Chimerix to Speak Today at The White House Cancer Moonshot Forum
Chimerix (NASDAQ: CMRX) announced that Chief Scientific Officer Dr. Joshua E. Allen will speak at the Biden Cancer Moonshot Mission Report 2024 forum. The presentation will focus on the program's impact on advancing therapies for brain and rare pediatric cancers, particularly H3 K27M-mutant diffuse glioma.
CEO Mike Andriole highlighted the Cancer Moonshot's achievements in improving health equity in clinical trials and expanding pediatric cancer patient navigation services. Dr. Allen emphasized the program's role as a critical platform for advancing innovation in pediatric and rare cancers.
The company recently submitted a New Drug Application (NDA) for dordaviprone to the FDA, seeking accelerated approval for recurrent H3 K27M-mutant diffuse glioma. With a requested Priority Review, a PDUFA action date could be set for Q3 2025. Dordaviprone has received Rare Pediatric Disease Designation and has applied for a Rare Pediatric Disease Priority Review Voucher.
Chimerix (NASDAQ: CMRX) ha annunciato che il Chief Scientific Officer, Dr. Joshua E. Allen, parlerà al forum del Biden Cancer Moonshot Mission Report 2024. La presentazione si concentrerà sull'impatto del programma nell'avanzare le terapie per i tumori cerebrali e rari pediatrici, in particolare sul glioma diffuso mutante H3 K27M.
Il CEO Mike Andriole ha evidenziato i successi del Cancer Moonshot nel migliorare l'equità nella salute negli studi clinici e nell'espandere i servizi di navigazione per i pazienti pediatrici affetti da cancro. Il Dr. Allen ha sottolineato il ruolo del programma come piattaforma fondamentale per promuovere l'innovazione nei tumori pediatrici e rari.
Recentemente, l'azienda ha presentato una Domanda di Nuovo Farmaco (NDA) per dordaviprone alla FDA, richiedendo l'approvazione accelerata per il glioma diffuso mutante H3 K27M recidivante. Con una richiesta di Revisione Prioritaria, una data per l'azione PDUFA potrebbe essere fissata per il terzo trimestre del 2025. Il dordaviprone ha ricevuto la Designazione di Malattia Pediatrica Rara e ha richiesto un Voucher per la Revisione Prioritaria della Malattia Pediatrica Rara.
Chimerix (NASDAQ: CMRX) anunció que el Director Científico, Dr. Joshua E. Allen, hablará en el foro del Informe de la Misión Biden Cancer Moonshot 2024. La presentación se centrará en el impacto del programa en el avance de terapias para cánceres cerebrales y raros pediátricos, particularmente en el glioma difuso mutante H3 K27M.
El CEO Mike Andriole destacó los logros del Cancer Moonshot en la mejora de la equidad en salud en ensayos clínicos y la expansión de los servicios de navegación para pacientes pediátricos con cáncer. El Dr. Allen enfatizó el papel del programa como una plataforma crítica para avanzar en la innovación en cánceres pediátricos y raros.
La empresa ha presentado recientemente una Solicitud de Nuevo Medicamento (NDA) para dordaviprone a la FDA, buscando la aprobación acelerada para el glioma difuso mutante H3 K27M recurrente. Con una solicitud de Revisión Prioritaria, podría establecerse una fecha de acción PDUFA para el tercer trimestre de 2025. El dordaviprone ha recibido la Designación de Enfermedad Pediátrica Rara y ha solicitado un Vale de Revisión Prioritaria para Enfermedades Pediátricas Raras.
Chimerix (NASDAQ: CMRX)는 최고 과학 책임자 Dr. Joshua E. Allen이 2024년 바이든 암 문샷 미션 보고서 포럼에서 발표할 것이라고 발표했습니다. 발표는 H3 K27M 변이 확산 교모세포종을 포함하여 뇌암 및 희귀 소아암 치료법 발전에 대한 프로그램의 영향을 중심으로 진행될 것입니다.
CEO Mike Andriole은 임상 시험에서 건강 형평성을 개선하고 소아암 환자 탐색 서비스 확대에서의 Cancer Moonshot의 성과를 강조했습니다. Allen 박사는 프로그램이 소아 및 희귀 암 분야에서 혁신을 발전시키기 위한 중요한 플랫폼 역할을 한다고 강조했습니다.
회사는 최근 신약 신청(NDA)을 위해 dordaviprone을 FDA에 제출했으며, 재발성 H3 K27M 변이 확산 교모세포종에 대한 가속 승인을 요청하고 있습니다. 우선 검토 요청과 함께 PDUFA 조치 날짜는 2025년 3분기로 설정될 수 있습니다. dordaviprone은 희귀 소아질환 지정이 되었으며, 희귀 소아질환 우선 검토 바우처를 신청했습니다.
Chimerix (NASDAQ: CMRX) a annoncé que le directeur scientifique, Dr. Joshua E. Allen, prendra la parole lors du forum du Rapport Mission Cancer Moonshot de Biden 2024. La présentation se concentrera sur l'impact du programme dans l'avancement des thérapies pour les cancers cérébraux et rares pédiatriques, notamment le gliome diffus mutant H3 K27M.
Le PDG Mike Andriole a souligné les réalisations du Cancer Moonshot en matière d'amélioration de l'équité en santé dans les essais cliniques et de l'expansion des services de navigation pour les patients pédiatriques atteints de cancer. Le Dr Allen a mis en avant le rôle du programme en tant que plateforme essentielle pour faire avancer l'innovation dans les cancers pédiatriques et rares.
L'entreprise a récemment soumis une Demande de Nouveau Médicament (NDA) pour le dordaviprone à la FDA, demandant une approbation accélérée pour le gliome diffus mutant H3 K27M récurrent. Avec une demande d'examen prioritaire, une date d'action PDUFA pourrait être fixée pour le troisième trimestre 2025. Le dordaviprone a reçu la désignation de Maladie Pédiatrique Rare et a demandé un Bon de Révision Prioritaire pour Maladie Pédiatrique Rare.
Chimerix (NASDAQ: CMRX) gab bekannt, dass der Chief Scientific Officer Dr. Joshua E. Allen auf dem Forum des Biden Cancer Moonshot Mission Reports 2024 sprechen wird. Die Präsentation wird sich auf die Auswirkungen des Programms auf die Entwicklung von Therapien für Hirntumoren und seltene pädiatrische Krebserkrankungen konzentrieren, insbesondere auf H3 K27M-mutiertes diffuses Gliom.
CEO Mike Andriole hob die Erfolge des Cancer Moonshot hervor, die Gesundheitsgleichheit in klinischen Studien zu verbessern und die Navigationsdienste für pädiatrische Krebspatienten auszubauen. Dr. Allen betonte die Rolle des Programms als kritische Plattform zur Förderung von Innovationen bei pädiatrischen und seltenen Krebserkrankungen.
Das Unternehmen hat kürzlich einen Neuen Arzneimittelantrag (NDA) für dordaviprone bei der FDA eingereicht und beantragt eine beschleunigte Genehmigung für rekurrierendes H3 K27M-mutiertes diffuses Gliom. Mit einer beantragten Prioritätsprüfung könnte ein PDUFA-Aktionsdatum für das dritte Quartal 2025 festgelegt werden. Dordaviprone hat die Bezeichnung als seltene pädiatrische Erkrankung erhalten und einen Antrag auf einen Prioritätsprüfvoucher für seltene pädiatrische Erkrankungen gestellt.
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Chief Scientific Officer, Joshua E. Allen, Ph.D. to Highlight Cancer Moonshot’s Impact on Brain Cancer and Rare Pediatric Disease Drug Development
DURHAM, N.C., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, announced today that Dr. Joshua E. Allen, Chief Scientific Officer at Chimerix, will speak at the Biden Cancer Moonshot Mission Report 2024 – And Beyond. Dr. Allen’s remarks will cover the program’s impact on advancing therapies for brain and rare pediatric cancers, including H3 K27M-mutant diffuse glioma.
“The Biden Cancer Moonshot has significantly improved the approach to cancer diagnosis and treatment with, among other achievements, programs to improve health equity in clinical trials as well as broadening patient navigation services for pediatric cancer,” said Mike Andriole, Chief Executive Officer of Chimerix. “The invitation to speak today is an opportunity to share more about the impact of Biden Cancer Moonshot on cooperative efforts to accelerate promising research in pediatric brain cancer drug development and chart new courses for the future.”
“The Biden Cancer Moonshot has provided a critical platform to advance innovation for pediatric and rare cancers where progress has been limited for decades. I am honored to speak today about the tireless collaborative efforts of researchers, physicians, regulators, and patient advocates to improve outcomes for the most challenging forms of brain cancer. The accelerated development of dordaviprone highlights the importance of this forum. The Biden Cancer Moonshot has provided a critical forum for action to occur with the urgency that cancer patients and their families deserve,” said Dr. Allen.
In December Chimerix submitted a New Drug Application (NDA) for dordaviprone to the U.S. FDA, seeking accelerated approval for recurrent H3 K27M-mutant diffuse glioma. The company also requested Priority Review, which, if granted, could result in a Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025. Dordaviprone has received Rare Pediatric Disease Designation and has applied for a Rare Pediatric Disease Priority Review Voucher as part of the NDA process.
About Chimerix
Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company’s most advanced clinical-stage development program, dordaviprone, is in development for H3 K27M-mutant glioma. The Company is conducting Phase 1 dose escalation studies of ONC206 to evaluate safety and PK data.
About Dordaviprone
Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things: the possible regulatory path forward for dordaviprone, including the potential to seek accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers and approval for marketing authorization; timing and consequences of an NDA submission to FDA; FDA’s acceptance for filings; the initial potential PDUFA timing. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks related to the ability to obtain and maintain accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers, and approval for marketing authorization; uncertainty on the response of regulators to including additional supportive data to be submitted in the NDA filing, including RANO 2.0 assessments, and uncertainty with respect to the initial potential PDUFA timing; risks related to the clinical development of our clinical candidates; and additional risks set forth in the Company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
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