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Noneurban-gro Expands Cannabis Sector Offering with Launch of New Processing and Extraction DivisionCDC chief urges focus on health threats as agency confronts political changesLDI 2025 Announced for December 3-9 in Las Vegas NEW YORK, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Questex's Live Design International (LDI) 2024 delivered an unforgettable experience, bringing together over 13,000 global live event and entertainment design technology professionals and over 350 exhibitors. Packed with groundbreaking gear and technology, unparalleled education, and industry-defining moments, LDI 2024 proved why it remains the ultimate gathering for live entertainment and production technology. A Milestone Year for LDI 2024 Bursting with cutting-edge technology, unmatched education programs, and unforgettable networking opportunities, LDI 2024 reached new heights. The event featured the largest professional training program in its history, a 50% increase in LDInstituteTM classes, more than 125 LDInnovationTM Conference sessions, and a 10% larger exhibit floor showcasing over 350 exhibitors. "LDI 2024 was a vibrant celebration of the creativity, innovation, and community that power the live entertainment industry,” said Jessi Cybulski, Show Director, LDI. "With outstanding professional training, an electric show floor, and countless opportunities to connect, this year's event exceeded expectations. We can't wait to see what the industry will create in the coming year and showcase at LDI 2025.” LDI 2024 Highlights: "As far as the quality of programming and the quality of showroom floor, it's definitely some of the top memories I'll have when it goes to conferences and attending events,” said Michaela Ternasky-Holland, Creator, Immersive, Spatial, & Interactive Experiences (VR, AR, AI). "It's been really, really great to come back and experience LDI and just seeing the growth that has happened in just a short amount of time, both in the size of the overall event and then also the technology. If you're thinking about coming to LDI or getting into this industry, I would certainly recommend you taking advantage of this amazing opportunity that happens every year. Just great exposure to many of the manufacturers, all of the technology that you see on any of the events that are happening out there is here at the LDI conference. Even better are the people and the relationships that make all the live events in the industry happen. It's all about the people and the products, and it all happens here at LDI,” said Shane Smith, Sr. Director Technology, LMG, Inc. "It's the perfect opportunity to see a showcase of the latest and greatest in tech, and also network and meet with the movers and shakers who are in this exciting field. As a first-time attendee when the Expo Floor opened, I was like a kid walking into a candy store. It was just incredible. The lights, the sounds, the noises, the people, the technology. Yeah, this is a great experience,” said Brian Crane, Founder, Crane Light & Design. "This is the conference that I go to because all of my friends are here. I was a lighting person back in the day. And this is the place that I come to see all the new technology, the new equipment. And now that I'm working more on the rigging side of things, I get a chance to come and talk about that this year,” said Kristi Ross-Clausen, Director of Education and Training, TheaterHealthandSafety.com. "LDI is a wonderful thing every year where all the vendors come together and you get an opportunity to see all of the new things out there. But, also, it's really a meeting of the minds where you get all the people who are actually creating this cutting-edge technology into one space. So, it's a great place to talk to people, pick up on what's coming up as far as ideas goes and what people have in the pipeline,” said Tyler DeLong, Managing Partner, DeLong Rigging Solutions. "LDI to me is the mecca for theater technology around the planet. If you want to broaden your horizons and know more about your craft, whatever that craft is, whether it's rigging, whether it's lighting, whatever it is, you come to LDI to see the latest products, to talk to the leaders in the industry and learn more about what it is that they do that makes them successful. It's honestly just a great place to get together with the OGs in the industry to swap stories, meet new people, encourage the young ones today to get into the business and help it grow, because this business is growing exponentially every day,” said Tracy Nunnally, Owner, Vertigo. "This is my favorite show. Not only do a lot of our customers come here, you have end users and production companies from some of the leading companies. So, we've met so many incredible contacts here. Many touring companies have come to visit our booth, and we're really excited for them to use INFiLED with some of the top performers in the country. Such amazing contacts, just a real incredible place, and really just a fun place to be. So, I definitely recommend everyone to be at LDI,” said Larry Lipsie, Senior Sales Manager, INFiLED. "It's been a great show. We've had a lot of really great interactions with tons of different people. Attendance has been really good this year,” said Will Komassa, President/CEO, Blizzard Lighting LLC. "It's been a fantastic show. We've seen all kinds of people here from students who are just starting out in their careers in the entertainment technology world, all the way up to the most seasoned professionals that we've ever seen at this show,” said Ryan Hindinger, Market Manager CT≤, ACT Entertainment. Looking Ahead to LDI 2025 LDI 2025 will take place December 3-9, 2025 at the West Hall in the Las Vegas Convention Center in Las Vegas, NV, with the conference starting December 3 and the expo floor open December 7-9. For sponsorship opportunities, contact Kelly Turner, Director of Sales, at [email protected] . About Live Design International (LDI) Established in 1988, Live Design International (LDI) is built on a 36-year history as the essential trade show and conference for global live design professionals. Attendees come to LDI to see the latest gear and entertainment technology in action, covering audio, lighting, projection, video, staging, special effects, and XR. It is also a great opportunity to refresh knowledge and professional training, in addition to networking and finding inspiration from colleagues, manufacturers, and distributors at the vanguard of entertainment technology. For more information, visit http://www.ldishow.com/ . LDI will take place December 3-9, 2025, at the West Hall in the Las Vegas Convention Center in Las Vegas, NV. About Questex Questex helps people live better and longer . Questex brings people together in the markets that help people live better : hospitality and wellness; the industries that help people live longer : life science and healthcare; and the technologies that enable and fuel these new experiences . We live in the experience economy - connecting our ecosystem through live events, surrounded by data insights and digital communities. We deliver experience and real results. It happens here. Media Contact Charlene Soucy LDI [email protected]
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In the end, Brendan and Emily's wedding was not just a celebration of their love for each other, but also a testament to the enduring power of love, connection, and the undeniable presence of loved ones, even in their absence. And as they embarked on their journey together as husband and wife, they knew that they were truly blessed by the love that surrounded them, both seen and unseen.The "Laba" festival also marks the beginning of a busy season for the swine industry, as producers gear up to meet the increased demand for pork products. Farmers may choose to ramp up their production in anticipation of higher prices, which could potentially lead to a temporary oversupply in the market. However, if demand remains strong during the festival season, this oversupply may be absorbed quickly, helping to support pork prices in the short term.
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Moreover, passenger safety and comfort are also top priorities for the NRA during this period of heightened travel activity. Measures are being implemented to improve the cleanliness and hygiene of trains and stations, as well as to enhance communication and information dissemination to passengers regarding their travel schedules and safety guidelines.
The dwindling player count on Steam may raise questions about the fate of "LGBT Warrior: A Solo Journey," but to the lone warrior still braving the digital frontier, this game represents much more than just entertainment. It is a symbol of defiance and perseverance, a stark reminder that even in solitude, one can find strength and purpose.
In the world of professional sports, athletes can experience incredible highs and devastating lows in the blink of an eye. One such striking example is that of 29-year-old footballer, Whetsch, whose worth has seen a staggering decline from its peak at esteemed club Inter Milan. Once valued at a commanding 65 million euros, Whetsch's worth has now plummeted to a mere 15 million euros, marking a significant 7th consecutive drop in his value.PITTSBURGH — Most of us are not professional chefs or caterers or decorators, so the thought of cooking for and entertaining a Thanksgiving crowd can be daunting. That's why we turned to the experts — professional chefs and caterers and interior designers — to discuss some typical Thanksgiving mistakes and how to avoid them. "The overriding first mistake people make is they think they have more time than they do," said Bistro to Go Cafe and Catering executive chef Kate Kobylinski. She regularly hosts her extended family of 30 and knows "every single problem." "Food takes longer to cook, the table takes longer to set and houses take longer to clean than you think." Clean your house on Monday. On Wednesday, dice vegetables so they're "food-show ready," as Kobylinski put it. Prepare (but don't cook) your green bean casserole (leaving off garnishes like fried onions) so it can just be popped in the oven and set the dining room table. Don't feel that you have to do everything yourself. But be as specific as possible when doling out the assignments. "Don't let them make their own decisions!" Kobylinski said emphatically. Thanksgiving is "micromanager's heaven." For example, have someone bring ice on Thanksgiving Day because going out to buy it takes time and ice hogs freezer space. If you don't like making desserts, have someone bring one. If a guest wants to prepare a side dish, great, but decide beforehand what they will bring. Ahead of dinner, interior designer Kacie Cope likes to set out all of her serving platters with Post-it notes attached denoting what will go on them. "You'll be amazed if you have them labeled," she said. "People can help in a jiff." During the evening, Kobylinski gives people assigned jobs, such as serving drinks or taking charge of an after-dinner game. And the chef is forgiving about using premade ingredients, like gravy or cranberry jelly. "There's no right or wrong way to make any of your foods," she said. But you might want to give a homemade touch to prepared ingredients, like adding sauteed onions or celery to prepared gravy. "Everyone goes into Thanksgiving Day with a half-frozen turkey," said Kobylinski. "And you can't get the bag of giblets out because they're frozen in place." It takes one day for every 4 pounds of turkey meat to defrost in the refrigerator. (No, it is not safe to leave your frozen turkey out on the counter to thaw and breed bacteria.) So if you've got a 20-pound bird, you've got to start thawing on the Saturday before Thanksgiving. However, there are other methods. Kobylinski suggests submerging the bird and running a thin stream of cold water over it. "It doesn't have to be a lot of water." The U.S. Department of Agriculture says there are only three ways to safely thaw food: In the refrigerator, in cold water or in the microwave. To safely thaw turkey in cold water, the USDA says it takes about 30 minutes per pound. Put the turkey in a leak-proof plastic bag to prevent cross-contamination and submerge it. Change the water every 30 minutes, and cook immediately when it's thawed. If opting for your microwave, follow its instructions for thawing and cook immediately. Then, if you're running late and need to speed things up to satisfy the hungry hordes, you can cut the bird in half before cooking (skin side up). This significantly reduces cooking time, requiring about 10 minutes per pound. Kobylinski also recommends resting the turkey on vegetables in the oven to keep the bottom from getting burned. Private chef and culinary educator Emily Larsen warns that those plastic thermometers in supermarket turkeys are setting you up for failure. The USDA says that you should cook a turkey until the internal temperature is 165 degrees. Plastic thermometers don't pop out until the breast meat is at about 180 degrees, "when your turkey is completely dry," Larsen said. Plus, people forget that meat continues to cook once it's out of the oven. She recommends taking a bird out of the oven when it is at 155 degrees — she likes to use an inexpensive instant-read folding probe thermometer — and continue to monitor it. (Insert it into the thickest part of the breast, avoiding the bone.) "Ten dollars [for the thermometer] can save your Thanksgiving," she said. Some feel that buying a frozen rather than fresh bird is another no-no, since freezing leaches water out of the turkey. However, if, despite your best efforts, your turkey is lacking moisture, Kobylinski has a fix: Put warm chicken or turkey stock and clarified butter into a mister and spritz sliced turkey with it before serving. "The same with stuffing if it's too dry," she said. Thanksgiving Day is not the time to try out a completely new recipe. And you don't have to lay out 10 side dishes. In addition to opting for a simple menu, Kobylinski also recommends figuring out how long your items will take to cook and what method of cooking it requires ahead of time. Your turkey will be monopolizing your oven for four hours, so other oven foods should be limited or be easily reheated during the time that the turkey is resting. (As for resting a turkey, the chef puts her turkey on a hot plate with towels over it so "the meat rebinds itself and stabilizes for a smoother cut.") "Stovetop items should be staggered," she said, so you don't have a frying pan and three pots all going at once. As a sample menu, she suggests you might have one baked potato dish and one mashed. And for vegetables, one baked dish and one that is blanched or grilled. Pittsburgh-area interior designers advise against going too crazy with holiday-specific décor. "There's a lot that's being sold to us that we feel like we need," said Pittsburgh interior designer Amanda Bock. Do you really need a turkey-shaped vase or pilgrim figurines? "They're out for two weeks, and then you have to figure out where to store them," agreed Cope. "It takes an already busy season and makes it stressful in an unnecessary way." Cope says you can take things that are already part of your menu and use them as décor — a bowl of nuts or cranberries, or even removing the label from a cranberry sauce tin and repurposing it as a vase for flowers and fall leaves. Bock adds that dining room table décor should be kept to a minimum, since you'll need space for your food. You don't have to have "big chargers and five plates and three different glasses, plus all of your Thanksgiving food on the table," Bock said. If you do have flowers or a centerpiece in the middle of the table, keep it low, Cope advised. "That way, you can actually see the person who's across the table from you." Tableware and tablecloths might be in fall colors, so they can be repurposed throughout the season. Water glasses or wine goblets could be amber-toned, Bock suggests. Well in advance of your guests' arrival, think critically about the setup of your home. Don't be afraid to rearrange your furniture so your guests move to different areas and don't all congregate in your kitchen. "You want to make sure that there are areas where people can sit and chat, watch the parade or just hang out together," Bock said. Set up a drinks station and an hors d'oeuvres station in different parts of the house, Bock suggests. Though, she admits, "I can't do that in my house because my dogs would just gobble up the hors d'oeuvres." She suggests repurposing a kitchen nook for kid seating, or as a serving area. Kobylinski might set up a half-built puzzle in a side room. She even puts out winter jackets and boots for "the gentlemen" for the moment when she urges them to go out on the porch to smoke cigars and drink brandy so they won't be underfoot. As a finishing touch, don't neglect to set the mood by using lamps around the room instead of harsh overhead lights. Putting out tapers or tea candles establishes an intimate feeling. "That just leans into the cozy fall vibe," Cope said of low lighting. But don't use scented candles, Bock warns. Or a smelly flower arrangement. "That can overwhelm you when you're eating," Bock said. Putting on a favorite music playlist can set the mood and take away self-consciousness, especially early in the evening. The most important thing on Thanksgiving is simply for everyone to enjoy each other's company. A little advance preparation can help you, the host, stay relaxed throughout the evening so you can interact with your guests. As Bock advised, "Keep it simple for Thanksgiving." Let friendship and fellowship be the stars of the show. ___ ©2024 PG Publishing Co. Visit at post-gazette.com . Distributed by Tribune Content Agency, LLC.
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"It's important for us to be brave in this game against Paris," said one Salzburg defender. "We know they have some of the best attackers in the world, but we can't let that intimidate us. We have to go into the game with confidence and believe in our abilities to compete at this level."
Northern California is a few days into the biggest winter storm this year so far. Wind knocked over trees , roads flooded and power outages were reported across Humboldt County. Major rivers are predicted to swell with another day of the long-lasting atmospheric river hitting the Pacific Northwest. So far, lower elevations have received 3-6 inches of rain while higher elevations have seen 10 inches, the National Weather Service in Eureka said in a social media post. More rain and wind is in the forecast — and Thursday is the beginning of a period of extreme risk of flash flooding from the Weather Prediction Center for most of Humboldt County, the west half of Trinity County and the northern half of Mendocino County. “Dangerous flooding across coastal areas of northwest California is expected due to the very strong and long duration atmospheric river currently impacting the region which will continue through tonight. Flooding and debris flows are likely which will include rock and landslide activity along with a threat for burn scar flash flooding,” the National Weather Service said Thursday morning on X. The bulk of rain is falling Thursday night, the National Weather Service office in Eureka said in a post. NWS Eureka expects an additional 4-10 inches of rain through Friday, with over 12 inches possible in the higher elevations. The continuous rain will bring the Eel River into major flooding stage at Fernbridge, expected to start late Thursday night into late Friday night. The peak of flooding there is expected for Friday at noon, reaching 25 feet. NWS Eureka said in a post the Eel River’s delta will see extensive flooding and flood waters could impact state Route 211 to Ferndale. The Mad River is also expected to reach flood stage around 8 a.m. Friday at 22 feet. Along with the swollen rivers, “Rapid rises of rivers, creeks, and streams are expected, along with ponding of water in low lying & poor drainage areas. Individuals are advised to take appropriate action for themselves and livestock,” NWS Eureka said on X. As for wind, which has caused power outages, NWS Eureka said to expect gusts from 45 to 65 mph across Humboldt County- meaning more outages are possible, though the speed of the gusts are forecasted to be less strong than Tuesday night’s deluge. The highest wind of the storm in Northern California so far was measured at Mattole Road, located at the peak above Cape Mendocino, at 98 miles per hour. The storm wrecked the roof of the Sanctuary in Arcata on Tuesday night, an art-based community center. About one-half inch of water got into the building, which now has extensive structural damage. “Everything was leaking from every place,” said Erica Davie, co-director of the Sanctuary. The walls bubbled with moisture and buckets were set up to catch dripping water. A crew of people showed up Wednesday morning to tarp the roof and started drying the building and belongings. The repairs needed are extensive. Over the hum of fans and dehumidifiers, Katie Belknap, building owner/co-director of the Sanctuary said they don’t know the extent of the damage, but estimates it will cost hundreds of thousands of dollars for water abatement, roof repair and the structural repairs. “It’s... uninhabitable, basically,” said Belknap. The center’s events will be rehomed for the time being, and the two directors said the center will be closed for an indefinite period of time. James Zeller, a local musician, said a lot of a people piece together incomes at the center, like through ceramics classes or shows, and it’s important they keep putting on events. A benefit show is planned for Saturday at the Arcata Playhouse at 6:30 p.m. Social media videos show fallen trees crushing cars and blocking roads. Five Humboldt County schools closed on Wednesday and the Humboldt County Office of Education is tracking open and closed schools. The PG&E outage map reports hundreds without power from the storm, especially in Northern Humboldt County. PG&E crews are staged at Redwood Acres and expect to be there for up to 2 weeks, Redwood Acres said in a social media post. “Things are gonna take a while but the crews are out working hard,” said Steve Madrone, 5th district supervisor, whose electricity had been out from winds Tuesday. “They’re all heroes, frankly,” he added. Thursday, the city of Trinidad asked residents to continue to conserve water after a failed water pipe was discovered Wednesday at the Water Treatment Plant. The city’s water system is operating with only one of its two water storage tanks. “Grid power surges, equipment failure, and leaks found in saturated areas of the distribution system overnight complicated the city’s ability to gain positive elevation in the water storage tank. Technicians are addressing equipment failure. Public Works staff continue to monitor and stabilize leaks caused by stormwater runoff, earth movement, and fallen trees and debris, specifically along Scenic Drive,” a message from the city clerk said. Extreme weather shelters can be found at https://211humboldt.org/extreme-weather-shelter-warming-stations/ Free sand can be picked up from the following locations: • City of Eureka Corp Yard at 945 W 14th St., available anytime • City of Arcata Corp Yard at 600 South G. St., available anytime • City of Ferndale at the Francis Street Bridge on Francis St., available anytime • City of Fortuna, behind the skating rink at Rohner Park located at 9 Park St., available anytime • City of Rio Dell, behind City Hall at 675 Wildwood Ave., available anytime • Blue Lake City Hall at 111 Greenwood Ave., available anytime The Humboldt County Animal Shelter recommended in a social media post keeping animals inside, updating ID tags with contact information and checking fences. If your pet is lost, call the shelter at 707-840-9132 or post on the Facebook page Humboldt Paws Cause. Pacific Gas and Electric customers can check for updates on outages at https://pgealerts.alerts.pge.com/outage-tools/outage-map/ School closures are being updated at https://tinyurl.com/5yzrun3p . For those traveling, Caltrans’ QuickMap website at https://quickmap.dot.ca.gov/ can provide real-time road conditions. It is also available as an app. Sage Alexander can be reached at 707-441-0504CARLSBAD, 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.
