General Dynamics awarded $198.96M Navy contract action
General Dynamics (GD) was awarded a $198.96M firm-fixed-price contract action for maintenance, modernization, and repair of USS America Fiscal 2026 Docking Selected Restricted Availability. This contract includes options which, if exercised, would bring the cumulative value of this contract to $209.23M. Work is expected to be completed by July 2027. FY25 other procurement funds in the amount of $181.2M; and FY25 operations and maintenance funds in the amount of $17.76M, will be obligated at the time of award, of which $17.76M will expire at the end of the current fiscal year. This contract was competitively procured using full and open competition via the System for Award Management website, with two offers received. Naval Sea Systems Command is the contracting activity.
Confident Investing Starts Here:
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Insider
a day ago
- Business Insider
RTX awarded $646.52M Navy contract modification
RTX (RTX) was awarded a $646.52M fixed-price incentive modification to a previously awarded contract to exercise options for hardware production of the AN/SPY-6 family of radars. Work is expected to be completed by September 2028. Naval Sea Systems Command is the contracting activity. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Business Wire
2 days ago
- Business Wire
Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)
PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today presented results from a pre-specified interim analysis of the Phase 3 VISIONARY study (NCT05248646) evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Patients treated with sibeprenlimab achieved a 51.2% (P<0.0001) reduction in proteinuria (as measured by 24-hour uPCR [urine protein-to-creatinine ratio]) at nine months of treatment when compared to placebo 1. The data were presented during a late-breaking clinical trials session at the European Renal Association (ERA) Congress in Vienna, Austria. The study, the largest Phase 3 IgAN trial conducted to date, also showed the safety profile of sibeprenlimab was favorable and consistent with previously reported data 1. Specifically, 76.3% of patients treated with sibeprenlimab experienced any Treatment Emergent Adverse Event (TEAE) versus 84.5% in the placebo group. 1 Patients who experienced a serious TEAE were 3.9% treated with sibeprenlimab compared to 5.4% treated with placebo. Sibeprenlimab received Priority Review designation from the FDA last month following its BLA filing in March. Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated regulatory approvals 2. Sibeprenlimab is an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN. APRIL plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation 3,4,5,6. By selectively binding and inhibiting APRIL, sibeprenlimab reduces the amount of immunoglobulin A (IgA) and Gd-IgA1 levels 1. Lower levels of Gd-IgA1 in people with IgAN provide less substrate for immune complex formation 7. Sibeprenlimab is administered in a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration or administration by caregiver, providing patients the option of convenience at home. 'We are confident about the potential of sibeprenlimab and are grateful to the patients who are helping to further the science by participating in these important trials,' said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. 'Proteinuria control is an important independent predictor for long-term prognosis, and this interim data reinforces our belief that selectively targeting APRIL has the potential to be an effective and safe approach for this progressive and irreversible kidney disease.' The VISIONARY study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further prespecified and exploratory analyses of the data will be conducted to determine the full potential of sibeprenlimab for the treatment of IgAN 1. 'The VISIONARY Phase 3 interim analysis shows a robust proteinuria reduction of 51.2% in the group treated with sibeprenlimab relative to placebo. These results affirm our belief in the efficacy of sibeprenlimab in the largest Phase 3 IgAN trial to date. The study enrolled a diverse patient population reflective of the disease epidemiology,' said Dr. Dana Rizk, professor of medicine in the division of nephrology at the University of Alabama at Birmingham. 'The safety data emerging from VISIONARY is reassuring and adds to our existing knowledge about sibeprenlimab's safety profile from prior programs. This is very exciting news for patients and adds a therapeutic option with a novel mechanism of action potentially targeting the immunologic pathogenesis of IgAN.' About the VISIONARY Study The VISIONARY study is the largest IgAN trial to date, and is a multicenter, randomized, double-blind, placebo-controlled trial consisting of approximately 510 adult patients with IgAN who were receiving standard-of-care therapy (defined as maximally tolerated ACE inhibitor or ARB +/- SGLT2 inhibitor), designed to evaluate the efficacy and safety of sibeprenlimab 400 mg administered subcutaneously every four weeks, compared to placebo 1. The primary efficacy endpoint is to evaluate the change in 24-hour uPCR at 9 months compared with baseline. The secondary endpoint is to evaluate the annualized slope of eGFR estimated over ~24 months 1. About Sibeprenlimab Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. Pre-clinical and early-stage trials of sibeprenlimab were also conducted by Visterra. Sibeprenlimab is an investigational monoclonal antibody that selectively binds to and inhibits the activity of APRIL and plays a key role in the 4-hit process. By selectively binding and inhibiting APRIL, sibeprenlimab reduces the amount of immunoglobulin A (IgA) and Gd-IgA1 levels 1. Lower levels of Gd-IgA1 in people with IgAN provide less substrate for immune complex formation 7. Decreased immune complex formation should result in diminished deposition in the kidney, and reduced proteinuria and kidney inflammation 8. By reducing the production of Gd-IgA1, sibeprenlimab may help slow kidney damage and progression toward ESKD 3,4,5,6. By inhibiting APRIL, sibeprenlimab may help address one of the IgAN-specific drivers for nephron loss. About IgAN and APRIL IgAN is a progressive, immune-mediated, chronic kidney disease that typically manifests in adults aged 20-40 years and leads to ESKD over the lifetime of most patients 9,10,11. IgAN is characterized by the accumulation of Gd-IgA1 complexes in the kidneys. IgAN can lead to progressive loss of kidney function and, eventually, ESKD, imposing a significant burden on patients 10. Despite supportive care, there is an unmet need for treatments that address the root causes of the condition. Continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients 5. APRIL, a cytokine in the tumor necrosis factor (TNF) family, is integral to the pathogenesis and progression of IgAN. It promotes the survival and class switching of B cells to produce IgA, particularly the pathogenic galactose-deficient IgA1 (Gd-IgA1) that forms immune complexes in the kidneys 5. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a 'big venture' company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies' 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 35,340 people worldwide and had consolidated sales of approximately USD 14.7 billion in 2024. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.'s global website is accessible at About Visterra Visterra is a biologics research and early-stage clinical development biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with immune-mediated kidney diseases and other hard-to-treat diseases. Its proprietary Hierotope® platform enables the design and engineering of precision biologics-based product candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches. The platform also includes Fc engineering capabilities for half-life extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterra's pipeline includes programs targeting kidney diseases, immunologically-driven diseases and infectious diseases. Visterra is an indirect subsidiary of Otsuka Pharmaceutical Co., Ltd. For more information, visit References Otsuka Pharmaceutical Development & Commercialization, Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Thompson A, Carroll K, Inker LA, et al. Proteinuria Reduction as a Surrogate End Pointin Trials of IgA Nephropathy. Clin J Am Soc Nephrol. 2019;14(3): Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003. Chang S, Li XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy ( Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 Gharavi, Ali G, et al. 'Aberrant Iga1 Glycosylation Is Inherited in Familial and Sporadic IGA Nephropathy.' Journal of the American Society of Nephrology : JASN, U.S. National Library of Medicine, May 2008, Kant, Sam, et al. 'Advances in Understanding of Pathogenesis and Treatment of Immune-Mediated Kidney Disease: A Review - American Journal of Kidney Diseases.' American Journal of Kidney Diseases, Apr. 2022, Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016 Cheung, Chee Kay & Boyd, JKF & Feehally, J.. (2012). Evaluation and management of IgA nephropathy. Clinical Medicine. 12. s27-s30. 10.7861/clinmedicine.12-6-s27.
Yahoo
3 days ago
- Yahoo
General Dynamics (GD) Announces US$1.50 Quarterly Dividend For Shareholders
General Dynamics recently affirmed a quarterly dividend of $1.50 per share, underscoring its commitment to rewarding shareholders. Over the last quarter, GD's stock price rose by 4%, in line with broader market trends. During this period, the company reported first-quarter earnings with a revenue increase to $12,223 million and a rise in net income to $994 million, which likely supported this upward move. The completion of a share repurchase tranche may have also added positive sentiment. In the context of a 13% market rise over the past year, General Dynamics' performance reflects steady growth. We've spotted 1 possible red flag for General Dynamics you should be aware of. Uncover 18 companies that survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. The recent reaffirmation of General Dynamics' quarterly dividend of US$1.50 per share and its 4% stock price rise in the last quarter align with broader market trends, potentially reinforcing investor confidence. Over the past five years, the company's total return, including share price and dividends, increased by 95.69%. This longer-term gain can offer a more comprehensive perspective on its overall performance. In comparison to the previous year, the company's return underperformed both the US Aerospace & Defense industry, which returned 32.2%, and the broader US market, which returned 12.6%, indicating challenges in keeping pace with industry and market growth. The certification of the G800 and strengthened order activity could positively affect future revenue and earnings forecasts. Analysts estimate an annual revenue growth of 3.4% over the next three years, supported by improvements in aerospace and marine efficiencies. However, challenges like supply chain issues and pressurized book-to-bill ratios could constrain growth. With a current share price of US$270.61, the analyst consensus price target of US$292.42 suggests a 7.5% higher market value, illustrating a fairly close alignment between current pricing and projected company value. Evaluate General Dynamics' prospects by accessing our earnings growth report. This 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. Companies discussed in this article include GD. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
