FDA Approves AstraZeneca's Imfinzi As First Perioperative Immunotherapy For Muscle-Invasive Bladder Cancer Patients
The FDA approval was based on results from the NIAGARA Phase 3 trial.
In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm.
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The estimated median event-free survival (EFS) has not yet been reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event-free at two years compared to 59.8% in the comparator arm.
Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy.
Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm.
Concurrently, AstraZeneca's Calquence (acalabrutinib) in combination with bendamustine and rituximab was recommended for approval in the European Union for adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation.
The positive opinion was based on the ECHO Phase 3 trial results.
Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
Median PFS was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone.
Price Action: AZN stock is down 0.86% at $73.16 at the last check Monday.
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This article FDA Approves AstraZeneca's Imfinzi As First Perioperative Immunotherapy For Muscle-Invasive Bladder Cancer Patients originally appeared on Benzinga.com
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Recognized by industry experts and selected for the Microsoft Top 100 Partner program, Sapiens is committed to partnering with our customers for their entire transformation journey and is continuously innovating to ensure their success. For more information visit sapiens or follow us on LinkedIn Investor and Media ContactYaffa Cohen-IfrahChief Marketing Officer and Head of Investor Relations, SapiensMobile: +1 917-533-4782Email: Investor ContactKimberly RogersManaging Director, Hayden IRPhone: +1 541-904-5075Email: kim@ Forward Looking Statements Certain matters discussed in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, and are based on our beliefs, assumptions and expectations, as well as information currently available to us. Such forward-looking statements may be identified by the use of the words "anticipate," "believe," "estimate," "expect," "may," "will," "plan" and similar expressions. Such statements reflect our current views with respect to future events and are subject to certain risks and uncertainties. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to: the degree of our success in our plans to leverage our global footprint to grow our sales; the degree of our success in integrating the companies that we have acquired through the implementation of our M&A growth strategy; the lengthy development cycles for our solutions, which may frustrate our ability to realize revenues and/or profits from our potential new solutions; our lengthy and complex sales cycles, which do not always result in the realization of revenues; the degree of our success in retaining our existing customers or competing effectively for greater market share; difficulties in successfully planning and managing changes in the size of our operations; the frequency of the long-term, large, complex projects that we perform that involve complex estimates of project costs and profit margins, which sometimes change mid-stream; the challenges and potential liability that heightened privacy laws and regulations pose to our business; occasional disputes with clients, which may adversely impact our results of operations and our reputation; various intellectual property issues related to our business; potential unanticipated product vulnerabilities or cybersecurity breaches of our or our customers' systems; risks related to the insurance industry in which our clients operate; risks associated with our global sales and operations, such as changes in regulatory requirements, wide-spread viruses and epidemics like the recent novel coronavirus pandemic, which adversely affected our results of operations, or fluctuations in currency exchange rates; and risks related to our principal location in Israel and our status as a Cayman Islands company. 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Adjusted EBITDA Calculation U.S. dollars in thousandsThree months endedSix months ended June 30, June 30, 2025202420252024GAAP operating profit 16,79721,88337,99342,405Non-GAAP adjustments: Amortization of capitalized software1,6751,5693,1863,114 Amortization of other intangible assets3,3662,0315,7505,043 Capitalization of software development(1,788)(1,823)(3,730)(3,540) Stock-based compensation8458111,6921,583 Compensation related to acquisition and acquisition-related costs2,1823652,743494Non-GAAP operating profit23,07724,83647,63449,099Depreciation1,0641,0952,0362,192Adjusted EBITDA24,14125,93149,67051,291 Summary of NON-GAAP Financial Information U.S. dollars in thousands (except per share amounts) Q2 2025Q1 2025Q4 2024Q3 2024Q2 2024 Revenues 141,602136,105134,305137,025136,800 Gross profit 64,83862,99562,69262,80962,481 Operating income 23,07724,55724,46825,10124,836 Adjusted EBITDA 24,14125,52925,35926,38925,931 Net income to Sapiens' shareholders 19,30520,67920,71021,09121,041 Diluted earnings per share 0.340.370.370.370.37 Annual Recurring Revenue ("ARR") U.S. dollars in thousands Three months ended June 30, 2025 2024 Annual Recurring Revenue 199,646168,593 Non-GAAP Revenues by Geographic Breakdown U.S. dollars in thousandsQ2 2025Q1 2025Q4 2024Q3 2024Q2 2024 North America 59,78256,87156,75355,75557,918 Europe 70,09567,48065,62469,28166,072 Rest of the World 11,72511,75411,92811,98912,810 Total 141,602136,105134,305137,025136,800 Non-GAAP Revenue breakdown U.S. dollars in thousands Three months endedSix months endedJune 30,June 30,2025202420252024 Software products and re-occurring post-production services (*) 109,85998,044217,916192,285 Pre-production implementation services (**) 31,74338,75659,79178,764 Total Revenues 141,602136,800277,707271,049 Three months endedSix months endedJune 30,June 30,2025202420252024 Software products and re-occurring post-production services (*) 58,43952,237117,931102,577 Pre-production implementation services (**) 6,39910,2449,90220,788 Total Gross profit 64,83862,481127,833123,365 Three months endedSix months endedJune 30,June 30,2025202420252024 Software products and re-occurring post-production services (*) 53.2 %53.3 %54.1 %53.3 % Pre-production implementation services (**) 20.2 %26.4 %16.6 %26.4 % Gross Margin 45.8 %45.7 %46.0 %45.5 % (*) Software products and re-occurring post-production services include mainly subscription, term license, maintenance, application maintenance, cloud solutions and post-production services. This revenue stream is a mix of recurring and re-occurring in nature. (**) Pre-production implementation services include mainly implementation services before go-live, which are one-time in nature. Adjusted Free Cash-FlowU.S. dollars in thousands Q2 2025Q1 2025Q4 2024Q3 2024Q2 2024 Cash-flow from operating activities 1,87325,35342,10913,0838,545 Increase in capitalized software development costs (1,788)(1,942)(1,759)(1,834)(1,823) Capital expenditures (1,003)(366)(419)(1,125)(666) Free cash-flow (918)23,04539,93110,1246,056 Cash payments attributed to acquisition-related costs(*) (**) 626-1,238124134 Adjusted free cash-flow (292)23,04541,16910,2486,190 (*) Included in cash-flow from operating activities (**) Acquisition-related payments pertain to charges on behalf of M&A agreements related to future performance targets and retention criteria, as well as completed or prospective third-party services, such as tax, accounting and legal rendered. SAPIENS INTERNATIONAL CORPORATION N.V. AND ITS SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEET U.S. dollars in thousandsJune 30,December 31,20252024 (unaudited) (unaudited) ASSETS CURRENT ASSETSCash and cash equivalents64,541163,690Short-term bank deposit10,00052,500Trade receivables, net and unbilled receivables134,94999,603Other receivables and prepaid expenses30,33419,350Total current assets239,824335,143 LONG-TERM ASSETSProperty and equipment, net11,19510,656Severance pay fund3,0653,208Goodwill and intangible assets, net439,166302,472Operating lease right-of-use assets22,76620,746Other long-term assets23,62819,486Total long-term assets499,820356,568 TOTAL ASSETS739,644691,711 LIABILITIES AND EQUITY CURRENT LIABILITIESTrade payables11,6158,414Current maturities of Series B Debentures19,80419,796Accrued expenses and other liabilities91,28677,390Current maturities of operating lease liabilities7,2846,440Deferred revenue44,69737,543Total current liabilities174,686149,583 LONG-TERM LIABILITIESSeries B Debentures, net of current maturities-19,792Deferred tax liabilities13,7106,899Other long-term liabilities11,26010,331Long-term operating lease liabilities18,28917,719Accrued severance pay9,5807,758Total long-term liabilities52,83962,499 REDEEMABLE NON-CONTROLLING INTEREST13,809- EQUITY 498,310479,629 TOTAL LIABILITIES AND EQUITY739,644691,711 SAPIENS INTERNATIONAL CORPORATION N.V. AND ITS SUBSIDIARIES CONSOLIDATED STATEMENT OF CASH FLOWU.S. dollars in thousands For the six months ended June 30,20252024(unaudited)(unaudited) Cash flows from operating activities:Net income 32,42036,118 Reconciliation of net income to net cash provided by operating activities:Depreciation of property and equipment 2,0362,192 Amortization of intangible assets and capitalized software 8,9368,157 Accretion of discount on Series B Debentures 1222 Capital (gain) loss from sale of property and equipment 1(9) Stock-based compensation related to options issued to employees 1,6921,583 Net changes in operating assets and liabilities, net of amount acquired:Increase in trade receivables, net and unbilled receivables (13,047)(12,723) Decrease in deferred tax liabilities, net (1,874)(1,428) Decrease in other operating assets 1,0113,445 Increase in trade payables 1,5044,446 Decrease in other operating liabilities (8,290)(8,354) Increase (decrease) in deferred revenues 1,966(6,587) Increase in accrued severance pay, net 859171 Net cash provided by operating activities 27,22627,033 Cash flows from investing activities:Purchase of property and equipment (1,399)(1,146) Proceeds from deposits 42,39012,136 Proceeds from sale of property and equipment 2714 Payments for business acquisitions, net of cash acquired (106,189)(375) Capitalized software development costs (3,730)(3,540) Net cash provided by (used in) investing activities (68,901)7,089 Cash flows from financing activities:Proceeds from employee stock options exercised -98 Distribution of dividend (37,037)(15,635) Repayment of Series B Debenture (19,796)(19,796) Acquisition deferred payment (455)- Acquisition of non-controlling interest -(4,131) Net cash used in financing activities (57,288)(39,464) Effect of exchange rate changes on cash and cash equivalents (186)1,272 Decrease in cash and cash equivalents (99,149)(4,070) Cash and cash equivalents at the beginning of period 163,690126,716 Cash and cash equivalents at the end of period 64,541122,646 Debentures Covenants As of June 30, 2025, Sapiens was in compliance with all of its financial covenants under the indenture for the Series B Debentures, based on having achieved the following in its consolidated financial results: Covenant 1 Target shareholders' equity (excluding non-controlling interest): above $120 million. 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For more information, please visit About Reflexivity ResearchReflexivity Research LLC is a leading research firm specializing in the creation of high-quality, in-depth research reports for the bitcoin and digital asset industry, empowering investors with valuable insights. For more information please visit About Neuronomics AGNeuronomics AG is a Swiss asset management firm specializing in AI-powered quantitative trading strategies. By integrating artificial intelligence, computational neuroscience and quantitative finance, Neuronomics delivers cutting-edge solutions that drive superior risk-adjusted performance in financial markets. For more information please visit Cautionary note regarding forward-looking information: This press release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. Forward-looking information includes, but is not limited to the financial results of the Company; the shareholder call; development of ETPs; the regulatory environment with respect to the growth and adoption of decentralized finance; the pursuit by DeFi Technologies and its subsidiaries of business opportunities; and the merits or potential returns of any such opportunities. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company, as the case may be, to be materially different from those expressed or implied by such forward-looking information. Such risks, uncertainties and other factors include, but is not limited to the growth and development of decentralized finance and the digital asset sector; rules and regulations with respect to decentralized finance and digital assets; general business, economic, competitive, political and social uncertainties. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company does not undertake to update any forward-looking information, except in accordance with applicable securities laws. THE CBOE CANADA EXCHANGE DOES NOT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE View original content to download multimedia: SOURCE DeFi Technologies Inc. View original content to download multimedia: 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
