Globalstar Signs Launch Services Agreement with SpaceX
Globalstar CEO Dr. Paul Jacobs stated 'The launch services agreement with SpaceX represents another important milestone as we continue to execute on our construction and launch plan. These satellites, constructed by our partners at MDA and Rocket Lab, will enhance our ability to provide the highest quality satellite services to our customers over the long-term.'
About Globalstar, Inc.
Globalstar empowers its customers to connect, transmit, and communicate smarter – easily, quickly, securely, and affordably – offering reliable satellite and terrestrial connectivity services as an international telecom infrastructure provider. The Company's low Earth orbit ("LEO") satellite constellation ensures secure data transmission for connecting and protecting assets, transmitting critical operational data, and saving lives for consumers, businesses, and government agencies across the globe. Globalstar's terrestrial spectrum, Band 53, and its 5G variant, n53, offer carriers, cable companies, and system integrators a versatile, fully licensed channel for private networks with a growing ecosystem to improve customer wireless connectivity, while Globalstar's XCOM RAN product offers significant capacity gains in dense wireless deployments. In addition to SPOT GPS messengers, Globalstar offers next-generation Internet of Things ("IoT") hardware and software products for efficiently tracking and monitoring assets, processing smart data at the edge, and managing analytics with cloud-based telematics solutions to drive safety, productivity, and profitability. For more information, visit www.globalstar.com.
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Business Wire
29 minutes ago
- Business Wire
UK MHRA Approves ImmunityBio's ANKTIVA ® Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for ANKTIVA ® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of certain bladder cancer patients. This is the first marketing approval outside the U.S. for this novel lymphocyte-stimulating agent. 'With the MHRA's authorization of ANKTIVA plus BCG, we can now offer our immunotherapy outside the U.S. to help patients with a disease that, if not effectively treated, can lead to bladder removal,' said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. 'This immune-boosting, lymphocyte-stimulating agent, the first of its kind, is central to our Cancer BioShield platform, which is designed to restore immune function and support long-term disease control.' 'ImmunityBio is honored to have received this important authorization from the UK MHRA. In light of the United States Most-Favored-Nation Prescription Drug Pricing policy implemented on May 12, 2025, we are actively evaluating our go-to-market strategy for the UK,' said Richard Adcock, CEO and President of ImmunityBio. ANKTIVA is a first-in-class IL-15 agonist that activates and proliferates natural killer (NK) cells and CD4+ and CD8+ T cells. It is designed to restore immune competence by reversing lymphopenia—a condition in which cancer and conventional therapies, such as chemotherapy, radiation and checkpoint inhibitors, reduce the number and function of immune cells. Restoring immune function is essential for immunosurveillance, immunogenic cell death, and sustained tumor control. The BioShield platform's effectiveness can be monitored using a routine complete blood count (CBC). ANKTIVA was designated a Breakthrough Therapy by the FDA and received approval from both the FDA and MHRA based on its safety and efficacy outcomes of complete response (CR) and duration of response (DOR). In a single-arm, multicenter trial, 77 evaluable patients received ANKTIVA with BCG for up to 37 months. As of the November 2023 data cutoff, the duration of complete response for some patients exceeded 47 months and remains ongoing. These extended duration of complete responses beyond 24 months with ANKTIVA and BCG surpasses the benchmark for meaningful clinical results set by experts from the International Bladder Cancer Group. ImmunityBio has also submitted regulatory applications to the European Medicines Agency (EMA) to expand availability of ANKTIVA across the 27 European Union (EU) member states, as well as Iceland, Norway and Liechtenstein. About NMIBC CIS Bladder cancer is the 10th most commonly-diagnosed cancer globally, 2 and in the UK, the Action Bladder Cancer UK estimates approximately 23,000 patients are diagnosed annually. 1 At the time of diagnosis, about 80% of cases are non-muscle invasive bladder cancer (NMIBC), wherein the cancer is found only on the inner layer of the bladder wall. 3 The standard therapy for NMIBC is intravesical instillation (delivery to the bladder via a catheter) of Bacillus Calmette-Guerin (BCG). 4,5 BCG is a benign bacteria that induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients. In ~30-40% of patients, however, BCG will fail, and in ~50% that initially respond, cancer will recur. 6 About ANKTIVA The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo. ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit INDICATION AND IMPORTANT SAFETY INFORMATION FROM THE FDA LABEL INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patient with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours. USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia. For more information about ANKTIVA, please see the Full Prescribing Information at You are encouraged to report negative side effects of prescription drugs to FDA. Visit or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482) About ImmunityBio ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit (Founder's Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. References: Action Bladder UK. Non-muscle invasive bladder cancer. May 2021. Available at: World Cancer Research Fund. Bladder Cancer Statistics. 2022. Available at: Aldousari S, Kassouf W. Update on the management of non-muscle invasive bladder cancer. Canadian Urological Association Journal, 4(1), 56–64. Holzbeierlein J, Bixler BR, Buckley DI, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment. J Urol. 2024;10.1097/JU.0000000000003846. Grabe-Heyne, et al. Intermediate and high-risk non-muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023 Jun 2;13:1170124. doi: 10.3389/fonc.2023.1170124. Kodera A, Mohammed M, Lim P, Abdalla O, Elhadi M. The Management of Bacillus Calmette-Guérin (BCG) Failure in High-Risk Non-muscle Invasive Bladder Cancer: A Review Article. Cureus. 2023 Jun 26;15(6):e40962. doi: 10.7759/cureus.40962. PMID: 37503461; PMCID: PMC10369196. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding clinical trial data and potential results and implications to be drawn therefrom, the belief that the MHRA authorization leads to increased revenue, the expectation that the EAP as previously reported will enable access to ANKTIVA for patients across all solid tumor types who have exhausted first-line therapy including chemo, radiation or immunotherapy, the RMAT designation as previously reported and potential results therefrom and regulatory submissions in connection therewith, the belief that ALC levels and NLR levels obtained from a CBC are predictors of clinical benefit and outcomes relating to overall survival, the belief that improving ALC levels and NLR levels correlates with enhanced overall survival and clinical benefit, the belief that reversal of lymphopenia correlates with improved survival, clinical trial and expanded access program enrollment, data and potential results to be drawn therefrom, anticipated components of ImmunityBio's Cancer BioShield platform, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents for the prevention or reversal of lymphopenia, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents across multiple tumor types and indications and for potential applications beyond oncology, potential regulatory pathways and the regulatory review process and timing thereof, the application of the Company's science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that has the potential to change the paradigm in cancer care, and ImmunityBio's approved product and investigational agents as compared to existing treatment options, and the impact of the MHRA on the Company's ex-United States go to market strategy, including in light of the recently implemented United States Most Favored Nation pricing policy on the Company's go-to-market strategy in the United Kingdom, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as 'anticipates,' 'believes,' 'continues,' 'goal,' 'could,' 'estimates,' 'scheduled,' 'expects,' 'intends,' 'may,' 'plans,' 'potential,' 'predicts,' 'indicate,' 'projects,' 'is,' 'seeks,' 'should,' 'will,' 'strategy,' and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio's management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio's statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the FDA regulatory submission, filing and review process and the timing thereof, (ii) risks and uncertainties regarding regulatory submissions in foreign jurisdictions, filing and review process and the timing thereof, (iii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iv) risks and uncertainties regarding commercial launch execution, success and timing, (v) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (vi) whether clinical trials will result in registrational pathways and the risks, (vii) whether clinical trial data will be accepted by regulatory agencies, (viii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (iv) potential delays in product availability and regulatory approvals, (x) ImmunityBio's ability to retain and hire key personnel, (xi) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xiii) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xiv) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xv) ImmunityBio's ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio's business are described under the heading 'Risk Factors' in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company's Form 10-Q filed with the SEC on May 12, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof.
Business Wire
an hour ago
- Business Wire
Faraday Future Announces the Launch of the Early Reservation Portal for Faraday X (FX) Official FX Super One B2C Pre-order Portal for Individual Users Building Upon the Success of the B2B Outreach
LOS ANGELES--(BUSINESS WIRE)--Faraday Future Intelligent Electric Inc. (NASDAQ: FFAI) ('Faraday Future', 'FF' or the 'Company'), a California-based global shared intelligent electric mobility ecosystem company, today announced the launch of early reservation portal for Faraday X (FX) official FX Super One B2C reservation for all individual users. Starting tomorrow, users who complete pre-registration and place a deposit will receive a unique FF ID and a confirmed queue number for earlier delivery, securing their trackable spot in line. Click the following link to reserve today and to secure earlier delivery: This initiative comes on the heels of the strong B2B momentum. FX has now secured a total of 4,100 B2B deposits, spanning four core sectors: FF Par (Partners), car rental companies, live e-commerce MCN agencies, and real estate brokerages. Please keep an eye on and the FF App. The Pre-Order Reservation Portal goes live today at 5:00 PM Los Angeles time. July 17 marks the Global Initial Launch of the FX Super One & Super EAI F.A.C.E. & FF EAI Embodied AI Agent 6 x 4 Architecture. Immediately following the launch event for the FX Super One on July 17, FX will push a one-click priority pre-order link to all users with a confirmed reservation—granting them exclusive pre-order access and priority delivery benefits. The FX Super One, is an affordable mass market MPV, targeted to have the first vehicles off the line in the U.S. by the end of 2025. Offering a spacious, meticulously crafted interior with high-end materials and advanced technology, the FX Super One prioritizes passenger comfort with a host of features including spacious seating, ambient lighting, and premium entertainment systems, to name a few. The Super One will be available with AWD and two powertrain options: battery electric and AI hybrid extended range (AIHER). ABOUT FARADAY FUTURE Faraday Future is a California-based global shared intelligent electric mobility ecosystem company. Founded in 2014, the Company's mission is to disrupt the automotive industry by creating a user-centric, technology-first, and smart driving experience. Faraday Future's flagship model, the FF 91, exemplifies its vision for luxury, innovation, and performance. The FX strategy aims to introduce mass production models equipped with state-of-the-art luxury technology similar to the FF 91, targeting a broader market with middle-to-low price range offerings. FF is committed to redefining mobility through AI innovation. Join us in shaping the future of intelligent transportation. For more information, please visit FORWARD LOOKING STATEMENTS This press release includes 'forward looking statements' within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. When used in this press release, the words 'plan to,' 'can,' 'will,' 'should,' 'future,' 'potential,' and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements, which include statements regarding the Super One MPV, Super EAI F.A.C.E., and EAI Embodied AI Agent 6x4 architecture, are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the Company's control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include, among others: the Company's ability to secure necessary agreements to license or produce FX vehicles in the U.S., the Middle East, or elsewhere, none of which have been secured; the Company's ability to homologate FX vehicles for sale in the U.S., the Middle East, or elsewhere; the Company's ability to secure the necessary funding to execute on its AI, EREV and Faraday X (FX) strategies, each of which will be substantial; the Company's ability to secure necessary permits at its Hanford, CA production facility; the Company's ability to secure regulatory approvals for the proposed Super One front grill; the potential impact of tariff policy; the Company's ability to continue as a going concern and improve its liquidity and financial position; the Company's ability to pay its outstanding obligations; the Company's ability to remediate its material weaknesses in internal control over financial reporting and the risks related to the restatement of previously issued consolidated financial statements; the Company's limited operating history and the significant barriers to growth it faces; the Company's history of losses and expectation of continued losses; the success of the Company's payroll expense reduction plan; the Company's ability to execute on its plans to develop and market its vehicles and the timing of these development programs; the Company's estimates of the size of the markets for its vehicles and cost to bring those vehicles to market; the rate and degree of market acceptance of the Company's vehicles; the Company's ability to cover future warranty claims; the success of other competing manufacturers; the performance and security of the Company's vehicles; current and potential litigation involving the Company; the Company's ability to receive funds from, satisfy the conditions precedent of and close on the various financings described elsewhere by the Company; the result of future financing efforts, the failure of any of which could result in the Company seeking protection under the Bankruptcy Code; the Company's indebtedness; the Company's ability to cover future warranty claims; the Company's ability to use its 'at-the-market' program; insurance coverage; general economic and market conditions impacting demand for the Company's products; potential negative impacts of a reverse stock split; potential cost, headcount and salary reduction actions may not be sufficient or may not achieve their expected results; circumstances outside of the Company's control, such as natural disasters, climate change, health epidemics and pandemics, terrorist attacks, and civil unrest; risks related to the Company's operations in China; the success of the Company's remedial measures taken in response to the Special Committee findings; the Company's dependence on its suppliers and contract manufacturer; the Company's ability to develop and protect its technologies; the Company's ability to protect against cybersecurity risks; and the ability of the Company to attract and retain employees, any adverse developments in existing legal proceedings or the initiation of new legal proceedings, and volatility of the Company's stock price. You should carefully consider the foregoing factors and the other risks and uncertainties described in the 'Risk Factors' section of the Company's Form 10-K filed with the SEC on March 31, 2025, and other documents filed by the Company from time to time with the SEC.
Business Wire
an hour ago
- Business Wire
Newegg Launches 11th Annual FantasTech Sale with Thousands of Tech Deals in the US and Canada
BUSINESS WIRE)--Newegg Commerce, Inc. (NASDAQ: NEGG) (the 'Company'), a leading global tech e-retailer, today launched its 11th annual FantasTech Sale, one of the company's biggest sales events of the year. Running from July 7 through July 13, the event features thousands of PC and tech deals across and spanning more than 50 product categories and offering deep discounts on everything from gaming laptops and desktop PCs to components, peripherals, and storage. 'FantasTech has become a summer tradition for many PC builders and gamers,' said Steven Chien, VP of Product Management at Newegg. 'With next-gen components and incredible deals, this is the sale many customers wait for, and we're elated to bring these savings to them for the 11th year in a row.' Featured FantasTech Deals About FantasTech Price Protection Customers who purchased an eligible product with the FantasTech Price Protection badge from June 20, 2025, through July 6, 2025, will receive an automatic refund if the item's price drops on and before July 13, 2025. No need to track prices or file claims Refunds will be issued to the original payment method by July 22, 2025 Email confirmations will be sent once processed Newegg's internal systems will check for price drops on all eligible purchases within the program period. Special Offer for Cardholders Newegg Store Credit Card holders can get $15 off their purchase using promo code TECH15OFF when they spend $150+ with their Newegg Store Credit Card.* Exclusions apply. Offer valid 7/7/25 – 7/13/25. Disclaimers Prices and availability are subject to change without notice. Products from third-party brands are sold by Newegg but manufactured and warrantied by their respective companies. For the latest updates, visit *Subject to credit approval. Code valid for one time use between 07-07-2025 to 07-13-2025 at 11:59PM PDT. In order to qualify for this offer, you must use your Newegg Store Credit Card account to make a qualifying single receipt purchase of $150 or more. Must input offer code at checkout. Offer code valid on a single qualifying purchase of in-stock merchandise. Offer excludes various merchandise including gift cards, pre-orders/back-orders, trade-in orders, subscriptions, will-call/UPS pickup, and select items. All purchases are subject to the site terms and conditions, which may change at any time. If you return merchandise, dollar value of offer will not be refunded. Offer is valid for Newegg Store Credit Card accounts only. About Newegg Newegg Commerce, Inc. (NASDAQ: NEGG), founded in 2001 and based in Diamond Bar, Calif., near Los Angeles, is a leading global online retailer for PC hardware, consumer electronics, gaming peripherals, home appliances, automotive and lifestyle technology. Newegg also serves businesses' e-commerce needs with marketing, supply chain, and technical solutions in a single platform. For more information, please visit This press release contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially due to factors beyond Newegg's control, including but not limited to market conditions, supply chain disruptions, and evolving customer demands. For additional information, please review Newegg's filings with the U.S. Securities and Exchange Commission.
