Representatives from the Chamber of Technology visited President-elect John Dramani Mahama on Tuesday to congratulate him on his victory in the 2024 presidential election. The delegation also expressed its readiness to collaborate with Mahama’s incoming administration to leverage technology for the advancement of Ghana’s economic and social objectives, emphasizing the importance of supporting and empowering local technology firms to drive the sector forward. Kofi Owusu-Nhyira, speaking on behalf of the Chamber, commended Mahama for his longstanding support of the technology sector. He highlighted several key initiatives implemented under Mahama’s leadership, including the establishment of the National Communication Authority (NCA) Headquarters, the rural fiber network from Accra to Bawku, the Accra Digital Centre, and significant projects like e-Justice, e-Health, and the e-payment gateway. These initiatives, Owusu-Nhyira said, laid a solid foundation for Ghana’s digital transformation and demonstrated Mahama’s understanding of the sector’s transformative potential. The Chamber also expressed its appreciation for the technology-focused proposals in Mahama’s manifesto, including the establishment of a $50 million fintech fund to support innovation and growth within the sector. Owusu-Nhyira further suggested the creation of a private equity fund on a merit-based system to aid technology businesses, along with other initiatives aimed at fostering inclusive development and bridging the technological gender gap. Sam George, Member of Parliament for Ningo-Prampram and the digital/ICT policy lead for Mahama’s manifesto team, underscored the President-elect’s commitment to inclusive technology initiatives. He cited the affirmative action bill and programs like ICT skills training for girls as examples of Mahama’s focus on equitable opportunities. George also emphasized the vital role technology would play in achieving a 24-hour economy, crucial to Ghana’s economic recovery and long-term growth. In his response, Mahama expressed gratitude for the Chamber’s congratulations and the constructive proposals presented. He acknowledged the importance of building upon the work already done in the technology sector and reaffirmed his administration’s commitment to fostering innovation across all sectors. Mahama emphasized that his government would work closely with industry stakeholders to ensure regulatory frameworks support technological growth while safeguarding the welfare of Ghanaians. The President-elect assured the Chamber of regular engagements to ensure technology remains a central pillar in Ghana’s development, both economically and socially. The meeting concluded with a shared enthusiasm for the future of Ghana’s technology sector as a key driver of economic and social transformation.
A Russian District Military Court on Friday anti-war activist and former Moscow municipal deputy Aleksei Gorinov to an additional three years in prison, according to local media. The court found Gorinov guilty of “justifying terrorism” and ordered him to serve his sentence in a stricter prison facility than the one he is currently in. Gorinov had been convicted of spreading false information in 2022 and was already serving a seven-year sentence for that conviction. The new charges stemmed from Gorinov’s conversations with fellow inmates at a prison hospital. According to investigators, Gorinov spoke favorably about the Crimean Bridge explosion and groups designated as terrorist organizations in Russia. Justifying terrorism is punishable under Article 205 of the . Gorinov, however, vehemently denied these claims, stating that he was provoked into political discussions and that his comments were misrepresented. Defense lawyer Alena Savelyeva argued that the evidence, including audio recordings and identical witness statements from inmates, was obtained through provocation and lacked credibility. Savelyeva pointed out that Gorinov’s conversations, recorded secretly over nearly 14 hours, resulted in charges based on just 14 words. Linguist Elena Novozhilova, testifying for the defense, concluded that Gorinov did not justify terrorism. She stated that the conversations were deliberately instigated by other inmates. Despite these arguments, the court dismissed motions to exclude the contentious evidence. In his final statement, Gorinov reaffirmed his anti-war stance, condemning Russia’s invasion of Ukraine as a catastrophic mistake. He criticized the political system for targeting peaceful dissenters while ignoring the real architects of violence and destruction. He that his guilt was that he, as a Russian citizen, allowed the war to happen and was unable to stop it. He added that he wanted his responsibility to be shared by those who support the war and those who persecute advocates of peace. Human rights organizations have decried the sentence as politically motivated. Amnesty International’s Russia Director Natalia Zviagina the ruling “outrageous” and a stark reminder of the Kremlin’s efforts to silence opposition. She stated that “Gorinov’s ongoing persecution reflects the ruthlessness of political reprisals in Russia” and urged authorities to release him and respect the right to free expression. South Africa becomes first country on continent to legalize same-sex marriage Same-sex marriages became legal in South Africa on November 30, 2006 as the country's Civil Union Act, 2006 went into effect, making South Africa the only country on the African continent to legalize same-sex marriage. the Civil Union Act, 2006. Justice Samuel Chase impeached On November 30, 1804, US Supreme Court Justice went on trial in the Senate for "arbitrary and oppressive conduct of trials." He was acquitted in March 1805.Read a C-SPAN on his 1992 book . Review a chronological list of .Trump encounters Senate GOP limits with failed Gaetz AG push
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After-hours movers: Marvell Technology, Salesforce, Okta and moreInvesting in growth stocks is the best method to grow your wealth so that you are better prepared for retirement . By allocating your money to such stocks, you can enjoy steady capital gains and see the value of your investment portfolio grow over time. To achieve this, you need to select companies that have strong competitive moats and a track record of increasing their revenue and free cash flows. These businesses should also possess catalysts and/or sustainable tailwinds that can take them to the next level. Here are four promising US growth stocks that can help to lift the value of your investment portfolio. Atlassian provides a cloud computing platform to help teams to organise, discuss, and collaborate on their work tasks. With the company’s software, its customers can better manage their time, become more productive, and deliver quality results. Atlassian reported a strong set of earnings for its fiscal 2024 (FY2024) ending 30 June 2024. Total revenue climbed 23.3% year on year to US$4.4 billion while gross profit increased by 22.6% year on year to US$3.6 billion. The business also churned out copious levels of free cash flow to the tune of US$1.4 billion for FY2024, up an impressive 68% year on year. The collaborative software maker’s good results have continued into the first quarter of fiscal 2025 (1Q FY2025). Total revenue jumped 21.5% year on year to US$1.2 billion while gross profit improved by 21.3% year on year to US$970.2 million. Once again, Atlassian churned out a positive free cash flow of US$74.3 million for the quarter. Customers are also spending more with Atlassian – those with more than US$10,000 in cloud annual recurring revenue jumped 17% year on year to 46,844 for 1Q FY2025. Management continues to innovate, recently releasing Rovo, its newest AI-powered product featuring features such as advanced enterprise search capabilities, and agents to help solve complex problems and handle repetitive tasks. Microsoft is a trillion-dollar software and hardware manufacturer that is famous for its Microsoft 365 suite of applications that includes Microsoft Word, Excel, and Powerpoint. The company also owns business networking site LinkedIn and offers cloud computing services for businesses. Microsoft reported a stellar set of earnings for FY2024 as its revenue jumped 15.7% year on year to US$245.1 billion. Operating and net profit rose 23.6% and 21.8% year on year, respectively, to US$109.4 billion and US$88.1 billion. The software company also generated a positive free cash flow of US$74.1 billion for FY2024, up nearly 25% year on year. AI-driven demand is changing how organisations work, and Microsoft is leaning on this trend to expand its opportunity set and garnering new customers in the process. For 1Q FY2025, Microsoft’s momentum has continued as the Redmond-based company posted a 16% year-on-year revenue increase to US$65.6 billion. Net profit increased by 10.7% year on year to US$24.7 billion while free cash flow generated amounted to US$19.3 billion. Its Microsoft 365 commercial products and cloud revenue increased by 13% year on year while LinkedIn revenue increased by 10% year on year. DocuSign is a digital signature company that allows its customers to seal contracts and documentation conveniently and securely. The company has over 1.6 million customers with more than a billion people in 180 countries using its solutions. The business reported a commendable set of earnings for the first nine months of fiscal 2025 (9M FY2025) ending 31 October 2024. Revenue increased by 7.4% year on year to US$2.2 billion while operating profit jumped more than sixfold year on year to US$139.5 million. DocuSign received a large tax credit that boosted its net profit to US$984.4 million, or around 21 times higher than the US$46.7 million of profit booked in the prior year. Free cash flow also came in strong at US$640.7 million, fairly constant against the US$638.6 million churned out a year ago. The business saw billings grow by 9% year on year to US$752 million for the third quarter of fiscal 2025 (3Q FY2025). Management believes that it is the market leader with a large untapped opportunity. The total addressable market for digital signatures stands at US$50 billion, offering DocuSign significant opportunities to grow its top and bottom lines. Snowflake runs a data cloud that helps organisations to unite siloed data and execute analytics to discover insights. The data cloud also helps to create solutions for applications, collaboration, data engineering, and cybersecurity, among others. For 9M FY2025, revenue shot up nearly 30% year on year to US$2.6 billion while gross profit increased by almost 28% year on year to US$1.8 billion. The business also churned out a positive free cash flow of US$468.6 million for 9M FY2025, up 10% year on year. Snowflake saw total customers increased by 20.3% year on year to 10,618 for 3Q FY2025. Of this number, Forbes Global 2,000 customers grew by around 7% year on year to 754. Also, customers with over US$1 million in product revenue climbed 25% year on year to 542 for the latest quarter. Snowflake believes that its total addressable market will more than double in just five years, going from US$152 billion in 2023 to US$342 billion by 2028. With this growing market, investors should feel confident that the business can continue to grow its top lines and generate higher free cash flow. Dive into the future of technology with our newest FREE report, “The Rise of Titans.” Discover how the big 7 US tech stocks can be your ticket to huge long-term gains. Download your copy today and see how easy it is to supercharge your portfolio. Follow us on Facebook and Telegram for the latest investing news and analyses! Disclosure: Royston Yang does not own shares in any of the companies mentioned. The post 4 US Growth Stocks to Supercharge Your Investment Portfolio appeared first on The Smart Investor .
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Drone sightings leadChinese President Xi Jinping will preside over a day of celebrations in Macau and inaugurate the city's new leader on Friday to mark 25 years since the former colony was returned to China. Macau is regarded by China as a shining example of its "One Country, Two Systems" model, and Xi praised the city as a "pearl in the nation's palm" at the start of his three-day visit. The Chinese casino hub has grown from a Portuguese trading outpost to the world's casino capital by gaming revenue and a popular destination for Chinese tourists. When Macau reverted to Chinese rule on December 20, 1999, Beijing promised that the city's "capitalist system and way of life shall remain unchanged for 50 years". Arriving in the city on Wednesday, Xi lauded Macau's "world-recognised success" in implementing the "One Country, Two Systems" framework and said the city had a bright future. "Macau is a pearl in the nation's palm, and I have always kept in my thoughts its development and the welfare of all its people," Xi said. The Chinese president added that he would use his trip for "extensive and in-depth exchanges with our friends from all places, and discuss plans for Macau's development". Friday's festivities will be centred around the inauguration of Sam Hou-fai, the former president of Macau's apex court, as the city's fourth post-handover leader, replacing Ho Iat-seng. Security was tight around the city on Thursday, with roadblocks set up around an event venue and authorities increasing checks on inbound visitors. - Casino hub - Following the end of 442 years of Portuguese rule, Macau's fortunes have risen in lockstep with China's economic growth. It is the only place in China where casino gambling is permitted and has long surpassed Las Vegas as the world's top casino hub, fuelled by two decades of Chinese visitor spending. Macau, which has a resident population of 687,000, saw just over 29 million visitor arrivals in the first 10 months of the year. Its GDP has soared from $6.4 billion in 1999 to more than $47 billion last year, and its population is the richest in China on a per capita basis. Under orders from Beijing to diversify the economy, Macau leaders have proposed fields such as financial services, technology and Chinese medicine as new economic drivers. But as of November, gaming-related taxes still made up 81 percent of government revenue and experts say Macau is years away from weaning itself off casino wealth. Xi on Thursday visited the Macau University of Science and Technology and was "briefed on the development of two state-level key laboratories" that involved Chinese medicine and planetary science, according to state news agency Xinhua. He also visited the Guangdong-Macao In-Depth Cooperation Zone on Hengqin Island, speaking to residents and people there in charge of planning, construction, management and services, Xinhua reported. Hengqin Island, a landmass adjacent to Macau and three times its size, was partly leased by Beijing to Macau to boost its land supply for non-gaming development. hol/oho/scoUC SAN DIEGO 73, JAMES MADISON 67
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enGene Holdings Inc. (Nasdaq: ENGN, or “enGene” or the “Company”), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid, (also known as detalimogene, and previously EG-70), is in an ongoing pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), announced its financial results for the full year ended October 31, 2024 and provided a business update. “Having demonstrated a 71% anytime complete response rate in the preliminary data from the LEGEND study’s pivotal cohort of BCG-unresponsive NMIBC patients, initiated three additional NMIBC patient cohorts, and raised an additional $60 million in funding, enGene is in a strong clinical and financial position as we close the year,” said Ron Cooper, Chief Executive Officer of enGene. “With trial recruitment open across all cohorts, the profile of detalimogene continues to become clearer and stronger and, with the protocol enhancements now in place, we look forward to sharing LEGEND study updates across all cohorts expected in the second half of 2025.” In September 2024, the Company announced preliminary data from 21 patients assessed at three months, including 17 patients who were also assessed at six months, in the ongoing pivotal cohort of the LEGEND study. The Complete Response (CR) rate at any time was 71%, the CR rate at three months was 67% and the CR rate at six months was 47%. Detalimogene was generally well-tolerated by patients and no patients discontinued due to treatment-related adverse events. In addition to reporting preliminary clinical data from LEGEND’s pivotal cohort, the Company has implemented protocol changes that affect how disease is managed throughout the trial as well as the criteria for study discontinuation. The Company believes the revised LEGEND protocol better aligns with current treatment standards and real-world practice. enGene initiated recruitment across three additional cohorts of NMIBC patients, including Cohort 2a and 2b (i.e., NMIBC patients with CIS who are naïve to treatment with BCG and NMIBC patients with CIS who have been exposed to BCG, but have not received adequate BCG treatment), and Cohort 3 (BCG-unresponsive high-risk NMIBC patients with papillary-only disease). The above-mentioned amendment to the LEGEND protocol also allows patients from any cohort who are in complete response at 12 months to continue receiving detalimogene on a dose-reduced maintenance schedule throughout their second year of treatment. At the end of year two, patients may optionally elect to remain on maintenance therapy for another year, for a total of three years of therapy. Maintenance treatment will consist of two instillations of detalimogene per three-month cycle, administered at week 1 and at week 2 of each cycle. The Company believes this could provide further evidence of the long-term benefit of detalimogene, with the dose-reduced maintenance regimen lessening the burden of frequent urology visits for instillations. The LEGEND study was selected for inclusion in the SUO-CTC, a U.S. and Canadian-based organization with over 250 trial sites dedicated to the successful enrollment and conduct of clinical trials for their patients with urologic cancers. In October 2024, the Company announced the appointment of Joan Connolly, a seasoned technical operations leader with more than 30 years’ experience, as Chief Technology Officer (CTO) and member of the corporate leadership team. enGene Co-Founder and former CTO, Anthony Cheung, Ph.D., transitioned to the role of Chief Scientific Officer, while Alex Nichols, Ph.D., previously the Chief Operating Officer, was appointed Chief Strategy and Operations Officer. As of October 31, 2024, cash, cash equivalents and marketable securities were $297.9 million. The Company expects that its existing cash and cash equivalents will fund operating expenses, debt obligations and capital expenditures into 2027. Total operating expenses were $62.3 million for the full year ended October 31, 2024, compared to $26.1 million for 2023. Research and development expenses increased by $21.9 million, mainly due to increasing manufacturing and clinical costs related to our LEGEND study and headcount costs. General and administrative expenses increased by $14.4 million, primarily driven by headcount costs and professional fees and other expenses as the Company scales its general and administrative function to support the operation of a public company. For the full year ended October 31, 2024, net loss attributable to common shareholders was approximately $55.1 million, or $1.46 per share, compared to approximately $104.7 million, or $151.22 per share, for the full year 2023. The decrease in net loss is mainly attributed to other expenses incurred in 2023 related to convertible debentures and warrants, partially offset by the increase in operating expenses during 2024. enGene is a clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is detalimogene voraplasmid (also known as detalimogene, and previously EG-70) for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) – a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 study, which includes a registrational cohort studying detalimogene in Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS). Detalimogene was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. For more information, visit . Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements regarding enGene’s management teams’ expectations, hopes, beliefs, intentions, goals or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “intends”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: the timing and anticipated results of our current and future clinical trials, including preliminary results, beliefs as to the timing and anticipated results of the LEGEND study, including the timing of preliminary data or other updates, the timing of our planned BLA submission to the Food and Drug Administration, the anticipated uses of our cash and cash equivalents, the potential benefits of detalimogene, and the expected period over which we estimate our cash and cash equivalents will be sufficient to fund our current operating plan . Many factors, risks, uncertainties and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the Company’s ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and enroll patients in its clinical trials, execute on the Company’s clinical development plans and ability to secure regulatory approval on anticipated timelines, and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2024 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov). You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. For media contact: For investor contact:CARLSBAD, Calif. , Dec. 19, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZATM (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare, genetic form of severe hypertriglyceridemia (sHTG) that can lead to potentially life-threatening acute pancreatitis (AP). TRYNGOLZA is the first-ever FDA-approved treatment that significantly and substantially reduces triglyceride levels in adults with FCS and provides clinically meaningful reduction in AP events when used with an appropriate diet (≤20 grams of fat per day). TRYNGOLZA is self-administered via an auto-injector once monthly. Experience the full interactive Multichannel News Release here: https://www.multivu.com/ionis-pharmaceuticals/9295551-en-tryngolza-olezarsen-fda-approval "Today's FDA approval of TRYNGOLZA heralds the arrival of the first-ever FCS treatment in the U.S. – a transformational moment for patients and their families. For the first time, adults with FCS can now access a treatment that substantially reduces triglycerides and the risk of debilitating and potentially life-threatening acute pancreatitis," said Brett P. Monia , Ph.D., chief executive officer, Ionis. "We are proud of our long-standing partnership with the FCS community and are grateful to the patients, families and investigators who participated in our clinical studies, enabling Ionis to make this new treatment a reality. The FDA approval of TRYNGOLZA is also a pivotal moment for Ionis, representing our evolution into a fully integrated commercial-stage biotechnology company – a goal we set out to achieve five years ago. With our rich pipeline of potentially life-changing medicines, we expect TRYNGOLZA to be the first in a steady cadence of innovative medicines we will deliver independently to people living with serious diseases." The FDA approval was based on positive data from the global, multicenter, randomized, placebo-controlled, double-blind Phase 3 Balance clinical trial in adult patients with genetically identified FCS and fasting triglyceride levels ≥880 mg/dL. In the Balance study, TRYNGOLZA 80 mg demonstrated a statistically significant placebo-adjusted mean reduction in triglyceride levels of 42.5% from baseline to six months (p=0.0084). Reductions from baseline to 12 months were further improved, with TRYNGOLZA achieving a placebo-adjusted 57% mean reduction in triglycerides. TRYNGOLZA also demonstrated a substantial, clinically meaningful reduction in AP events over 12 months; one patient (5%) experienced one episode of AP in the TRYNGOLZA group compared with seven patients (30%) who experienced 11 total episodes of AP in the placebo group. TRYNGOLZA demonstrated a favorable safety profile. The most common adverse reactions (incidence >5% of TRYNGOLZA-treated patients and at a >3% higher frequency than placebo) were injection site reactions (19% and 9%, respectively), decreased platelet count (12% and 4%, respectively) and arthralgia (9% and 0%, respectively). Results from the Phase 3 Balance study were previously published in The New England Journal of Medicine (NEJM). "With no treatment options previously available, we were limited to relying only on extremely strict diet and lifestyle changes as the sole preventative treatment option," said Alan Brown , M.D., FNLA, FACC, FAHA, clinical professor of medicine, Rosalind Franklin University of Medicine and Science ; Balance trial investigator. "The FDA approval of TRYNGOLZA is an important moment for people living with FCS, their families and physicians who now, for the first time, have a treatment that significantly lowers triglycerides and decreases the risk of potentially life-threatening acute pancreatitis events, as an adjunct to a low-fat diet. I am excited to have a medicine I can prescribe to my patients that has been shown to change the course of their disease." FCS is a rare, genetic, potentially life-threatening form of sHTG that prevents the body from breaking down fats and severely impairs the body's ability to remove triglycerides from the bloodstream due to an impaired function of the enzyme lipoprotein lipase (LPL). While healthy levels for adults are below 150 mg/dL, people with FCS often have triglyceride levels of more than 880 mg/dL and often have a history of pancreatitis. Those living with FCS have a high risk of potentially fatal AP, which is a painful inflammation of the pancreas, and chronic health issues such as fatigue and severe, recurrent abdominal pain. People living with FCS can also experience psychological and financial stress, which can significantly impact their quality of life. In the U.S., FCS is estimated to impact up to approximately 3,000 people, the vast majority of whom remain undiagnosed. "As a rare and difficult to diagnose disease, FCS has a profound impact on the lives of patients and families. Many people living with FCS have experienced severe pain their whole lives – sometimes so intense they require lengthy hospitalization stays – and struggle through life with daily fatigue, nausea, brain fog and stomach pain," said Lindsey Sutton Bryan , co-founder and co-president, FCS Foundation. "Until now, our treatment options have been limited, relying on diet alone to try to manage triglyceride levels and keep acute pancreatitis attacks at bay. For the first time, adults with FCS have seen their hope for a treatment become a reality." TRYNGOLZA will be available in the U.S. before year end. Ionis is committed to helping people access the medicines they are prescribed and will offer a suite of services designed to meet the unique needs of the FCS community through Ionis Every StepTM. As part of Ionis Every Step , patients and healthcare providers will have access to services throughout the treatment journey provided by dedicated Patient Education Managers and Ionis Every Step Case Managers, including insurance and affordability support, as well as services and resources, such as disease and nutrition education. Visit TRYNGOLZA.com for more information. TRYNGOLZA was reviewed by the FDA under Priority Review and had previously been granted Fast Track designation for the treatment of FCS, Orphan Drug designation and Breakthrough Therapy designation. Olezarsen is undergoing review in the European Union and regulatory filings in other countries are planned. Olezarsen is currently being evaluated in three Phase 3 clinical trials – CORE, CORE2 and ESSENCE – for the treatment of sHTG. Olezarsen has not been reviewed or approved for the treatment of sHTG by regulatory authorities. Webcast Ionis will hold a webcast today at 6:45pm ET to discuss the FDA approval. Interested parties may access the webcast here . A webcast replay will be available for a limited time. About TRYNGOLZATM (olezarsen) TRYNGOLZATM (olezarsen) was approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). TRYNGOLZA is an RNA-targeted medicine designed to lower the body's production of apoC-III, a protein produced in the liver that is a key regulator of triglyceride metabolism. It is the only treatment currently indicated in the U.S. for FCS, a potentially life-threatening disease. For more information about TRYNGOLZA, visit TRYNGOLZA.com . IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to TRYNGOLZA or any of the excipients in TRYNGOLZA. Hypersensitivity reactions requiring medical treatment have occurred. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills and myalgias) have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur. ADVERSE REACTIONS The most common adverse reactions (incidence >5% of TRYNGOLZA-treated patients and >3% higher frequency than placebo) were injection site reactions, decreased platelet count and arthralgia. Please see full Prescribing Information for TRYNGOLZA. About Familial Chylomicronemia Syndrome (FCS) FCS is a rare, genetic disease characterized by extremely elevated triglyceride levels. It is caused by impaired function of the enzyme lipoprotein lipase (LPL). Because of limited LPL production or function, people with FCS cannot effectively break down chylomicrons, lipoprotein particles that are 90% triglycerides. FCS is estimated to impact up to approximately 3,000 people in the U.S. People living with FCS are at high risk of acute pancreatitis (AP) in addition to other chronic health issues such as fatigue and severe, recurrent abdominal pain. People living with FCS are sometimes unable to work, adding to the burden of disease. About the Balance Study Balance is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of olezarsen in patients with FCS at six and 12 months. The primary endpoint was the percent change from baseline in fasting triglyceride levels at six months compared to placebo. Secondary endpoints included percent changes in triglyceride levels at 12 months, percent changes in other lipid parameters and adjudicated acute pancreatitis event rates over the treatment period. Following treatment and the end-of-trial assessments, patients were eligible to enter an open-label extension study to continue receiving olezarsen once every four weeks. About Ionis Pharmaceuticals, Inc. For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis has discovered and developed six marketed medicines for serious diseases, including breakthrough medicines for neurologic and cardiovascular diseases. Ionis has a leading pipeline in neurology, cardiology and other areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit Ionis.com and follow us on X (Twitter) , LinkedIn and Instagram . Ionis Forward-Looking Statements This press release includes forward-looking statements regarding Ionis' business and the therapeutic and commercial potential of TRYNGOLZA, Ionis' technologies and other products in development. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including but not limited to those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended Dec. 31, 2023 , and most recent Form 10-Q, which are on file with the SEC. Copies of these and other documents are available at www.Ionis.com . Ionis Pharmaceuticals® and TRYNGOLZATM are trademarks of Ionis Pharmaceuticals, Inc. Ionis Investor Contact: D. Wade Walke , Ph.D. info@ionis.com 760-603-2331 Ionis Media Contact: Hayley Soffer media@ionis.com 760-603-4679 View original content: https://www.prnewswire.com/news-releases/tryngolza-olezarsen-approved-in-us-as-first-ever-treatment-for-adults-living-with-familial-chylomicronemia-syndrome-as-an-adjunct-to-diet-302336747.html SOURCE Ionis Pharmaceuticals, Inc.The NFL suspended Tennessee Titans safety Julius Wood six games on Tuesday for violating the policy on performing-enhancing substances. There are five games remaining this season for the Titans (3-9), so Wood's suspension will bleed into Week 1 of 2025. Javascript is required for you to be able to read premium content. Please enable it in your browser settings. Stacker analyzed data from the National Retail Federation, NielsenIQ, and other sources to see how gifting is becoming greener this holiday season. Click for more. How to shop greener for the holidays. Tips for eco-conscious gifters of all levels.
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