DDN and Nebius Collaborate to Power Next-Generation AI Infrastructure for Seamless Enterprise Adoption
CHATSWORTH, Calif.--(BUSINESS WIRE)-- DDN, a global leader in AI and data intelligence solutions, has partnered with Nebius, one of the world's most advanced AI cloud providers, to deliver unprecedented performance, scalability, and efficiency for enterprise AI workloads. By integrating DDN Infinia and EXAScaler into its AI cloud, Nebius is setting a new industry benchmark—offering enterprises an end-to-end, high-performance solution tailored to the demands of next-generation AI.
Powering the Future of AI with an End-to-End AI Cloud
As an elite AI cloud provider, Nebius is building some of the world's most highly performant infrastructure to power AI innovation. Recognizing the increasing demand for ultra-fast, scalable AI infrastructure, Nebius sought out a best-in-class data intelligence platform to empower enterprises in training, inferencing, and real-time AI applications. DDN emerged as a clear choice, providing a dual-stack solution—Infinia for high-performance data orchestration and EXAScaler for extreme parallel file system performance—capable of delivering maximum efficiency at scale.
Why Nebius Chose DDN Infinia and EXAScaler
DDN's AI-native, high-performance data architecture now powers Nebius AI Cloud, providing enterprises with:
AI-Optimized, SLA-Driven Performance – Infinia guarantees extreme reliability and speed, accelerating AI model training and deployment while EXAScaler delivers unmatched data throughput and I/O consistency.
Seamless Scaling Across Cloud and On-Prem Environments – Businesses can instantly scale workloads across Nebius' AI cloud, hybrid setups, and air-gapped systems without bottlenecks using EXAScaler's industry-leading parallel file system.
Ultra-Fast Data Processing for AI at Scale – Infinia and EXAScaler eliminate data latency challenges, ensuring AI pipelines operate at peak efficiency—even for multi-trillion-parameter models.
Enterprise-Ready AI Infrastructure – With DDN and Nebius, enterprises can deploy AI workloads faster, more efficiently, and at a lower cost than ever before.
A Bold Vision for the Future of AI
"To lead in AI, enterprises require infrastructure that delivers breakthrough speed, scalability, and seamless integration,' said Paul Bloch, President and Co-Founder at DDN. "By partnering with Nebius, we're breaking down traditional barriers to AI adoption and delivering a next-generation cloud platform that transforms how AI is built and scaled worldwide."
"Our mission is to provide cutting-edge AI cloud infrastructure that enables innovation worldwide at speed and scale," said Arkady Volozh, CEO of Nebius. "With DDN, we're able to help enterprises do this seamlessly and efficiently."
Together, Nebius and DDN are redefining enterprise AI, delivering the fastest, most scalable AI cloud infrastructure available today—empowering businesses to lead in the AI era. To learn more, please visit ddn.com.
About Nebius
Nebius (NASDAQ:NBIS) is a technology company building full-stack infrastructure to service the explosive growth of the global AI industry, including large-scale GPU clusters, cloud platforms, and tools and services for developers. Headquartered in Amsterdam and listed on Nasdaq, the company has a global footprint with R&D hubs across Europe, North America and Israel.
Nebius's core business is an AI-centric cloud platform built for intensive AI workloads. With proprietary cloud software architecture and hardware designed in-house (including servers, racks and data center design), Nebius gives AI builders the compute, storage, managed services and tools they need to build, tune and run their models.
A Preferred cloud service provider in the NVIDIA Partner Network, Nebius offers high-end infrastructure optimized for AI training and inference. The company boasts a team of over 500 skilled engineers, delivering a true hyperscale cloud experience tailored for AI builders.
To learn more, please visit www.nebius.com.
About DDN
DDN is the world's leading AI and data intelligence company, empowering organizations to maximize the value of their data with end-to-end HPC and AI-focused solutions. Its customers range from the largest global enterprises and AI hyperscalers to cutting-edge research centers, all leveraging DDN's proven data intelligence platform for scalable, secure, and high-performance AI deployments that drive 10x returns.
Follow DDN: LinkedIn, X, and YouTube.
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Ambarella, Inc. Announces First Quarter Fiscal Year 2026 Financial Results
SANTA CLARA, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Ambarella, Inc. (NASDAQ: AMBA), an edge AI semiconductor company, today announced first quarter fiscal 2026 financial results for the period ended April 30, 2025. Revenue for the first quarter of fiscal 2026 was $85.9 million, up 57.6% from $54.5 million in the same period in fiscal 2025. Gross margin under U.S. generally accepted accounting principles (GAAP) for the first quarter of fiscal 2026 was 60.0%, compared with 60.9% for the same period in fiscal 2025. GAAP net loss for the first quarter of fiscal 2026 was $24.3 million, or loss per diluted ordinary share of $0.58, compared with a GAAP net loss of $37.9 million, or loss per diluted ordinary share of $0.93, for the same period in fiscal 2025. Financial results on a non-GAAP basis for the first quarter of fiscal 2026 are as follows: Gross margin on a non-GAAP basis for the first quarter of fiscal 2026 was 62.0%, compared with 63.4% for the same period in fiscal 2025. Non-GAAP net profit for the first quarter of fiscal 2026 was $3.0 million, or earnings per diluted ordinary share of $0.07. This compares with non-GAAP net loss of $10.5 million, or loss per diluted ordinary share of $0.26, for the same period in fiscal 2025. Based on information available as of today, Ambarella is offering the following guidance for the second quarter of fiscal year 2026, ending July 31, 2025: Revenue is expected to be between $86.0 million and $94.0 million. Gross margin on a non-GAAP basis is expected to be between 60.5% and 62.0%. Non-GAAP operating expenses are expected to be between $52.5 million and $55.5 million. Ambarella reports gross margin, net income (loss) and earnings (losses) per share in accordance with GAAP and, additionally, on a non-GAAP basis. Non-GAAP financial information excludes the impact of stock-based compensation and acquisition-related costs adjusted for the associated tax impact, which includes the effect of any benefits or shortfalls recognized. A reconciliation of the GAAP to non-GAAP gross margin, net income (loss) and earnings (losses) per share for the periods presented, as well as a description of the items excluded from the non-GAAP calculations, is included in the financial statements portion of this press release. Total cash, cash equivalents and marketable debt securities on hand at the end of the first quarter of fiscal 2026 was $259.4 million, compared with $250.3 million at the end of the prior quarter and $203.3 million at the end of the same quarter a year ago. 'As the established edge AI market leader, we achieved our fourth consecutive quarter of record AI revenue with results in the upper half of our Q1 revenue guidance range. We are increasing our fiscal 2026 revenue growth guidance to a range of 19% to 25%, or approximately $348 million at the mid-point, with the broader guidance range reflecting our consideration of the uncertain geopolitical environment,' said Fermi Wang, President & CEO. 'We continue to innovate at a rapid pace, and by leveraging our low power and scalable 3rd generation AI silicon and software architecture, our development of a new SoC is efficiently extending our reach into the edge AI infrastructure market.' Stock Repurchase During the second quarter of fiscal year 2026, Ambarella's Board of Directors approved an extension of the current share repurchase program for an additional twelve months ending June 30, 2026. In the first quarter of fiscal year 2026, the company repurchased a total of 24,152 shares for total consideration of approximately $1.0 million. As of today, there is approximately $48.0 million available for repurchase under the company's stock repurchase program. The repurchase program does not obligate the company to acquire any particular amount of ordinary shares, and it may be suspended at any time at the company's discretion. Quarterly Conference Call Ambarella plans to hold a conference call at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time today with Fermi Wang, President and Chief Executive Officer, and John Young, Chief Financial Officer, to discuss the first quarter of fiscal year 2026 results. A live and archived webcast of the call will be available on Ambarella's website at for up to 30 days after the call. About Ambarella Ambarella's products are used in a wide variety of edge AI and human vision applications, including video security, advanced driver assistance systems (ADAS), electronic mirror, drive recorder, driver/cabin monitoring, autonomous driving and robotics applications. Ambarella's low-power systems-on-chip (SoCs) provide powerful deep neural network processing to enable intelligent perception, fusion and planning, and offer high-resolution video compression, advanced image and radar processing. For more information, please visit "Safe harbor" statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements that are not historical facts and often can be identified by terms such as 'outlook,' 'projected,' 'intends,' 'will,' 'estimates,' 'anticipates,' 'expects,' 'believes,' 'could,' 'should,' or similar expressions, including the guidance for the second quarter of fiscal year 2026 ending July 31, 2025, and the comments of our CEO relating to our expectation of future revenue growth, the growth potential for our edge AI inference products, our ability to continue to innovate, and our ability to expand into edge infrastructure. The achievement or success of the matters covered by such forward-looking statements involves risks, uncertainties and assumptions. Our actual results could differ materially from those predicted or implied and reported results should not be considered as an indication of our future performance. The risks and uncertainties referred to above include, but are not limited to, global economic and political conditions; changes in government policies, including possible trade tariffs and restrictions; revenue being generated from new customers or design wins, neither of which is assured; the commercial success of our customers' products; our customers' ability to manage their inventory requirements; our growth strategy; our ability to anticipate future market demands and future needs of our customers, particularly for AI inference applications; our ability to introduce, and to generate revenue from, new and enhanced solutions; our ability to develop, and to generate revenue from, new advanced technologies, such as computer vision, AI functionality and advanced networks, including vision-language models and GenAI; our ability to retain and expand customer relationships and to achieve design wins; the expansion of our current markets and our ability to successfully enter new markets and applications, such as edge infrastructure; anticipated trends and challenges, including competition, in the markets in which we operate; risks associated with global health conditions and associated risk mitigation measures; our ability to effectively manage growth; our ability to retain key employees; and the potential for intellectual property disputes or other litigation. Further information on these and other factors that could affect our financial results is included in the company's Annual Report on Form 10-K for our 2025 fiscal year, which is on file with the Securities and Exchange Commission. Additional information will also set forth in the company's quarterly reports on Form 10-Q, annual reports on Form 10-K and other filings the company makes with the Securities and Exchange Commission from time to time, copies of which may be obtained by visiting the Investor Relations portion of our web site at or the SEC's web site at Undue reliance should not be placed on the forward-looking statements in this release, which are based on information available to us on the date hereof. The results we report in our Quarterly Report on Form 10-Q for the first fiscal quarter ended April 30, 2025 could differ from the preliminary results announced in this press release. Ambarella assumes no obligation and does not intend to update the forward-looking statements made in this press release, except as required by law. Non-GAAP Financial Measures The company has provided in this release non-GAAP financial information, including non-GAAP gross margin, net income (loss), and earnings (losses) per share, as a supplement to the condensed consolidated financial statements, which are prepared in accordance with generally accepted accounting principles ("GAAP"). Management uses these non-GAAP financial measures internally in analyzing the company's financial results to assess operational performance and liquidity. The company believes that both management and investors benefit from referring to these non-GAAP financial measures in assessing its performance and when planning, forecasting and analyzing future periods. Further, the company believes these non-GAAP financial measures are useful to investors because they allow for greater transparency with respect to key financial metrics that the company uses in making operating decisions and because the company believes that investors and analysts use them to help assess the health of its business and for comparison to other companies. Non-GAAP results are presented for supplemental informational purposes only for understanding the company's operating results. The non-GAAP information should not be considered a substitute for financial information presented in accordance with GAAP, and may be different from non-GAAP measures used by other companies. With respect to its financial results for the first quarter of fiscal year 2026, the company has provided below reconciliations of its non-GAAP financial measures to its most directly comparable GAAP financial measures. With respect to the company's expectations for the second quarter of fiscal year 2026, a reconciliation of non-GAAP gross margin and non-GAAP operating expenses guidance to the closest corresponding GAAP measure is not available without unreasonable efforts on a forward-looking basis due to the high variability and low visibility with respect to the charges excluded from these non-GAAP measures. We expect the variability of the above charges to have a significant, and potentially unpredictable, impact on our future GAAP financial results. AMBARELLA, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) Three Months Ended April 30, 2025 2024 Revenue $ 85,872 $ 54,473 Cost of revenue 34,336 21,313 Gross profit 51,536 33,160 Operating expenses: Research and development 58,819 54,137 Selling, general and administrative 18,575 18,468 Total operating expenses 77,394 72,605 Loss from operations (25,858 ) (39,445 ) Other income, net 2,175 2,271 Loss before income taxes (23,683 ) (37,174 ) Provision for income taxes 645 758 Net loss $ (24,328 ) $ (37,932 ) Net loss per share attributable to ordinary shareholders: Basic $ (0.58 ) $ (0.93 ) Diluted $ (0.58 ) $ (0.93 ) Weighted-average shares used to compute net loss per share attributable to ordinary shareholders: Basic 42,219,972 40,774,991 Diluted 42,219,972 40,774,991 The following tables present details of stock-based compensation and acquisition-related costs included in each functional line item in the condensed consolidated statements of operations above: Three Months Ended April 30, 2025 2024 (unaudited, in thousands) Stock-based compensation: Cost of revenue $ 951 $ 607 Research and development 17,585 17,621 Selling, general and administrative 7,594 7,808 Total stock-based compensation $ 26,130 $ 26,036 Three Months Ended April 30, 2025 2024 (unaudited, in thousands) Acquisition-related costs: Cost of revenue $ 757 $ 757 Research and development — — Selling, general and administrative 456 520 Total acquisition-related costs $ 1,213 $ 1,277 The difference between GAAP and non-GAAP gross margin was 2.0% and 2.5%, or $1.7 million and $1.4 million, for the three months ended April 30, 2025 and 2024, respectively. The differences were due to the effect of stock-based compensation and amortization of acquisition-related costs. AMBARELLA, INC. RECONCILIATION OF GAAP TO NON-GAAP DILUTED EARNINGS (LOSSES) PER SHARE (in thousands, except share and per share data) Three Months Ended April 30, 2025 2024 (unaudited) GAAP net loss $ (24,328 ) $ (37,932 ) Non-GAAP adjustments: Stock-based compensation expense 26,130 26,036 Acquisition-related costs 1,213 1,277 Income tax effect 14 152 Non-GAAP net income (loss) $ 3,029 $ (10,467 ) GAAP - diluted weighted average shares 42,219,972 40,774,991 Non-GAAP - diluted weighted average shares 42,451,235 40,774,991 GAAP - diluted net loss per share $ (0.58 ) $ (0.93 ) Non-GAAP adjustments: Stock-based compensation expense 0.62 0.64 Acquisition-related costs 0.03 0.03 Income tax effect — — Effect of Non-GAAP - diluted weighted average shares — — Non-GAAP - diluted net income (loss) per share $ 0.07 $ (0.26 ) AMBARELLA, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) April 30, January 31, 2025 2025 ASSETS Current assets: Cash and cash equivalents $ 141,285 $ 144,622 Marketable debt securities 118,102 105,643 Accounts receivable, net 30,235 29,767 Inventories 39,289 34,428 Restricted cash 441 7 Prepaid expenses and other current assets 6,197 6,084 Total current assets 335,549 320,551 Property and equipment, net 10,248 9,084 Intangible assets, net 44,895 47,279 Operating lease right-of-use assets, net 4,377 5,188 Goodwill 303,625 303,625 Other non-current assets 3,224 3,241 Total assets $ 701,918 $ 688,968 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable 35,290 21,775 Accrued and other current liabilities 73,479 80,781 Operating lease liabilities, current 2,335 2,829 Income taxes payable 1,633 1,383 Deferred revenue, current 12,114 14,226 Total current liabilities 124,851 120,994 Operating lease liabilities, non-current 2,056 2,436 Other long-term liabilities 2,295 4,126 Total liabilities 129,202 127,556 Shareholders' equity: Preference shares — — Ordinary shares 19 19 Additional paid-in capital 848,756 813,683 Accumulated other comprehensive income (loss) 326 (233 ) Accumulated deficit (276,385 ) (252,057 ) Total shareholders' equity 572,716 561,412 Total liabilities and shareholders' equity $ 701,918 $ 688,968 Contact: Louis Gerhardy408.636.2310lgerhardy@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
7 minutes ago
- Business Upturn
BeOne Medicines Presents New SEQUOIA Study Results Reinforcing BRUKINSA's Differentiated Profile with or without Venetoclax in Frontline CLL at ASCO 2025
San Carlos, Calif., United States: BRUKINSA plus venetoclax demonstrated high response rates and a favorable safety profile across CLL patient types in SEQUOIA Arm D, including those with high-risk del(17p) mutational status At 5-year follow-up of SEQUOIA Arm C, BRUKINSA monotherapy showed sustained OS and PFS benefit in hard-to-treat del(17p) CLL patients versus historical data BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today will present new data from the Arm C and D cohorts of the pivotal, global Phase 3 SEQUOIA trial of BRUKINSA® (zanubrutinib). The findings underscore the strong and consistent efficacy of BRUKINSA across CLL patient types, including high-risk mutation status. These data will be presented in two rapid oral presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Data from the Arm D of SEQUOIA demonstrate that treatment with BRUKINSA plus venetoclax has the potential to drive progression-free survival and overall deep and durable responses across the frontline CLL patient spectrum, including patients with high-risk mutational status. The best undetectable minimal residual disease (uMRD) rate in peripheral blood at a sensitivity level 10-4 was 59%. These efficacy responses observed in Arm D, despite the high proportion of high-risk patients enrolled, are in line with recent fixed-duration studies in fitter, healthier patient populations. Additionally, 11 patients in Arm D were able to discontinue treatment early due to meeting uMRD-guided stopping criteria, and 9 patients remain in ongoing clinical remission with sustained uMRD (1 patient discontinued study while in clinical remission), allowing them to remain treatment-free. In patients without del(17p) and TP53 mutations, 43% achieved uMRD by cycle 16 and 60% by cycle 28. These data were published today in the Journal of Clinical Oncology. 'While many first-line CLL studies have excluded patient populations with high-risk disease features, BeOne included those patients in SEQUOIA,' said Lai Wang, Ph.D., Global Head of R&D at BeOne. 'Nearly 88% of patients with del(17p) and /or TP53 treated with BRUKINSA plus venetoclax remain progression-free at 36 months, which represents an unprecedented outcome for a doublet regimen in this difficult-to-treat patient population. These new SEQUOIA data reinforce BRUKINSA's versatility across the spectrum of CLL patients and reflect BeOne's commitment to progressing a pipeline built to meet unmet patient needs and elevate the standard of care.' Arm D Highlights (Abstract 7009) SEQUOIA Arm D investigated BRUKINSA plus venetoclax in 114 patients with treatment-naïve (TN) CLL / small lymphocytic lymphoma (SLL) with or without del(17p) and/or TP53 high-risk mutations. At a median follow-up of 31.2 months, the combination induced a high 24-month progression-free survival (PFS) rate of 92% (95% CI, 85-96%) and an impressive overall response rate (ORR) of 97%. The 24-month overall survival (OS) rate was 96% (95% CI, 90%-98%). Of those patients with del(17p) and/or TP53 mutations, 94% were progression-free at 24 months and 87.6% were progression-free at 36 months. The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. 'The zanubrutinib and venetoclax combination achieved deep, durable responses across risk groups, including patients with TP53 mutations, with a generally manageable safety profile. Notably, several patients were able to discontinue treatment and maintain remission, highlighting the potential for time-limited therapy with meaningful disease control,' said Mazyar Shadman, M.D., M.P.H., Associate Professor and Innovators Network Endowed Chair, Medical Director, Cellular Immunotherapy and the Bezos Family Immunotherapy Clinic at Fred Hutch Cancer Center. 'Generating data to inform future CLL treatment strategies that allow for both continuous therapy and planned time off treatment is essential, particularly for high-risk patients who are the most likely to succumb to this disease.' Arm C Highlights (Abstract 7011) Arm C of the SEQUOIA study investigated BRUKINSA monotherapy in patients with TN CLL / SLL and del(17p) mutations and is the largest prospective cohort of CLL/SLL patients with del(17p). At a median follow-up of over 5.5 years (65.8 months), most patients remained progression-free. Notably, at 60 months, 72.2% of patients who received BRUKINSA remained progression-free (95% CI, 62.4, 79.8). When adjusted for the impact of the COVID-19 pandemic, 73.0% of patients in the cohort remained progression-free (95% CI, 63.3, 80.6) at 60 months. The 60-month OS rate was 85.1% (95% CI, 76.9, 90.6) and 87.0% (95% CI, 79.0, 92.1) when adjusted for COVID-19. At the time of data cut-off, the ORR was 97.3%, and 62.2% of patients were still receiving treatment with BRUKINSA. The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. For additional information about our presence at the 2025 ASCO Annual Meeting, please visit our meeting hub: About Chronic Lymphocytic Leukemia Chronic lymphocytic leukemia (CLL) is a life-threatening cancer of adults. It is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues.1,2 CLL is the most common type of leukemia in adults, accounting for about one-third of new cases.2,3 Approximately 20,700 new cases of CLL will be diagnosed in the U.S. in 2024.3 About 50% of CLL patients have high-risk genetic features – including del(17p), TP53 or unmutated IGHV – that may limit the effectiveness of some treatments (e.g. chemotherapy) and increase the likelihood of disease progression.4,5 About SEQUOIA SEQUOIA (NCT03336333) is a randomized, multicenter, global Phase 3 trial designed to evaluate the efficacy and safety of BRUKINSA in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial consists of three cohorts: Cohort 1 (n=479): randomized 1:1 to receive BRUKINSA (n=241) or bendamustine plus rituximab (n=238) until disease progression or unacceptable toxicity, in patients not harboring del(17p); data from this group comprise the primary endpoint; Cohort 2/Arm C (n=110): patients with del(17p) receiving BRUKINSA as a monotherapy; and Cohort 3/Arm D (n=114): 66 patients with del(17p) and/or pathogenic TP53 mutation and 47 patients without del(17p) or TP53 were enrolled, with 110 patients receiving BRUKINSA in combination with venetoclax. The results of Cohort 1 of the SEQUOIA study led to the regulatory approval of BRUKINSA monotherapy in the treatment of TN CLL in many countries across the world, including approvals by the U.S. Food and Drug Administration and the European Medicines Agency. The primary endpoint of the trial is progression-free survival (PFS), as assessed by an independent review committee (IRC). Secondary endpoints include investigator-assessed PFS, IRC- and investigator-assessed overall response rate (ORR), overall survival (OS), and safety, as well as PFS and ORR in patients with del(17p). About BRUKINSA® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton's tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets, and more than 200,000 patients have been treated globally. U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib) INDICATIONS BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Waldenström's macroglobulinemia (WM). Mantle cell lymphoma (MCL) who have received at least one prior therapy. Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hemorrhage Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding. Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed. Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by othersolid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Cardiac Arrhythmias Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Hepatotoxicity, Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA. Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Adverse Reactions The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Drug Interactions CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily. CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers. Specific Populations Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily. Please see full U.S. Prescribing Information including U.S. Patient Information. About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne's ability to deliver advanced and effective treatments for a broad range of cancer patients; BRUKINSA's role across CLL patients; the ability of BeOne's pipeline to meeting evolving patient needs and elevate the standard of care; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne's ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our News & Media site. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
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CF Bankshares' (NASDAQ:CFBK) investors will be pleased with their splendid 129% return over the last five years
The worst result, after buying shares in a company (assuming no leverage), would be if you lose all the money you put in. But on a lighter note, a good company can see its share price rise well over 100%. For instance, the price of CF Bankshares Inc. (NASDAQ:CFBK) stock is up an impressive 118% over the last five years. Now it's worth having a look at the company's fundamentals too, because that will help us determine if the long term shareholder return has matched the performance of the underlying business. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. While markets are a powerful pricing mechanism, share prices reflect investor sentiment, not just underlying business performance. By comparing earnings per share (EPS) and share price changes over time, we can get a feel for how investor attitudes to a company have morphed over time. During five years of share price growth, CF Bankshares achieved compound earnings per share (EPS) growth of 2.7% per year. This EPS growth is slower than the share price growth of 17% per year, over the same period. This suggests that market participants hold the company in higher regard, these days. And that's hardly shocking given the track record of growth. The company's earnings per share (over time) is depicted in the image below (click to see the exact numbers). Dive deeper into CF Bankshares' key metrics by checking this interactive graph of CF Bankshares's earnings, revenue and cash flow. As well as measuring the share price return, investors should also consider the total shareholder return (TSR). The TSR is a return calculation that accounts for the value of cash dividends (assuming that any dividend received was reinvested) and the calculated value of any discounted capital raisings and spin-offs. So for companies that pay a generous dividend, the TSR is often a lot higher than the share price return. In the case of CF Bankshares, it has a TSR of 129% for the last 5 years. That exceeds its share price return that we previously mentioned. And there's no prize for guessing that the dividend payments largely explain the divergence! It's nice to see that CF Bankshares shareholders have received a total shareholder return of 25% over the last year. That's including the dividend. Since the one-year TSR is better than the five-year TSR (the latter coming in at 18% per year), it would seem that the stock's performance has improved in recent times. In the best case scenario, this may hint at some real business momentum, implying that now could be a great time to delve deeper. If you would like to research CF Bankshares in more detail then you might want to take a look at whether insiders have been buying or selling shares in the company. If you are like me, then you will not want to miss this free list of undervalued small caps that insiders are buying. Please note, the market returns quoted in this article reflect the market weighted average returns of stocks that currently trade on American exchanges. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
