Dan V. Iosifescu, MD, Professor of Psychiatry at the New York University School of Medicine and Director of Clinical Research Division at the Nathan Kline Institute for Psychiatric Research, commented, In clinical trials, Auvelity has demonstrated rapid and statistically significant improvement in depressive symptoms as early as Week 1, and increased rates of remission at Week 2 compared to Placebo.. Early commercial-stage drugs tend to take a few quarters to begin to penetrate the market. FDA clearance is a big deal for Nanox. 5 Ways to Beat the Fed (and Crush Inflation), Norwegian Cruise Line (NCLH) Q1 2023 Earnings Call Transcript, The Next $1.8 Trillion Tech Bull Run Is Starting Now - Here's What to Do, Do Not Sell or Share My Personal Information. Merck's ( MRK) own wonder cancer drug Keytruda has taken much of Opdivo's thunder and has seen sales explode, jumping 19% year-over-year in the first quarter of 2021. Only Zacks Rank stocks included in Zacks hypothetical portfolios at the beginning of each month are included in the return calculations. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. ET, Nanox stock was up by a whopping 60%. Do you think that might make it easier for Lilly or others to win accelerated approval as well? Skyclarys, for its part, is expected to rake in approximately $400 million in U.S. sales in 2030. See. KemPharm uses Ligand Activated Therapy (LAT) to discover and develop prodrugs which are used to improve a drug's bioavailability, extend its duration of action, reduce its susceptibility to abuse, and/or increase safety. The Motley Fool has positions in and recommends Reata Pharmaceuticals. Reata also filed its 10-K report wherein it mentioned its financial results for 2022. 89BIOs earnings beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 10.08%. In Nanox's annual report, filed Monday, management said it received FDA clearance for its multi-source device on April 28. Reatacurrently has a Zacks Rank #3 (Hold). Skyclarys is the first drug to be approved specifically for the treatment of Friedreichs ataxia and is also Reatas first commercial product. Making the world smarter, happier, and richer. "The FDA approval of the Azstarys NDA is a transformational event for KemPharm and, we believe, an important advancement in the treatment of ADHD," said Travis C. Mickle, president and CEO of KemPharm. The prodrug was praised by Dr. Ann Childress, President of the Center for Psychiatry and Behavioral Medicine. However, the company intends to build its business around its multi-source device, and it didn't have FDA clearance for that one. Ownership data provided by Refinitiv and Estimates data provided by FactSet. I guess maybe it does seem reasonable that Lilly got bid up on the news, but we have to see what Lilly actually wants to do. JPMorgan Rescues First Republic. The Centers for Disease Control and Prevention estimatesthat8.4% of children and 2.5% of adults in the US have ADHD. They were allowed to finish the study. Reata expects patients to gain access through insurance and a patient-assistance program. 06:43AM: Reata (RETA) Stock Jumps as FDA Approves Rare Disease Drug . The FDA gave SER-109, a . Visit www.zacksdata.com to get our data and content for your mobile app or website. The average earnings surprise for EFTR is 104.56%. This means Veru stock ranks in the leading 6% of all stocks in terms of 12-month performance, according to IBD Digital. ados_load(); Is SoFi Stock a Buy Now? Axsome shares have exploded today after its depression therapy won approval from the FDA. According to its business model, Nanox's management plans to place its multi-source imaging devices in clinics, medical practices, hospitals, and other sites around the world at low cost -- or even at no cost. The other is a potential rival. That's not a bad start for a newly approved rare disease medicine, but it is also far from the upper end of the drug's long-term commercial opportunity. If it surprisingly goes in the opposite direction, the stock could have an exaggerated move. In Nanox's annual report, filed Monday, management said it received FDA clearance for its multi-source device on April 28. The FDA gave clearance for Nanox's flagship 3D X-ray imaging device -- a huge development. Shares of medical technology company Nano-X Imaging (NASDAQ: NNOX), also known as Nanox, skyrocketed on Monday after the company received clearance from the Food and Drug Administration (FDA) for its flagship medical device. Gocovri has been approved to treat. Morgan Stanleys (MS)Vikram Purohitrecently reiterated a Hold rating on the stock alongside a price target of $55. Learn More. Find out more about how we use your personal data in our privacy policy and cookie policy. Reata expects the drug to be available commercially in the second quarter of 2023. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. You can see the complete list of todays Zacks #1 Rank stocks here. Zacks Equity Research Avadel Pharmaceuticals ( NASDAQ: AVDL) shares added ~12% on Monday after announcing that the FDA granted final approval for its sleep disorder therapy Lumryz for cataplexy or excessive daytime . Founded in 1993 by brothers Tom and David Gardner, The Motley Fool helps millions of people attain financial freedom through our website, podcasts, books, newspaper column, radio show, and premium investing services. Jon Quast has positions in Nano-X Imaging. ados.run = ados.run || []; The companys net loss was $311.9 million in 2023, wider than $297.4 million in 2021. Barder also gives an update on the company's discussions with the FDA regarding MED3000, saying that he expects approval to . Shares have a strong Relative Strength Rating of 94 out of a best-possible 99. Or to contact Money Morning Customer Service, click here. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services. Nanox.ARC is a "multi-source digital 3D tomosynthesis system that utilizes novel, cold cathode X . Only patients bilirubin levels and lipid parameters should be monitored prior to the initiation of Skyclarys. With this approval, the companys oral treatment Auvelity now becomes the first and only one available for major depressive disorder. Realtime quote and/or trade prices are not sourced from all markets. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.*. Backtested performance is developed with the benefit of hindsight and has inherent limitations. No cash balance or cash flow is included in the calculation. In particular, Lilly has high hopes for Alzheimer's. as well as other partner offers and accept our, Registration on or use of this site constitutes acceptance of our. Nonetheless, the biotech's stock might still be undervalued. Visit Performance Disclosure for information about the performance numbers displayed above. Why isn't Reata stock trading even higher after such a landmark approval? Veru stock collapsed Thursday after the FDA's advisors voted against the company's cancer drug turned Covid treatment. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service. Lilly has two Alzheimer's disease drugs at least, solanezumab, which reduced amyloid compared to placebo, but not statistically significant amount at least in the study that I looked at. The Motley Fool has a disclosure policy. Please disable your ad-blocker and refresh. This news caused shares of the. The news sent Veru stock close to a record high in August. Therefore, there's financial risk to be aware of as well. Copyright 2023 Zacks Investment Research | 10 S Riverside Plaza Suite #1600 | Chicago, IL 60606. But Viking announced results on Tuesday from a phase 1 . To ensure this doesnt happen in the future, please enable Javascript and cookies in your browser. Why Reata Pharmaceuticals Stock Skyrocketed This Week (Motley Fool)-6.83%. on May 1, 2023. That's right -- they think these 10 stocks are even better buys. The FDA briefing documents come ahead of an advisory committee meeting set for Wednesday. The information has been obtained from sources we believe to be reliable; however no guarantee is made or implied with respect to its accuracy, timeliness, or completeness. Follow Allison Gatlin on Twitter at @IBD_AGatlin. I think it's more of a guess at this point on whether Lilly is actually more valuable based on this FDA news. The U.S. offers the largest market for Bluebird's beti-cel, but the drug failed to catch on commercially in Europe just three years ago after receiving approval. The U.S. Food and Drug Administration (FDA) granted accelerated approval to Biogen 's ( BIIB 1.28%) Alzheimer's disease drug Aduhelm (aducanumab) on Monday. KemPharm is eligible to receive up to $468 million in milestone payments as well as royalties from sales of the prodrug. ALLISON GATLIN. Any reproduction, copying, or redistribution (electronic or otherwise, including the world wide web), of content from this webpage, in whole or in part, is strictly prohibited without the express written permission of Money Morning. Additionally, the. By clicking Sign up, you agree to receive marketing emails from Insider Moreover, in its annual report, Nanox management says, "We expect that we will need to obtain additional financing to implement our business plan." Shares of medical technology companyNano-X Imaging (NNOX 68.41%), also known as Nanox, skyrocketed on Monday after the company received clearance from the Food and Drug Administration (FDA) for its flagship medical device. Wall Street, though, is more optimistic, with a Moderate Buy consensus rating and anaverage AXSM price target of $69.11, which implies 21.8% upside potential. Founded in 1993 by brothers Tom and David Gardner, The Motley Fool helps millions of people attain financial freedom through our website, podcasts, books, newspaper column, radio show, and premium investing services. Our experts who have appeared on FOXBusiness, CNBC, NPR, and BloombergTV deliver daily investing tips and stock picks, provide analysis with actions to take, and answer your biggest market questions. Wall Street Thinks This Growth Stock Could Blast Off by 358%, but Should You Buy It Today? *Average returns of all recommendations since inception. It subsequently gave up all of those gains and then some over the next few weeks. From there, it intends to make its money on a per-image basis and from its software. Enter your email to receive our newsletter. Is this happening to you frequently? Cost basis and return based on previous market day close. . In the example illustrated below, Novo Nordisk was given an update by the FDA on 5/3/17 (PD Update) that it could expect a decision on Fiasp on 9/29/17 (forward-looking PD-Expect date). In other words, the road ahead for Nanox isn't just complex, it's also going to be expensive. One of its devices, its single-source device, received FDA clearance way back in April 2021. site: MoneyMorning.com, Our goal is to help our millions of e-newsletter subscribers and Moneymorning.com visitors become smarter, more confident investors. All of that said, Nanox took a massive step forward on Monday, and it's understandable why the market was so fired up about it. Founded in 1993 by brothers Tom and David Gardner, The Motley Fool helps millions of people attain financial freedom through our website, podcasts, books, newspaper column, radio show, and premium investing services. Drugmakers can often pick up. Learn how you can make more money with IBD's investing tools, top-performing stock lists, and educational content. Vowst, formerly called . Speights: Brian, do you think the fact that the FDA has granted accelerated approval for Aduhelm. 04:03 PM ET 04/25/2023. I guess I don't agree with the FDA, so I don't know. A simple, equally-weighted average return of all Zacks Rank stocks is calculated to determine the monthly return. If you have an ad-blocker enabled you may be blocked from proceeding. Sign up for free today. The FDA's approval of Azstarys, will earn. Youre reading a free article with opinions that may differ from The Motley Fools Premium Investing Services. The Motley Fool has no position in any of the stocks mentioned. If you wish to go to ZacksTrade, click OK. Another company that is making a drug for Friedreichs ataxia is PTC Therapeutics (PTCT Quick QuotePTCT - Free Report) . Certain assumptions have been made for modeling purposes and are unlikely to be realized. PTC Therapeutics, Inc. (PTCT) - free report >>, Reata Pharmaceuticals, Inc. (RETA) - free report >>, eFFECTOR Therapeutics, Inc. (EFTR) - free report >>. Brian Orelli, PhD has no position in any of the stocks mentioned. These returns cover a period from January 1, 1988 through April 3, 2023. Are there any other stocks investors might want to check out as well? Protected by copyright of the United States and international treaties. Youre reading a free article with opinions that may differ from The Motley Fools Premium Investing Services. /* load placement for account: Money Map Press, Shares of Reata have surged 200.3% in the past year against theindustrys 9.9% decline. This implies a negative hedge fund confidence signal in the stock. Keith Speights has no position in any of the stocks mentioned. The Food and Drug Administration pushed its review date for Amylyx Pharmaceuticals ' ( AMLX) controversial ALS treatment on Friday, and the biotech stock skyrocketed. Nanox.ARC is a "multi-source digital 3D tomosynthesis system that utilizes novel, cold cathode X-ray tubes." Zacks Ranks stocks can, and often do, change throughout the month. Despite the large gains, most analysts still see the stock as a Buy. If you would like to customise your choices, click 'Manage privacy settings'. This dedication to giving investors a trading advantage led to the creation of our proven Zacks Rank stock-rating system. That doesn't mean Nanox will fail -- indeed, it could overcome each subsequent hurdle with flying colors. It needs to manufacture, find places to install, ship, and deploy its machines. Cost basis and return based on previous market day close. The Motley Fool has a disclosure policy. Loss estimates for eFFECTOR Therapeutics for 2023have narrowed from 96 cents to 88 cents in the past 60 days. var ados = ados || {}; Specifically, backtested results do not reflect actual trading or the effect of material economic and market factors on the decision-making process. BioNTech Pares Losses After Doubling Profits, Raising 2022 Guidance, Verve, Beam Stocks Crash After FDA Halts Plan To Test Gene Editor In People, How To Research Growth Stocks: Why This IBD Tool Simplifies The Search For Top Stocks, Find The Best Long-Term Investments With IBD Long-Term Leaders, Join IBD Live For Stock Ideas Each Morning Before The Open. Your email address will not be published. Click here to jump to comments. Result: You can see the stock experienced a slight increase after the FDA approval start date in early May. Amazon Leads 5 Stocks Near Buy Points Post-Earnings. Apr 26, 2023. Wenn Sie Ihre Auswahl anpassen mchten, klicken Sie auf Datenschutzeinstellungen verwalten. Nano-X Imaging ( NNOX) shares jumped more than 45% after the FDA approved Nanox.ARC X-ray system. The company still has to execute on the rest of its plan, and management expects that it will need to raise more money to do that. ET, Nanox stock was up by a whopping 60%. Having investigated AZSTARYS and directly observed its clinical impact on patients, I believe this product will be an important new tool for physicians to use in providing effective care for patients with ADHD.". 26, 2023 4:05 PM ET Biogen Inc. (BIIB) , ESALF , ESAIY LLY By: Dulan Lokuwithana , SA News Editor 6 Comments . TipRanks is a comprehensive research tool that helps investors make better, data-driven investment decisions. From there, it intends to make its money on a per-image basis and from its software. I noticed that Eli Lilly (LLY 2.51%) stock, ticker there is LLY. On the stock market today, Veru stock catapulted 39.5% to 14.44. Although this condition only affects approximately 5,000 individuals in the U.S., Wall Street still thinks Skyclarys could rake in over $1 billion a year in U.S. sales at peak. Axsome is focused on developing therapies for central nervous system (CNS) conditions. Biogen (BIIB 2.26%) stock skyrocketed after its Alzheimer's disease drug Aduhelm won U.S. Food and Drug Administration (FDA) approval. PTC Therapeutics vatiquinone has been granted Orphan Drug Designation and Fast Track Designation by the FDA. KemPharm's stock was down nearly 15% over the past six months before Wednesday's jump in share prices. In briefing documents ahead of the advisory committee meeting, the FDA reviewer acknowledged Veru met the goals of its study. .setZone(136136); That doesn't mean Nanox will fail -- indeed, it could overcome each subsequent hurdle with flying colors. Under the License Agreement, KemPharm will be eligible for up to $468 million in regulatory and sales milestone payments, as well as significant tiered royalty payments. Real time prices by BATS. NYSE and AMEX data is at least 20 minutes delayed. Opiant plans to file for clearance of Narcan with the U.S. Food and Drug Administration (FDA) by the end of 2022. Want to learn more about investing? 89BIO is expected to report its fourth-quarter results next month. Reata Pharmaceuticals RETA stock skyrocketed almost 200% on Wednesday, a day after the FDA approved its drug Skyclarys, or omaveloxolone, across a broad patient population of an. Friedreich's. All rights reserved. Please. Zacks Rank stock-rating system returns are computed monthly based on the beginning of the month and end of the month Zacks Rank stock prices plus any dividends received during that particular month. Can Earnings Recharge Electric Vehicle Stocks? 3 Stocks That Already Doubled in 2023 and Could Keep Climbing, 3 Supercharged Stocks Near 52-Week Highs That Could Keep Climbing, The Nasdaq Is Rebounding: 2 Supercharged Growth Stocks to Buy in February, Why Reata Pharmaceuticals Stock Is Soaring Today, Why Reata Pharmaceuticals Stock Got Absolutely Crushed on Thursday, Why I Refuse to Chase the Maximum Social Security Benefit, U.S. Money Supply Is Doing Something It Hasn't Done in 90 Years, and It May Signal a Big Move for Stocks. Reata has priced Skyclarys at an annual cost of $370,000. A panel of independent experts will decide whether the benefits of Veru's (VERU) drug, dubbed VERU-111, outweigh its risks in some Covid patients. See our report's 7 new picks today, absolutely FREE. The FDA approval of Skyclarys was based on efficacy and safety data from the MOXIe Part 2 study and a post hoc analysis of the open-label MOXIe extension study. This week, Reata Pharmaceuticals' stock bolted higher in response to the FDA approval of its Friedreich's ataxia candidate. With the higher pricing, Ramakanth increased Fotivda's projected price per U.S. patient from $100,000 to $200,000. Today's Change (2.78%) $10.43 Current Price $385.24 Price as of April 21, 2023, 4:00 p.m. It is uncertain whether or not it will be marketed as Mounjaro in the weight-loss indication if it's approved. The analyst expects Fotivda to rule the roost, at least until generics enter in . The stock has been halted,. The clearance applies to both Nanox's medical device and the accompanying software known as the Nanox.CLOUD. ECOR Stock Soars After Inspiring FDA Designation The breakthrough device designation is a major win for the company, as it substantially accelerates the time to market. By Mary de Wet. While eFFECTOR Therapeutics sports a Zacks Rank #1 (Strong Buy), 89BIO has a Zacks Rank #2 (Buy). We, Yahoo, are part of the Yahoo family of brands. But it also believes the same drug could help hospitalized patients with moderate to severe Covid who are also at heightened risk of acute respiratory distress syndrome, or ARDS. I'm not sure. Nanox stock rose by 60% Monday morning, but it's still down 89% from its all-time high. If the stock goes against you, it could do so drastically. Orelli: That trades over-the-counter. Further, a TipRanks Smart Score of 7 indicates Axsome shares could outperform the broader indices in the coming periods. Veru had enrolled an additional 54 patients at that point. The FDA's approval of Azstarys, will earn KemPharm a . Shares of medical technology company Nano-X Imaging ( NNOX 53.94%), also known as Nanox, skyrocketed on Monday after the company received clearance from the Food and Drug Administration (FDA). The U.S. Food and Drug Administration (FDA) could approve the drug as early as late 2023. Is Eli Lilly Stock a Strong Buy After Q1 Earnings? After eight weeks, the infection rate was 12.8% in the Vowst group compared with 39 . document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); Shares of medical technology company Nano-X Imaging (NASDAQ: NNOX), also known as Nanox, skyrocketed on Monday after the company received clearance from the Food and Drug Administration (FDA) for its flagship medical device. Elanco Animal Health Inc. received conditional approval from the Food and Drug Administration on Monday for its drug Varenzin-CA1 to treat anemia in cats with chronic kidney disease. However, the company intends to build its business around its multi-source device, and it didn't have FDA clearance for that one. Also benefits from the approval because it's partnered with Biogen on Aduhelm, and other Alzheimer's disease drugs. Please note all regulatory considerations regarding the presentation of fees must be taken into account. To learn more, click here. Today, you can download 7 Best Stocks for the Next 30 Days. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating indiv idual securities. Ann Childress, M.D. But both camps should strive to keep emotions in check. *Stock Advisor returns as of June 7, 2021. After more than a decade of developing a microbiome drug, Seres Therapeutics Inc. has won its first approval from the U.S. Food and Drug Administration. ET, Nanox stock was up by a whopping 60%. However, the company still has a long road ahead. Viking Therapeutics Inc. ( VKTX . But . The results reflect performance of a strategy not historically offered to investors and does not represent returns that any investor actually attained. Comment on This Story Click here to cancel reply. *Average returns of all recommendations since inception. Array BioPharma (NASDAQ: ARRY), G1 Therapeutics (NASDAQ: GTHX), and CEL-SCI (NYSEMKT: CVM) skyrocketed last week by at last 37%. Why I Refuse to Chase the Maximum Social Security Benefit, U.S. Money Supply Is Doing Something It Hasn't Done in 90 Years, and It May Signal a Big Move for Stocks. BIIB stock skyrocketed after the FDA approved Biogen's controversial Alzheimer's drug. Entering text into the input field will update the search result below. Backtested performance is not an indicator of future actual results. You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. This approval is a major win for the company, and rapid market share gains could be on the horizon. Shares of the rare disease specialist Reata Pharmaceuticals (RETA 0.94%) jumped by 94.1% over the first three and a half days of trading this week, according to data provided byS&P Global Market Intelligence. (SecondSide/stock.adobe.com). Shares of biopharmaceutical company Axsome Therapeutics (AXSM) are up substantially in todays trading session after its depression therapy gained approval from the U.S. Food and Drug Administration (FDA). The big gain after Reata announced that the Food and Drug Administration (FDA) approved its Friedreich's ataxia candidate, Skyclarys (omaveloxolone), for patients 16 and older. And according to data from Grandview Research, the ADHD pharmacology market could hit $24.9 billion by 2025. If you do not, click Cancel. As of 10:30 a.m. Here are the 10 best-performing stocks of 2023 among companies that trade on major U.S. exchanges and have market capitalizations of at least $1 billion: 10. Weitere Informationen ber die Verwendung Ihrer personenbezogenen Daten finden Sie in unserer Datenschutzerklrung und unserer Cookie-Richtlinie. In other words, the road ahead for Nanox isn't just complex, it's also going to be expensive. If you're a patient investor, I think the answer is yes. Is SoFi Stock a Buy Now? Keith Speights: Anytime there's big news like we've seen with Biogen'sFDA approval for Aduhelm in treating Alzheimer's disease, there are a lot of times there's sympathy moves with other stocks. Lilly stock jumped by more than 10% earlier this week after the FDA approval decision for Aduhelm was announced. SG&A expenses were $109.3 million, up 10.4% year over year. Join the conversation. Address: 1125 N Charles St. | Baltimore, MD, 21201 | USA | Phone: 888.384.8339 | Disclaimer | Sitemap | Privacy Policy | Whitelist Us | Do Not Sell or Share My Personal Information. Since trades have not actually been executed, results may have under- or over-compensated for the impact, if any, of certain market factors, such as lack of liquidity, and may not reflect the impact that certain economic or market factors may have had on the decision-making process. Why Is SoFi Stock Down After Earnings? This information is provided for illustrative purposes only. The profusion of opinions on social media and financial blogs makes it impossible to distinguish between real growth potential and pure hype. If approved, commercial sales from Narcan could jump to over $200 million, as projected by Indivior. 04:15 PM ET 06/03/2022. George Budwell has no position in any of the stocks mentioned. Fewer patients who received VERU-111 died in the study. Here's what lit a fire beneath these three biotech stocks and . *Real-time prices by Nasdaq Last Sale. Nanox stock rose by 60% Monday morning, but it's still down 89% from its all-time high. Most investors dont have major gainers like TSLA or NVDA on their radar from the start. Our experts picked 7 Zacks Rank #1 Strong Buy stocks with the best chance to skyrocket within the next 30-90 days. Changes in these assumptions may have a material impact on the backtested returns presented. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.*. Get instant access to exclusive stock lists, expert market analysis and powerful tools with 2 months of IBD Digital for only $20! 10 stocks we like better than Nano-X ImagingWhen our analyst team has a stock tip, it can pay to listen. R&D expenses were $169.8 million in 2022, up almost 9% year over year. Veru is testing its drug in patients with forms of breast and prostate cancer. Invest better with The Motley Fool. Earlier, shares soared nearly 54%. The agency isn't bound by the panel's vote, though it takes it under consideration. Risk on - This is definitely a risky trade. It's important to note, Veru is asking for an emergency use authorization rather than a full approval for VERU-111 in Covid patients. Wall Street is eyeing more gains from the stock. Avadel Pharmaceuticals plc's (NASDAQ:AVDL) shares are up Monday after the FDA granted final approval to Lumryz, an extended-release formulation of sodium oxybate indicated . We use cookies to understand how you use our site and to improve your experience. Privacy Policy | No cost, no obligation to buy anything ever. Nanox intends to disrupt the world of X-ray technology with a medical imaging device that it says provides 3D digital images for a fraction of the cost of previously available technologies. Join Over Half a Million Premium Members And Get More In-Depth Stock Guidance and Research, Copyright, Trademark and Patent Information. The FDA granted Breakthrough Therapy designation to teplizumab and priority review designation for the marketing application.
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