Here's Why Nanox Stock Soared on Wednesday, Why Shares of Nanox Climbed 10.6% in June, This Controversial Growth Stock Could Be a Brilliant Contrarian Pick, Why Nanox Stock Continued Jumping Higher Today, 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. Ownership data provided by Refinitiv and Estimates data provided by FactSet. 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. The companys net loss was $311.9 million in 2023, wider than $297.4 million in 2021. This implies a negative hedge fund confidence signal in the stock. Reatas stock jumps 175% in premarket trading after FDA approval (MarketWatch) 07:17AM: Why Reata Pharma Shares Are Skyrocketing Today (Benzinga) 07:14AM: Reata expects patients to gain access through insurance and a patient-assistance program. Reata Pharmaceuticals (RETA Quick QuoteRETA - Free Report) stock skyrocketed almost 200% on Wednesday, a day after the FDA approved its drug Skyclarys, or omaveloxolone, across a broad patient population of an ultra-rare disease called Friedreichs ataxia. Click to get this free report Biogen Inc. (BIIB): Free Stock Analysis Report AstraZeneca PLC (AZN): Free Stock Analysis Report Eli. }); Money Morning gives you access to a team of market experts with more than 250 years of combined investing experience for free. Why isn't Reata stock trading even higher after such a landmark approval? The Motley Fool has positions in and recommends Reata Pharmaceuticals. 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. 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. More than 20 million adults in the U.S. suffered from major depressive disorder (MDD) annually before the COVID-19 pandemic, and the number increased to over 80 million adults during the pandemic. That's a big opportunity for a company with a market cap of $3.1 billion at the time of this writing. authenticate users, apply security measures, and prevent spam and abuse, and, display personalised ads and content based on interest profiles, measure the effectiveness of personalised ads and content, and, develop and improve our products and services. 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. From there, it intends to make its money on a per-image basis and from its software. Actual performance may differ significantly from backtested performance. However, the company intends to build its business around its multi-source device, and it didn't have FDA clearance for that one. Additionally, the. But it's necessary for investors to be aware of how much more work the company has to do. . This news caused shares of the. Invest better with The Motley Fool. A simple, equally-weighted average return of all Zacks Rank stocks is calculated to determine the monthly return. Skyclarys is the first drug to be approved specifically for the treatment of Friedreichs ataxia and is also Reatas first commercial product. *Real-time prices by Nasdaq Last Sale. But . Maybe that's the missing thing that Lilly doesn't have. Sign up for free today. The TipRanks Smart Score performance is based on backtested results. Thats on top of the stock almost tripling in the past year. Weitere Informationen ber die Verwendung Ihrer personenbezogenen Daten finden Sie in unserer Datenschutzerklrung und unserer Cookie-Richtlinie. *Average returns of all recommendations since inception. Making the world smarter, happier, and richer. The tablets are expected to be available in the market in the fourth quarter of 2022. Nano-X Imaging ( NNOX) shares jumped more than 45% after the FDA approved Nanox.ARC X-ray system. Catalyst Pharma is looking to get Firdapse approved in the United States for treatment of Lambert-Eaton myasthenic . Visit www.zacksdata.com to get our data and content for your mobile app or website. Recent stocks from this report have soared up to +178.7% in 3 months - this month's picks could be even better. PTC Therapeutics is developing vatiquinone (PTC743) in phase III pivotal studies for children and young adults with Friedreich ataxia. Then it has a donanemab which appears to reduce amyloid plaques compared to placebo in the phase 2 study. Shares of KemPharm skyrocketed as much as 90% on Wednesday after the FDA approved the company's once-daily treatment for ADHD called Azstarys. 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. 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. Axsome is focused on developing therapies for central nervous system (CNS) conditions. Since 1988 it has more than doubled the S&P 500 with an average gain of +24.27% per year. Veru is testing its drug in patients with forms of breast and prostate cancer. The FDA's approval of Azstarys, will earn. 2000-2023 Investor's Business Daily, LLC. Find out more about how we use your personal data in our privacy policy and cookie policy. Although they said it was stopped, and then the data came out later that showed that it was actually stopped because it wasn't working. Are there any other stocks investors might want to check out as well? Your email address will not be published. This expert insight from Fool.com originally ran in May. Now what Nanox stock rose by 60% Monday morning, but it's still down 89% from its all-time high. Tesla stock rose above a key level early Tuesday as China sales rebounded in May, easing concerns. Sign up for our newsletter to get the inside scoop on what traders are talking about delivered daily to your inbox. Delayed quotes by FIS. 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. I'm not sure. Please note all regulatory considerations regarding the presentation of fees must be taken into account. Authors may own the stocks they discuss. Why Is SoFi Stock Down After Earnings? 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). Biogen ( BIIB 1.28%) stock skyrocketed. 04:03 PM ET 04/25/2023. ET One is Biogen's partner. See. However, the company still has a long road ahead. ET, Nanox stock was up by a whopping 60%. Importantly, the therapy had received breakthrough therapy designation and was reviewed under priority by the FDA. The FDA granted Breakthrough Therapy designation to teplizumab and priority review designation for the marketing application. Despite the large gains, most analysts still see the stock as a Buy. R&D expenses were $169.8 million in 2022, up almost 9% year over year. As of 10:30 a.m. Moreover, it seemed like the FDA's review process would never end. Markets Close Flat After Eventful Day; MGM, NXPI, CHGG Beat in Q1, Buy the Opportunity in These Stocks After Earnings, Top Stock Reports for AMD, Cigna & Moderna, Market Leader NVIDIA Breaking Out on Volume. Only Zacks Rank stocks included in Zacks hypothetical portfolios at the beginning of each month are included in the return calculations. Is this happening to you frequently? Copyright 2023 Zacks Investment Research | 10 S Riverside Plaza Suite #1600 | Chicago, IL 60606. In Nanox's annual report, filed Monday, management said it received FDA clearance for its multi-source device on April 28. The recommended dosage of Skyclarys is 150 mg taken orally once daily. The FDA gave clearance for Nanox's flagship 3D X-ray imaging device -- a huge development. Orelli: I don't see why not, although I think the difference maybe is that Biogen has this convoluted clinical trial data that also shows that improved cognition in one study. *Average returns of all recommendations since inception. In other words, the road ahead for Nanox isn't just complex, it's also going to be expensive. TipRanks is a comprehensive research tool that helps investors make better, data-driven investment decisions. Why Reata Pharmaceuticals Stock Skyrocketed This Week (Motley Fool)-6.83%. 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. That's right -- they think these 10 stocks are even better buys. Shares of KemPharm skyrocketed as much as 90% on Wednesday after the FDA approved the company's once-daily treatment for ADHD called Azstarys. Reata expects the drug to be available commercially in the second quarter of 2023. Sie knnen Ihre Einstellungen jederzeit ndern, indem Sie auf unseren Websites und Apps auf den Link Datenschutz-Dashboard klicken. Shares of biopharmaceutical company Axsome Therapeutics ( AXSM) are up substantially in today's trading session after its depression therapy gained approval from the U.S. Food and Drug Administration (FDA). Specifically, backtested results do not reflect actual trading or the effect of material economic and market factors on the decision-making process. The Motley Fool has a disclosure policy. There are no currently approved disease-modifying therapies forFriedreichs ataxia, which means Reata will enjoy the first-mover advantage for some time. But Viking announced results on Tuesday from a phase 1 . Access your favorite topics in a personalized feed while you're on the go. ZacksTrade and Zacks.com are separate companies. on May 1, 2023. Also benefits from the approval because it's partnered with Biogen on Aduhelm, and other Alzheimer's disease drugs. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services. 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. You can change your choices at any time by clicking on the 'Privacy dashboard' links on our sites and apps. 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. Join Over Half a Million Premium Members And Get More In-Depth Stock Guidance and Research, Motley Fool Issues Rare All In Buy Alert, Copyright, Trademark and Patent Information. FDA clearance is a big deal for Nanox. This disease, which is usually diagnosed during adolescence, causes progressive loss of coordination, muscle weakness and fatigue, eventually resulting in loss of mobility and finally death. Zacks Equity Research Cost basis and return based on previous market day close. It's important to note, Veru is asking for an emergency use authorization rather than a full approval for VERU-111 in Covid patients. Join Over Half a Million Premium Members And Get More In-Depth Stock Guidance and Research, Motley Fool Issues Rare All In Buy Alert, Copyright, Trademark and Patent Information. The FDA based its approval on Phase 3 results showing Vowst reduced the rate of recurrence of C. diff infection. 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. A developer of cellular therapies to treat cancer and diabetes, this is another one of the biotech penny stocks that could make big moves once it has updates from the FDA. 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. Each of the company logos represented herein are trademarks of Microsoft Corporation; Dow Jones & Company; Nasdaq, Inc.; Forbes Media, LLC; Investor's Business Daily, Inc.; and Morningstar, Inc. Youre reading a free article with opinions that may differ from The Motley Fools Premium Investing Services. 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. And each of these steps comes with execution risks. Backtested results are calculated by the retroactive application of a model constructed on the basis of historical data and based on assumptions integral to the model which may or may not be testable and are subject to losses. Certain Zacks Rank stocks for which no month-end price was available, pricing information was not collected, or for certain other reasons have been excluded from these return calculations. That's right -- they think these 10 stocks are even better buys. The profusion of opinions on social media and financial blogs makes it impossible to distinguish between real growth potential and pure hype. The Centers for Disease Control and Prevention estimatesthat8.4% of children and 2.5% of adults in the US have ADHD. Youre reading a free article with opinions that may differ from The Motley Fools 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. This includes personalizing content and advertising. The analyst expects Fotivda to rule the roost, at least until generics enter in . Your email address will not be published. Backtested performance is not an indicator of future actual results. Further, backtesting allows the security selection methodology to be adjusted until past returns are maximized. Nanox.ARC is a "multi-source digital 3D tomosynthesis system that utilizes novel, cold cathode X-ray tubes." The stock jumped nearly 26% year to date by early March. Skyclarys is the first FDA-approved treatment for the ultra-rare genetic disorder. The U.S. Food and Drug Administration (FDA) could approve the drug as early as late 2023. If approved, commercial sales from Narcan could jump to over $200 million, as projected by Indivior. The company hit highs of $18.72 per share on December 18 of last year and has seen its stock fall since, but the recent FDA approval was a game-changer for the biotech firm, accord to the company's CEO. Click here to jump to comments. ALLISON GATLIN. It needs to manufacture, find places to install, ship, and deploy its machines. The FDA has approved KemPharm's once-daily treatment for ADHD, AZSTARYS. It is uncertain whether or not it will be marketed as Mounjaro in the weight-loss indication if it's approved. Youre reading a free article with opinions that may differ from The Motley Fools Premium Investing Services. 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. Shares have a strong Relative Strength Rating of 94 out of a best-possible 99. Brian Orelli, PhD has no position in any of the stocks mentioned. That makes the FDA's approval of Nanox.CLOUD just as important as its approval of the device itself. 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. The prodrug was praised by Dr. Ann Childress, President of the Center for Psychiatry and Behavioral Medicine. Sales for cancer drug Verzenio skyrocketed 60% to almost $751 million. From there, it intends to make its money on a per-image basis and from its software. Biogen gains as Medicare to cover new Alzheimer's drug with full FDA approval Apr. They just revealed what they believe are the ten best stocks for investors to buy right now and Eli Lilly and Company wasn't one of them! These returns cover a period from January 1, 1988 through April 3, 2023. "Today's approval highlights both the value potential of SDX, our prodrug of d-MPH, and the ability of our LAT platform technology to develop new prodrugs of approved medications that improve one or more of the attributes of the parent drug," the CEO added. Earnings of eFFECTOR Therapeutics beat estimates in each of the trailing four quarters. Amazon Leads 5 Stocks Near Buy Points Post-Earnings. 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. Certain assumptions have been made for modeling purposes and are unlikely to be realized. Only patients bilirubin levels and lipid parameters should be monitored prior to the initiation of Skyclarys. Could Government Drug-Price Negotiations Sound The Death Knell For Biotech Stocks? In particular, Lilly has high hopes for Alzheimer's. But it's necessary for investors to be aware of how much more work the company has to do. No cash balance or cash flow is included in the calculation. 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. 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 agency isn't bound by the panel's vote, though it takes it under consideration. 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. Axsome shares have exploded today after its depression therapy won approval from the FDA. In addition to the approval, the FDA also granted Reata a rare pediatric disease priority review voucher. Entering text into the input field will update the search result below. PTC Therapeutics expects to report results from the MOVE-FAphase III study on vatiquinone in the second quarter of 2023. Bei der Nutzung unserer Websites und Apps verwenden wir, unsere Websites und Apps fr Sie bereitzustellen, Nutzer zu authentifizieren, Sicherheitsmanahmen anzuwenden und Spam und Missbrauch zu verhindern, und, Ihre Nutzung unserer Websites und Apps zu messen, personalisierte Werbung und Inhalte auf der Grundlage von Interessenprofilen anzuzeigen, die Effektivitt von personalisierten Anzeigen und Inhalten zu messen, sowie, unsere Produkte und Dienstleistungen zu entwickeln und zu verbessern. Speights: Brian, do you think the fact that the FDA has granted accelerated approval for Aduhelm. 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). We, Yahoo, are part of the Yahoo family of brands. The results reflect performance of a strategy not historically offered to investors and does not represent returns that any investor actually attained. As of 10:30 a.m. Or to contact Money Morning Customer Service, click here. eFFECTOR Therapeutics is expected to report its fourth-quarter results next month. NYSE and AMEX data is at least 20 minutes delayed. Because it didn't seem like it was working and then they passed the data and looked at only the patients who got a high level of the drug, and they showed that it works. 2023 Money Morning All Rights Reserved. If you do not want us and our partners to use cookies and personal data for these additional purposes, click 'Reject all'. Further, a TipRanks Smart Score of 7 indicates Axsome shares could outperform the broader indices in the coming periods. Is Eli Lilly Stock a No-Brainer Buy After Mounjaro's Latest Big Win? Brian Orelli: Yeah. JPMorgan Rescues First Republic. /* load placement for account: Money Map Press, That makes the FDA's approval of Nanox.CLOUD just as important as its approval of the device itself. If you have an ad-blocker enabled you may be blocked from proceeding. Therefore, there's financial risk to be aware of as well. At the center of everything we do is a strong commitment to independent research and sharing its profitable discoveries with investors. PTC Therapeutics vatiquinone has been granted Orphan Drug Designation and Fast Track Designation by the FDA. I guess I don't agree with the FDA, so I don't know. As of 10:30 a.m. Get market updates, educational videos, webinars, and stock analysis. 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. In short, this stock's price is prone to strong, emotion-driven moves propelled by both bulls and bears. 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. Orelli: That trades over-the-counter. This page has not been authorized, sponsored, or otherwise approved or endorsed by the companies represented herein. ET, Nanox stock was up by a whopping 60%. In short, this stock's price is prone to strong, emotion-driven moves propelled by both bulls and bears. Cost basis and return based on previous market day close. The FDA's approval of Azstarys, will earn KemPharm a . Total revenues, comprising collaboration revenues, were $2.2 million in 2022 compared with $11.5 million in 2021. 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. The company's pipeline features several promising programs, as well. ados.run = ados.run || []; And each of these steps comes with execution risks. Nanox.ARC is a "multi-source digital 3D tomosynthesis system that utilizes novel, cold cathode X . Save my name, email, and website in this browser for the next time I comment. Shares of Reata have surged 200.3% in the past year against theindustrys 9.9% decline. ados.run.push(function() { PTC Therapeutics, Inc. (PTCT) - free report >>, Reata Pharmaceuticals, Inc. (RETA) - free report >>, eFFECTOR Therapeutics, Inc. (EFTR) - free report >>. Learn how you can make more money with IBD's investing tools, top-performing stock lists, and educational content. 04:15 PM ET 06/03/2022. Making the world smarter, happier, and richer. Avadel stock rises on FDA nod to import sleep disorder drug Lumryz ahead of potential approval, Avadel: Sleeping Soundly, Why We're Giving A 'Buy' Rating Ahead Of Lumryz Launch, With the approval, Lumryz becomes the first once-at-bedtime oxybate indicated, Due to the potential for abuse and misuse, Lumryz comes with a boxed warning, and its availability is restricted under a Risk, In February, following a patent win over Jazz Pharma (. Friedreichs ataxia is an ultra-rare genetic, progressive, neurodegenerative movement disorder that affects approximately 5,000 diagnosed patients in the United States. Make more money in stocks with 2 months of access to IBD Digital for only $20! Nanox stock rose by 60% Monday morning, but it's still down 89% from its all-time high. However, the company still has a long road ahead. 89BIOs earnings beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 10.08%. The FDA has also not issued any post-approval requirements. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services. By clicking Sign up, you agree to receive marketing emails from Insider But both camps should strive to keep emotions in check. Shares of 89BIO have increased 249.1% in the past year. If it surprisingly goes in the opposite direction, the stock could have an exaggerated move. Skyclarys, for its part, is expected to rake in approximately $400 million in U.S. sales in 2030. Learn how to trade stocks like a pro with just 3 email lessons! 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. By Mary de Wet. 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). Wall Street is eyeing more gains from the stock. General assumptions include: XYZ firm would have been able to purchase the securities recommended by the model and the markets were sufficiently liquid to permit all trading. For the past decade, we have developed and perfected technology designed to help private investors, just like you, find the best opportunities, with the greatest upside potential, in any financial climate., Invest Like a Pro with Unique Data & Simplifed Tools, Axsome Therapeutics to Present Five Abstracts Including New Data from the Positive SHARP Study of SUNOSI (solriamfetol) in Participants with Cognitive Impairment with Excessive Daytime Sleepiness in Obstructive Sleep Apnea at the 2023 American Academy of Neurology (AAN) Annual Meeting, Axsome Therapeutics to Present at the 22nd Annual Needham Virtual Healthcare Conference, Axsome Therapeutics to Report First Quarter 2023 Financial Results on May 8. 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 . According to itsbusiness 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. See our report's 7 new picks today, absolutely FREE. But both camps should strive to keep emotions in check. Still, Veru stock surged to a two-month high Monday. Protected by copyright of the United States and international treaties. Wall Street Thinks This Growth Stock Could Blast Off by 358%, but Should You Buy It Today? ados_add_placement(9794, 307044, "azk740606", 2629) That doesn't mean Nanox will fail -- indeed, it could overcome each subsequent hurdle with flying colors. The monthly returns are then compounded to arrive at the annual return. 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. The . No representations and warranties are made as to the reasonableness of the assumptions. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. One of its devices, its single-source device, received FDA clearance way back in April 2021. Ann Childress, M.D. Early commercial-stage drugs tend to take a few quarters to begin to penetrate the market. 06:43AM: Reata (RETA) Stock Jumps as FDA Approves Rare Disease Drug . Although prodrugs aren't well known, an estimated 10% of drugs worldwide are considered to be prodrugs. The results were so successful that independent experts said Veru could stop the study early. I noticed that Eli Lilly (LLY 2.51%) stock, ticker there is LLY. This information is provided for illustrative purposes only. The information and content are subject to change without notice. An example of the value driving power of a good late-stage clinical readout is Sage Therapeutics (NASDAQ: SAGE) shares skyrocketed as much as 85 percent to hit a record high after announcing. as well as other partner offers and accept our, Registration on or use of this site constitutes acceptance of our. This dedication to giving investors a trading advantage led to the creation of our proven Zacks Rank stock-rating system. *Stock Advisor returns as of June 7, 2021. If you're a patient investor, I think the answer is yes. ET, Nanox stock was up by a whopping 60%. I think the idea is that if the FDA is going to improve things just based on amyloid plaque removal, then maybe Lilly can submit one or both of these drugs and try to get them approved.
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