Bivalirudin Plus High-Dose Infusion Versus Heparin Monotherapy in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention After Fibrinolysis: a Randomized Trial

This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis. Participants will be randomly assigned in a 1:1 ratio to receive either bivalirudin or heparin, with follow-up at 30 days and 1 year. The primary endpoint is a composite of all-cause mortality and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 30 days.

Start Date01 May 2025

Sponsor / Collaborator

First Affiliated Hospital of Xi'an Jiaotong University

NCT06080074

/ RecruitingPhase 2IIT

Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac Failure

There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to:
1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of support in children with severe heart failure with the goal to support its FDA clearance in children.
2. To evaluate heparin versus bivalirudin as the primary blood thinner (anticoagulant) in a randomized trial of children supported with the Cardiohelp ECMO System with the goal to plan a phase III (pivotal) randomized clinical trial
The main questions the Cardiohelp single-arm trial seeks to answer are:
* What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO?
* Should the Cardiohelp device be FDA-cleared for children based on the results of the study?
* What are the optimal performance specifications of the Cardiohelp device in children?
The main questions the blood thinner randomized trial seeks to answer are:
* Which blood thinner is more promising (i.e., more effective and safer) in children on the Cardiohelp device?
* How should a pivotal trial of heparin vs. bivalirudin be designed so it is the most informative and efficient to determine the best blood thinner?
Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. For the Cardiohelp device trial, participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. For the blood thinner randomized trial, participants will be randomized 1:1 to blood thinner strategy to determine which blood thinner has the fewest bleeding and clotting complications.
For the Cardiohelp single-arm trial, participant outcomes will be compared to performance goals (PG) derived from the ECMO literature. For the blood thinner randomized trial, the amount of bleeding and clotting will be measured.
The study is funded by an R01 grant from the FDA's Office of Orphan Product Development (OOPD).

Start Date15 Apr 2025

Sponsor / Collaborator

Stanford University

[+2]

CTRI/2024/11/077189

/ Not yet recruitingPhase 4IIT

Randomized controlled trial of Heparin Vs Bivalirudin anticoagulation in neonates and infants undergoing Arterial switch operation on integrated ECMO-CPB circuit

Start Date24 Dec 2024

Sponsor / Collaborator

All India Institute of Medical Sciences

100 Clinical Results associated with Bivalirudin

100 Translational Medicine associated with Bivalirudin

100 Patents (Medical) associated with Bivalirudin

1,780

Literatures (Medical) associated with Bivalirudin

01 Feb 2026·Current Opinion in Anesthesiology

Anticoagulation and hemostasis in the extracorporeal membrane oxygenation patient

Review

Author: Schmidt, Matthieu ; Levy, David ; Saura, Ouriel

Purpose of review:

To provide an updated overview of hemostatic disturbances and anticoagulation management during extracorporeal membrane oxygenation (ECMO), emphasizing the mechanisms underlying the dual risk of bleeding and thrombosis, current therapeutic strategies, and future perspectives.

Recent findings:

Bleeding and thrombotic events remain the most frequent and life-threatening complications of ECMO, occurring in up to 50% of patients. Advances in mechanistic understanding have highlighted the roles of platelet activation and dysfunction, acquired von Willebrand syndrome, fibrinolytic imbalance, and hemolysis-induced endothelial injury. While unfractionated heparin remains the mainstay of anticoagulation, direct thrombin inhibitors such as bivalirudin have emerged as potential alternatives with comparable safety and efficacy. Viscoelastic testing, platelet function assays, and anti-Xa monitoring are increasingly integrated into clinical practice to refine anticoagulation titration.

Summary:

Hemostatic disturbances during ECMO reflect a complex interplay between patient severity, circuit-related shear stress, and systemic anticoagulation. Understanding these mechanisms is key to preventing both bleeding and thrombosis. Standardization of monitoring and the development of personalized, physiology-based anticoagulation protocols, supported by emerging technologies and more biocompatible circuits, represent the next step toward improving outcomes in ECMO-supported patients.

01 Jan 2026·ANNALS OF VASCULAR SURGERY

Safety and Efficacy of Bivalirudin as a Heparin Alternative in Patients Undergoing Carotid Artery Stenting

Article

Author: Maningat, Alexandra L ; Lewis, Anthony J ; Shah, Sahaj ; Elmore, James ; Guo, Tian ; Salzler, Gregory G ; Ryer, Evan J ; Kania, Thomas A

BACKGROUND:

Transfemoral carotid artery stenting (TFCAS) and transcarotid artery revascularization (TCAR) are commonly used to treat carotid stenosis. However, the need for heparin alternatives during these procedures and their impact on outcomes remain unclear. This study evaluates the safety and efficacy of bivalirudin, the most commonly used heparin alternative, compared to heparin.

METHODS:

The Vascular Quality Initiative registry was queried for carotid artery stenting procedures performed from 2010 to 2022. Propensity-matched analyses compared outcomes between patients receiving intraprocedural heparin and those receiving bivalirudin. Primary outcomes were postoperative neurological events, including stroke or transient ischemic attack, and bleeding. Secondary outcomes included 30-day rates of reintervention and myocardial infarction, and mortality at 30 days and 1 year.

RESULTS:

Among 80,172 carotid artery stenting procedures, 2,789 (3.47%) were performed with bivalirudin. In the heparin group, 24,797 (34.1%) underwent TFCAS with distal embolic protection, while 47,961 (65.9%) underwent TCAR with flow reversal. In the bivalirudin group, 2,494 (91.2%) underwent TFCAS, and 240 (8.8%) underwent TCAR. Propensity matching created 2 cohorts of 957 patients each. There were no significant differences in neurological events (odds ratio, [OR]: 1.44, 95% confidence interval [CI]: 0.72-2.86; P = 0.30), bleeding (OR: 1.0, 95% CI: 0.53-1.90; P = 1.00), 30-day mortality (OR: 2.05, 95% CI: 0.62-6.85; P = 0.24), or 1-year mortality (OR: 1.37, 95% CI: 0.84-2.24; P = 0.21).

CONCLUSION:

Bivalirudin is a safe and effective alternative to heparin for patients with contraindications to heparin undergoing carotid artery stenting. These findings suggest no significant differences in outcomes, supporting bivalirudin as a viable anticoagulation option.

01 Jan 2026·Cardiovascular Revascularization Medicine

Editorial: Refining the hemocompatibility paradigm in AMI-cardiogenic shock: Insights from an early Impella 5+ experience with DAPT and bivalirudin

Author: Molina, Ezequiel J

News (Medical) associated with Bivalirudin

02 Sep 2025

·www.fiercebiotech.com

Aiming to disrupt the cardiovascular space, 2 industry vets unveil Boston biotech with preventive RNAi asset

Corsera’s lead program is a dual-acting preventive RNAi candidate that is expected to enter the clinic this year.\n Industry giants Clive Meanwell, M.D., and John Maraganore, Ph.D., have unveiled Corsera Health, a new biotech aiming to disrupt the cardiovascular landscape with a once-annual preventive heart disease candidate and an artificial intelligence risk-predicting tool.“Imagine a world without cardiovascular disease. That\'s what we\'re aiming to do,” Corsera co-CEO Maraganore, founding CEO of RNAi pioneer Alnylam Pharmaceuticals, told Fierce Biotech in an interview.“This is the most important thing I\'ve ever done,” continued Maraganore, who has been involved in the discovery and development of several first-in-class drugs, such as anticoagulant Angiomax (bivalirudin). “This is an opportunity to really transform the future of medicine and save potentially millions of lives by preventing cardiovascular disease.” “We\'re very good at treating heart attacks and strokes now,” co-CEO Meanwell said in a joint interview with Fierce.“But everyone we\'re talking to is really agreeing that preventing them in the first place would be a much better idea,” continued Meanwell, who helped create PE firm Population Health, Leqvio-developer and Novartis-acquired The Medicines Company, plus next-gen obesity biotech Metsera. The two biotech veterans have pooled their own money and brought in a few others to raise $50 million, money that is fueling the Boston-based company through the early stages. “It\'s not any formal investment group at this point,” Maraganore explained. “Obviously, we\'re going to raise more capital and bring in professional investors. But, to be honest, we\'ve wanted to keep control of the reins of this effort ourselves, without worrying about other voices and other things that might derail our conviction in what we\'re doing.” The heart of Corsera The money has powered discovery efforts for Corsera’s lead program, a preventive RNA interference (RNAi) candidate that is slated to enter the clinic before the end of this year.The dual-acting RNAi medicine is designed to reduce the production of two cardiovascular disease markers: PCSK9 for cholesterol and angiotensinogen (AGT) for blood pressure.The strategy is supported by data from Corsera scientific co-founder Brian Ference, M.D., that found early reduction in LDL cholesterol and blood pressure can prevent cardiovascular disease two to three times more effectively than intervening later in life. The Mendelian randomization included almost 370,000 participants and was shared as a late-breaking presentation at the European Society of Cardiology Congress.Corsera plans on filing an investigational new drug (IND) application for the PCSK9 monomer in about a month, according to Maraganore. The proposed dose-escalation study will evaluate the durability of the candidate over one year, he said.A second IND submission focused on the AGT biology will likely follow in four to six months, he said.The asset was discovered under a Corsera contract at Axolabs, a CRO/CDMO that touts its own RNA platform. The two companies have been working on the product’s design for the last two years.Corsera’s other key focus is an AI tool dubbed Klotho Health. The calculation tool is driven by causal AI and is built to predict an individual’s lifetime risk of heart disease. The tool quantifies the benefit that lowering LDL cholesterol—often referred to as “bad cholesterol”—and blood pressure can have on cardiovascular health.Currently, 10-year cardiovascular risk scoring is available, but Corsera’s AI approach differentiates itself because it can be used at any age for any time span, Maraganore explained.Together, the experimental RNAi medicine and AI tool make up Corsera’s proactive approach that the leaders hope will help intervene before cardiovascular damage occurs, subsequently slashing morbidity and mortality rates associated with the disease. Act III The two co-CEOs are industry titans on their own, but they also have a 30-year track record working with each other.“This is our third act, and it is, without a doubt, the most important of our three acts,” Maraganore said.Back in the ‘90s, when Maraganore invented a drug at Biogen, he partnered with Meanwell’s The Medicines Company to develop and bring the drug—now sold as Angiomax—to market. That was the first act.Then, in 2013, Maraganore-led Alnylam partnered with The Medicines Company again, this time on a drug called inclisiran, later sold as Leqvio.The siRNA injectable lowers LDL cholesterol and garnered the attention of Big Pharma Novartis. The Swiss drugmaker decided to acquire The Medicines Company for $9.7 billion in 2019 for the next-gen heart drug, which snagged FDA approval in 2021. Now, the two are back together again and expect their efforts to shake up the cardiovascular space even more than before.The co-CEOs are viewing drug development differently than most this time. Corsera isn’t going for bigger: The biotech is aiming for easier. “There\'s a bit of an obsession with ‘mine’s bigger than yours,’ usually,” Meanwell said, describing the focus on having best-in-class potency or effect. He cited the PCSK9 monoclonal antibodies space as an example, with different drugmakers zeroing in on LDL-lowering percentages, and also obesity drug developers’ intense focus on exact weight loss percentages.“But here, we\'re not necessarily going for ‘mine is bigger than yours,’” Meanwell continued. “We\'re going for ‘mine’s easier than yours, mine’s more reliable than yours, mine\'s lower cost than yours, more accessible than yours.’”And the duo believes Corsera is uniquely positioned to do just that. The table is already set From past experience, the partners know how to bring new drugs to market at a lower cost. When the pair worked on Angiomax, they ran clinical evidence generation at about a third of the industry’s average cost for the same quality and speed, Meanwell said.“The tools that we need are already on the kitchen table,” Meanwell explained, referencing the two leaders’ combined expertise and industry innovations. “And what we\'re trying to do here is bolt them together in a new industrial model.”“The trick here is to—and I\'ll use the word ‘disrupt’ in a true Christensen sense—disrupt the way we think of cardiovascular disease,” he continued.The innovation theory centers on a new product that enters the bottom of an existing market and eventually displaces established competitors, normally by being more affordable and accessible.Meanwell believes the strategy is “the only viable way” to reach millions of people with heart health issues.But the two aren’t going at it alone. Joining the blockbuster pair at the table is fellow Corsera co-founder Chris Cox, co-founder and general partner of Population Health; Chief Operating Officer Rena Denoncourt, formerly of Alnylam; scientific co-founder and clinical advisor Brian Ference, M.D.; Chief Scientific Advisor Hans-Peter Vornlocher, Ph.D,; and co-founder and development advisor Peter Wijngaard, Ph.D.; among others. A stadium full of people At the heart of Corsera’s pitch is the fact that cardiovascular disease is the leading cause of death worldwide, with 21 million people dying every year. “That\'s a stadium full of people a day that die—46,000 [deaths] a day,” Meanwell emphatically described the figure. “It\'s just a colossal burden.”Corsera’s focus on preventive care and consumer wellness is designed to change the trajectory of cardiovascular disease for millions, an effort that would not only improve life quality and longevity but also cut down on healthcare costs and improve human productivity.“We\'re taking all the tools that are that have been put on the table—in part by us, but also by others—and putting them together to create something very disruptive,” Maraganore said.

Acquisition

15 May 2025

·www.prnewswire.com

Abzena Announces Establishment of Scientific Advisory Board to Support Innovation Strategy

SAN DIEGO, May 15, 2025 /PRNewswire/ -- Abzena, the leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, has announced today the formation of its Scientific Advisory Board (SAB) comprised of biopharma industry experts with diversified expertise in Discovery Research & Development (R&D) and Chemistry, Manufacturing, and Controls (CMC). The new advisory board will work closely with Abzena's scientific and commercial leadership to provide strategic guidance and expert insights that support Abzena's continued commitment to growth and innovation. Matt Stober, CEO of Abzena, said, "The establishment of the Scientific Advisory Board was a strategic decision to help guide the future of Abzena. We have seen considerable momentum over the past few years in supporting complex and innovative modalities, such as Antibody-drug conjugates (ADCs), Antibody-oligonucleotide conjugates (AOCs), and bispecifics. We aim to continue building upon this by offering the most state-of-the-art technologies and capabilities to support our customers' programs. These experts will be instrumental in assisting us with this mission by evaluating our strategies and providing recommendations that will further enhance our ability to move medicines forward to patients faster." Joe Principe, CCO of Abzena, said, "We are honored to welcome these distinguished individuals to our Scientific Advisory Board. These founding members are recognized leaders in our industry, bringing a wealth of expertise that will help guide us as we continue through this significant phase of our growth. We look forward to their contributions and the positive impact that they will have on our organization." Founding members of Abzena's Scientific Advisory Board are: John Knight, Ph.D., is the founder of JKONSULT, a UK-based consulting firm, where he provides process chemistry and CMC consulting services for early-stage chemical development and transfer-to-plant projects, with a primary focus on material supplies for toxicological studies, Phase I, and Phase II clinical trials. Dr Knight has 38 years of pharmaceutical industry experience, with prior roles at GSK, Vernalis, and Evotec. Kamal Egodage, Ph.D., MBA, is the President of Lasanth® Consulting, where he provides consultation services for biologics that span from discovery through commercialization, including CMC development, regulatory strategy, interactions with health authorities, and corporate development strategy. Prior to establishing his consultancy in 2017, Dr. Egodage accumulated over 20 years of industry experience at Eli Lilly, Pharmacia, Monsanto, Symic Bio, and Novartis (Switzerland), where he was the Head of Strategy and Business Development for Biologics. Morris Rosenberg, D.Sc., is an independent consultant with over 25 years of experience in the development of therapeutic agents to treat a variety of human diseases. As a consultant, he provides advisory services to early research and clinical-stage companies on product development strategies for biologics, biosimilars, and ADC therapies. Prior to this, Dr Rosenberg played a key role in the development and commercialization of ADC-based therapies at Seattle Genetics and Immunomedics and participated in the development and launch of Trodelvy®, Adcetris®, Avonex®, Angiomax®, Xigris®, and Forteo®. Scott Rudge, Ph.D., co-founded RMC Pharmaceutical Solutions in 2004, which was acquired by Syner-G BioPharma Group in January 2023. He is a Principal Consultant with Syner-G, and leads its Commercial and Scientific Advisory Boards, and is a member of the Syner-G Board. He also currently serves as SVP of Product Development at Margaux Biologics, Head of CMC for Antidote Therapeutics and Optigo Biotherapeutics, is a Key Advisor to Jurata, and is an Adjunct Professor of Chemical Engineering at the University of Colorado. Dr Rudge has over 33 years of experience directing Process Engineering, Process Development, Product Development, and overall Pharmaceutical Operations, and has built and led several organizations in the biopharmaceutical industry. Steven Sandoval is the founder and serves as the CEO/ Operations Head of Pharmaceutical Technical Solutions, Inc. (PTSI). Providing technical oversight and client representative support to the Biotechnology, Gene Therapy, Viral Vector, Cell Therapy, T-CELL, CAR T, mRNA, 503a/ 503b Compounding, and Vaccine Pharmaceutical Industries since 2010. Prior to this, he held senior leadership roles at Pfenex Inc., Parsons (BMS), and Amgen. He has over 30 years of experience in biopharmaceutical manufacturing, operations, CMC tech transfer, engineering, facilities, and quality leadership services. Tatyana Touzova is the Chief Pharmaceutical Development & Manufacturing Officer at SERA Medicines, where she oversees CMC, regulatory, and nonclinical development from drug discovery through clinical stages. Prior to this, she held the position of Chief Operating Officer at AstralBio, AlmataBio, and ValenzaBio, where she directed CMC, manufacturing, and regulatory operations for multiple clinical-stage programs. She has over 35 years of experience in drug development, regulatory affairs, and commercial manufacturing of biologics and complex therapeutics and is recognized as an expert in CMC strategy, GMP compliance, and global regulatory submissions. About Abzena Abzena is the leading end-to-end bioconjugate and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. With the ability to tailor its strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule and move medicines forward faster. The company has research, development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK. Abzena is owned by Welsh, Carson, Anderson & Stowe, one of the world's leading private equity investors. Learn more at abzena.com. SOURCE Abzena WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AcquisitionPhase 2Executive Change

10 Dec 2024

·www.globenewswire.com

CAMP4 Appoints John Maraganore and Rachel Meyers as Strategic Advisors

Industry veterans John Maraganore, Ph.D., and Rachel Meyers, Ph.D., to provide strategic guidance on the company’s RNA Actuating platform to develop a new class of RNA medicines that upregulate protein coding genesCAMBRIDGE, Mass., Dec. 10, 2024 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4”) (Nasdaq: CAMP), a clinical-stage biotechnology company developing a pipeline of regRNA-targeting therapeutics designed to upregulate gene expression with the goal of restoring healthy protein levels across a range of genetic diseases, today announced the appointments of John Maraganore, Ph.D., and Rachel Meyers, Ph.D., as strategic advisors to the Company. For nearly 20 years, Dr. Maraganore served as the founding Chief Executive Officer and Director of Alnylam where he led the company’s programs in RNA interference through global commercialization, resulting in the launch of the first four RNAi therapeutics, ONPATTRO®, GIVLAARI®, OXLUMO®, and LEQVIO®. Additionally, Dr. Meyers brings more than two decades of life sciences leadership, research, and development experience in RNA-based medicines, having spent nearly 14 years at Alnylam where she most recently served as Senior Vice President of Research and RNAi Lead Development. She currently sits on the company’s Scientific Advisory Board. “We feel privileged and are delighted to welcome Drs. Maraganore and Meyers to our CAMP4 team as strategic advisors,” said Josh Mandel-Brehm, Chief Executive Officer of CAMP4. “We view their joining the team as a testament to the promise and potential of our approach for upregulating gene expression to potentially address a broad range of diseases. As we prepare for 2025, we look forward to benefiting from their insights and expertise as we advance our efforts in bringing potentially transformative RNA medicines to patients in need of disease-modifying solutions.” Dr. Maraganore added, “The targeted upregulation of gene expression has been a long-standing challenge for the field, and by applying established and clinically validated antisense oligonucleotide technology to groundbreaking science, CAMP4 could potentially make a meaningful impact on patients across a broad range of diseases. I look forward to working with them as they pioneer the field of upregulation.” Prior to his role at Alnylam, Dr. Maraganore led the product franchises in oncology, cardiovascular, inflammatory, and metabolic diseases for Millennium Pharmaceuticals, in addition to leadership of M&A, strategy, and biotherapeutics. Earlier in his career, Dr. Maraganore invented and spearheaded the development of ANGIOMAX® (bivalirudin) for injection while at Biogen and was also a scientist at ZymoGenetics, Inc., and the Upjohn Company. He currently serves as a Venture Partner at ARCH Venture Partners, a Venture Advisor at Atlas Ventures, an Executive Partner at RTW Investments, a Senior Advisor for Blackstone Life Sciences, and a Senior Advisor for Jeffries Financial Group. Beyond his leadership roles in the investment community, Dr. Maraganore also sits on the Board of Directors for multiple publicly traded companies, including Beam Therapeutics, Kymera Therapeutics, Rapport Therapeutics, and Takeda Pharmaceuticals. He received his B.A., M.S., and Ph.D. in biochemistry and molecular biology at the University of Chicago. Dr. Meyers currently serves as a member of the Board of Directors of Korro Bio (Nasdaq: KRRO), a biopharmaceutical company focused on discovering, developing, and commercializing a new class of genetic medicines based on editing RNA, and also holds a variety of advisory roles within the biotech community. Most recently, she served as Founder and Chief Scientific Officer at Faze Medicines, a Third Rock Ventures-spawned biotech company focused on treating diseases of high unmet need through the perturbation of biomolecular condensates. Earlier in her career, Dr. Meyers was a senior scientist at Millennium Pharmaceuticals and today serves on multiple scientific advisory boards, including the National Advisory Board on Innovation and Entrepreneurship through the Department of Commerce. Furthermore, she is listed as an inventor on numerous patents and patent applications and has authored many peer-reviewed publications. Dr. Meyers received her postdoctoral training with Lew Cantley at Harvard Medical School in signal transduction and earned her Ph.D. in biology from Nobel laureate Phil Sharp at the Massachusetts Institute of Technology in in vitro transcription. She earned her BA in Biochemistry from Brandeis University. “I’ve had the unique opportunity to work alongside tremendously talented professionals who have led the shaping of the RNA medicines space,” said Dr. Meyers. “Having been at the forefront of these scientific breakthroughs, I believe now more than ever RNA-based therapies are poised to continue transforming how we treat patients with complex diseases. Having the opportunity to advise CAMP4 as they continue advancing the field is an extension of the work to which I’ve committed my career.” About CAMP4 Therapeutics CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regRNAs, which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAP Platform™ enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. Learn more about us at www.CAMP4tx.com and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning CAMP4’s plans, objectives, expectations and intentions; the timing and results of ongoing and future clinical trials, including expectations on the timing of reporting SAD and MAD data from and seeking regulatory approval for the CMP-CPS-001 trial; its growth strategy; and cash balance guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; risks related to the operations of the Company’s suppliers; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain and are not guarantees of future events. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, you should not unduly rely on these forward-looking statements. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contacts Investor Relations:Sandya von der WeidLifeSci Advisorssvonderweid@lifesciadvisors.com Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com

Executive ChangeOligonucleotide

100 Deals associated with Bivalirudin

External Link

KEGG	Wiki	ATC	Drug Bank
D03136	Bivalirudin	B01AE06	DB00006

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Coronary Artery Disease	Canada	Avir Pharma, Inc.	24 Sep 2020
Heparin-induced thrombocytopenia and thrombosis	United States	Maia Pharmaceuticals, Inc.	25 Jul 2019
Coronary Disease	United States	Baxter Healthcare Corp.	21 Dec 2017
Thrombocytopenia	China	Shenzhen Salubris Pharmaceuticals Co., Ltd.	15 Aug 2011
Acute Coronary Syndrome	United States	Sandoz, Inc.	30 Nov 2005
Non-St Elevated Myocardial Infarction	European Union	The Medicines Company UK Ltd.	20 Sep 2004
Non-St Elevated Myocardial Infarction	Iceland	The Medicines Company UK Ltd.	20 Sep 2004
Non-St Elevated Myocardial Infarction	Liechtenstein	The Medicines Company UK Ltd.	20 Sep 2004
Non-St Elevated Myocardial Infarction	Norway	The Medicines Company UK Ltd.	20 Sep 2004
ST Elevation Myocardial Infarction	European Union	The Medicines Company UK Ltd.	20 Sep 2004
ST Elevation Myocardial Infarction	Iceland	The Medicines Company UK Ltd.	20 Sep 2004
ST Elevation Myocardial Infarction	Liechtenstein	The Medicines Company UK Ltd.	20 Sep 2004
ST Elevation Myocardial Infarction	Norway	The Medicines Company UK Ltd.	20 Sep 2004
Angina, Unstable	United States	Sandoz, Inc.	15 Dec 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Aortic Valve Stenosis	Phase 3	Canada	The Medicines Co.	01 Oct 2012
Aortic Valve Stenosis	Phase 3	France	The Medicines Co.	01 Oct 2012
Aortic Valve Stenosis	Phase 3	Germany	The Medicines Co.	01 Oct 2012
Aortic Valve Stenosis	Phase 3	Italy	The Medicines Co.	01 Oct 2012
Aortic Valve Stenosis	Phase 3	Netherlands	The Medicines Co.	01 Oct 2012
Aortic Valve Stenosis	Phase 3	Switzerland	The Medicines Co.	01 Oct 2012
Aortic Valve Stenosis	Phase 3	United Kingdom	The Medicines Co.	01 Oct 2012
Acute myocardial infarction	Phase 3	United States	The Medicines Co.	01 Apr 2004
Cardiovascular Diseases	Phase 3	United States	The Medicines Co.	01 Apr 2004
Myocardial Infarction	Phase 3	United States	The Medicines Co.	01 Aug 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2025	Not Applicable	Heparin-induced thrombocytopenia	4	Ultra-low-dose argatroban purge	rlgcdolxoy(tdziubwwlv) = without bleeding yjwiyjkxtv (crrgrhiuyc ) View more	Positive	06 Dec 2025
NCT03822975 (BRIGHT-4, Pubmed \| BMC Med)	Not Applicable	ST Elevation Myocardial Infarction	6,016	Bivalirudin	idafiwtter(evzwpqefnm) = fzpadshkvc melydmhckp (bxgnsmnapf )	Positive	30 Sep 2025
				Heparin	idafiwtter(evzwpqefnm) = kgsqotlskv melydmhckp (bxgnsmnapf )
NCT03318393 (Pubmed \| Pediatr Crit Care Med)	Phase 4	Extracorporeal membrane oxygenation complication	-	Bivalirudin	hprnqiszqm(eqwboofjew) = uuflawjbcq ocrxekdwvd (exbtqghdnd, 2.5 - 8.4) View more	-	25 Nov 2024
				Heparin	hprnqiszqm(eqwboofjew) = fedpcjtsia ocrxekdwvd (exbtqghdnd, 5.5 - 14.5)
NCT03822975 (BRIGHT-4, Pubmed \| BMC Med)	Not Applicable	-	6,016	Bivalirudin plus post-PCI high-dose infusion	donzrsydnl(qeruyigwyz) = szebpibbxx ifbcmioqop (uyaloswkmb ) View more	Positive	27 Sep 2024
				Heparin monotherapy	donzrsydnl(qeruyigwyz) = wmqgmbzeyy ifbcmioqop (uyaloswkmb ) View more
NCT02311231 (VALIDATE-SWEDEHEART, Pubmed \| Cardiovasc Revasc Med) Manual	Phase 4	Non-St Elevated Myocardial Infarction \| ST Elevation Myocardial Infarction	6,006	Bivalirudin	nyjjtraiki(erupbrxxjc) = cttrrypvek buladsaenx (vuveykkfyw ) View more	Similar	26 Mar 2024
				Heparin	nyjjtraiki(erupbrxxjc) = xswkcxsgxg buladsaenx (vuveykkfyw ) View more
NCT02311231 (VALIDATE-SWEDEHEART, ESC2023)	Phase 4	ST Elevation Myocardial Infarction \| Non-St Elevated Myocardial Infarction	6,006	Bivalirudin	phjyhxvjbk(jaglumbzjo) = jfzbekpnmw ezznpuvqzc (wvkgmvgblr )	Negative	28 Aug 2023
				Heparin	phjyhxvjbk(jaglumbzjo) = ygtowvbsow ezznpuvqzc (wvkgmvgblr )
NCT03318393 (CTgov)	Phase 4	Extracorporeal membrane oxygenation complication \| Acute Lymphoblastic Leukemia	30	Unfractionated heparin (Unfractionated Heparin Group)	fsvgfzchmu(hwlvrknepi) = gxdxtawnlm zdrefpvuqs (fzyqgvlahg, ftaotbyhes - nnmhekestc) View more	-	31 Jan 2023
				Bivalirudin (Bivalirudin Group)	fsvgfzchmu(hwlvrknepi) = ppitvpaepq zdrefpvuqs (fzyqgvlahg, zptbovqauu - ekngwbdqrz) View more
NCT03707418 (Pubmed \| ASAIO J)	Phase 1	Extracorporeal membrane oxygenation complication	-	Bivalirudin	xawayscyiw(pkhdixlixr): P-Value = 0.01	Positive	04 Oct 2022
				Heparin
NCT02311231 (VALIDATE-SWEDEHEART, Pubmed \| Circ Cardiovasc Interv)	Phase 4	ST Elevation Myocardial Infarction	6,006	Bivalirudin	ipmvqptydv(sbxjinydkl) = hehehlusby zqydiemosw (wxeallgdif ) View more	Negative	14 Dec 2021
				Heparin	ipmvqptydv(sbxjinydkl) = zhrkeoaxuf zqydiemosw (wxeallgdif ) View more
ISTH2020	Not Applicable	-	8	Bivalirudin	whzkctehva(nzhexsmnbv) = GI bleed x2 qcyonunkxg (yyqsjgyheh ) View more	-	12 Jul 2020

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