Merus Receives FDA extension of PDUFA for zenocutuzumab
Merus announced that the FDA has extended the PDUFA goal date for zenocutuzumab (Zeno) Biologics License Application, currently under priority review. The new PDUFA date is February 4, 2025, allowing time to review recently submitted CMC information. No additional clinical data were requested. The company emphasizes that securing a commercialization partnership is important for making Zeno available to NRG1+ cancer patients, pending approval.
Merus ha annunciato che la FDA ha esteso la data obiettivo PDUFA per la Biologics License Application di zenocutuzumab (Zeno), attualmente in fase di revisione prioritaria. La nuova data PDUFA è il 4 febbraio 2025, per consentire la revisione delle recenti informazioni CMC presentate. Non sono stati richiesti ulteriori dati clinici. L'azienda sottolinea che ottenere un partenariato per la commercializzazione è importante per rendere disponibile Zeno ai pazienti affetti da cancro NRG1+, in attesa dell'approvazione.
Merus anunció que la FDA ha extendido la fecha objetivo PDUFA para la Solicitud de Licencia Biológica de zenocutuzumab (Zeno), que actualmente está bajo revisión prioritaria. La nueva fecha PDUFA es el 4 de febrero de 2025, permitiendo tiempo para revisar la información CMC presentada recientemente. No se solicitaron datos clínicos adicionales. La empresa enfatiza que asegurar un asociación comercial es importante para hacer que Zeno esté disponible para pacientes con cáncer NRG1+, a la espera de la aprobación.
Merus는 FDA가 현재 우선 심사 중인 제노쿠투주맙(Zeno)의 생물학적 라이센스 신청서를 위한 PDUFA 목표 날짜를 연장했다고 발표했습니다. 새로운 PDUFA 날짜는 2025년 2월 4일로, 최근에 제출된 CMC 정보를 검토할 시간을 허용합니다. 추가 임상 데이터는 요청되지 않았습니다. 회사는 상업화 파트너십 확보가 Zeno를 NRG1+ 암 환자에게 제공하는 데 중요하다고 강조하고 있습니다. 승인 대기 중입니다.
Merus a annoncé que la FDA a prolongé la date cible PDUFA pour la demande de licence biologique du zenocutuzumab (Zeno), actuellement en cours d'examen prioritaire. La nouvelle date PDUFA est le 4 février 2025, permettant d'examiner les informations CMC récemment soumises. Aucune donnée clinique supplémentaire n'a été demandée. La société souligne qu'assurer un partenariat de commercialisation est important pour rendre Zeno disponible pour les patients atteints de cancer NRG1+, en attente d'approbation.
Merus hat bekannt gegeben, dass die FDA das PDUFA-Zieltermin für die Biologics License Application von zenocutuzumab (Zeno), die derzeit einer prioritären Überprüfung unterliegt, verlängert hat. Das neue PDUFA-Datum ist der 4. Februar 2025, was Zeit zur Überprüfung der kürzlich eingereichten CMC-Informationen bietet. Es wurden keine zusätzlichen klinischen Daten angefordert. Das Unternehmen betont, dass die Sicherung einer Kommerzialisierungspartnerschaft wichtig ist, damit Zeno NRG1+-Krebspatienten zur Verfügung gestellt werden kann, beklagt die Genehmigung.
- No additional clinical data requested by FDA
- BLA remains under priority review status
- Extension primarily for CMC review, not clinical concerns
- PDUFA date delayed by FDA to February 4, 2025
- Commercialization partnership still needed for market launch
- Additional CMC information requirements from FDA
Insights
The FDA's PDUFA extension for zenocutuzumab represents a 3-month delay in the potential approval timeline, shifting from November 2024 to February 4, 2025. The extension stems from Chemistry, Manufacturing and Controls (CMC) information requirements rather than clinical efficacy concerns, which is relatively common in the regulatory process. The absence of additional clinical data requests suggests the FDA's primary focus is on manufacturing specifications and quality control.
The company's emphasis on securing a commercialization partnership is strategically important for market penetration in the NRG1+ cancer space. This targeted therapy addresses a specific genetic alteration found in various cancers, representing a precision medicine approach. The CMC review extension, while causing a slight delay, allows for a more thorough evaluation of manufacturing processes, which is important for maintaining consistent product quality in commercial production.
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for zenocutuzumab (Zeno) Biologics License Application (BLA) currently under priority review.
The US FDA has extended the PDUFA goal date to February 4, 2025 to enable sufficient time to review information recently submitted by the Company in response to a CMC information request. No additional clinical data have been requested.
Merus believes that obtaining a commercialization partnership agreement is an important step in bringing Zeno to patients with NRG1+ cancer, if approved.
About Merus N.V.
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus’ website, and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding the content and timing of regulatory developments and updates for zenocutuzumab; the BLA review, goal PDUFA date; and our belief that obtaining a commercialization partnership agreement is an important step in bringing Zeno to patients with NRG1+ cancer, if approved. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the volatility in the global economy, including global instability, including the ongoing conflicts in Europe and the Middle East; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended September 30, 2024, filed with the Securities and Exchange Commission, or SEC, on October 31, 2024, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.
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