "aim", "anticipate", "before", "believe", "closer", "confident", "could", "eligible", "enable", "ensure", "estimated", "expect", "intend", "lead", "leverage", "makes", "may", "mitigate", "plan", "position", "potential", "prior", "promise", "projected", "proposed", "provide", "purpose", "ready", "significant", "strong", "toward", "will", "would", and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in the Company's management's discussion and analysis for the year ended May 31, 2025, dated September 26, 2025, which is available on the Company's profile at www.sedarplus.ca.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/270646
