PharmaTher Announces Path to Ketamine Commercialization with No Planned Financing, Confirms FDA Approval Goal Date of August 9th, 2025 for Ketamine
PharmaTher (OTCQB: PHRRF) has announced significant progress in its ketamine commercialization strategy, with the FDA setting an approval goal date of August 9th, 2025. The company confirms it is fully funded through FDA approval and initial U.S. commercial launch, with no plans for new financing before the approval date.
The company has secured U.S.-based manufacturing and is preparing for international expansion in Europe, UK, Canada, Japan, and APAC regions in H2 2025. PharmaTher is targeting a ketamine market projected to reach $3.42 billion by 2034, growing at 16.4% CAGR from its current $750 million valuation. The company is also advancing new ketamine applications for conditions including Parkinson's disease, ALS, and CRPS through pre-INDs and INDs submissions.
PharmaTher (OTCQB: PHRRF) ha annunciato importanti progressi nella sua strategia di commercializzazione della ketamina, con la FDA che ha fissato come data obiettivo per l'approvazione l'9 agosto 2025. L'azienda conferma di essere completamente finanziata fino all'approvazione FDA e al lancio commerciale iniziale negli Stati Uniti, senza piani di nuovi finanziamenti prima di tale data.
La società ha assicurato una produzione basata negli Stati Uniti e si sta preparando per l'espansione internazionale in Europa, Regno Unito, Canada, Giappone e nelle regioni APAC nella seconda metà del 2025. PharmaTher punta a un mercato della ketamina previsto raggiungere 3,42 miliardi di dollari entro il 2034, con una crescita annua composta (CAGR) del 16,4% rispetto all'attuale valutazione di 750 milioni di dollari. L'azienda sta inoltre sviluppando nuove applicazioni della ketamina per patologie come il morbo di Parkinson, la SLA e la CRPS tramite sottomissioni pre-IND e IND.
PharmaTher (OTCQB: PHRRF) ha anunciado avances significativos en su estrategia de comercialización de ketamina, con la FDA estableciendo como fecha objetivo de aprobación el 9 de agosto de 2025. La empresa confirma que está completamente financiada hasta la aprobación de la FDA y el lanzamiento comercial inicial en EE. UU., sin planes de financiamiento adicional antes de esa fecha.
La compañía ha asegurado la fabricación en EE. UU. y se está preparando para la expansión internacional en Europa, Reino Unido, Canadá, Japón y las regiones APAC en la segunda mitad de 2025. PharmaTher apunta a un mercado de ketamina que se proyecta alcance los 3.42 mil millones de dólares para 2034, creciendo a una tasa compuesta anual (CAGR) del 16.4% desde su valoración actual de 750 millones de dólares. La empresa también está avanzando en nuevas aplicaciones de ketamina para enfermedades como Parkinson, ELA y CRPS mediante presentaciones pre-IND e IND.
PharmaTher (OTCQB: PHRRF)는 케타민 상용화 전략에서 중요한 진전을 발표했으며, FDA가 승인 목표일을 2025년 8월 9일로 설정했습니다. 회사는 FDA 승인과 미국 내 초기 상용 출시까지 완전한 자금 조달이 되어 있으며, 승인일 이전에 추가 자금 조달 계획이 없음을 확인했습니다.
회사는 미국 내 제조를 확보했으며 2025년 하반기에 유럽, 영국, 캐나다, 일본 및 아시아 태평양(APAC) 지역으로 국제 확장을 준비 중입니다. PharmaTher는 2034년까지 34억 2천만 달러에 이를 것으로 예상되는 케타민 시장을 목표로 하고 있으며, 현재 7억 5천만 달러 평가액에서 연평균 16.4%의 성장률(CAGR)을 보이고 있습니다. 또한 파킨슨병, ALS, CRPS 등 질환을 위한 새로운 케타민 적용을 위해 pre-IND 및 IND 제출을 진행 중입니다.
PharmaTher (OTCQB : PHRRF) a annoncé des progrès significatifs dans sa stratégie de commercialisation de la kétamine, avec la FDA fixant une date cible d'approbation au 9 août 2025. La société confirme qu'elle est entièrement financée jusqu'à l'approbation par la FDA et le lancement commercial initial aux États-Unis, sans prévisions de nouveaux financements avant cette date.
L'entreprise a sécurisé une production basée aux États-Unis et se prépare à une expansion internationale en Europe, au Royaume-Uni, au Canada, au Japon et dans les régions APAC au second semestre 2025. PharmaTher vise un marché de la kétamine estimé à 3,42 milliards de dollars d'ici 2034, avec un taux de croissance annuel composé (CAGR) de 16,4 % à partir de sa valorisation actuelle de 750 millions de dollars. La société fait également progresser de nouvelles applications de la kétamine pour des pathologies telles que la maladie de Parkinson, la SLA et le CRPS via des soumissions pre-IND et IND.
PharmaTher (OTCQB: PHRRF) hat bedeutende Fortschritte bei seiner Ketamin-Kommerzialisierungsstrategie bekannt gegeben, wobei die FDA ein Ziel-Datum für die Zulassung auf den 9. August 2025 festgelegt hat. Das Unternehmen bestätigt, dass es bis zur FDA-Zulassung und dem ersten US-Produktlaunch vollständig finanziert ist und keine Pläne für neue Finanzierungen vor diesem Datum bestehen.
Das Unternehmen hat eine US-basierte Produktion gesichert und bereitet sich auf eine internationale Expansion in Europa, Großbritannien, Kanada, Japan und die APAC-Regionen in der zweiten Hälfte des Jahres 2025 vor. PharmaTher zielt auf einen Ketamin-Markt ab, der bis 2034 voraussichtlich 3,42 Milliarden US-Dollar erreichen wird, mit einer jährlichen Wachstumsrate (CAGR) von 16,4 % ausgehend von einem aktuellen Wert von 750 Millionen US-Dollar. Das Unternehmen arbeitet zudem an neuen Ketamin-Anwendungen für Erkrankungen wie Parkinson, ALS und CRPS durch Pre-IND- und IND-Einreichungen.
- FDA approval goal date set for August 9th, 2025, providing clear regulatory timeline
- Company fully funded through FDA approval and initial U.S. commercial launch with no dilutive financing planned
- Secured U.S.-based manufacturing ensuring supply chain control
- Targeting expansion into multiple international markets in H2 2025
- Operating in growing market projected to reach $3.42B by 2034 with 16.4% CAGR
- Success heavily dependent on FDA approval outcome
- Faces potential competition in rapidly growing ketamine market
- Multiple regulatory approvals needed for international expansion
TORONTO, July 02, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on the development and commercialization of ketamine-based pharmaceuticals, is pleased to provide a corporate update to its shareholders, outlining a clear strategy to become the global leader in unlocking the pharmaceutical potential of ketamine. The Company has reached a pivotal stage in its growth, marked by a defined regulatory timeline and a strategic plan for commercial and international expansion for its ketamine-based products.
Key Highlights:
- FDA Approval Goal Date Set: The U.S. Food and Drug Administration (FDA) has set its approval goal date of August 9, 2025, for the potential approval of PharmaTher’s ketamine product on or before this date.
- Fully-Funded for Commercial Launch: PharmaTher is fully-funded through its FDA approval goal date of August 9, 2025, and for its initial U.S. commercial launch.
- Commitment to Shareholder Value: The Company has no plans for new equity or debt financing before the FDA approval goal date, underscoring its confidence in its current cash position and commitment to mitigating shareholder dilution through its existing capital structure.
- Secure, US-Based Manufacturing: The manufacturing for the Company’s ketamine product is based in the United States, ensuring supply chain security, quality control, and readiness for commercial scale-up.
- Strategic Global Expansion: PharmaTher is preparing for international regulatory submissions in Europe, the United Kingdom, Canada, Japan, and the APAC regions, expected to commence in the second half of 2025.
- Advancing New Indications Inspired by HHS Initiatives on Psychedelics: The Company is actively exploring the expansion of ketamine's therapeutic applications, inspired by growing bipartisan support for psychedelic-assisted therapies, including recent federal initiatives on Kennedy-backed Make America Healthy Again movement. The Company has already submitted pre-INDs and INDs for ketamine in indications such as Parkinson's disease, ALS, CRPS, and for novel delivery systems, including an on-body wearable pump and microneedle patch.
A Clear Pathway to U.S. Market Approval
The establishment of an FDA approval goal date of August 9, 2025, represents the single most significant milestone in the Company’s history. This date provides investors with a clear and material catalyst, marking the culmination of years of dedicated research and development. An FDA approval would unlock a multi-billion-dollar market opportunity and establish PharmaTher as a frontrunner in the regulated psychedelics space, specifically by unlocking the pharmaceutical potential of ketamine. The current global market for ketamine is valued at
Fabio Chianelli, CEO of PharmaTher, stated, “Receiving an approval goal date from the FDA provides a clear line of sight to potential approval and commercialization for our ketamine product. Our primary focus between now and August 9, 2025, is executing on our pre-commercial strategy. We have the team, the capital, and the plan in place to deliver on our commitment. We believe this milestone significantly de-risks our path forward and presents a powerful value proposition for our shareholders.”
Financial Strength and Commitment to Shareholders
In a market environment where capital preservation is paramount, PharmaTher stands in a sound position. The Company is funded for all planned operations, including regulatory affairs, marketing preparations, and the initial U.S. commercial launch of ketamine.
“We have been diligent in our financial management to ensure we can achieve our objectives without diluting our shareholders’ stake in our collective success,” continued Mr. Chianelli. “Our current plan is not to seek any new equity or debt financing before our FDA approval goal date on August 9, 2025.”
Commercial Readiness and Future Growth
With a secure, U.S.-based manufacturing partner, PharmaTher has mitigated potential supply chain disruptions and is well-prepared to meet anticipated market demand upon approval for ketamine. Looking beyond the initial U.S. launch of ketamine, PharmaTher is positioning itself for global leadership. The Company is preparing regulatory dossiers for submission to key international bodies, including the European Medicines Agency (EMA) and Health Canada, beginning in H2 2025. This global expansion strategy signifies our commitment to growth and leadership in ketamine-based pharmaceuticals.
Furthermore, PharmaTher is at the forefront of the next wave of psychedelic medicine. Inspired by growing legislative momentum and support from influential figures like Robert F. Kennedy Jr. for expanded access and research into psychedelic therapies, the Company is strategizing to broaden its clinical pipeline. PharmaTher aims to leverage its expertise in ketamine to explore new indications and combination therapies, solidifying its role as an innovator in psychiatric, pain and neurological disorders.
“We are building a global ketamine pharmaceutical franchise,” concluded Mr. Chianelli. “The upcoming FDA approval goal date is our beachhead. From there, we will expand globally and into new indications, driven by science and a commitment to patients. We believe the coming 12-18 months will be transformative for PharmaTher, and we are thrilled to have our shareholders on this exciting journey.”
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the research and commercialization of KETARX™ (Ketamine) to fill the unmet medical needs for surgery, pain, mental health, neurological, and medical countermeasures indications. Learn more at 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 Statement
This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “closer”, "could", “confident”, "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, “provide”, “mitigate”, “before”, “prior”, 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 Company's management's discussion and analysis for the three and nine months ended February 28, 2025 dated April 24, 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.
FAQ
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