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Maher urges Americans to 'not let politics f--- up the holidays': Shouldn't 'cut people off' for Trump win
Phio Pharmaceuticals Announces $1.15 Million Registered Direct Offering Priced At-the-Market Under Nasdaq RulesCARLSBAD, 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.Villaggio Italia beckons visitors at Old Doha Port
Hannah, Montgomery lead Bradley to 81-75 OT win over ValparaisoNEW YORK (AP) — U.S. stock indexes drifted lower in the runup to the highlight of the week for the market, the latest update on inflation. The S&P 500 slipped 0.3% Tuesday and marked its first back-to-back losses in three weeks. The Dow Jones Industrial Average fell 0.3%, and the Nasdaq composite also fell 0.3%. Oracle dragged on the market after reporting weaker growth than analysts expected. Treasury yields rose in the bond market ahead of Wednesday’s inflation report, which will be among the final big pieces of data before the Federal Reserve’s meeting on interest rates next week. THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below. NEW YORK (AP) — U.S. stock indexes are drifting lower Tuesday in the runup to the highlight of the week for the market, the latest update on inflation that’s coming on Wednesday. The S&P 500 dipped by 0.2% in late trading, a day after pulling back from its latest all-time high . The index is on track for its first back-to-back losses in more than three weeks, as momentum slows following a big rally that has it on track for one of its best years of the millennium . The Dow Jones Industrial Average was down by 7 points, or less than 0.1%, with roughly an hour remaining in trading, and the Nasdaq composite fell 0.3%. Tech titan Oracle dragged on the market and sank 7.8% after reporting growth for the latest quarter that fell just short of analysts’ expectations. It was one of the heaviest weights on the S&P 500, even though CEO Safra Catz said the company saw record demand related to artificial-intelligence technology for its cloud infrastructure business, which trains generative AI models. AI has been a big source of growth that’s helped many companies’ stock prices skyrocket. Oracle’s stock had already leaped nearly 81% for the year coming into Tuesday, which raised the bar of expectations for its profit report. C3.ai fell 2.1% despite reporting a smaller loss for the latest quarter than analysts expected. The AI software company increased its forecast for how big a loss it expects to take this fiscal year from its operations. In the bond market, Treasury yields ticked higher ahead of Wednesday’s report on the inflation that U.S. consumers are feeling. Economists expect it to show roughly similar increases as the month before. That and a report on Thursday about inflation at the wholesale level will be the final big pieces of data the Federal Reserve will get before its meeting next week, where many investors expect the year’s third cut to interest rates . The Fed has been easing its main interest rate from a two-decade high since September to lift the slowing jobs market, after bringing inflation nearly down to its 2% target. Lower rates would help give support to the economy, but they could also provide more fuel for inflation. The yield on the 10-year Treasury rose to 4.22% from 4.20% late Monday. Even though the Fed has been cutting its main interest rate, mortgage rates have been more stubborn and have been volatile since the autumn. That has hampered the housing industry, and homebuilder Toll Brothers’ stock fell 5.2% even though it beat analysts’ expectations for profit and revenue in the latest quarter. CEO Douglas Yearley Jr. said the luxury builder has been seeing strong demand since the start of its fiscal year six weeks ago, an encouraging signal as it approaches the beginning of the spring selling season in mid-January Elsewhere on Wall Street, Alaska Air Group soared 13.6% after raising its forecast for profit in the current quarter. The airline said demand for flying around the holidays has been stronger than expected. It also approved a plan to buy back up to $1 billion of its stock, along with new service from Seattle to Tokyo and Seoul . Boeing climbed 5.2% after saying it's resuming production of its bestselling plane , the 737 Max, for the first time since 33,000 workers began a seven-week strike that ended in early November. Vail Resorts rose 2.7% after the ski resort operator reported a narrower first-quarter loss than expected in what is traditionally its worst quarter. In stock markets abroad, indexes were mixed in China after the world’s second-largest economy said its exports rose by less than expected in November. Stocks rose 0.6% in Shanghai but fell 0.5% in Hong Kong. ___ AP Business Writers Matt Ott and Elaine Kurtenbach contributed. Stan Choe, The Associated Press
TRYNGOLZATM (olezarsen) approved in U.S. as first-ever treatment for adults living with familial chylomicronemia syndrome as an adjunct to diet
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FORESTVILLE, Calif. (AP) — A major storm moving through Northern California on Thursday toppled trees and dropped heavy snow and record rain after damaging homes, killing two people and knocking out power to hundreds of thousands in the Pacific Northwest. Forecasters warned that the risk of flash flooding and rockslides would continue, and scores of flights were canceled at San Francisco's airport. In Washington, more than 320,000 people — most of them in the Seattle area — were still without power as crews worked to clear streets of electrical lines, fallen branches and debris. Utility officials said the outages, which began Tuesday, could last into Saturday. Meanwhile on the East Coast, where rare wildfires have raged, New York and New Jersey welcomed much-needed rain that could ease the fire danger for the rest of the year. The National Weather Service extended a flood watch into Saturday for areas north of San Francisco as the region was inundated by the strongest atmospheric river — a long plume of moisture that forms over an ocean and flows through the sky over land — this season. The system roared ashore Tuesday as a “bomb cyclone,” unleashing fierce winds . Communities in Washington opened warming centers offering free internet and device charging. A number of medical clinics closed because of power outages. “I’ve been here since the mid-’80s. I haven’t seen anything like this,” said Trish Bloor, who serves on the city of Issaquah’s Human Resources Commission, as she surveyed damaged homes. Up to 16 inches (about 41 centimeters) of rain was forecast in southwestern Oregon and California's northern counties through Friday. The Sonoma County Airport, in the wine country north of San Francisco, received 6.92 inches (17.5 centimeters) Wednesday, breaking a record dating to 1998. In nearby Forestville, one person was hurt when a tree fell on a house. Small landslides were reported across the North Bay region, including one on State Route 281 on Wednesday that caused a car crash, according to Marc Chenard, a weather service meteorologist. Rain slowed somewhat, but “persistent heavy rain will enter the picture again by Friday morning,” the weather service's San Francisco office said on the social platform X. “We are not done!” Dangerous flash flooding, rockslides and debris flows were possible, especially where hillsides were loosened by recent wildfires, officials warned. Scott Rowe, a hydrologist with the weather service in Sacramento, said that so far the ground has been able to absorb the rain in California's Butte and Tehama counties, where the Park Fire burned over the summer. “It’s not necessarily how much rain falls; it’s how fast the rain falls,” Rowe said. Northern Mendocino and southern Humboldt counties received between 4 and 8 inches (10 and 20 centimeters) of rain in the last 48 hours, and similar amounts were expected over the next 48 hours, forecasters said. Wind gusts could top 50 mph (80 kph). The storm system, which first hit the Pacific Northwest on Tuesday, reached the status of “ bomb cyclone ,” which occurs when a cyclone intensifies rapidly. A winter storm watch was in place for the northern Sierra Nevada above 3,500 feet (1,066 meters), with 15 inches (38 centimeters) of snow possible over two days. Wind gusts could top 75 mph (121 kph) in mountain areas, forecasters said. Sugar Bowl Resort, north of Lake Tahoe near Donner Summit, picked up a foot (30 centimeters) of snow overnight, marketing manager Maggie Eshbaugh said Thursday. She said the resort will welcome skiers and boarders on Friday, the earliest opening date in 20 years. “And then we’re going to get another whopping of another foot or so on Saturday, so this is fantastic,” she said. Another popular resort, Palisades Tahoe, is also opening Friday, five days ahead of schedule, according to its website. The storm already dumped more than a foot of snow along the Cascades in Oregon by Wednesday night, according to the weather service. Forecasters warned of blizzard and whiteout conditions and nearly impossible travel at pass level. Falling trees struck homes and littered roads across western Washington, killing at least two people. A woman in Lynnwood was killed when a large tree fell on a homeless encampment, and another in Bellevue died when a tree fell on a home. More than a dozen schools closed in the Seattle area Wednesday, and some opted to extend the closures through Thursday. In Enumclaw, east of Seattle, residents were cleaning up after their town clocked the highest winds in the state Tuesday night: 74 mph (119 kph). Resident Sophie Keene said the powerful gusts caused transformers to blow out around town. “Things were exploding, like, everywhere,” Keene told the Seattle Times. “Like the transformers over by the park. One blew big, it looked like fireworks just going off.” Ben Gibbard, lead singer of the indie rock bands Death Cab for Cutie and Postal Service, drove from his Seattle neighborhood Thursday morning to the woods of Tiger Mountain for his regular weekday run, but there were too many trees blocking the trail. “We didn’t get hit that hard in the city,” he said. “I just didn’t assume it would be this kind of situation out here. Obviously you feel the most for people who had their homes partially destroyed by this.” In California, there were reports of more than 20,000 power outages on Thursday. Only 50 vehicles per hour were allowed through part of northbound Interstate 5 from 10 miles (16 kilometers) north of Redding to 21 miles (34 kilometers) south of Yreka due to snow, according to California's Department of Transportation. Transportation officials also shut down a two-mile (3.2 kilometer) stretch of the famed Avenue of the Giants, a scenic drive named for its towering coast redwoods, due to flooding. About 150 flights were delayed and another two dozen were canceled early Thursday at San Francisco International Airport after hundreds of delays and dozens of cancelations the previous day, according to tracking service FlightAware. Parched areas of the Northeast got a much-needed shot of precipitation Thursday, providing a bit of respite in a region plagued by wildfires and dwindling water supplies. More than 2 inches (5 centimeters) of rain was expected by Saturday morning in areas north of New York City, with snow mixed in at higher elevations. “Any rainfall is going to be significant at this point,” said Brian Ciemnecki, a weather service meteorologist in New York City, where the first drought warning in 22 years was issued this week. “Is it going to break the drought? No, we’re going to need more rain than that.” Har reported from San Francisco, and Weber from Los Angeles. Associated Press writers Hallie Golden and Gene Johnson in Seattle; Martha Bellisle in Issaquah, Washington; Sarah Brumfield in Washington, D.C.; and Michael Hill in Albany, New York, contributed.DEADLINE NEXT WEEK: Berger Montague Advises Paragon 28 (NYSE: FNA) Investors to Contact the ...
Podeli : Belgrade University deans expressed strong support for the protesting students and condemned attacks and threats on the academic community. Students have been blockading several colleges for days, demanding accountability for the deaths of 15 people in the fall of a canopy roof at Novi Sad Railway Station and other things. “The University of Belgrade strongly supports students in their initial demands as self-aware, academic citizens, particularly highlighting our students’ readiness to respond to events of public and social significance,” a statement said after a meeting of the Extended Rector’s Collegium. It noted that the students clearly expressed concern for the state of society. “The University stands in defense of students and colleagues who are confronted with unacceptable media insults, physical attacks, and threats, as well as inadmissible rhetoric directed at the academic community. We condemn any actions by those who violently provoke reactions from students, collaborators, and teachers, while simultaneously strongly supporting the manner in which the integrity of the academic community is preserved,” it added. “We publicly appeal to all political players and the media to refrain from using student gatherings to achieve their goals, to respect the autonomy of the University, and the right of students to express their views,” the statement said. It said that students will not be punished for protesting, preserving the integrity of the academic community, their critical thinking and their actions as a vital part of society. “We expect students not to interfere with the conduct of the administrative affairs of the Rectorate and all members of the University,” it added. The statement demanded urgent action by the authorities to meet the students’ initial requests.
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Banks' 28 lead UMBC past American 96-93 in double OTFormer President Jimmy Carter's quotations reveal a deep well of wisdom on politics, morality, and society. From candid interviews to public speeches, his words have long stressed unity, human rights, and personal morality. In his 1975 book, "Why Not the Best?" Carter emphasized how leadership should nurture human attributes towards self-fulfillment. Throughout his career, Carter remained a vocal critic of political and social injustice, including his pointed remarks on the impact of racism and the importance of respecting different perspectives within governance. Even in his post-presidency, his introspection on matters like race, religion, and global challenges continues to guide influential dialogues. Recent reflections suggest Carter believes America is still in search of its ultimate values and direction, but he remains hopeful for the country's future. (With inputs from agencies.)
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