DIAMOND study is a national, multicentre, randomized, parallel-group, open label study in patients (aged ≥18 years) with aortic bioprosthesis (excluding TAVI) at least 7 days after cardiac surgery.
Experimental group:
Patients treated with apixaban 5 mg twice daily (BID)
Active Comparator group:
Aspirin 75 to 100mg once a day
The primary objective is to demonstrate that antithrombotic treatment with apixaban is superior to aspirin in patients with recent surgical bioprosthetic aortic valve replacement for the primary composite efficacy endpoint of death from any cause, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis after 105 days of follow-up.

Start Date01 Sep 2025

Sponsor / Collaborator

Eske Corp. SAC

NCT07005024

/ Not yet recruitingPhase 3IIT

A Comparison of Anticoagulant Dosing Strategies to Reduce VTE and Mortality in Cancer Outpatients: A Randomized, Pragmatic Trial

Blood clots, also known as venous thromboembolism (VTE), are a common and serious complication for people with cancer. They can lead to pain, hospitalizations, delayed cancer treatment, and even death. Although national guidelines recommend using blood thinners (anticoagulants) to prevent clots in cancer patients who are at higher risk, these medications are not commonly prescribed due to concerns about bleeding and inconvenience.
This study will test different ways of using a commonly prescribed blood thinner called apixaban (brand name Eliquis) to see if it can safely and effectively reduce the risk of blood clots and death in cancer patients who are at moderate risk for VTE. The study focuses on people who have a "Khorana score" of 2, which puts them at intermediate risk for developing blood clots.
The study will include approximately 996 participants with solid tumors or lymphoma who are starting or recently started cancer-directed therapy. Participants will be randomly assigned to one of three groups:
Group 1: Apixaban 2.5 mg twice a day (standard prophylactic dose)
Group 2: Apixaban 5 mg once a day (an alternative, more convenient dose)
Group 3: No anticoagulant (standard care)
Participants will take the assigned treatment (if applicable) for 6 months. Researchers will monitor whether participants develop blood clots, experience serious bleeding events, or die from any cause during the study period.
By comparing these three groups, the researchers hope to learn whether a once-daily dose of apixaban can work as well as the standard twice-daily dose, and whether either dosing strategy is better than no anticoagulation at all. If successful, the study may help increase the safe use of VTE prevention in cancer patients and improve overall outcomes, especially in patients at intermediate risk.
This is a pragmatic trial, meaning it is designed to fit into real-world clinical practice with minimal extra procedures. The study drug is not provided by the sponsor and will be prescribed and filled through usual care channels. Participants and their doctors will decide whether to continue the medication after the study ends.

Start Date01 Aug 2025

Sponsor / Collaborator

University of Vermont

NCT06933056

/ Not yet recruitingEarly Phase 1IIT

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study

This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.

Start Date01 Aug 2025

Sponsor / Collaborator

University of Michigan

[+1]

100 Clinical Results associated with Apixaban

100 Translational Medicine associated with Apixaban

100 Patents (Medical) associated with Apixaban

6,784

Literatures (Medical) associated with Apixaban

01 Jan 2026·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Harmonizing drug analysis and sustainability: Spectroscopic quantification of antiplatelet-anticoagulant regimens

Article

Author: Elama, Heba Samir ; El Abass, Samah Abo ; Altamimi, Abdulmalik S A ; Elmansi, Heba ; Abdallah, Nora A ; Alossaimi, Manal A

One of the most commonly prescribed medications are antithrombotic agents which consisting of antiplatelet and anticoagulant medications. Currently, millions of patients rely on them to avoid blood-clot-related issues across various cardiovascular diseases. The combined administration of apixaban, aspirin and clopidogrel is an example of this therapy which can be used for the risk reduction in cardiovascular death. The importance of such medications encourages us to investigate novel analytical assay methods for determination of such drugs in dosage forms as well as in human plasma. Spectroscopic technique was the best choice to design new analytical methods due to its applicability and simplicity. Three spectroscopic methods were introduced for concurrent determination of apixaban, aspirin and clopidogrel. The designed methods were; A direct measurement for determination of apixaban without interference from the other two drugs (method I), Ratio spectra (method II) and first derivative ratio spectra (method III). The first method enables us to determine apixaban through direct measurement of its absorption spectrum at 310 nm with no reading from aspirin or clopidogrel. Ratio spectra method (method II) was performed at ΔP = 223.6-245.2 nm for aspirin, ΔP = 293.2-307.0 nm for apixaban and ΔP = 251.0-260.0 nm for clopidogrel. The third first derivative ratio spectra method was based on measuring apixaban at 255 nm, aspirin at 242 nm and clopidogrel at 260 nm using the other two analytes as a double divisor. The linearity of the designed methods was 0.5-18 μg/mL for apixaban by the three methods while were 2.0-28 μg/mL for both aspirin and clopidogrel by method II & III. These developed approaches were effectively applied for estimation of the three studied drugs in their raw materials, synthetic mixtures and dosage forms simultaneously. The co-administration of these treatments enables us to extend the application for determination of them in spiked human plasma without complicated procedures. The applied methods were validated following the ICH Q2(R1) guidelines. The greenness of the designed methods was evaluated using six different tools including; Analytical Eco-scale, GAPI, AGREE metrics, NEMI, whiteness and blueness assessment.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Nationwide extrapolation of economic benefit of therapeutic innovation: a 10-year retrospective budget impact of direct oral anticoagulants introduction in France

Article

Author: Belhassen, M. ; Lesage, H. ; Moreau, R. ; Guilmet, C. ; Cotté, F. E. ; Née, M. ; Danchin, N. ; Marant Micallef, C. ; Guitard-Dehoux, D.

OBJECTIVES:

Patients with atrial fibrillation (AF) face increased risks of strokes and systemic thromboembolism (SE), traditionally managed with vitamin K antagonists (VKAs), which are associated with major bleeding (MB) risks. The nationwide real-life data-based NAXOS study, comparing Direct Oral Anticoagulants (DOACs: apixaban, dabigatran, rivaroxaban) to VKAs in over 400,000 AF patients in France, showed that DOACs are more effective, safer, and associated with lower total costs. This study evaluates the 10-year budget impact of DOACs in France, focusing on reductions in strokes/SE, MB, and monitoring costs (INRt).

METHODS:

A retrospective budget impact model from 2014 to 2023 compared scenarios with and without DOACs, using clinical and cost data from the NAXOS study. The target population of DOAC-eligible patients ranged from 725,000 in 2014 to 1.4 million in 2023. Market shares trends were derived from the public national drugs database, indicating that VKAs' use decreased from 67% to 11%, while DOACs, especially apixaban, rose sharply (2% to 55%) over the same period. Costs included treatment acquisition, strokes/SE, MB, and international normalized ratio testing (INRt) for VKAs.

RESULTS:

Over a 10-year horizon, the introduction of DOACs is estimated to have prevented 73,009 strokes, 97,234 major bleeding, and 19,567 stroke-related deaths among patients with NVAF. DOAC introduction increased treatment costs by €5.15 billion over 10 years, and reduced costs for strokes/SE (-€4.24 billion), MB (-€3.22 billion), and INRt (-€1.14 billion), leading to €3.45 billion of savings for National Insurance over 10 years, with apixaban contributing 55% of savings.

LIMITATIONS:

This analysis may not account for all contextual variables, such as indirect costs related to productivity losses.

CONCLUSION:

Over 10 years, the introduction of DOACs in France has generated substantial savings in AF-related costs, highlighting their clinical and economic benefits and the importance for authorities to valorise the external effects of therapeutic innovations.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Decision model to evaluate the cost of clinical events associated with switching from apixaban to rivaroxaban among patients with non-valvular atrial fibrillation in the United States and Germany

Article

Author: Dworatzek, Elke ; Kongnakorn, Thitima ; Duan, Cecilia ; Shah, Anshul ; Kisser, Agnes ; Hines, Dionne M. ; Subash, Rupesh ; Hagan, Melissa ; Zhang, Michelle

AIMS:

Direct-acting oral anticoagulants (DOACs) have emerged as the preferred treatment for nonvalvular atrial fibrillation (NVAF). However, evidence concerning the economic outcomes of DOAC switching remains limited. This study aimed to assess the economic outcomes of DOAC switching in the US and Germany, two countries with a high AF prevalence and DOAC utilization.

METHODS:

A decision model was developed to assess the incidence and cost of stroke/systemic embolism (SE) and major bleeding (MB) associated with switching from apixaban to rivaroxaban in patients with NVAF. The model compared two scenarios: continuers (patients continuing apixaban) and switchers (patients switching from apixaban to rivaroxaban). Model inputs on clinical event rates were sourced from a published real-world study, cost inputs were from a standard costing database and published literature. The analysis was conducted over a 1-year time horizon from US Medicare fee-for-service and German public healthcare payer perspectives.

RESULTS:

Over one year, 47,036 patients among a hypothetical plan size of 1,000,000 US Medicare fee-for-service members and 1,019,079 patients among the German adult population size of 70,107,122 were estimated to be treated for NVAF with apixaban. Switching all patients from apixaban to rivaroxaban resulted in 1,498 and 32,447 additional clinical events (stroke/SE and MB) and deaths in the US and Germany, respectively, compared to continuing with apixaban. This led to a total incremental cost of $17.3 million and €153 million from Medicare fee-for-service and German public healthcare perspectives, respectively.

LIMITATIONS:

The incidence and hazard ratios of clinical events informing this analysis were based on a US commercial and Medicare Advantage population and may not be generalizable to other populations.

CONCLUSIONS:

Switching from apixaban to rivaroxaban was associated with increased clinical events, deaths, and higher medical care costs, potentially representing a less favorable strategy economically compared to continuing apixaban among patients with NVAF.

292

News (Medical) associated with Apixaban

07 Aug 2025

·www.prnewswire.com

CytoSorbents Reports Second Quarter 2025 Financial Results and Provides Business Update

PRINCETON, N.J., Aug. 7, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today reported financial results for the second quarter ended June 30, 2025, and recent business highlights. Second Quarter 2025 Financial Results Revenue was $9.6 million, an increase of 9%, or 4% on a constant currency basis, compared to $8.8 million in Q2 2024, driven by 22% year-over-year and sequential sales growth in Germany. Gross margin was 70.9% compared to 73.5% in Q2 2024. Operating loss was $3.6 million, flat compared to Q2 2024. Net income was $1.9 million or $0.03 per basic and diluted share, compared to a net loss of $4.3 million or $0.08 per basic and diluted share in Q2 2024. Adjusted net loss was $3.7 million or $0.06 per basic and $0.05 per diluted share, compared to an adjusted net loss of $2.8 million, or $0.05 per basic and diluted share in Q2 2024. Adjusted EBITDA loss was $2.6 million compared to a loss of $2.2 million in Q2 2024. Total cash, cash equivalents, and restricted cash of $11.7 million at June 30, 2025, compared to $13.1 million as of March 31, 2025, which includes $1.7 million of proceeds received from the sale of its 2023 and amended 2022 Net Operating Loss and R&D tax credits from the Technology Business Tax Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority (NJEDA). "Our performance in the second quarter was led by strong 22% year-over-year and sequential sales growth in Germany and continued strength in our other direct sales territories. Distributor sales were among our best ever, second only to a record quarter for distributor sales in the prior year," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "We initiated a proactive reorganization of our German commercial team and sales approach in the first quarter following two years of flat growth in this important market which caused a temporary sales disruption in the first quarter. With the second quarter behind us, we are pleased with our initial progress of our Germany reorganization and remain confident it will lead to stronger execution, improved performance, and more robust sales growth in our overall business this year and beyond. Meanwhile, we are focused on driving growth in our key, high impact clinical applications, improving our gross margins, controlling costs and driving efficiencies to manage our core business to near breakeven as we exit 2025." DrugSorb™-ATR Updates In July, the Company conducted an in-person appeal hearing with the U.S. FDA for supervisory review (administrative appeal) under 21 CFR 10.75 for its De Novo Request for DrugSorb™-ATR. The appeal hearing included FDA senior leadership and review team, Company management, our FDA regulatory counsel, and our external cardiac surgery experts. The Company continues to believe that remaining deficiencies in its DeNovo application can be effectively resolved through this supervisory review process which is expected to be completed by the end of August 2025, and that a final regulatory decision can be achieved in 2025. The Company continues to work with Health Canada after receipt of their Notice of Refusal in June. As part of Health Canada's prescribed reconsideration process, and after discussions with Health Canada, the Company has filed a Level 1 "Request for Reconsideration" and with agreement from the Medical Devices Directorate Bureau Director, will pursue the review following the completion of the Company's review with the U.S. FDA. In May 2025, Prof. Matthias Thielmann, STAR Registry investigator, received the "Best Oral Presentation Award" at the 73rd International Congress of the European Society for Cardiovascular and Endovascular Surgery for his presentation entitled, "Early CABG with Intraoperative Hemoadsorption in Patients on Ticagrelor: Real World Data from the International Safe and Timely Antithrombotic Removal (STAR) Registry" - underscoring the importance of our technology and these findings in the international community. In May 2025, a new comparative real-world data analysis was presented at EuroPCR, highlighting the intraoperative use of our technology to significantly and safely reduce the severity of bleeding in urgent coronary artery bypass grafting (CABG) patients on the blood thinner, ticagrelor (Brilinta®, AstraZeneca) who had not completed the recommended drug washout period, reinforcing the clinical value of our therapy. "Following our recent meeting with the FDA, we remain committed to working collaboratively with the agency to secure marketing authorization for DrugSorb-ATR, an FDA Breakthrough Designated Device," said Dr. Chan. "Meanwhile adoption of our blood thinner removal application continues to grow with an increasing number of heart centers around the world incorporating our technology as part of their standard care to reduce bleeding complications in patients on blood thinners undergoing cardiac surgery. We remain confident in the strength of our DrugSorb-ATR market authorization requests with both FDA and Health Canada and believe that the remaining issues can be expeditiously and successfully addressed." Turning the Tide in Sepsis and Septic Shock with CytoSorb Dr. Chan stated, "On September 10, 2025, we invite you to participate in our World Sepsis Day Global Webinar that is intended to spotlight the vital and evolving role of CytoSorb® in the treatment of sepsis and septic shock – among the deadliest challenges in critical care medicine today – and a major global growth opportunity for us. This special presentation, which will feature physician-user guests discussing CytoSorb therapy best practices and its impact in the fight against sepsis, along with our recent press release on the topic, commemorates Sepsis Awareness Month and World Sepsis Day in September." Turning the Tide in Sepsis and Septic Shock: Real World Insights with CytoSorb Date: Wednesday, September 10, 2025 Time: 11:00 AM EDT Webinar registration required: "CytoSorbents has worked closely with clinicians and scientists for more than a decade to advance the treatment of sepsis and septic shock by complementing traditional antibiotics with the broad-spectrum, blood purification capability of CytoSorb®. While antibiotics fight the infection, CytoSorb broadly targets the other key drivers of septic shock, including severe inflammation driven by cytokine storm and bacterial toxins, circulatory collapse, capillary leak, fluid overload, and organ failure. We believe this dual approach, when combined with standard of care therapy, represents a paradigm shift in how to treat septic shock - emphasizing early, intensive, and sufficiently long CytoSorb treatment, much like the principles guiding effective antibiotic therapy." "This philosophy of treating the "Right Patient at the Right Time with the Right Dose" was highlighted in recent published, peer-reviewed septic shock studies, including: The first CytoSorb septic shock meta-analysis from Steindl et al., from the well-respected Charité Berlin Hospital in Germany, showing a statistically significant reduction of mortality with CytoSorb, in the Journal of Clinical Medicine (2025) A large retrospective 175 patient septic shock study from Berlot and team emphasizing high survival with early and intensive CytoSorb treatment, in the Journal of Intensive Care Medicine (2025), and The positive clinical outcomes from the first 150 patients (58% had septic shock) enrolled in the international, prospective COSMOS (CytOSorb treatMent Of critically ill patientS) critical care registry, reported by Ferrer et al. in the Journal of Intensive Medicine (2025) Backed by these and other robust peer-reviewed clinical and scientific data, CytoSorb is being used by physicians around the world to help turn the tide for patients with sepsis and septic shock by sequentially achieving the following key treatment goals: 1) Break the vicious cycle of uncontrolled inflammation 2) Reverse shock and restore oxygenated blood flow 3) Promote the repair of leaky blood vessels 4) Actively remove excessive fluid and reduce fluid overload in organs 5) Prevent or treat multiple organ failure Our World Sepsis Day Global Webinar on September 10, 2025 is intended to highlight the leadership role that CytoSorbents and its many collaborators have been playing to advance a new era in sepsis management. We also invite you to follow our new septic shock blog series where we delve into greater detail on these points, found here. Meanwhile, watch videos from healthcare providers from around the world who detail their first-hand experiences with CytoSorb in the treatment of septic shock and other critical illnesses in our "Voices Around the World" segment, found here." Second Quarter 2025 Earnings Conference Call CytoSorbents' management will host a live conference call, presentation webcast, and a question-and-answer session with the following information: Date: Thursday August 7, 2025 Time: 4:30 PM EDT North American toll-free: 1-800-836-8184 International toll: 1-646-357-8785 Live webcast link: It is recommended that participants dial in approximately 10 minutes prior to the start of the call. An archived recording of the conference call will be available under the Investor Relations section of the Company's website at About Non-GAAP Financial Measures To supplement our condensed consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, and Adjusted EBITDA which further excludes non-cash stock compensation expense, and gain or loss of foreign exchange translation. We also use the non-GAAP financial measures of Adjusted Net Income or Loss and Adjusted Net Income or Loss Per Common Share which excludes non-cash stock compensation expense and gain or loss of foreign exchange translation from Net Loss and Net Loss Per Common Share, respectively. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The reconciliations of the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP should be carefully evaluated. We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our performance and that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP financial measures are useful to investors because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they are used by investors and the analyst community to help them analyze the performance of our business, the Company's cash available for operations, and the Company's ability to meet future capital expenditure and working capital requirements. For a reconciliation of non-GAAP financial measures to the most comparable GAAP measure, see the reconciliation included in the financial tables. All non-GAAP adjustments are presented pre-tax. About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with nearly 300,000 devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not yet approved or cleared in the United States. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. On April 25, 2025, the FDA issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process. In July 2025, the Company attended an appeal hearing with the FDA for supervisory review (administrative appeal) under 21 CFR10.75. The appeal hearing included FDA senior leadership and review team, Company management, our FDA regulatory counsel, and our external cardiac surgical experts. The Company continues to believe that remaining deficiencies in its DeNovo application can be effectively resolved through this supervisory review process which is expected to be completed by the end of August 2025, and that a final regulatory decision can be achieved in 2025. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. On June 26, 2025, Health Canada issued a Notice of Refusal of the Company's Medical Device License application, identifying remaining deficiencies that must be addressed before the application may be granted and the device authorized for commercialization. As part of Health Canada's prescribed reconsideration process, and after discussions with Health Canada, the Company has filed a Level 1 "Request for Reconsideration" and with agreement from the Medical Devices Directorate Bureau Director, will pursue the review following the completion of the Company's review with the U.S. FDA. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's website at or follow us on Facebook and X. Forward-Looking Statements This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany, our ability to resolve deficiencies in the FDA denial letter and the Health Canada Notice of Refusal and/or successfully appeal the FDA's and Health Canada's decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. Please Click to Follow Us on Facebook and X U.S. Company Contact: Peter J. Mariani, Chief Financial Officer 305 College Road East Princeton, NJ 08540 [email protected] Investor Relations Contact: Aman Patel, CFA & Adanna G. Alexander, PhD ICR Healthcare [email protected] See accompanying notes to condensed consolidated financial statements See accompanying notes to condensed consolidated financial statements. See accompanying notes to condensed consolidated financial statements See accompanying notes to condensed consolidated financial statements. SOURCE Cytosorbents Corp WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalBreakthrough TherapyFinancial StatementClinical Result

31 Jul 2025

·pharma.economictimes.indiatimes.com

Bristol Myers posts better-than-expected second quarter results on strength of top sellers

Bengaluru: Bristol Myers Squibb posted much better-than-expected second-quarter results on Wednesday on strong sales of its most established and best-selling brands, blood thinner Eliquis and cancer treatments Opdivo and Revlimid . Shares of the drugmaker rose more than 2 per cent to $47 in premarket trading. Revenue in the quarter, which analysts had expected to fall due to the loss of patent protection on some of its products, including Revlimid, rose 1 per cent to $12.3 billion. Analysts, on average, were looking for revenue of $11.4 billion, according to LSEG data. The U.S. drugmaker said it earned $2.9 billion, or $1.46 per share, down from $4.2 billion, or $2.07, a year earlier. Analysts had expected earnings of $1.07 a share. "The majority of our brands outperformed consensus in the quarter," Chief Financial Officer David Elkins said in an interview. "We just have really solid commercial execution." Sales of Eliquis, which Bristol Myers shares with Pfizer , rose 8 per cent to $3.7 billion in the quarter, while cancer immunotherapy Opdivo brought in $2.6 billion, up 7 per cent from a year ago. Analysts, on average, had forecast sales of $3.3 billion and $2.3 billion for those drugs, respectively. Revlimid sales fell 38 per cent to $838 million, but still topped analyst estimates by about $300 million. Bristol has been contending with a steep revenue decline from Revlimid, which raked in nearly $13 billion in 2021 but $5.8 billion last year due to generic rivals. Some of its other cancer drugs such as Pomalyst, Sprycel and Abraxane are contending with the same issue. Still, Revlimid has held up better than initially feared, and the company now expects 2025 sales of around $3 billion, Chief Commercialization Officer Adam Lenkowsky said. The company had previously said it expected 2025 Revlimid sales to be near $2.5 billion. Bristol Myers raised its full-year revenue forecast to a range of $46.5 billion to $47.5 billion from its prior view of $45.8 billion to $46.8 billion. It now expects full-year earnings, including a charge from a development deal with Germany's BioNTech, to be $6.35 to $6.65 a share. Analysts are estimating 2025 earnings of around $6.24 per share. (Reporting by Michael Erman; Additional reporting by Bhanvi Satija in Bengaluru Editing by Bill Berkrot)

Financial StatementBiosimilar

31 Jul 2025

·firstwordpharma.com

BMS ups guidance, but its financial prospects fail to capture investor enthusiasm

Bristol Myers Squibb posted a beat-and-raise second quarter on Thursday, but despite the seeming success, investors appeared unimpressed, with the pharma's shares falling as much as 5% during afternoon trading.While analysts had been expecting a roughly 6% drop in revenues from the drugmaker's $12.2 billion sales figure from the second quarter of 2024, BMS eked out a 1% increase to $12.3 billion. The win prompted the pharma to raise its full-year guidance from $45.8 billion-$46.8 billion to a range of $46.5 billion-$47.5 billion.All eyes on growth driversThe investor reaction to BMS's financial results may be due to disappointment in which products were behind the expectation-beating quarter.Similar to its first-quarter earnings, BMS once again reported higher-than-expected sales for its legacy cancer drug Revlimid. The product brought in $838 million in revenue, down 38% from the year-ago period, although surpassing estimates of roughly $500 million. Revlimid's sales have been falling steadily since it started facing US generic competition in 2022. Another legacy product, anticoagulant Eliquis, also exceeded expectations. The factor Xa inhibitor, which BMS markets with Pfizer, raked in $3.7 billion, up 8% year-over-year and beating analyst predictions of about $3.3 billion. The partners plan to launch in September a direct-to-consumer (DTC) service to allow uninsured or underinsured patients to purchase Eliquis for $346 monthly. On Thursday's investor call, CEO Christopher Boerner called the DTC programme "a way for us to offer meaningful decreases in out-of-pocket costs for patients, increase transparency, and take a step… in cutting out traditional middlemen."Opdivo, another long-time fixture on BMS's balance sheet, posted a revenue increase — although the pharma designates the immunotherapy as a growth product, despite its upcoming patent expiration in 2028. The PD-1 inhibitor brought in $2.6 billion, ahead of sales estimates of about $2.3 billion and representing a 7% gain over the same period last year. And, while several other products comprising its growth portfolio posted impressive gains for the second quarter— most notably immuno-oncology drugs Breyanzi, Reblozyl and Camzyos — driving an 18% portfolio revenue increase to $6.6 billion, none have yet cracked the $1-billion revenue mark. A recent FirstWord analysis found that while BMS has spent about $40 billion on M&A since 2020, none of its acquired assets look likely to meaningfully drive growth. For more, see Vital Signs: BMS's BD blunders come to bear.The drugmaker, however, is hoping two recent deals can turn that trend around. BMS paid $1.5 billion upfront in June for rights to co-develop BioNTech's VEGF/PD-L1 bispecific BNT327, and is on the hook for up to $11 billion in milestones (see – Spotlight On: BMS's bispecific deal with BioNTech — The key takeaways).The programme "has the potential to become a new standard of care for many patients and could transform the current landscape as a backbone of cancer treatment," BMS Chief Commercial Officer Adam Lenkowsky said on the call. And BMS says its schizophrenia drug Cobenfy, gained via its $14-billion buyout of Karuna Therapeutics in late 2023, is "performing in-line with expectations" — it brought in $35 million in sales for the quarter, slightly ahead of analyst expectations of about $32 million. Those expectations, however, are sky-high. BMS is billing Cobenfy as a pipeline-in-a-product, and has launched several clinical trials in patients with Alzheimer's disease. FirstWord recently sat down with Ken Rhodes, VP of neuroscience at BMS, to get more insight on the pharma's neuro aspirations (see – ViewPoints: Inside Bristol Myers' Alzheimer's disease playbook).Those expectations, however, are sky-high. BMS is billing Cobenfy as a pipeline-in-a-product, and has launched several clinical trials in patients with Alzheimer's disease. FirstWord recently sat down with Ken Rhodes, VP of neuroscience at BMS, to get more insight on the pharma's neuro aspirations (see – ViewPoints: Inside Bristol Myers' Alzheimer's disease playbook).

AcquisitionImmunotherapyFinancial StatementIPO

100 Deals associated with Apixaban

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KEGG	Wiki	ATC	Drug Bank
D03213	Apixaban	B01AF02	DB06605

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Recurrent deep vein thrombosis	European Union	Accord Healthcare SLU	23 Jul 2020
Recurrent deep vein thrombosis	Iceland	Accord Healthcare SLU	23 Jul 2020
Recurrent deep vein thrombosis	Liechtenstein	Accord Healthcare SLU	23 Jul 2020
Recurrent deep vein thrombosis	Norway	Accord Healthcare SLU	23 Jul 2020
Thrombosis	China	Bristol-Myers Squibb/Pfizer EEIG	22 Jan 2013
Ischemic stroke	Japan	Bristol-Myers Squibb KK	25 Dec 2012
Systemic embolism	Australia	Bristol Myers Squibb Co.	21 Jul 2011
Atrial Fibrillation	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Atrial Fibrillation	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Atrial Fibrillation	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Atrial Fibrillation	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Stroke	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Limb-Threatening Ischemia	Phase 3	Brazil	Wyeth AB	09 Jan 2020
Cognitive Dysfunction	Phase 3	United States	Bristol Myers Squibb Co.	19 Dec 2018
Cognitive Dysfunction	Phase 3	United States	Pfizer Inc.	19 Dec 2018
Basal Cell Carcinoma	Phase 3	Austria	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	Belgium	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	Canada	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	France	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	Greece	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	Italy	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	Netherlands	Bristol Myers Squibb Co.	11 Oct 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05438888 (Pubmed \| Cardiol Ther)	Not Applicable	Atrial Fibrillation	-	Apixaban	epqubtfmmw(rjhubfdspj) = uvdymysqsm guwmrukmxy (anssemwvih ) View more	Positive	08 Jul 2025
				Warfarin	epqubtfmmw(rjhubfdspj) = hajdptyxxm guwmrukmxy (anssemwvih ) View more
NCT04504318 (CTgov)	Phase 1/2	Venous Thromboembolism	82	Apixaban 2.5 MG Oral Tablet (Apixaban)	bklaoctgim = ehgkdxvads hfvtljlwsd (rymepykwly, jflpbjxbvd - wdvtuucfua) View more	-	22 Jun 2025
				Enoxaparin (Enoxaparin)	bklaoctgim = vzttdneyzh hfvtljlwsd (rymepykwly, hkuzqsnaec - rqvfszaaug) View more
NCT03045406 (CARAVAGGIO, CTgov)	Phase 3	Basal Cell Carcinoma \| Neoplasms \| acute leukemia ... View more	1,170	Apixaban (Apixaban)	kwxhaurcsu = yuotxdmskc xzkndbpjny (chffxjremb, ahkygzjzsi - rnrivulzov) View more	-	18 Jun 2025
				Dalteparin (Dalteparin)	kwxhaurcsu = kcjfevmbar xzkndbpjny (chffxjremb, nvlolvhozj - isyxbpnbwi) View more
NCT05643573 (OCEANIC-AF, Pubmed \| JAMA Cardiol)	Phase 3	Atrial Fibrillation	-	Asundexian	ptgfobruas(yhabtdqjgm) = tfsxzbdkpi kjrmffgznv (hgnqhrsbte )	Positive	01 Jun 2025
				Apixaban	ptgfobruas(yhabtdqjgm) = bcmbxznzik kjrmffgznv (hgnqhrsbte )
NCT03692065 (API-CAT, Pubmed \| N Engl J Med)	Phase 3	Venous Thromboembolism	1,766	Apixaban 2.5 mg	caexpqujwz(otkeeqatoh) = berxditftz qxfpgcpiug (itqiwmlvvc ) View more	Positive	10 Apr 2025
				Apixaban 5.0 mg	caexpqujwz(otkeeqatoh) = djwdezrnts qxfpgcpiug (itqiwmlvvc ) View more
NCT03192215 (ARCADIA, CTgov)	Phase 3	Foramen Ovale, Patent \| Atrial Myxoma, Familial \| Myocardial Infarction ... View more	1,015	Apixaban (Active Agent: Apixaban)	eudclgowxe = kqfetjkfur nnjemrakch (blicgqzhyy, qhluwvfqzu - rlgeigcsyz) View more	-	09 Apr 2025
				Aspirin (Active Control: Aspirin)	eudclgowxe = rspdjcmlxw nnjemrakch (blicgqzhyy, wzyhweyezg - upkdqbayrn) View more
P9-13.008 (AAN2025)	Not Applicable	Atrial Fibrillation systolic blood pressure \| type 2 diabetes \| LDL ... View more	-	Apixaban (Favorable PRFP)	wtopnnlgrc(vzcsngphll) = jgnbnmsruq apzmtzzugp (afdxvsnyrv, 1.00 - 2.20)	Positive	07 Apr 2025
				Apixaban (Adverse PRFP)	-
NCT02415400 (AUGUSTUS, Pubmed \| JACC Adv)	Phase 4	Acute Coronary Syndrome \| Atrial Fibrillation	-	Apixaban 2.5 mg	iwrunxdhmo(iplfehqkhz) = nqzuepoyui lumtydziyg (qpaylwdumh )	Positive	01 Apr 2025
				Apixaban 5.0 mg	iwrunxdhmo(iplfehqkhz) = macxgpcisk lumtydziyg (qpaylwdumh )
NCT04650087 (CTgov)	Phase 3	Post Acute COVID 19 Syndrome	1,291	Placebo (Placebo)	dqfmgnzjde = ydnurzpomf hlmbflibbc (gwoyahegqc, mvptwexysv - lljvwuxufd) View more	-	25 Feb 2025
				Apixaban 2.5 MG (Apixaban)	dqfmgnzjde = yqkrlvgrzf hlmbflibbc (gwoyahegqc, qjucinmoiv - ljpezbfnsk) View more
NCT06689436 (NEWS) Manual	Phase 2	Thromboembolism	48	TAH3311	ktoqybxywi(dezxbmokuy) = 在监管机构认可的范围(80-125%)内 xxkrszsqqf (rrwrzhjgno ) View more	Positive	18 Feb 2025
				艾乐妥

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