PharmaTher Announces FDA Extends Review Period for Ketamine; New Approval Goal Date August 9, 2025
PharmaTher Holdings (OTCQB: PHRRF) announced that the FDA has extended its review period for the company's ketamine new drug application. The new approval goal date is set for August 9, 2025, pushed back from the original June 4, 2025 date. The extension is due to the FDA requiring additional time to review information requests, classified as a minor amendment.
The company confirmed it has already addressed all issues from the FDA's previous Complete Response Letter from October 2024. CEO Fabio Chianelli stated that the extension is not expected to significantly impact PharmaTher's operational, business development, and commercialization initiatives for 2025.
PharmaTher Holdings (OTCQB: PHRRF) ha annunciato che la FDA ha prorogato il periodo di revisione per la domanda di nuovo farmaco a base di ketamina dell'azienda. La nuova data obiettivo per l'approvazione è fissata per il 9 agosto 2025, posticipata rispetto alla data iniziale del 4 giugno 2025. L'estensione è dovuta alla necessità della FDA di più tempo per esaminare le richieste di informazioni, classificate come modifica minore.
L'azienda ha confermato di aver già risolto tutte le problematiche evidenziate nella precedente Lettera di Risposta Completa della FDA di ottobre 2024. Il CEO Fabio Chianelli ha dichiarato che l'estensione non dovrebbe influire in modo significativo sulle iniziative operative, di sviluppo commerciale e di commercializzazione di PharmaTher per il 2025.
PharmaTher Holdings (OTCQB: PHRRF) anunció que la FDA ha extendido el período de revisión para la solicitud de nuevo medicamento de ketamina de la compañía. La nueva fecha objetivo de aprobación está establecida para el 9 de agosto de 2025, retrasándose desde la fecha original del 4 de junio de 2025. La extensión se debe a que la FDA requiere más tiempo para revisar las solicitudes de información, clasificadas como una modificación menor.
La compañía confirmó que ya ha abordado todos los problemas señalados en la Carta de Respuesta Completa previa de la FDA de octubre de 2024. El CEO Fabio Chianelli afirmó que la extensión no se espera que impacte significativamente las iniciativas operativas, de desarrollo comercial y de comercialización de PharmaTher para 2025.
PharmaTher Holdings (OTCQB: PHRRF)는 FDA가 회사의 케타민 신약 신청서에 대한 검토 기간을 연장했다고 발표했습니다. 새 승인 목표일은 원래 2025년 6월 4일에서 2025년 8월 9일로 연기되었습니다. 이번 연장은 FDA가 추가 정보 요청을 검토하는 데 더 많은 시간이 필요했기 때문이며, 이는 경미한 수정 사항으로 분류되었습니다.
회사는 이미 2024년 10월 FDA의 완전 응답서에서 제기된 모든 문제를 해결했다고 확인했습니다. CEO Fabio Chianelli는 이번 연장이 2025년 PharmaTher의 운영, 사업 개발 및 상업화 계획에 큰 영향을 미치지 않을 것으로 예상한다고 밝혔습니다.
PharmaTher Holdings (OTCQB : PHRRF) a annoncé que la FDA a prolongé la période d'examen de la demande de nouveau médicament de la société concernant la kétamine. La nouvelle date cible d'approbation est fixée au 9 août 2025, repoussée par rapport à la date initiale du 4 juin 2025. Cette extension est due au fait que la FDA nécessite plus de temps pour examiner les demandes d'informations, classées comme une modification mineure.
La société a confirmé avoir déjà résolu tous les problèmes soulevés dans la lettre de réponse complète précédente de la FDA d'octobre 2024. Le PDG Fabio Chianelli a déclaré que cette extension ne devrait pas avoir d'impact significatif sur les initiatives opérationnelles, de développement commercial et de commercialisation de PharmaTher pour 2025.
PharmaTher Holdings (OTCQB: PHRRF) gab bekannt, dass die FDA die Prüfungsfrist für den neuen Zulassungsantrag des Unternehmens für Ketamin verlängert hat. Das neue Zielgenehmigungsdatum ist auf den 9. August 2025 verschoben worden, ursprünglich war der 4. Juni 2025 vorgesehen. Die Verlängerung erfolgt, weil die FDA mehr Zeit benötigt, um Informationsanfragen zu prüfen, die als geringfügige Änderung eingestuft wurden.
Das Unternehmen bestätigte, dass alle Probleme aus dem vorherigen vollständigen Antwortschreiben der FDA vom Oktober 2024 bereits behoben wurden. CEO Fabio Chianelli erklärte, dass die Verlängerung voraussichtlich keine wesentlichen Auswirkungen auf die operativen, geschäftlichen Entwicklungs- und Vermarktungsinitiativen von PharmaTher im Jahr 2025 haben wird.
- None.
- FDA approval timeline delayed by approximately 2 months
- Additional information requests from FDA requiring review
TORONTO, May 16, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) ("PharmaTher" or the "Company"), a specialty pharmaceutical company focused on ketamine for unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has extended the approval goal date for the review of its new drug application for ketamine. The new approval goal date is August 9, 2025, revised from the previous date of June 4, 2025. The extension allows the FDA additional time to review additional information requests, which the FDA has classified as a MINOR amendment. Importantly, this is not a Complete Response Letter. PharmaTher confirms it has previously addressed all issues raised in the FDA's Complete Response Letter dated October 22, 2024.
"While we were prepared for a decision by June 4, 2025, we acknowledge the FDA's need for additional time to review our recent submission and additional information request for the ketamine new drug application," said Fabio Chianelli, CEO of PharmaTher. "We do not anticipate this extension to August 9, 2025, will materially impact our ongoing operational, business development, and commercialization initiatives for 2025."
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
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FAQ
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