mick
2 meses hace
#2 --- Cerus stock price target unchanged as TD Cowen cites evolving EU strategy and increased BARDA funding
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Ahmed Abdulazez Abdulkadir
Company News
Published 10/17/2024, 11:02 AM
https://www.investing.com/news/company-news/cerus-stock-price-target-unchanged-as-td-cowen-cites-evolving-eu-strategy-and-increased-barda-funding-93CH-3669038
Cerus stock price target unchanged as TD Cowen cites evolving EU strategy and increased BARDA funding
On Thursday, TD Cowen maintained a positive outlook on Cerus (NASDAQ:CERS) Corporation (NASDAQ:CERS) despite a recent setback in its European regulatory progress. The firm reiterated its Buy rating and a $5.00 price target for the blood transfusion company.
Cerus recently encountered a challenge with its CE Mark application for the INTERCEPT Red Blood Cell (RBC) system in Europe,
which did not receive approval. Following this, the company is exploring alternative strategies for CE Mark submission.
Despite this hiccup in Europe, Cerus is making strides in the United States with its RBC program.
The company is planning a Pre-Market Approval (PMA) submission after the completion of its ReDeS clinical trial.
Moreover, Cerus has secured substantial support from the U.S. government,
with the Biomedical Advanced Research and Development Authority (BARDA) committing up to $248 million in additional funding.
This funding is designated to further the development of the INTERCEPT blood system,
which is designed to enhance the safety of blood transfusions by inactivating a broad range of pathogens such as viruses,
bacteria, and parasites that may be present in donated blood.
The analyst from TD Cowen highlighted these developments,
noting the company's ongoing efforts to advance its blood safety system in the U.S. market.
With the additional BARDA funding, Cerus is expected to continue its progress despite
the regulatory challenges faced in the European Union.
Investors and stakeholders in Cerus Corporation continue to watch the company's advancements
in blood safety technology and its efforts to navigate regulatory pathways in different markets.
The support from BARDA underscores the potential of the INTERCEPT blood system to address critical needs in transfusion medicine.
In other recent news, Cerus Corporation has experienced a series of significant developments.
The biomedical company's annual product revenue guidance for 2024 has been
revised upwards to between $175 million and $178 million,
marking a substantial increase from the previous range of $172 million to $175 million.
This adjustment is largely due to a 16% year-over-year growth in product revenue,
primarily driven by the increased use of Cerus' INTERCEPT blood system.
Furthermore, Cerus has secured a contract with the
Biomedical Advanced Research and Development Authority (BARDA) valued at up to $248 million.
This contract will support the development of its INTERCEPT red blood cell (RBC) system in the United States.
However, the company recently faced a setback when the European Union's review of its INTERCEPT RBC
product concluded without granting approval, citing the need for additional data.
On the analyst front, Stifel has adjusted its price target for Cerus to $3.00, down from the previous $6.00,
but maintains a Buy rating on the stock.
Meanwhile, BTIG analysts have reiterated a Neutral rating for Cerus, following the company's stronger-than-expected
performance in the second quarter.
InvestingPro Insights
While TD Cowen maintains a positive outlook on Cerus Corporation (NASDAQ:CERS),
recent InvestingPro data provides additional context for investors.
Despite the company's revenue growth of 10.79% over the last twelve months as of Q2 2023, Cerus is not currently profitable,
with an adjusted operating income of -$14.48 million for the same period.
This aligns with one of the InvestingPro Tips, which indicates that analysts do not anticipate the company will be profitable this year.
mick
2 meses hace
selling for about 2-1/2 times book value.
Cerus Corporation Provides Updates on INTERCEPT Red Blood Cell Programs in the U.S. and Europe
Company to Host Conference Call and Webcast on Wednesday, October 16, 2024 at 5:00 p.m. EDT
CONCORD, CA, October 16, 2024 - 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 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.”
US – 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.
2
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 US, 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.
mick
2 meses hace
#2 \\// $CERS --- Cerus Corporation Provides Updates on INTERCEPT Red Blood Cell Programs in the U.S. and Europe
Company to Host Conference Call and Webcast on Wednesday, October 16, 2024 at 5:00 p.m. EDT
CONCORD, CA, October 16, 2024 - 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 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.”
US – 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.
2
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 US, 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.
mick
2 meses hace
Cerus Corporation Provides Updates on INTERCEPT Red Blood Cell Programs in the U.S. and Europe
Company to Host Conference Call and Webcast on Wednesday, October 16, 2024 at 5:00 p.m. EDT
CONCORD, CA, October 16, 2024 - 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 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.”
US – 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.
2
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 US, 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.
mogman
7 años hace
NAVY Department worth more than today's 4 cent CERS SP rise. Description: Department of the Navy
Bureau of Medicine and Surgery
U.S. Naval Hospital Guam
US Naval Hospital Guam intends to award a sole-source drop-shipment contract under the authority of FAR 13, due to the only source available to meet the Government's needs, to Cerus Corporation, 2550 Stanwell Drive, Concord, CA 94520. Reference NAICS Code 325412. The following products will be procured: 0001. INTERCEPT Platelet Small Volume Processing Set, P/N INT2110B. Quantity: 8 Cases (2 cases to be delivered on March 2018, May 2018, July 2018, and Sep 2018). 0002. INTERCEPT Platelet Processing Set with Dual Storage Containers, P/N INT2510B. Quantity: 5 Cases (2 cases to be delivered on March 2018, 1 case to be delivered on May 2018, July 2018, and Sep 2018. This notice of intent is not a request for competitive proposals.
FULL INFO https://www.fbo.gov/spg/DON/BUMED/N68096/N6809618Q0008/listing.html
Time for a big thumbs up on that start!!
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