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The 2024-25 N.J. indoor track season opened yesterday, but most teams and athletes won’t get their action underway until the third week of the month. Until then, NJ.com has you covered with a comprehensive preview package to keep you engaged and up to date with everything going on throughout the next few weeks. Things to know Key Dates Group and Sectional Classifications Returning All-State & All Group Selections: Boys | Girls Compelling storylines to watch in 2024-25 (Coming Dec. 16) Runners to watch Boys Runners Girls Runners (Coming Dec. 11) Teams to watch (Coming Dec. 14) Boys Teams Girls Teams Preseason Fab 50 (Coming Dec. 19) Boys Fab 50 Girls Fab 50 Bakari Tice can be reached at btice@njadvancemedia.com . Follow him on X at @BakariTice . The N.J. High School Sports newsletter is now appearing in mailboxes 5 days a week. Sign up now! Follow us on social: Facebook | Instagram | X (formerly Twitter)
bioAffinity Technologies stock hits 52-week low at $1.21
SOMERVILLE, Mass.--(BUSINESS WIRE)--Dec 8, 2024-- bluebird bio, Inc. (Nasdaq: BLUE) today announced new and updated data from LYFGENIATM (lovotobegligene autotemcel, or lovo-cel) gene therapy for patients with sickle cell disease who have a history of vaso-occlusive events (VOEs). The data will be presented at the 66 th American Society of Hematology (ASH) Annual Meeting and Exposition in an oral presentation on Sunday, December 8 at 9:30 a.m. Pacific Time and a poster presentation on Sunday, December 8 at 6 p.m. Pacific Time. As of July 2024, 70 patients were treated across the full lovo-cel clinical development program, with follow-up beyond 9 years in the earliest treated patients. “Data presented at ASH demonstrate that the potentially transformative benefits of LYFGENIA are sustained through additional long-term follow-up and consistent across sub-populations, including patients with overt stroke, not studied in any other clinical development program of gene therapy for sickle cell disease.” said Richard Colvin, M.D., Ph.D., chief medical officer, bluebird bio. “These data continue to distinguish LYFGENIA as the most deeply studied gene therapy for sickle cell disease, with the most patients treated, longest follow-up, and broadest range of clinical presentations evaluated across the field.” Updated efficacy data continue to support sustained, transformational impact on VOE burden and hematologic markers of disease An update on clinical response to lovo-cel in patients living with sickle cell disease focused on 58 patients who received lovo-cel in the HGB-206 Group C (n=36) and HGB-210 (n=22) studies, following enhancements to the manufacturing and treatment protocols, will be presented in Oral Presentation #511: An Update on Lovotibeglogene Autotemcel (lovo-cel) Clinical Trials for Sickle Cell Disease (SCD) and Analysis of Early Predictors of Response to Lovo-cel. Median follow-up time was 47.7 months (4.0 years), with 15 study participants having 5 or more years of follow-up. Stacy Rifkin-Zenenberg, DO, Hackensack Meridian Health said: “These data demonstrate that the significant clinical benefits of lovo-cel for people living with sickle cell disease are durable through continued long-term follow-up. Additionally, the number of patients treated, and duration of follow-up, has enabled detailed exploration of the pharmacology and mechanism of action of LVV gene therapy for sickle cell disease, providing even greater support that one-time treatment with lovo-cel has the potential to permanently address the underlying cause of sickle cell disease.” As of the July 2024 cutoff date, all patients continued to have stable production of anti-sickling adult hemoglobin after infusion through last follow-up (median >40% HbA T87Q ) and total Hb at last visit was 12.4 (6.6, 15.1) g/dL and was stable without transfusion support post engraftment. VOEs and severe vaso-occlusive events (sVOEs) were eliminated or significantly reduced in all patients. Specific findings include: The safety profile of the lovo-cel treatment regimen was generally consistent with underlying sickle cell disease and the known effects of myeloablative conditioning. There were no cases of graft failure or graft-versus-host disease (GVHD), no vector-related complications, and no insertional oncogenesis. For complete safety information please refer to the U.S. Prescribing Information noted below. Data from patients with sickle cell disease and a history of overt stroke show no recurrence of stroke following treatment with lovo-cel The first focused analysis of the clinical impact of lovo-cel on patients with sickle cell disease with a history of stroke, including overt stroke, will be presented in Poster Presentation #3576: Participants with a History of Stroke in Lovotibeglogene Autotemcel (lovo-cel) Clinical Trials. Data showed that patients with a history of overt stroke remained stable without recurrent stroke up to 9 years post-treatment (n=6), with median follow-up of 6.5 years. Jennifer Jaroscak, MD, Director, Pediatric Non-Malignant Transplant, Medical University of South Carolina, said “We are extremely pleased to report that no study participants with a history of overt or silent stroke experienced recurrent strokes following treatment with lovo-cel gene therapy, despite discontinuing transfusions. This finding is remarkable, as these patients face an exceedingly high risk of subsequent strokes, and transfusions alone provide only modest protection against secondary strokes. These data are unique in the field as lovo-cel is the only gene therapy for sickle cell disease with data on patients with a history of stroke.” Overt ischemic stroke is a devastating complication of sickle cell disease and requires lifelong chronic transfusions or allogeneic hematopoietic stem cell transplantation, which carry significant risk of complications. One in four patients living with sickle cell disease have a stroke by age 45. Other clinical outcomes in patients with a history of stroke—including expression of gene therapy derived anti-sickling hemoglobin (HBA T87Q ), improvements in total hemoglobin, and impact on other hematologic markers—were consistent with those patients’ respective study populations (HGB-206 Group A and HGB-206 Group C). The analysis also included 21 patients who had evidence of silent stroke based on available MRI data at screening. In this cohort there were no reports of recurrent overt or silent stroke among patients with follow-up MRIs, with a median 3.5 years follow-up (.48, 6.88 years). Silent ischemic stroke adversely affects neurocognitive function and is associated with increased risk of overt stroke. It occurs in an estimated 39% of patients with sickle cell disease. Safety findings for participants with a history of overt stroke did not differ from that in the overall treatment group. No increase in hypertension, bleeding issues, prolonged thrombocytopenia or catheter-related thromboses were observed. As previously reported, cases of acute myeloid leukemia were observed in two patients from the HGB-206 Group A cohort who were treated with an earlier version of the therapy prior to enhancements to the treatment and manufacturing processes. Both patients died due to aforementioned leukemia. About LYFGENIATM (lovotibeglogene autotemcel) or lovo-cel LYFGENIA is a one-time ex-vivo lentiviral vector gene therapy approved for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events (VOEs). LYFGENIA works by adding a functional β-globin gene to patients’ own hematopoietic (blood) stem and progenitor cells (HSPCs). Durable production of adult hemoglobin with anti-sickling properties (HbAT87Q) is possible following successful engraftment. HbAT87Q has a similar oxygen-binding affinity to wild-type HbA, limits sickling of red blood cells and has the potential to reduce VOEs. The Phase 1/2 HGB-206 study of LYFGENIA is complete and the Phase 3 HGB-210 study evaluating LYFGENIA is ongoing. bluebird bio is also conducting a long-term safety and efficacy follow-up study (LTF-307) for patients with sickle cell disease who have been treated with LYFGENIA in bluebird bio-sponsored clinical studies. Indication LYFGENIA is indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events (VOEs). Limitations of Use Following treatment with LYFGENIA, patients with α-thalassemia trait (-α3.7/-α3.7) may experience anemia with erythroid dysplasia that may require chronic red blood cell transfusions. LYFGENIA has not been studied in patients with more than two α-globin gene deletions. Important Safety Information Boxed WARNING: HEMATOLOGIC MALIGNANCY Hematologic malignancy has occurred in patients treated with LYFGENIA. Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through integration site analysis at Months 6, 12, and as warranted. Hematologic Malignancy Hematologic malignancy has occurred in patients treated with LYFGENIA (Study 1, Group A). At the time of initial product approval, two patients treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure (Study 1, Group A) developed acute myeloid leukemia (AML). One patient with α-thalassemia trait (Study 1, Group C) has been diagnosed with myelodysplastic syndrome (MDS). The additional hematopoietic stress associated with mobilization, conditioning, and infusion of LYFGENIA, including the need to regenerate the hematopoietic system, may increase the risk of a hematologic malignancy. Patients with sickle cell disease have an increased risk of hematologic malignancy as compared to the general population. Patients treated with LYFGENIA may develop hematologic malignancies and should have lifelong monitoring. Monitor for hematologic malignancies with a complete blood count (with differential) at least every 6 months for at least 15 years after treatment with LYFGENIA, and integration site analysis at Months 6, 12, and as warranted. In the event that a malignancy occurs, contact bluebird bio at 1-833-999-6378 for reporting and to obtain instructions on collection of samples for testing. Post-Marketing Long Term Follow-Up Study: Patients who intend to receive treatment with LYFGENIA are encouraged to enroll in the study, as available, to assess the long-term safety of LYFGENIA and the risk of malignancies occurring after treatment with LYFGENIA by calling bluebird bio at 1-833-999-6378. The study includes monitoring (at pre-specified intervals) for clonal expansion. Delayed Platelet Engraftment Delayed platelet engraftment has been observed with LYFGENIA. Bleeding risk is increased prior to platelet engraftment and may continue after engraftment in patients with prolonged thrombocytopenia. Two patients (4%) required more than 100 days post treatment with LYFGENIA to achieve platelet engraftment. Patients should be made aware of the risk of bleeding until platelet recovery has been achieved. Monitor patients for thrombocytopenia and bleeding according to standard guidelines. Conduct frequent platelet counts until platelet engraftment and platelet recovery are achieved. Perform blood cell count determination and other appropriate testing whenever clinical symptoms suggestive of bleeding arise. Neutrophil Engraftment Failure There is a potential risk of neutrophil engraftment failure after treatment with LYFGENIA. Neutrophil engraftment failure is defined as failure to achieve three consecutive absolute neutrophil counts (ANC) ≥ 0.5 × 109 cells/L obtained on different days by Day 43 after infusion of LYFGENIA. Monitor neutrophil counts until engraftment has been achieved. If neutrophil engraftment failure occurs in a patient treated with LYFGENIA, provide rescue treatment with the back-up collection of CD34+ cells. Insertional Oncogenesis There is a potential risk of lentiviral vector-mediated insertional oncogenesis after treatment with LYFGENIA. Hypersensitivity Reactions Allergic reactions may occur with the infusion of LYFGENIA. The dimethyl sulfoxide (DMSO) or dextran 40 in LYFGENIA may cause hypersensitivity reactions, including anaphylaxis. Anti-retroviral Use Patients should not take prophylactic HIV anti-retroviral medications for at least one month prior to mobilization and until all cycles of apheresis are completed. There are some long-acting anti-retroviral medications that may require a longer duration of discontinuation for elimination of the medication. If a patient is taking anti-retrovirals for HIV prophylaxis, confirm a negative test for HIV before beginning mobilization and apheresis of CD34+ cells. Hydroxyurea Use Patients should not take hydroxyurea for at least 2 months prior to mobilization and until all cycles of apheresis are completed. If hydroxyurea is administered between mobilization and conditioning, discontinue 2 days prior to initiation of conditioning. Iron Chelation Drug-drug interactions between iron chelators and the mobilization process and myeloablative conditioning agent must be considered. Iron chelators should be discontinued at least 7 days prior to initiation of mobilization or conditioning. Do not administer myelosuppressive iron chelators (e.g., deferiprone) for 6 months post-treatment with LYFGENIA. Non-myelosuppressive iron chelation should be restarted no sooner than 3 months after LYFGENIA infusion. Phlebotomy can be used in lieu of iron chelation, when appropriate. Interference with PCR-based Testing Patients who have received LYFGENIA are likely to test positive by polymerase chain reaction (PCR) assays for HIV due to integrated BB305 LVV proviral DNA, resulting in a possible false-positive PCR assay test result for HIV. Therefore, patients who have received LYFGENIA should not be screened for HIV infection using a PCR-based assay. Adverse Reactions The most common adverse reactions ≥ Grade 3 (incidence ≥ 20%) were stomatitis, thrombocytopenia, neutropenia, febrile neutropenia, anemia, and leukopenia. Three patients died during LYFGENIA clinical trials; one from sudden cardiac death due to underlying disease and two from acute myeloid leukemia who were treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure (Study 1, Group A). Pregnancy/Lactation Advise patients of the risks associated with myeloablative conditioning agents, including on pregnancy and fertility. LYFGENIA should not be administered to women who are pregnant, and pregnancy after LYFGENIA infusion should be discussed with the treating physician. LYFGENIA is not recommended for women who are breastfeeding, and breastfeeding after LYFGENIA infusion should be discussed with the treating physician. Females and Males of Reproductive Potential A negative serum pregnancy test must be confirmed prior to the start of mobilization and re-confirmed prior to conditioning procedures and before LYFGENIA administration. Women of childbearing potential and men capable of fathering a child should use an effective method of contraception (intra-uterine device or combination of hormonal and barrier contraception) from start of mobilization through at least 6 months after administration of LYFGENIA. Advise patients of the options for fertility preservation. Please see full Prescribing Information for LYFGENIA including Boxed WARNING and Medication Guide . About bluebird bio, Inc. bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days. Founded in 2010, bluebird has been setting the standard for gene therapy for more than a decade—first as a scientific pioneer and now as a commercial leader. bluebird has an unrivaled track record in bringing the promise of gene therapy out of clinical studies and into the real-world setting, having secured FDA approvals for three therapies in under two years. Today, we are proving and scaling the commercial model for gene therapy and delivering innovative solutions for access to patients, providers, and payers. With a dedicated focus on severe genetic diseases, bluebird has the largest and deepest ex-vivo gene therapy data set in the field, with industry-leading programs for sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward. bluebird continues to forge new paths as a standalone commercial gene therapy company, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements, such as statements regarding the therapeutic potential of LYFGENIA. Such forward-looking statements are based on historical performance and current expectations and projections about bluebird’s future goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond bluebird’s control and could cause bluebird’s future goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bio’s business, particularly those identified in the risk factors discussion in bluebird bio’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by its subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC. These risks and uncertainties include, but are not limited to: the risk that the efficacy and safety results from bluebird’s prior and ongoing clinical trials will not continue or be seen in the commercial context; the risk that there is not sufficient patient demand or payer reimbursement to support continued commercialization of LYFGENIA; the risk of insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation, including the risk of hematologic malignancy; and the risk that bluebird’s products, including LYFGENIA, will not be successfully commercialized. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. View source version on businesswire.com : https://www.businesswire.com/news/home/20241208134842/en/ CONTACT: Investors: Courtney O’Leary, 978-621-7347 coleary@bluebirdbio.com Media: Jess Rowlands, 857-299-6103 jess.rowlands@bluebirdbio.com KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE BIOTECHNOLOGY RESEARCH GENERAL HEALTH HEALTH GENETICS OTHER HEALTH SOURCE: bluebird bio, Inc. Copyright Business Wire 2024. PUB: 12/08/2024 12:30 PM/DISC: 12/08/2024 12:30 PM http://www.businesswire.com/news/home/20241208134842/en Copyright Business Wire 2024.
President-elect Donald Trump says he will nominate former Florida Attorney General Pam Bondi to serve as U.S. Attorney General in his new administration. "For too long, the partisan Department of Justice has been weaponized against me and other Republicans," Trump wrote in an announcement of the nomination. "Not anymore. Pam will refocus the DOJ to its intended purpose of fighting crime, and making America safe again." Bondi was Florida's attorney general from 2011 to 2019. During her tenure, she brought or participated in lawsuits to overturn the Affordable Care Act. Bondi was also a defense lawyer for Trump during his first impeachment trial in the U.S. Senate and has worked at the conservative nonprofit America First Policy Institute . Bondi's nomination is subject to Senate confirmation. RELATED STORY | Matt Gaetz says he's removing his name for consideration for attorney general Bondi's nomination comes the same day that former Florida Rep. Matt Gaetz withdrew himself from consideration for the position. Trump nominated Gaetz last week, a decision that was quickly criticized by both Democrats and Republicans. On Thursday, Trump thanked Gaetz for his efforts to try and secure the support of the senators needed for confirmation. "Matt has a wonderful future, and I look forward to watching all of the great things he will do," Trump said on Truth Social. This is a developing story and will be updated.None
CRANBURY, N.J.--(BUSINESS WIRE)--Dec 10, 2024-- Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, announced today that it intends to offer and sell $150 million of shares of its common stock in an underwritten public offering. In addition, Rocket intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of shares of its common stock offered in the public offering. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Morgan Stanley, Leerink Partners and Cantor are acting as joint book-running managers for the offering, and LifeSci Capital is acting as lead manager for the offering. The shares are being offered by Rocket pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov . When available, copies of the prospectus supplement relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by email at prospectus@morganstanley.com ; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105 or by email at syndicate@leerink.com ; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York, 10022, or by email at prospectus@cantor.com . You may also obtain a copy of this document free of charge by visiting the SEC’s website at http://www.sec.gov . This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Rocket Pharmaceuticals, Inc. Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) is a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of investigational genetic therapies designed to correct the root cause of complex and rare disorders. Rocket’s innovative multi-platform approach allows us to design the optimal gene therapy for each indication, creating potentially transformative options that enable people living with devastating rare diseases to experience long and full lives. Rocket’s lentiviral (LV) vector-based hematology portfolio consists of late-stage programs for Fanconi Anemia (FA), a difficult-to-treat genetic disease that leads to bone marrow failure (BMF) and potentially cancer, Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, and Pyruvate Kinase Deficiency (PKD), a monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia. Rocket’s adeno-associated viral (AAV) vector-based cardiovascular portfolio includes a late-stage program for Danon disease, a devastating heart failure condition resulting in thickening of the heart, an early-stage program in clinical trials for PKP2-arrhythmogenic cardiomyopathy (ACM), a life-threatening heart failure disease causing ventricular arrhythmias and sudden cardiac death, and a pre-clinical program targeting BAG3-associated dilated cardiomyopathy (DCM), a heart failure condition that causes enlarged ventricles. Rocket Cautionary Statement Regarding Forward-Looking Statements Various statements in this release concerning the timing and completion of the public offering on the anticipated terms or at all may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of substantial risks and uncertainties, many of which are outside Rocket’s control, that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include fluctuations in Rocket’s stock price, changes in market conditions and satisfaction of customary closing conditions related to the public offering, as well as those risks more fully discussed in the section entitled "Risk Factors" in the prospectus supplement and registration statement referenced above, Rocket’s Annual Report on Form 10-K for the year ended December 31, 2023, filed February 27, 2024 with the SEC and subsequent filings with the SEC including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that Rocket will be able to complete the public offering on the anticipated terms. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law. View source version on businesswire.com : https://www.businesswire.com/news/home/20241210060247/en/ CONTACT: Media & Investors Meg Dodge mdodge@rocketpharma.comMedia Kevin Giordano media@rocketpharma.comInvestors Brooks Rahmer investors@rocketpharma.com KEYWORD: NEW JERSEY UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: ONCOLOGY HEALTH GENETICS OTHER HEALTH GENERAL HEALTH PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Rocket Pharmaceuticals, Inc. Copyright Business Wire 2024. PUB: 12/10/2024 04:01 PM/DISC: 12/10/2024 04:00 PM http://www.businesswire.com/news/home/20241210060247/en
GRAPEVINE, Texas, Dec. 10, 2024 (GLOBE NEWSWIRE) -- GameStop Corp. (NYSE: GME) ("GameStop” or the "Company”) today released financial results for the third quarter ended November 2, 2024. The Company's condensed and consolidated financial statements, including GAAP and non-GAAP results, are below. The Company's Form 10-Q and supplemental information can be found at https://investor.gamestop.com. THIRD QUARTER OVERVIEW NON-GAAP MEASURES AND OTHER METRICS As a supplement to the Company's financial results presented in accordance with U.S. generally accepted accounting principles ("GAAP”), GameStop may use certain non-GAAP measures, such as adjusted SG&A expenses, adjusted operating loss, adjusted net income (loss), adjusted earnings (loss) per share, adjusted EBITDA and free cash flow. The Company believes these non-GAAP financial measures provide useful information to investors in evaluating the Company's core operating performance. Adjusted SG&A expenses, adjusted operating loss, adjusted net income (loss), adjusted earnings (loss) per share and adjusted EBITDA exclude the effect of items such as certain transformation costs, asset impairments, severance, as well as divestiture costs. Free cash flow excludes capital expenditures otherwise included in net cash flows provided by (used in) operating activities. The Company's definition and calculation of non-GAAP financial measures may differ from that of other companies. Non-GAAP financial measures should be viewed as supplementing, and not as an alternative or substitute for, the Company's financial results prepared in accordance with GAAP. Certain of the items that may be excluded or included in non-GAAP financial measures may be significant items that could impact the Company's financial position, results of operations or cash flows and should therefore be considered in assessing the Company's actual and future financial condition and performance. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS - SAFE HARBOR This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are based upon management's current beliefs, views, estimates and expectations, including as to the Company's industry, business strategy, goals and expectations concerning its market position, strategic and transformation initiatives, future operations, margins, profitability, sales growth, capital expenditures, liquidity, capital resources, expansion of technology expertise, and other financial and operating information, including expectations as to future operating profit improvement. Forward-looking statements are subject to significant risks and uncertainties and actual developments, business decisions, outcomes and results may differ materially from those reflected or described in the forward-looking statements. The following factors, among others, could cause actual developments, business decisions, outcomes and results to differ materially from those reflected or described in the forward-looking statements: economic, social, and political conditions in the markets in which we operate; the competitive nature of the Company's industry; the cyclicality of the video game industry; the Company's dependence on the timely delivery of new and innovative products from its vendors; the impact of technological advances in the video game industry and related changes in consumer behavior on the Company's sales; interruptions to the Company's supply chain or the supply chain of our suppliers; the Company's dependence on sales during the holiday selling season; the Company's ability to obtain favorable terms from its current and future suppliers and service providers; the Company's ability to anticipate, identify and react to trends in pop culture with regard to its sales of collectibles; the Company's ability to maintain strong retail and ecommerce experiences for its customers; the Company's ability to keep pace with changing industry technology and consumer preferences; the Company's ability to manage its profitability and cost reduction initiatives; turnover in senior management or the Company's ability to attract and retain qualified personnel; potential damage to the Company's reputation or customers' perception of the Company; the Company's ability to maintain the security or privacy of its customer, associate or Company information; occurrence of weather events, natural disasters, public health crises and other unexpected events; risks associated with inventory shrinkage; potential failure or inadequacy of the Company's computerized systems; the ability of the Company's third party delivery services to deliver products to the Company's retail locations, fulfillment centers and consumers and changes in the terms the Company has with such service providers; the ability and willingness of the Company's vendors to provide marketing and merchandising support at historical or anticipated levels; restrictions on the Company's ability to purchase and sell pre-owned products; the Company's ability to renew or enter into new leases on favorable terms; unfavorable changes in the Company's global tax rate; legislative actions; the Company's ability to comply with federal, state, local and international laws and regulations and statutes; potential future litigation and other legal proceedings; the value of the Company's securities holdings; concentration of the Company's investment portfolio into one or few holdings; the recognition of losses in a particular security even if the Company has not sold the security; volatility in the Company's stock price, including volatility due to potential short squeezes; continued high degrees of media coverage by third parties; the availability and future sales of substantial amounts of the Company's Class A common stock; fluctuations in the Company's results of operations from quarter to quarter; the Company's ability to incur additional debt; risks associated with the Company's investment in marketable, nonmarketable and interest-bearing securities, including the impact of such investments on the Company's financial results; and the Company's ability to maintain effective control over financial reporting. Additional factors that could cause results to differ materially from those reflected or described in the forward-looking statements can be found in GameStop's most recent Annual Report on Form 10-K and other filings made from time to time with the SEC and available at www.sec.gov or on the Company's investor relations website (https://investor.gamestop.com). Forward-looking statements contained in this press release speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Condensed Statements of Operations (in millions, except per share data) (unaudited) November 2, 2024 October 28, 2023 Consolidated Statements of Operations (in millions, except per share data) (unaudited) November 2, 2024 October 28, 2023
On Football analyzes the biggest topics in the NFL from week to week. For more On Football analysis, head here . Saquon Barkley has become the Shohei Ohtani of the NFL. There’s no better home run hitter playing football right now. Barkley had touchdown runs of 72 and 70 yards for the Philadelphia Eagles in a 37-20 victory over the Los Angeles Rams on Sunday night. He now has five runs of 50-plus yards this season and is on pace to break Eric Dickerson’s single-season record of 2,105 yards set in 1984. Barkley’s historic performance against the Rams — his 255 yards set a team record — captivated a national audience and turned him into a fan favorite for the AP NFL MVP award. He’s not the betting favorite, however. Josh Allen has the best odds at plus-150, according to Bet MGM Sportsbook. Two-time MVP Lamar Jackson is next at plus-250 followed by Barkley at plus-400. Running backs have won the award 18 times, including three-time winner Jim Brown, who was the AP’s first NFL MVP in 1957. Quarterbacks have dominated the award, winning it 45 times. Only three players who weren’t QBs or RBs have been MVP. It takes a special season for a non-QB to win it mainly because the offense goes through the signal caller. Quarterbacks handle the ball every offensive snap, run the show and get the credit when things go well and the blame when it doesn’t. Adrian Peterson was the most recent non-QB to win it when he ran for 2,097 yards and 12 touchdowns for the Minnesota Vikings in 2012. Playing for a winning team matters, too. Nine of the past 11 winners played for a No. 1 seed with the other two winners on a No. 2 seed. The Vikings earned the sixth seed when Pederson was MVP. Barkley is a major reason why the Eagles (9-2) are leading the NFC East and only trail Detroit (10-1) by one game for the top spot in the conference. Does he have a realistic chance to win the MVP award? Kicker Mark Moseley was the MVP in the strike-shortened 1982 season when he made 20 of 21 field goals and 16 of 19 extra points in nine games for Washington. If voters once selected a kicker, everyone has a chance, especially a game-changer such as Barkley. Defensive tackle Alan Page was the MVP in 1971 and linebacker Lawrence Taylor won it in 1986. Story continues below video Running back Christian McCaffrey finished third in voting last year and wide receiver Justin Jefferson placed fifth in 2022. The Offensive Player of the Year award and Defensive Player of the Year award recognize the best all-around players on both sides of the ball, allowing voters to recognize non-QBs if they choose. Wide receivers and running backs have won the AP OPOY award seven times over the past 11 seasons. McCaffrey was the 2023 winner. The AP’s new voting format introduced in 2022 also gives non-QBs a better opportunity to get MVP recognition. Voter submit their top five picks for each award, with a weighted point system. Previously, voters made one choice for each award. A nationwide panel of 50 media members who regularly cover the league vote for MVP and seven other awards. The awards are based on regular-season performance. The Chiefs (10-1) and Bills (9-2) already are in position to lock up postseason berths right after Thanksgiving. Kansas City clinches a playoff berth with a win over Las Vegas on Black Friday and a loss by Miami on Thursday night, or a win plus a loss by Denver on Monday night. Buffalo can wrap up a fifth straight AFC East title with a victory over San Francisco on Sunday and a loss by the Dolphins. It’s not a given that the Dallas Cowboys will be looking for a new head coach after this season. Owner Jerry Jones said Tuesday on local radio that Mike McCarthy could end up getting a contract extension. “I don’t think that’s crazy at all. This is a Super Bowl-winning coach. Mike McCarthy has been there and done that. He has great ideas. We got a lot of football left,” Jones said. McCarthy led the Cowboys (4-7) to three straight 12-win seasons, but they went 1-3 in the playoffs and haven’t reached the NFC championship game since winning the Super Bowl 29 years ago. Injuries have contributed to the team’s struggles this season, but Dallas was just 3-5 before Dak Prescott was lost for the rest of the season. The Cowboys upset Washington last week and their next four games are against teams that currently have losing records. If they somehow end up 9-8 or even 8-9, Jones could make a case for keeping McCarthy. AP NFL: https://apnews.com/hub/nfl
New Syria PM calls for 'stability and calm'Scemblix demonstrated sustained superior major molecular response (MMR) vs. all investigator-selected TKIs (74.1% vs. 52%) and vs. imatinib alone (76.2% vs. 47.1%), meeting both ASC4FIRST 96-week key secondary endpoints 1 Scemblix showed a clinically relevant 15.1% higher MMR rate vs. second generation (2G) TKIs (72.0% vs. 56.9%) 1 96-week data extend favorable safety and tolerability profile for Scemblix vs. imatinib and 2G TKIs, with fewer grade ≥3 AEs and less than half the discontinuation rate due to AEs 1 Latest results strengthen Scemblix as a standard of care following expanded indication in newly diagnosed and previously treated adult patents with Ph+ CML-CP and NCCN category 1 recommendation 1-3 Basel, December 8, 2024 – Novartis today announced positive, longer-term results from the pivotal Phase III ASC4FIRST trial with Scemblix ® (asciminib) showing superior major molecular response (MMR) rates at week 96 1 . The study compared the MMR rate of Scemblix to investigator-selected standard-of-care (SoC) tyrosine kinase inhibitors (TKIs) (imatinib, nilotinib, dasatinib and bosutinib) and to imatinib alone in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) at the week 96 evaluation, the study’s key secondary endpoints 1 . The longer-term results showed an increasing difference in Scemblix MMR rate vs. SoC, vs. imatinib and vs. 2G TKIs (nilotinib, dasatinib and bosutinib) 1 . Results were presented at the 66 th American Society of Hematology Annual Meeting & Exposition (ASH) 1 . “These 96-week results are very encouraging for clinicians who aspire to obtain a balance of efficacy and tolerability profiles to help newly diagnosed adult CML patients achieve and maintain treatment goals,” said Jorge Cortes, M.D., Director, Georgia Cancer Center. “The sustained superior efficacy, deeper and more durable responses, and favorable safety and tolerability profile compared to standard of care TKIs continue to support the promise of Scemblix as a potentially practice-changing treatment option.” The median follow-up was 2.2 years for Scemblix and investigator-selected SoC TKIs 1 . Over 22% more patients treated with once-daily Scemblix achieved MMR at week 96 vs. all investigator-selected SoC TKIs, and nearly 30% more patients achieved MMR at week 96 vs. imatinib alone 1 . The Scemblix MMR rate was 15.1% (95% CI: 2.3, 28.0; not crossing zero) higher vs. 2G TKIs (72% vs. 56.9%) 1 . Patients treated with Scemblix also achieved deeper rates of molecular responses (MR4 and MR4.5) compared with investigator-selected SoC TKIs 1 . The safety profile of Scemblix at 96-weeks was consistent with the 4-year follow-up of the Phase III ASCEMBL trial, with no new safety concerns observed to date 1,2,4 . Fewer grade ≥3 AEs and dose adjustments to manage AEs were reported for Scemblix, and discontinuation due to AEs was more than 50% lower for Scemblix vs. both imatinib and 2G TKIs 1 . The most frequent AEs (≥15%) were diarrhea, headache, fatigue, musculoskeletal pain, and rash 1 . Novartis also presented today at ASH interim data from the Phase II ASC2ESCALATE dose-escalation study in both the second line (2L) and newly diagnosed Ph+ CML-CP settings 5 . In the analysis of 2L patients at week 24 (n=28) Scemblix demonstrated MMR rates of 42.9% and deep molecular responses (MR4 25% and MR4.5 10.7%), with a consistent safety and tolerability profile 5 . The most common AEs (>15%) were nausea, hypertension, and vomiting 5 . “Novartis’ decades-long work in CML and deep relationships within the community have informed our Scemblix clinical trial program of over 10 years, the centerpiece of our continuing drive to address ongoing unmet medical needs for people with CML,” said Jeff Legos, Executive Vice President, Global Head of Oncology Development, Novartis. “These latest findings reinforce the differentiated efficacy, safety and tolerability profile of Scemblix in newly diagnosed and previously treated adult CML patients.” Scemblix was recently granted accelerated approval in the US to treat newly diagnosed adults with Ph+ CML-CP, which together with its approval in previously treated adult patients with Ph+ CML-CP expands the population of Scemblix-eligible patients by four-fold 2 . In addition, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for the treatment of CML, recommending asciminib as a category 1 – preferred treatment for newly diagnosed Ph+ CML-CP and across all risk categories 3 . About the ASC4FIRST Phase III Clinical Trial ASC4FIRST ( NCT04971226 ) is a Phase III, head-to-head, multi-center, open-label, randomized study of oral Scemblix ® 80 mg QD vs. IS first- or second-generation TKIs (imatinib, nilotinib, dasatinib or bosutinib) in 405 adult patients with newly diagnosed Ph+ CML-CP 2,6 . The trial met both primary endpoints with Scemblix demonstrating superior MMR rates at week 48 vs. investigator-selected SoC TKIs (imatinib, nilotinib, dasatinib and bosutinib) (67.7% vs. 49.0%) and imatinib alone (69.3% vs. 40.2%) as well as the secondary, non-powered endpoint for the 2G TKI stratum of (66% vs 57.8%) 1,6 . The study remains ongoing with further efficacy and safety readouts planned. About the ASC2ESCALATE Phase II Study ASC2ESCALATE ( NCT05384587 ) is a Phase II, multicenter, single-arm, dose-escalation study of oral Scemblix ® 80 mg QD in both the second line (2L) and newly diagnosed (1L) Ph+ CML-CP settings in the US 5,7 . While Scemblix is already approved across lines of therapy, this is the first prospective trial to assess asciminib in the 2L setting and a dose-escalation strategy of asciminib as 2L and 1L treatment for patients with CML-CP not meeting molecular milestones 5 . The proportion of patients achieving MMR at 12 months in the 2L setting will be measured as the primary endpoint 5 . The study remains ongoing and has completed enrollment with 196 patients (100 patients in 2L, 96 patients in 1L) 5 . About Scemblix ® (asciminib) Scemblix ® is the first CML treatment that works by Specifically Targeting the ABL Myristoyl Pocket (referred to as a STAMP inhibitor in scientific literature) 4,8,9 . Other currently approved CML treatments are TKIs that target the ATP-binding site (ATP-competitive) 9 . In the US, Scemblix was granted accelerated approval to treat newly diagnosed adults with Ph+ CML-CP and is also approved for previously treated adult patients with Ph+ CML-CP. Outside the US, it is approved in more than 75 countries, including the EU, to treat those who have previously been treated with two or more TKIs with Ph+ CML-CP 2,10,11 . In some countries, including the US, Scemblix is also approved in patients with Ph+ CML-CP with the T315I mutation 2,3,10 . Scemblix is being studied across multiple treatment lines for Ph+ CML-CP, both as a monotherapy and in combination 2,4,6,8,10,12-24 . Patient Access and Support Novartis, with its 20+ year history in CML, is committed to continuing to address areas of unmet patient need and reducing barriers to patient access and affordability that prevent patients from benefiting from innovation. Novartis Patient Support is available to help guide eligible patients through the various aspects of getting started on treatment including help understanding insurance coverage and identifying potential financial assistance options. Patients or providers can call 866-433-8000 or visit support.scemblix.com to learn more. About Novartis Commitment to CML Novartis has a long-standing scientific commitment to patients living with CML. For more than two decades, our bold science has helped transform CML from a life-limiting condition for many patients. Despite these advancements, there’s still work to be done. We continue to research ways to target the disease more selectively and to address the challenges of not reaching treatment efficacy goals, experiencing treatment resistance and/or intolerance that many patients face. Our legacy inspires our future innovation – we continue to lead the way in developing novel medicines to address serious unmet needs in CML. Our commitment also goes beyond science. Our 20+ year collaboration with the Max Foundation has provided access to Gleevec (imatinib), Tasigna (nilotinib) and now Scemblix and is delivering tremendous patient impact in low- and middle-income countries, with over 100,000 patients supported to date. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “may,” “committed,” “contingent,” “lead,” “continue,” “ongoing,” “to deliver,” “allowing,” “continuing,” “commitment,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Scemblix, or regarding potential future revenues from Scemblix. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Scemblix will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Scemblix will be commercially successful in the future. In particular, our expectations regarding Scemblix could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . References Cortes JE, Hochhaus A, Hughes TP, et al. Asciminib Continues to Provide Superior Efficacy and Favorable Safety and Tolerability vs Tyrosine Kinase Inhibitors In Newly Diagnosed Chronic Myeloid Leukemia in ASC4FIRST: Week 96 Update. Presented at: 66th ASH Annual Meeting & Exposition; December 7 – 10, 2024; San Diego, CA. Scemblix (asciminib) Prescribing information. East Hanover, New Jersey, USA: Novartis Pharmaceuticals Corporation; October 2024. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Chronic Myeloid Leukemia Version 2.2025. November 13, 2024. Accessed November 22, 2024. https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf Rea D, Mauro MJ, Boquimpani C, et al. A Phase 3, Open-Label, Randomized Study of Asciminib, a STAMP Inhibitor, vs Bosutinib in CML After 2 or more prior TKIs. Blood. 2021;138(21):2031-2041. doi:10.1182/blood.2020009984 Atallah EL, Levy MY, Koller P, et al. Efficacy and Safety of Asciminib in Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Interim Results from the Phase 2 ASC2ESCALATE Trial in the Cohort of Patients (Pts) after 1 Prior Tyrosine Kinase Inhibitor (TKI). Presented at: 66th ASH Annual Meeting & Exposition; December 7 – 10, 2024; San Diego, CA. A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP (ASC4FIRST). ClinicalTrials.gov identifier: NCT04971226. Updated March 25, 2024. Accessed March 26, 2024. https://clinicaltrials.gov/study/NCT04971226 Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia (ASC2ESCALATE) ClinicalTrials.gov identifier: NCT05384587. Updated October 30, 2024. Accessed November 21, 2024. https://clinicaltrials.gov/study/NCT05384587 Cortes JE, Hughes TP, Mauro MJ, et al. Asciminib, a First-in-Class STAMP Inhibitor, Provides Durable Molecular Response in Patients (pts) with Chronic Myeloid Leukemia (CML) Harboring the T315I Mutation: Primary Efficacy and Safety Results from a Phase 1 Trial. Oral presentation at: ASH Annual Meeting; Dec. 7, 2020. Schoepfer J, Jahnke W, Berellini G, et al. Discovery of Asciminib (ABL001), an Allosteric Inhibitor of the Tyrosine Kinase Activity of BCR-ABL1. J Med Chem. 2018;61(18):8120-8135. doi:10.1021/acs.jmedchem.8b01040 Novartis data on file. Scemblix. EMA Summary of Product Characteristics. Novartis Europharm Limited; 2022. Wylie AA, Schoepfer J, Jahnke W, et al. The allosteric inhibitor ABL001 enables dual targeting of BCR–ABL1. Nature. 2017;543(7647):733-737. doi:10.1038/nature21702 Hughes TP, Mauro MJ, Cortes JE, et al. Asciminib in Chronic Myeloid Leukemia after ABL Kinase Inhibitor Failure . N Engl J Med. 2019; 381(24):2315-2326. doi:10.1056/NEJMoa1902328 Hughes TP, et al. Expanded Phase 1 Study of ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Reveals Significant and Durable Responses in Patients with CML-Chronic Phase with Failure of Prior TKI Therapy. Presented at: ASH Annual Meeting & Exposition; Dec. 5, 2016. Ottmann OG, Alimena G, DeAngelo DJ, et al. ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Exhibits Safety and Promising Single- Agent Activity in a Phase I Study of Patients with CML with Failure of Prior TKI Therapy. Blood. 2015;126(23):138. doi:10.1182/blood.V126.23.138.138 Mauro MJ, Kim DW, Cortes J, et al. Combination of Asciminib Plus Nilotinib (NIL) or Dasatinib (DAS) in Patients (PTS) with Chronic Myeloid Leukemia (CML): Results from a Phase 1 Study. Presented at: EHA Annual Meeting; June 15, 2019. Cortes JE, Lang F, Kim DW, et al. Combination Therapy Using Asciminib Plus Imatinib (IMA) in Patients (PTS) with Chronic Myeloid Leukemia (CML): Results from a Phase 1 Study. Presented at: EHA Annual Meeting; June 15, 2019. Manley PW, Barys L, Cowan-Jacob SW. The specificity of asciminib, a potential treatment for chronic myeloid leukemia, as a myristate-pocket binding ABL inhibitor and analysis of its interactions with mutant forms of BCR-ABL1 kinase. Leuk Res. 2020;98:106458. doi:10.1016/j.leukres.2020.106458 Study of Efficacy of CML-CP Patients Treated with ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs. ClinicalTrials.gov identifier: NCT03106779. Updated February 7, 2024. Accessed April 3, 2024. https://clinicaltrials.gov/ct2/show/NCT03106779 Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and WithoutT315I Mutation (AIM4CML). ClinicalTrials.gov identifier: NCT04666259. Updated September 7, 2023. Accessed April 3, 2024. https://clinicaltrials.gov/ct2/show/NCT04666259 Study of Efficacy And Safety Of Asciminib In Combination With Imatinib In Patients With Chronic Myeloid Leukemia In Chronic Phase (CML-CP). ClinicalTrials.gov identifier: NCT03578367. Updated March 22, 2024. Accessed April 3, 2024. https://clinicaltrials.gov/ct2/show/NCT03578367 Study of Efficacy and Safety of CML-CP Patients Treated With Asciminib Versus Best Available Therapy, Previously Treated With 2 or More Tyrosine Kinase Inhibitors. ClinicalTrials.gov identifier: NCT04795427. Updated October 19, 2023. Accessed April 3, 2024. https://clinicaltrials.gov/ct2/show/NCT04795427 A Phase I Study of Oral ABL001 in Patients With CML or Ph+ ALL. ClinicalTrials.gov identifier: NCT02081378. Updated March 18, 2024. Accessed April 3, 2024. https://clinicaltrials.gov/ct2/show/NCT02081378 Asciminib Treatment Optimization in ≥ 3rd Line CML-CP. ClinicalTrials.gov identifier: NCT04948333. Updated February 28, 2024. Accessed April 3, 2024. https://clinicaltrials.gov/ct2/show/NCT04948333 # # #
By KAREEM CHEHAYEB BEIRUT (AP) — In 2006, after a bruising monthlong war between Israel and Lebanon’s powerful Hezbollah militant group, the United Nations Security Council unanimously voted for a resolution to end the conflict and pave the way for lasting security along the border. But while there was relative calm for nearly two decades, Resolution 1701’s terms were never fully enforced. Now, figuring out how to finally enforce it is key to a U.S.-brokered ceasefire deal approved by Israel on Tuesday. In late September, after nearly a year of low-level clashes , the conflict between Israel and Hezbollah spiraled into all-out war and an Israeli ground invasion . As Israeli jets pound deep inside Lebanon and Hezbollah fires rockets deeper into northern Israel, U.N. and diplomatic officials again turned to the 2006 resolution in a bid to end the conflict. Years of deeply divided politics and regionwide geopolitical hostilities have halted substantial progress on its implementation, yet the international community believes Resolution 1701 is still the brightest prospect for long-term stability between Israel and Lebanon. Almost two decades after the last war between Israel and Hezbollah, the United States led shuttle diplomacy efforts between Lebanon and Israel to agree on a ceasefire proposal that renewed commitment to the resolution, this time with an implementation plan to try to bring the document back to life. In 2000, Israel withdrew its forces from most of southern Lebanon along a U.N.-demarcated “Blue Line” that separated the two countries and the Israeli-annexed Golan Heights, which most of the world considers occupied Syrian territory. U.N. peacekeeping forces in Lebanon, known as UNIFIL , increased their presence along the line of withdrawal. Resolution 1701 was supposed to complete Israel’s withdrawal from southern Lebanon and ensure Hezbollah would move north of the Litani River, keeping the area exclusively under the Lebanese military and U.N. peacekeepers. Up to 15,000 U.N. peacekeepers would help to maintain calm, return displaced Lebanese and secure the area alongside the Lebanese military. The goal was long-term security, with land borders eventually demarcated to resolve territorial disputes. The resolution also reaffirmed previous ones that call for the disarmament of all armed groups in Lebanon — Hezbollah among them. “It was made for a certain situation and context,” Elias Hanna, a retired Lebanese army general, told The Associated Press. “But as time goes on, the essence of the resolution begins to hollow.” For years, Lebanon and Israel blamed each other for countless violations along the tense frontier. Israel said Hezbollah’s elite Radwan Force and growing arsenal remained, and accused the group of using a local environmental organization to spy on troops. Lebanon complained about Israeli military jets and naval ships entering Lebanese territory even when there was no active conflict. “You had a role of the UNIFIL that slowly eroded like any other peacekeeping with time that has no clear mandate,” said Joseph Bahout, the director of the Issam Fares Institute for Public Policy at the American University of Beirut. “They don’t have permission to inspect the area without coordinating with the Lebanese army.” UNIFIL for years has urged Israel to withdraw from some territory north of the frontier, but to no avail. In the ongoing war, the peacekeeping mission has accused Israel, as well as Hezbollah , of obstructing and harming its forces and infrastructure. Hezbollah’s power, meanwhile, has grown, both in its arsenal and as a political influence in the Lebanese state. The Iran-backed group was essential in keeping Syrian President Bashar Assad in power when armed opposition groups tried to topple him, and it supports Iran-backed groups in Iraq and Yemen. It has an estimated 150,000 rockets and missiles, including precision-guided missiles pointed at Israel, and has introduced drones into its arsenal . Hanna says Hezbollah “is something never seen before as a non-state actor” with political and military influence. Israel’s security Cabinet approved the ceasefire agreement late Tuesday, according to Prime Minister Benjamin Netanyahu’s office. The ceasefire is set to take hold at 4 a.m. local time Wednesday. Efforts led by the U.S. and France for the ceasefire between Israel and Hezbollah underscored that they still view the resolution as key. For almost a year, Washington has promoted various versions of a deal that would gradually lead to its full implementation. International mediators hope that by boosting financial support for the Lebanese army — which was not a party in the Israel-Hezbollah war — Lebanon can deploy some 6,000 additional troops south of the Litani River to help enforce the resolution. Under the deal, an international monitoring committee headed by the United States would oversee implementation to ensure that Hezbollah and Israel’s withdrawals take place. It is not entirely clear how the committee would work or how potential violations would be reported and dealt with. The circumstances now are far more complicated than in 2006. Some are still skeptical of the resolution’s viability given that the political realities and balance of power both regionally and within Lebanon have dramatically changed since then. “You’re tying 1701 with a hundred things,” Bahout said. “A resolution is the reflection of a balance of power and political context.” Now with the ceasefire in place, the hope is that Israel and Lebanon can begin negotiations to demarcate their land border and settle disputes over several points along the Blue Line for long-term security after decades of conflict and tension.
Taxation has long been a sensitive issue in Nigeria. With a system that’s often criticised as complex, inefficient, and inequitable and has left many citizens feeling burdened and frustrated. Widespread tax evasion, poor compliance, and a general lack of trust in the system have only deepened the divide between the government and the people. But President Bola Tinubu is looking to change that. Two months ago, he introduced four tax reform bills to the National Assembly: the Nigeria Tax Bill 2024, the Tax Administration Bill, the Nigeria Revenue Service Establishment Bill, and the Joint Revenue Board Establishment Bill. The goal of these reforms, as Segun Onagoruwa, Managing Partner at Vertex Consulting Limited, explains, is to create a tax system that works for everyone. According to Onagoruwa, “The new tax reforms represent a bold and comprehensive step toward creating a system that works for everyone. From individuals who benefit from higher allowances and lower tax burdens to businesses that receive support for growth and from the federal government’s potential to increase revenue to regions and local governments that are incentivised to develop economically, these reforms promise a more inclusive and progressive future.” But as the bills make their way through the National Assembly, one question persists: Who will win, who could lose, and how will this affect the average Nigerian? To answer these questions, we spoke with Onagoruwa, a tax policy expert with over 17 years of experience, who explained the proposed changes and what they mean for individuals and businesses across the country. Onagoruwa explains that these reforms offer real benefits to everyday Nigerians. The most significant change for many people will be the reduction in Personal Income Tax (PIT), which applies to salaries, wages, and rental income. By raising the tax-free threshold, more people will be exempt from paying PIT altogether, putting more money in their pockets. For example, if you earn below a certain threshold—say, N30,000 per month—you will no longer pay PIT. This means less money is taken out of your salary, leaving more to spend on daily expenses or save for the future. “The reforms propose raising this threshold, allowing more low-income workers to fall within the tax-exempt category. Everyday workers earning below the new threshold will retain more of their earnings. It will reduce financial stress on low-income earners, increasing disposable income for essential needs.” In addition to this, the new reforms will simplify the tax bands, making the system more progressive. This means that high-income earners will pay a higher share of taxes, while middle- and low-income earners will pay less. Onagoruwa adds: “Nigeria’s tax bands include rates ranging from 7% to 24% for different income brackets. The reforms propose fewer, clearer tax bands with adjusted rates to ensure higher earners pay more while middle- and low-income earners face lower rates.” While many Nigerians will see their tax burdens ease, high-income earners may not fare as well. The new progressive taxation system means that wealthier individuals will contribute a larger share. However, low- and middle-income earners stand to gain the most. “The tax reforms aim to alleviate the burden on low and middle-income earners by raising the tax threshold and introducing progressive income tax rates. With the introduction of a new tax band and increased personal allowances, more Nigerians will be taxed less or not at all, leading to greater disposable income and financial relief,” says Onagoruwa. Onagoruwa also pointed out that the proposed tax reform bill could help reduce the everyday costs for average Nigerians. One of the main changes is that more essential items will be exempt from VAT (Value Added Tax). This is a major win for families, especially those on low budgets. “Everyday items such as rice, beans, garri, and basic healthcare products may become cheaper as VAT is no longer applied. Families with tight budgets will benefit from reduced costs for essentials, improving their overall standard of living,” Onagoruwa explains. Currently, VAT is charged at 7.5% on most goods and services, with only a few essentials being exempt. The new tax bill will expand the list of VAT-exempt items, which could make basic goods and medicines more affordable for Nigerians. “Locally made goods may become more affordable due to tax reliefs, encouraging citizens to buy Nigerian products. A boost in local production can stabilize prices, reduce import dependency, and support job creation, indirectly benefiting households.” The reforms also aim to support local businesses. By offering tax breaks on locally produced products, the government hopes to encourage Nigerians to buy more local goods. This could help boost local industries, reduce reliance on imports, and create jobs. “Locally made goods may become more affordable due to tax reliefs, encouraging citizens to buy Nigerian products. A boost in local production can stabilize prices, reduce import dependency, and support job creation, indirectly benefiting households,” says Onagoruwa. The VAT rate itself will remain unchanged, which means there won’t be any immediate price hikes for everyday goods. Instead, the government plans to target luxury goods and non-essential items to raise revenue. This ensures that low-income earners won’t face higher prices for basic goods. “The stability in the VAT rate ensures no immediate increase in the cost of goods and services for the average citizen. The government’s focus on widening the tax base (e.g., taxing more luxury goods) rather than raising rates protects low-income earners from additional financial burdens,” Onagoruwa adds. The reforms also bring good news for small and medium-sized businesses (SMEs). A key part of the reforms is the increase in the turnover threshold for Corporate Income Tax (CIT) exemptions. Businesses with turnovers below ₦50 million (up from ₦25 million) will be exempt from CIT. “This change is expected to free up resources for smaller businesses, enabling them to reinvest in growth,” Onagoruwa says. Medium-sized businesses (those with turnovers between ₦25 million and ₦100 million) will also benefit from reduced CIT rates, making it easier for them to expand operations. Larger businesses will see a gradual reduction in CIT rates from 30% to 25% over the next two years. “The revised tax rates in the new bill aim to strike a balance between revenue generation and economic growth. For individuals, the changes reduce the burden on low- and middle-income earners while promoting equity through progressive taxation. For companies, lower CIT rates encourage investment and compliance, particularly in strategic sectors. These reforms create a tax environment that is fairer, more efficient, and supportive of Nigeria’s economic development goals.” While the proposed tax reforms offer potential benefits, Onagoruwa cautions that their success will depend heavily on how effectively they are implemented. He notes that the reforms could improve everyday life for Nigerians if they lead to increased government revenue, which is then properly allocated. “If the tax reforms lead to increased government revenue and these funds are efficiently allocated, they can improve infrastructure, healthcare, and education, reducing out-of-pocket expenses for citizens,” Onagoruwa said. However, he also points out that there are risks associated with the reforms, particularly when it comes to businesses. For instance, he explains that new taxes or higher rates—such as those on VAT or excise duties—might cause businesses to pass those costs onto consumers, ultimately raising the prices of goods and services. “The extent to which the reforms alleviate or exacerbate the rising cost of living depends on their design, implementation, and the government’s commitment to addressing systemic inefficiencies,” Onagoruwa explained. “If well-executed, the reforms could lay a foundation for long-term economic stability and reduced costs. However, without mitigating measures, they risk exacerbating financial pressures on Nigerians, particularly the poor and middle class.” Another concern Onagoruwa raises is the potential impact of digital services taxes, which could make online subscriptions, e-commerce, and other digital services more expensive for Nigerians. As many people rely on these services for everyday needs, any increase in cost could put additional strain on household budgets. Onagoruwa also observes that Nigeria’s tax reforms are largely in line with global and African trends, particularly in expanding the tax base and targeting the digital economy. However, he stresses that there are areas where the reforms could be improved. “Nigeria’s tax reforms align broadly with global and African trends, particularly in expanding the tax base and targeting the digital economy. However, there are areas where it could improve, such as ensuring equity, simplifying tax compliance, and providing adequate social protections,” he noted. Onagoruwa suggests that lessons could be drawn from countries like Rwanda, South Africa, and India, which have made strides in technology adoption, equity in taxation, and simplifying tax compliance, respectively. He believes these lessons could make the reforms more effective and increase public acceptance. As the bills continue to be debated, there are calls for broader consultations with various stakeholders. Will Tinubu’s tax reform bill live up to its promise? Like Onagoruwa said, only time and execution will tell. But for now, he did advise Nigerians to prepare for the changes ahead, stating, “Preparation for the Nigerian Tax Bill, 2024, requires proactive education, planning, and adaptation by both citizens and businesses.”. “By leveraging available resources, staying compliant, and advocating for transparency, individuals and organisations can not only mitigate the impact of the reforms but also position themselves to take advantage of opportunities the changes might create.
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