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Cerus Corp

Cerus Corp (CERS)

1.79
-0.03
(-1.65%)
마감 19 1월 6:00AM
1.80
0.01
(0.56%)
시간외 거래: 9:59AM

실시간 토론 및 거래 아이디어: 강력한 플랫폼으로 자신있게 거래하세요.

주요 통계 및 세부정보

가격
1.79
매수가
1.70
매도가
1.80
거래량
1,057,729
1.745 일간 변동폭 1.84
1.375 52주 범위 2.585
market_cap
전일 종가
1.82
개장가
1.84
최근 거래 시간
1000
@
1.8
(formt)
마지막 거래 시간
재정 규모
US$ 1,885,110
VWAP
1.7822
평균 볼륨(3m)
1,480,256
발행 주식
185,715,415
배당수익률
-
주가수익률
-8.87
주당순이익(EPS)
-0.2
매출
186.8M
순이익
-37.49M

Cerus Corp 정보

Cerus Corp is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria, and parasites. The company sells its INT... Cerus Corp is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria, and parasites. The company sells its INTERCEPT platelet and plasma systems in the United States of America, Europe, the Commonwealth of Independent States countries, the Middle East and selected countries in other regions around the world. The firm continues to operate in only one segment: Blood safety and generates revenue from the same. 더 보기

섹터
Surgical,med Instr,apparatus
산업
Biological Pds,ex Diagnstics
웹사이트
본부
Wilmington, Delaware, USA
설립됨
2010
Cerus Corp is listed in the Surgical,med Instr,apparatus sector of the 나스닥 with ticker CERS. The last closing price for Cerus was US$1.82. Over the last year, Cerus shares have traded in a share price range of US$ 1.375 to US$ 2.585.

Cerus currently has 185,715,415 shares in issue. The market capitalisation of Cerus is US$338 million. Cerus has a price to earnings ratio (PE ratio) of -8.87.

CERS 최신 뉴스

Cerus Corporation Announces Preliminary Fourth Quarter and Full-Year 2024 Product Revenue and Provides Business Update

Preliminary Full-Year 2024 Product Revenues Total $180.3 million, 15% Over 2023 Results and Exceed Prior Product Revenue Guidance 2025 Product Revenues Expected to be Between $194-$200 million...

기간변동변동 %시가고가저가평균 일일 거래량VWAP
10.2314.74358974361.561.8851.5118173071.72411297CS
40.2113.29113924051.581.8851.514628411.64597619CS
120.137.83132530121.662.031.514802561.70846737CS
26-0.565-23.9915074312.3552.541.37512766941.83122769CS
520.116.547619047621.682.5851.37512831441.89433937CS
156-3.94-68.76090750445.7361.20514119583.09576306CS
260-2.45-57.78301886794.2491.20515526564.48206772CS

CERS - Frequently Asked Questions (FAQ)

What is the current Cerus share price?
The current share price of Cerus is US$ 1.79
How many Cerus shares are in issue?
Cerus has 185,715,415 shares in issue
What is the market cap of Cerus?
The market capitalisation of Cerus is USD 338M
What is the 1 year trading range for Cerus share price?
Cerus has traded in the range of US$ 1.375 to US$ 2.585 during the past year
What is the PE ratio of Cerus?
The price to earnings ratio of Cerus is -8.87
What is the cash to sales ratio of Cerus?
The cash to sales ratio of Cerus is 1.78
What is the reporting currency for Cerus?
Cerus reports financial results in USD
What is the latest annual turnover for Cerus?
The latest annual turnover of Cerus is USD 186.8M
What is the latest annual profit for Cerus?
The latest annual profit of Cerus is USD -37.49M
What is the registered address of Cerus?
The registered address for Cerus is 1209 ORANGE STREET, WILMINGTON, DELAWARE, 19801
What is the Cerus website address?
The website address for Cerus is www.cerus.com
Which industry sector does Cerus operate in?
Cerus operates in the BIOLOGICAL PDS,EX DIAGNSTICS sector

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CERS Discussion

게시물 보기
lambchops lambchops 2 월 전
Mick--in again on 12/2 at 30,000 shares. You in Cers?I'm doing a Short term trade only. Looked like a little Momo EOD trades.

LC

CERS
👍️0
lambchops lambchops 3 월 전
Hey Mick, Out again for a nice profit today. Are you making money here on CERS? I'm going to be buying in again (maybe) EOD.

LC

CERS
👍️0
lambchops lambchops 3 월 전
Back in EOD. Quick hitter for $900+bucks. See ya' Monday.

LC

CERS
👍️0
lambchops lambchops 3 월 전
I'm out Mick. Back in again if it goes below $1.67.

LC

CERS
👍️0
mick mick 3 월 전
👍️0
mick mick 3 월 전
hi there
👍️0
lambchops lambchops 3 월 전
It's got a gap up to file Mick, Picked up 5000 more, Don't be caught bag holding when I sell. I'll probably sell at $1.80 and buy back in on the dips.

LC

CERS
👍️0
lambchops lambchops 3 월 전
It's got a gap up to file Mick, Picked up 5000 more, Don't be caught bag holding when I sell. I'll probably sell at $1.80 and buy back in on the dips.

LC

CERS
👍️0
mick mick 3 월 전
👍️0
lambchops lambchops 3 월 전
Looks like a good buying opportunity, Big volume EOD on Friday. Mick.Short term it looks to me like it'll gap up short term. Also, quarterly results are coming 10/30. What's your opinion?

LC

CERS
👍️0
mick mick 3 월 전

https://www.stockscores.com/
👍️0
lambchops lambchops 3 월 전
I picked up 20000 shares. Let's see if we are as good at picking as we think we are. I made good returns on OKLO today too.

LC

CERS
👍️0
mick mick 3 월 전
i like cers
👍️0
mick mick 3 월 전
yes and long term hold too. writes are good.
👍️0
lambchops lambchops 3 월 전
Got my shares.

LC
CERS
👍️0
lambchops lambchops 3 월 전
Got my shares.

LC
CERS
👍️0
lambchops lambchops 3 월 전
Mick---I'm buying in Friday morning. I've done some DD on CERS and like it for a short term trade. But, of course, do your own evaluation Baaaaaa-oyz!

LC

CERS
👍️0
mick mick 3 월 전
https://www.barchart.com/stocks/quotes/CERS/overview#google_vignette
👍️0
mick mick 3 월 전
However, it's worth noting that Cerus operates with a moderate level of debt
and its liquid assets exceed short-term obligations,
potentially providing financial flexibility as it navigates regulatory challenges and pursues market expansion.

The substantial BARDA funding mentioned in the article could further strengthen the company's financial position.

Investors should also consider that Cerus is trading at a high Price / Book multiple of 6.74,
which may reflect market expectations for future growth despite current profitability challenges.

For a more comprehensive analysis, InvestingPro offers 5 additional tips for Cerus Corporation,
providing deeper insights into the company's financial health and market position.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
👍️0
mick mick 3 월 전
#2 --- Cerus stock price target unchanged as TD Cowen cites evolving EU strategy and increased BARDA funding
Investing.com
Editor
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.
👍️0
mick mick 3 월 전
Cerus stock price target unchanged as TD Cowen cites evolving EU strategy and increased BARDA funding
Investing.com
Editor
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
👍️0
mick mick 3 월 전
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.
👍️0
mick mick 3 월 전
#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.
👍️0
mick mick 3 월 전
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.
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mick mick 3 월 전
CERS
Cerus Corp
1.4788
-0.3262 (-18.07%)
Volume: 2,395,912
Day Range: 1.375 - 1.64
Bid: 1.47
Ask: 1.48
Last Trade Time: 10:34:39 AM EDT
Total Trades: 6,116
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mick mick 3 월 전
with new contract do we need europe ?????
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mick mick 3 월 전
with new contract should be higher ,

https://www.otcmarkets.com/filing/html?id=17898975&guid=RbL-kamhH0mnJth
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mick mick 3 월 전
how you like contract unknown ????? anyone ?????
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Eastwood Bets Eastwood Bets 8 월 전
This stock is on the move ...
Do NOT miss it before it takes off!!
Nearly 70% of of all analyst agree !
At 2 bucks your nuts 🥜 not to pick up some shares now !
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Monksdream Monksdream 10 월 전
Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?orderBy=percentChange&orderDir=desc
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Awl416 Awl416 10 월 전
Cerus Corporation Announces Positive Topline Results for the Phase 3 Clinical Trial of the INTERCEPT Blood System for Red Blood Cells in Cardiovascular Surgery Patients
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Monksdream Monksdream 1 년 전
CERS new 52 week low
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BottomBounce BottomBounce 4 년 전
$CERS Book Value Per Share (mrq) ONLY $0.65
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mogman mogman 4 년 전
Looks like CP using Intercept plasma will push the SP well over $7 and just could go over $20 if key metrics indicate a possible buy out. Since the closest competition Mirasol is now a non-starter with the FDA last week, CERS occupies a monopoly position. That is not to mention RBS approval in the next few years as well as the now released info that American Red Cross will not guarantee requested shipment fulfillment if Intercept is not stipulated. CERS now owns the market along with locked in distributors throughout the world. No brainer investment for the whole next decade. Even buying at $20 SP will be a 10 bagger in5 yeas or less. Probably less. Very long here.
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Porterhouse10 Porterhouse10 5 년 전
Looking for entry, awesome growth and balance sheet, could be a good Covid play jmo
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ClayTrader ClayTrader 5 년 전
* * $CERS Video Chart 02-13-2020 * *

Link to Video - click here to watch the technical chart video

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ClayTrader ClayTrader 5 년 전
* * $CERS Video Chart 02-04-2020 * *

Link to Video - click here to watch the technical chart video

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ClayTrader ClayTrader 6 년 전
* * $CERS Video Chart 06-29-2019 * *

Link to Video - click here to watch the technical chart video

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TrendTrade2016 TrendTrade2016 7 년 전
CERS been in this play for 2 months now...time to make some noise!!!
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cottonmather cottonmather 7 년 전
Longer term technical promise. http://stockcharts.com/public/1164099
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mogman mogman 7 년 전
From Berkshire Hathaway's - Business Wire

CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation (Nasdaq: CERS) today announced financial results for the fourth quarter and year ended December 31, 2017.

Recent developments and highlights include:

*Reported record fourth quarter product revenue of $16.2 million, an increase of 60% compared to the
same period in the year prior.
*Established 2018 annual product revenue guidance of $51 million to $53 million, which would
represent a

17% to 22% increase over 2017 reported product revenue.

*Successfully met primary safety and efficacy endpoints in SPARC, Cerus’ European Phase 3 clinical trial *evaluating INTERCEPT red cell transfusions in thalassemia patients.
*Completed an underwritten public offering of common stock raising gross proceeds of $57.5 million.
*Advanced release assay for commercial manufacturing of the S303 compound used in the INTERCEPT
red blood cell system to enable H2 2018 CE Mark submission.

IMO it is up from here and a buy at $5.
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mogman mogman 7 년 전
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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StockRacer87 StockRacer87 7 년 전
Shorts attacked it well today
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QuidRunner QuidRunner 7 년 전
Good new out yesterday after regarding CERS trials. Stock is steadily moving UP!!!
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lugan lugan 7 년 전
Yesterday, today and tomorrow!
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ClayTrader ClayTrader 7 년 전
* * $CERS Video Chart 11-03-17 * *

Link to Video - click here to watch the technical chart video

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Marvy Marvy 7 년 전
Big news!!!
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jonnyvs jonnyvs 7 년 전
Is this today's bio play?
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ResearchDD ResearchDD 7 년 전
What a joke!!!!!!!!!!!!!!!!!!!!!!! Played the Zika! Pump and now Dump!!!
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ClayTrader ClayTrader 7 년 전
* * $CERS Video Chart 08-08-17 * *

Link to Video - click here to watch the technical chart video

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