An email has been sent to your address with instructions for changing your password.
There is no user registered with this email.
Sign Up
To create a free account, please fill out the form below.
Thank you for signing up!
A confirmation email has been sent to your email address. Please check your email and follow the instructions in the message to complete the registration process. If you do not receive the email, please check your spam folder or contact us for assistance.
Welcome to our platform!
Oops!
Something went wrong while trying to create your new account. Please try again and if the problem persist, Email Us to receive support.
Cerus (Nasdaq:CERS) has provided updates on its INTERCEPT red blood cell (RBC) programs in the U.S. and Europe. In the U.S., Cerus has secured a new $248 million contract with BARDA to support the program through FDA approval and commercialization. The company recently announced positive topline results for the ReCePI study, a pivotal U.S. Phase 3 clinical trial.
In Europe, the CE Mark review under the Medical Device Regulation (MDR) has concluded without approval. Cerus is assessing strategies for a potential new regulatory submission. The company remains confident in the need for pathogen inactivated RBCs and plans to leverage additional data, including results from the U.S. Phase 3 ReCePI trial, for a potential new CE Mark submission.
Cerus (Nasdaq:CERS) ha fornito aggiornamenti sui suoi programmi di globuli rossi (RBC) INTERCEPT negli Stati Uniti e in Europa. Negli Stati Uniti, Cerus ha ottenuto un nuovo contratto di 248 milioni di dollari con BARDA per supportare il programma fino all'approvazione della FDA e alla commercializzazione. L'azienda ha recentemente annunciato risultati positivi per il ReCePI study, uno studio clinico cruciale di Fase 3 negli Stati Uniti.
In Europa, la revisione del Marchio CE sotto il Regolamento sui Dispositivi Medici (MDR) è stata completata senza approvazione. Cerus sta valutando strategie per una potenziale nuova presentazione normativa. L'azienda rimane fiduciosa nella necessità di RBC inattivati da patogeni e prevede di sfruttare ulteriori dati, compresi i risultati dello studio ReCePI di Fase 3 negli Stati Uniti, per una potenziale nuova presentazione del Marchio CE.
Cerus (Nasdaq:CERS) ha proporcionado actualizaciones sobre sus programas de glóbulos rojos (RBC) INTERCEPT en EE. UU. y Europa. En EE. UU., Cerus ha asegurado un nuevo contrato de 248 millones de dólares con BARDA para apoyar el programa hasta la aprobación de la FDA y la comercialización. La compañía anunció recientemente resultados positivos en la línea principal del estudio ReCePI, un ensayo clínico pivotal de Fase 3 en EE. UU.
En Europa, la revisión de la Marca CE bajo el Reglamento de Dispositivos Médicos (MDR) ha concluido sin aprobación. Cerus está evaluando estrategias para una posible nueva presentación regulatoria. La empresa sigue confiando en la necesidad de RBC inactivados por patógenos y planea aprovechar datos adicionales, incluidos los resultados del estudio ReCePI de Fase 3 en EE. UU., para una posible nueva presentación de Marca CE.
Cerus (Nasdaq:CERS)는 미국 및 유럽의 INTERCEPT 적혈구(RBC) 프로그램에 대한 업데이트를 제공했습니다. 미국에서는 Cerus가 FDA 승인 및 상용화를 지원하기 위해 BARDA와 2억4800만 달러의 새로운 계약을 체결했습니다. 회사는 최근 미국의 중요한 3상 임상 시험인 ReCePI 연구에서 긍정적인 초기 결과를 발표했습니다.
유럽에서는 의료 기기 규정(MDR) 하의 CE 마크 검토가 승인 없이 완료되었습니다. Cerus는 잠재적인 새로운 규제 제출을 위한 전략을 평가하고 있습니다. 회사는 병원체 비활성화 적혈구의 필요성에 대해 자신감을 보이고 있으며, 미국 3상 ReCePI 시험의 결과를 포함한 추가 데이터를 활용하여 잠재적인 새로운 CE 마크 제출을 계획하고 있습니다.
Cerus (Nasdaq:CERS) a fourni des mises à jour sur ses programmes de globules rouges (RBC) INTERCEPT aux États-Unis et en Europe. Aux États-Unis, Cerus a obtenu un nouveau contrat de 248 millions de dollars avec BARDA pour soutenir le programme jusqu'à son approbation par la FDA et sa commercialisation. L'entreprise a récemment annoncé des résultats préliminaires positifs pour l'étude ReCePI, un essai clinique pivot de phase 3 aux États-Unis.
En Europe, l'examen du marquage CE dans le cadre du Règlement sur les Dispositifs Médicaux (MDR) a été finalisé sans approbation. Cerus évalue des stratégies pour une nouvelle soumission réglementaire potentielle. L'entreprise reste confiante quant à la nécessité de globules rouges inactivés par des agents pathogènes et prévoit d'exploiter des données supplémentaires, y compris les résultats de l'essai ReCePI de phase 3 aux États-Unis, pour une éventuelle nouvelle soumission de marquage CE.
Cerus (Nasdaq:CERS) hat Updates zu seinen INTERCEPT-Erythrozyten(RBC)-Programmen in den USA und Europa bereitgestellt. In den USA hat Cerus einen neuen Vertrag über 248 Millionen Dollar mit BARDA abgeschlossen, um das Programm bis zur Genehmigung durch die FDA und zur Vermarktung zu unterstützen. Das Unternehmen hat kürzlich positive erste Ergebnisse der ReCePI-Studie bekannt gegeben, einer entscheidenden klinischen Studie der Phase 3 in den USA.
In Europa wurde die Prüfung des CE-Zeichens gemäß der Verordnung über Medizinprodukte (MDR) ohne Genehmigung abgeschlossen. Cerus bewertet Strategien für einen möglichen neuen Zulassungsantrag. Das Unternehmen bleibt zuversichtlich, dass es Bedarf an pathogeninaktivierten RBCs gibt, und plant, zusätzliche Daten, einschließlich der Ergebnisse der US-Phase-3-ReCePI-Studie, für einen möglichen neuen CE-Zeichenantrag zu nutzen.
Positive
Secured new $248 million BARDA contract for U.S. RBC program
Positive topline results from ReCePI Phase 3 clinical trial
BARDA awarded $32.1 million for the initial base period
Potential for broader clinical indication in future European submission
Negative
CE Mark review in Europe concluded without approval
Delay in enrollment at new RedeS study sites may impact study completion timing
European regulatory setback may require new submission and extended timeline
Insights
The update on Cerus 's INTERCEPT Red Blood Cell (RBC) programs reveals mixed progress. In the U.S., the company secured a significant $248 million contract from BARDA, which will support the program through FDA approval and commercialization. This funding is important for advancing the development, including a planned modular PMA submission to the FDA.
However, in Europe, the CE Mark review concluded without approval, which is a setback for Cerus. The Competent Authority found insufficient data in the active pharmaceutical ingredient module, leading to the closure of the MDR application. This highlights the challenges in meeting different regulatory standards across markets.
The positive results from the U.S. Phase 3 ReCePI study are encouraging, demonstrating non-inferiority of INTERCEPT RBCs compared to conventional RBCs in complex cardiac surgery patients. This data could potentially strengthen a future European submission.
Overall, while the U.S. program is progressing well with strong financial backing, the European setback may delay market entry in that region, impacting near-term revenue potential from INTERCEPT RBCs in Europe.
The $248 million BARDA contract is a significant financial boost for Cerus, providing substantial funding for the INTERCEPT RBC program in the U.S. This contract, with an initial $32.1 million base period, reduces the company's financial burden for R&D and potential commercialization.
However, the European CE Mark setback could impact potential revenue streams in the near term. Cerus will likely incur additional costs and face delays in addressing the regulatory concerns for a new submission.
Investors should note that while the U.S. program is advancing, the timeline for the RedeS study completion and subsequent PMA submission remains uncertain due to delayed site enrollments. This could affect the company's projected cash burn and time to market.
The stock may experience volatility as the market digests the mixed news. Long-term prospects remain positive with the BARDA support, but short-term headwinds from the European setback could pressure the stock price.
Company to Host Conference Call and Webcast on Wednesday, October 16, 2024 at 5:00 p.m. EDT
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (Nasdaq:CERS) today announced updates on the INTERCEPT red blood cell (RBC) programs in the U.S. and in Europe:
U.S. – New $248 million BARDA contract supports program beyond U.S. Phase 3 studies through anticipated PMA licensure and into commercialization
Europe – CE Mark review has been concluded without approval; assessing strategy for anticipated future filing
“We are pleased with the progress we have made with our U.S. RBC program, which will now receive additional support from BARDA through a new contract valued at up to $248 million, intended to fund activities including continued improvement in the design of the product candidate and a future scale-up of commercial manufacturing activities,” commented Obi Greenman, Cerus’ president and chief executive officer. “In Europe, our CE Mark review under the Medical Device Regulation (MDR) has concluded without an approval. We believe that we can address the issues which prevented our approval in the context of an anticipated new regulatory submission.”
U.S. – BARDA award and program update
In the U.S., Cerus has entered into a new six-year agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, to further advance the development of the INTERCEPT RBC system. Valued at up to $248 million, this additional funding is intended to support a planned U.S. Food and Drug Administration (FDA) modular premarket approval (PMA) application and potential post-approval studies, accelerate development of an improved version of the INTERCEPT RBC system, and scale up the chemistry, manufacturing and controls (CMC) activities to enable a broad product launch, if approved. BARDA has awarded $32.1 million for the initial base period, with additional funding contingent on meeting specific contractual milestones.
In March 2024, Cerus announced positive topline results for the BARDA-funded ReCePI study, a pivotal U.S. Phase 3 clinical trial demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs when transfused to complex cardiac surgery patients. The Company is currently enrolling patients in its ongoing, BARDA-funded RedeS clinical trial, the second pivotal U.S. Phase 3 clinical trial in patient populations requiring RBC transfusion for acute and chronic anemia. Results from both trials are expected to be part of a planned modular PMA submission to the FDA, with the planned final PMA module expected to be submitted upon the anticipated completion of the RedeS trial.
“ReCePI investigators will be presenting a number of abstracts with study data at the Annual AABB meeting next week in Houston, including a plenary presentation,” said Richard Benjamin, M.D., Ph.D., Cerus’ chief medical officer. “We have recently begun enrolling at two additional RedeS study sites, including the Turkey site, but we are still assessing the potential impact to the anticipated timing of study completion and modular PMA submission, since these new sites began enrollment later than previously anticipated.”
The new BARDA contract will be funded in whole or in part with federal funds from the Department of Health and Human Services’ Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority under Contract No. 75A50124C00046.
Europe – CE Mark review update
For Cerus’ MDR application in Europe, Cerus’ Notified Body, TÜV-SÜD, reviewed the modules for clinical, non-clinical, manufacturing and quality and found them to be satisfactory. However, the Competent Authority, CBG-MEB, reviewed the active pharmaceutical ingredient module and concluded that the data included in the module were insufficient to support the proposed classification of the impurity profile of the final product, necessitating TÜV-SÜD’s closure of Cerus’ MDR application without an approval. The Company, in collaboration with TÜV-SÜD, is assessing strategies for a potential enhanced new regulatory submission and the associated timeline.
“We continue to believe strongly in the need for pathogen inactivated RBCs and the regulatory dossier we filed in Europe. In addition to how we address the new questions CBG has raised, we want to take this opportunity to be thoughtful about leveraging the additional data that we have accumulated since our original CE Mark submission,” said Carol Moore, Cerus’ senior vice president. “For example, we believe the positive results from our U.S. Phase 3 ReCePI trial substantially expand the data available to evaluate the clinical safety and efficacy of INTERCEPT RBCs. We will be assessing how these data could allow us to propose a broader clinical indication in a potential new CE Mark submission in consultation with TÜV.”
Webcast
The Company will host a webcast later today at 5:00 P.M. EDT, during which management will provide an update on the INTERCEPT red blood cell program. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir.
A replay will be available on Cerus’ website approximately three hours after the call through October 30, 2024.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. In the U.S., the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is in late-stage clinical development. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
FORWARD-LOOKING STATEMENTS
Except for the historical statements contained herein, this press release contains forward-looking statements concerning the Cerus’ INTERCEPT RBC programs and prospects, including statements relating to: the potential value of and funding opportunity under the new BARDA agreement; Cerus’ expectations with respect to activities intended to be funded under the new BARDA agreement, including with respect to Cerus’ planned modular PMA application to the FDA for the INTERCEPT RBC system; the anticipated completion of the RedeS clinical trial and the related planned final PMA module submission; the potential approval and launch of the INTERCEPT RBC system in the U.S.; the potential for Cerus to submit an enhanced new regulatory submission for the INTERCEPT RBC system in Europe and Cerus’ belief in its ability to address the issues that prevented CE mark approval for the INTERCEPT RBC system; and other statements that are not historical fact. Actual results could differ materially from these forward-looking statements as a result of certain factors, including without limitation, risks associated with: the uncertain nature of BARDA’s funding over which Cerus has no control as well as actions of Congress and governmental agencies that may adversely affect the availability of funding under the new BARDA agreement and/or BARDA’s exercise of any potential subsequent option periods, such that the total actual value of the new BARDA agreement to Cerus may be substantially less than anticipated; unfavorable provisions in government contracts, including the risks that BARDA is entitled to terminate the new BARDA agreement at any time for its convenience and is not otherwise obligated to provide continued funding beyond current year amounts from Congressionally approved annual appropriations; the uncertain and time-consuming development and regulatory process, including the risks that (a) the FDA could require additional clinical data not contemplated by the new BARDA agreement to support Cerus’ planned modular PMA submission for the INTERCEPT RBC system and that if additional clinical development is required, it will require funding that Cerus does not currently have, (b) Cerus may be unable to meet FDA requirements to initiate or complete its planned modular PMA submission for the RBC system in a timely manner or at all, and even if such planned modular PMA submission is submitted, Cerus may be unable to obtain FDA approval of the RBC system in a timely manner or at all, (c) Cerus may be unable to complete enrollment in its RedeS study and/or report data from its RedeS study in a timely manner or at all, and even if completed, the results of the RedeS study may not be supportive of Cerus’ planned modular PMA submission for the INTERCEPT RBC system and/or any FDA approval of the INTERCEPT RBC system, (d) Cerus may be unable to address the issues that prevented CE mark approval for the INTERCEPT RBC system in a timely manner or at all, (e) Cerus may be unable to meet the applicable requirements for a new regulatory submission in Europe for INTERCEPT RBCs in a timely manner or at all, and that Cerus may otherwise determine to substantially delay or abandon its efforts to seek CE Mark approval of the INTERCEPT RBC system, and (f) Cerus may otherwise be unable to obtain any regulatory approvals of the INTERCEPT RBC system in a timely manner or at all; Cerus’ ability to maintain an effective, secure manufacturing supply chain, including the risk that Cerus may be required to engage and validate a new supplier for key components of the INTERCEPT RBC system, which would substantially delay any new regulatory submission in Europe for INTERCEPT RBCs and/or a review decision thereon; commercialization and market acceptance of, and customer demand for, the INTERCEPT RBC system, if approved; successfully launching a new commercial product; Cerus‘ ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction and the INTERCEPT Blood System, including the INTERCEPT RBC system, is safe, effective and economical; future opportunities and plans, including the uncertainty of Cerus’ future capital requirements and the sufficiency of its cash resources and anticipated funding under the new BARDA agreement, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Cerus’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 1, 2024. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
What is the value of Cerus 's new BARDA contract for the INTERCEPT RBC program?
Cerus (CERS) has secured a new six-year agreement with BARDA valued at up to $248 million to advance the development of the INTERCEPT RBC system in the U.S.
What was the outcome of Cerus 's CE Mark review for INTERCEPT RBC in Europe?
The CE Mark review for Cerus 's (CERS) INTERCEPT RBC system in Europe concluded without approval. The company is now assessing strategies for a potential new regulatory submission.
What were the results of Cerus 's ReCePI Phase 3 clinical trial for INTERCEPT RBC?
Cerus (CERS) announced positive topline results for the ReCePI study, a pivotal U.S. Phase 3 clinical trial, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs in complex cardiac surgery patients.
How much initial funding has BARDA awarded to Cerus for the INTERCEPT RBC program?
BARDA has awarded Cerus (CERS) $32.1 million for the initial base period of the new contract, with additional funding contingent on meeting specific contractual milestones.
