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2025 Kvartalsrapport (Q2) | 8. aug. | |
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- 31. jan. 2022 · Endret31. jan. 2022 · EndretCLSD INSIDE OWNERSHIP at $1.69 ⚡️🍀🤑 since yesterday it’s 6% up... lets hope it stay up. Took small portion playing with 1000 stocks to stay safe side Investors who take an interest in Clearside Biomedical, Inc. (NASDAQ:CLSD) should definitely note that insider Bradford Whitmore recently paid US$1.69 per share to buy US$105k worth of the stock. Although the purchase only increased their holding by 2.1%, it is still a solid purchase in our view. https://www.google.co.uk/amp/s/simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-clsd/clearside-biomedical/news/bradford-whitmore-of-clearside-biomedical-inc-nasdaqclsd-jus/amp Bradford Whitmore of Clearside Biomedical, Inc. (NASDAQ:CLSD) Just Spent US$105k On Shares BySimply Wall StPublished2020-11-19T04:53:37.310Z NasdaqGM:CLSD Investors who take an interest in Clearside Biomedical, Inc. (NASDAQ:CLSD) should definitely note that insider Bradford Whitmore recently paid US$1.69 per share to buy US$105k worth of the stock. Although the purchase only increased their holding by 2.1%, it is still a solid purchase in our view. View our latest analysis for Clearside Biomedical The Last 12 Months Of Insider Transactions At Clearside Biomedical Notably, that recent purchase by insider Bradford Whitmore was not the only time they bought Clearside Biomedical shares this year. They previously made an even bigger purchase of US$572k worth of shares at a price of US$1.65 per share. That means that an insider was happy to buy shares at around the current price of US$1.70. While their view may have changed since the purchase was made, this does at least suggest they have had confidence in the company's future. If someone buys shares at well below current prices, it's a good sign on balance, but keep in mind they may no longer see value. The good news for Clearside Biomedical share holders is that insiders were buying at near the current price. In the last twelve months Clearside Biomedical insiders were buying shares, but not selling. The chart below shows insider transactions (by companies and individuals) over the last year. If you click on the chart, you can see all the individual transactions, including the share price, individual, and the date! insider-trading-volume NasdaqGM:CLSD Insider Trading Volume November 19th 2020 Clearside Biomedical is not the only stock that insiders are buying. For those who like to find winning investments this free list of growing companies with recent insider purchasing, could be just the ticket. Insider Ownership Another way to test the alignment between the leaders of a company and other shareholders is to look at how many shares they own. We usually like to see fairly high levels of insider ownership. From our data, it seems that Clearside Biomedical insiders own 7.9% of the company, worth about US$6.5m. Whilst better than nothing, we're not overly impressed by these holdings. So What Does This Data Suggest About Clearside Biomedical Insiders? It is good to see the recent insider purchase. And the longer term insider transactions also give us confidence. But we don't feel the same about the fact the company is making losses. We would certainly prefer see higher levels of insider ownership but analysis of the insider transactions suggests that Clearside Biomedical insiders are expecting a bright future. So these insider transactions can help us build a thesis about the stock, but it's also worthwhile knowing the risks facing this company. Our analysis shows 4 warning signs for Clearside Biomedical (1 is concerning!) and we strongly recommend you look at them before investing. If you would prefer to check out another company -- one with potentially superior financials -- then do not miss this free list of interesting companies, that have HIGH return on equity and low debt. For the purposes of this article, insiders are those individuals who report their transactions to the relevant regulatory body. We currently account for open market transactions and private dispositions, but not derivative transactions. Promoted If you decide to trade Clearside Biomedical, use the lowest-cost* platform that is rated #1 Overall by Barron’s, Interactive Brokers. Trade stocks, options, futures, forex, bonds and funds on 135 markets, all from a single integrated account. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. *Interactive Brokers Rated Lowest Cost Broker by StockBrokers.com Annual Online Review 2020
- 31. jan. 2022 · Endret31. jan. 2022 · Endrethttps://www.nasdaq.com/press-release/clearside-biomedical-announces-data-presentations-at-the-american-academy Clearside Biomedical Announces Data Presentations at the American Academy Ophthalmology (AAO) 2020 Annual Meeting and Publication on the Suprachoroidal Injection Procedure in Translational Vision Science and Technology PUBLISHED NOV 16, 2020 7:05AM EST ALPHARETTA, Ga., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that two presentations of Clearside preclinical and clinical data were given at the virtual American Academy Ophthalmology (AAO) 2020 Annual Meeting. Clearside also announced a clinical characterization of the suprachoroidal injection procedure across three retinal disorders was published in the Association for Research in Vision and Ophthalmology (ARVO) peer-reviewed, Medline-indexed journal, Translational Vision Science and Technology, which can be accessed here. The data described in this paper demonstrate that suprachoroidal injection was well accepted by physician-investigators, and that the device and procedure may accommodate a wide range of anatomic and demographic variables. These data suggest that suprachoroidal injection could be readily adopted in clinical practice for targeted, compartmentalized delivery of ocular therapies. “Reflecting on the past year, I am grateful to our team and the numerous physicians and researchers who have delivered 33 presentations on our assets and suprachoroidal space (SCS®) injection platform during 2020,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. “In addition to our conference presentations, we have placed four publications in peer reviewed journals to further educate the medical community on our clinical progress. This coverage and attention on our programs have established Clearside as the leader in suprachoroidal delivery. We look forward to continuing to advance our suprachoroidal delivery programs with data expected in 2021 from our CLS-AX (axitinib injectable suspension) Phase 1/2a clinical trial, and our integrin inhibitor preclinical studies.” Dr. Ciulla continued, “In addition to our internal progress, we are pleased with the advancements of our clinical development partners. This weekend at the AAO conference, suprachoroidal delivery was featured by our gene therapy partner, REGENXBIO, as well as in a late breaking presentation from Aura Biosciences in choroidal melanoma. Both of these companies are using our SCS Microinjector® to deliver their assets into the suprachoroidal space.” Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)Authors: Robert Bhisitkul; Viral Kansara; Thomas CiullaConclusions: CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection. Axitinib has intrinsic high potency and pan-VEGF inhibition through receptor blockade. In pharmacokinetic studies, CLS-AX demonstrated prolonged duration. The U.S. Food and Drug Administration has accepted Clearside’s Investigational New Drug Application and a Phase 1/2a clinical trial in wet age-related macular degeneration (wet AMD) is expected to initiate by the end of 2020. Title: Systemic Therapy and Efficacy of CLS-TA: Results from the Phase 3 PEACHTREE Clinical Trial Authors: Quan Nguyen; Thomas Ciulla Conclusions: These post hoc results corroborate the pre-specified study analyses in the PEACHTREE trial. The visual acuity and macular edema improvements associated with suprachoroidally injected CLS-TA versus the control in treating macular edema associated with noninfectious uveitis, was noted regardless of administration of systemic therapy at baseline. About Clearside’s Suprachoroidal Space (SCS®) Injection Platform Clearside’s patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside’s proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. Clearside’s unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy. About CLS-AX (axitinib injectable suspension) CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD. About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye and being investigated for the treatment of macular edema associated with non-infectious uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (“Bausch Health”) (NYSE/TSX: BHC), has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and exclusive options for the right to commercialize and develop XIPERE in Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health’s affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea. About Clearside Biomedical Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. Clearside’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX and XIPERE, including the timing of initiation of and data from the Phase 1/2a clinical trial for CLS-AX in wet AMD, as well as the timing of data from preclinical studies in Clearside’s integrin inhibitor program. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 13, 2020, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor and Media Contacts:Jenny Kobin Remy Bernarda ir@clearsidebio.com(678) 430-8206 Source: Clearside Biomedical, Inc. logo color s and clearside.jpg Clearside Biomedical, Inc. IN THIS STORY
- 31. jan. 2022 · Endret31. jan. 2022 · Endrethttps://www.nasdaq.com/articles/a-stock-to-consider-as-biotech-solutions-proliferate-2020-11-12 A Stock to Consider as Biotech Solutions Proliferate CONTRIBUTOR Martin Tillier PUBLISHED NOV 12, 2020 11:04AM EST Biotech - Shutterstock photo CREDIT: SHUTTERSTOCK PHOTO FEATURED IN SMART INVESTING Learn More One of the things that has struck me as the pharma industry has come up with a response to Covid-19 is just how mainstream the once niche area of biotech has become, and how dependent we have become on what are known as “large molecule” therapies. Basically, the first place we now look for solutions to medical problems is within our own bodies, rather than chemistry, for answers. The fact that biotech solutions to a novel virus were sought -- and hopefully found -- shouldn’t come as much of a surprise, given the medical fields that biotech already serves. My wife, for example, works for a (privately owned) pharma company in the dermatology field. That is an area traditionally served primarily by creams and the like, but they too are launching a monoclonal antibody next year. It seems that there is a shift away from treating symptoms with chemical compounds and towards attacking diseases within the body. That is true in another area of medicine that may not immediately occur to some people: ophthalmology. We tend to think of drops and surgeries to treat eye diseases, but here too, there is a movement towards biotech solutions. One company that specializes in those therapies is Clearside Biomedical (CLSD). When I first came across Clearside, I was reluctant to write about it or buy the stock myself, for a few reasons (Full disclosure: I intend to buy this stock within the next day or two). First and foremost, the chart is not exactly inspiring: There are a few reasons for that. Other firms have already launched therapies in the space, giving them first to market advantage. As with all small biotech firms, cash flow at this point in the process has been a worry. Trials are being conducted and preparations made for a product launch, and all of that costs money at a time when sales are basically zero. Companies like Clearside often receive advance payments from licensing partners when they hit development milestones, but it is often uncertain whether they will enable the company to last through the later stages of development without selling the family jewels to stay afloat. The first of those issues don’t worry me in this case. First to market can be a plus, but it can also be a negative. The first product to market uncovers potential problems and patient resistance to new treatments, and has to work to overcome this, often making subsequent entrants easier and cheaper to launch. In addition, CLSD’s lead candidate right now, CLS-AX, targets wet AMD (Age-related Macular Degeneration), a market that has plenty of room for multiple therapies, because AMD affects over 11 million people in America right now. That patient population is predicted to double by 2050 as the U.S. population continues to skew older. Cash burn is a more worrying problem, but recent news here allays some of the fears about that for CLSD. Their Q3 results released on Thursday showed a lower loss than expected, and most analysts now believe that the company has enough cash and projected cash flow to last until around Q3 2021. That should give time for a product launch, assuming good trial results, and the better than expected numbers this quarter are a good sign that the company’s management has a handle on the potential problem. Obviously, a stock like CLSD is not for everybody. It is a high risk/high reward play, but if you are able to bear that degree of risk, it looks like a decent way to play the march towards the ubiquity of biotech in general. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
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- 31. jan. 2022 · Endret31. jan. 2022 · EndretCLSD INSIDE OWNERSHIP at $1.69 ⚡️🍀🤑 since yesterday it’s 6% up... lets hope it stay up. Took small portion playing with 1000 stocks to stay safe side Investors who take an interest in Clearside Biomedical, Inc. (NASDAQ:CLSD) should definitely note that insider Bradford Whitmore recently paid US$1.69 per share to buy US$105k worth of the stock. Although the purchase only increased their holding by 2.1%, it is still a solid purchase in our view. https://www.google.co.uk/amp/s/simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-clsd/clearside-biomedical/news/bradford-whitmore-of-clearside-biomedical-inc-nasdaqclsd-jus/amp Bradford Whitmore of Clearside Biomedical, Inc. (NASDAQ:CLSD) Just Spent US$105k On Shares BySimply Wall StPublished2020-11-19T04:53:37.310Z NasdaqGM:CLSD Investors who take an interest in Clearside Biomedical, Inc. (NASDAQ:CLSD) should definitely note that insider Bradford Whitmore recently paid US$1.69 per share to buy US$105k worth of the stock. Although the purchase only increased their holding by 2.1%, it is still a solid purchase in our view. View our latest analysis for Clearside Biomedical The Last 12 Months Of Insider Transactions At Clearside Biomedical Notably, that recent purchase by insider Bradford Whitmore was not the only time they bought Clearside Biomedical shares this year. They previously made an even bigger purchase of US$572k worth of shares at a price of US$1.65 per share. That means that an insider was happy to buy shares at around the current price of US$1.70. While their view may have changed since the purchase was made, this does at least suggest they have had confidence in the company's future. If someone buys shares at well below current prices, it's a good sign on balance, but keep in mind they may no longer see value. The good news for Clearside Biomedical share holders is that insiders were buying at near the current price. In the last twelve months Clearside Biomedical insiders were buying shares, but not selling. The chart below shows insider transactions (by companies and individuals) over the last year. If you click on the chart, you can see all the individual transactions, including the share price, individual, and the date! insider-trading-volume NasdaqGM:CLSD Insider Trading Volume November 19th 2020 Clearside Biomedical is not the only stock that insiders are buying. For those who like to find winning investments this free list of growing companies with recent insider purchasing, could be just the ticket. Insider Ownership Another way to test the alignment between the leaders of a company and other shareholders is to look at how many shares they own. We usually like to see fairly high levels of insider ownership. From our data, it seems that Clearside Biomedical insiders own 7.9% of the company, worth about US$6.5m. Whilst better than nothing, we're not overly impressed by these holdings. So What Does This Data Suggest About Clearside Biomedical Insiders? It is good to see the recent insider purchase. And the longer term insider transactions also give us confidence. But we don't feel the same about the fact the company is making losses. We would certainly prefer see higher levels of insider ownership but analysis of the insider transactions suggests that Clearside Biomedical insiders are expecting a bright future. So these insider transactions can help us build a thesis about the stock, but it's also worthwhile knowing the risks facing this company. Our analysis shows 4 warning signs for Clearside Biomedical (1 is concerning!) and we strongly recommend you look at them before investing. If you would prefer to check out another company -- one with potentially superior financials -- then do not miss this free list of interesting companies, that have HIGH return on equity and low debt. For the purposes of this article, insiders are those individuals who report their transactions to the relevant regulatory body. We currently account for open market transactions and private dispositions, but not derivative transactions. Promoted If you decide to trade Clearside Biomedical, use the lowest-cost* platform that is rated #1 Overall by Barron’s, Interactive Brokers. Trade stocks, options, futures, forex, bonds and funds on 135 markets, all from a single integrated account. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. *Interactive Brokers Rated Lowest Cost Broker by StockBrokers.com Annual Online Review 2020
- 31. jan. 2022 · Endret31. jan. 2022 · Endrethttps://www.nasdaq.com/press-release/clearside-biomedical-announces-data-presentations-at-the-american-academy Clearside Biomedical Announces Data Presentations at the American Academy Ophthalmology (AAO) 2020 Annual Meeting and Publication on the Suprachoroidal Injection Procedure in Translational Vision Science and Technology PUBLISHED NOV 16, 2020 7:05AM EST ALPHARETTA, Ga., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that two presentations of Clearside preclinical and clinical data were given at the virtual American Academy Ophthalmology (AAO) 2020 Annual Meeting. Clearside also announced a clinical characterization of the suprachoroidal injection procedure across three retinal disorders was published in the Association for Research in Vision and Ophthalmology (ARVO) peer-reviewed, Medline-indexed journal, Translational Vision Science and Technology, which can be accessed here. The data described in this paper demonstrate that suprachoroidal injection was well accepted by physician-investigators, and that the device and procedure may accommodate a wide range of anatomic and demographic variables. These data suggest that suprachoroidal injection could be readily adopted in clinical practice for targeted, compartmentalized delivery of ocular therapies. “Reflecting on the past year, I am grateful to our team and the numerous physicians and researchers who have delivered 33 presentations on our assets and suprachoroidal space (SCS®) injection platform during 2020,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. “In addition to our conference presentations, we have placed four publications in peer reviewed journals to further educate the medical community on our clinical progress. This coverage and attention on our programs have established Clearside as the leader in suprachoroidal delivery. We look forward to continuing to advance our suprachoroidal delivery programs with data expected in 2021 from our CLS-AX (axitinib injectable suspension) Phase 1/2a clinical trial, and our integrin inhibitor preclinical studies.” Dr. Ciulla continued, “In addition to our internal progress, we are pleased with the advancements of our clinical development partners. This weekend at the AAO conference, suprachoroidal delivery was featured by our gene therapy partner, REGENXBIO, as well as in a late breaking presentation from Aura Biosciences in choroidal melanoma. Both of these companies are using our SCS Microinjector® to deliver their assets into the suprachoroidal space.” Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)Authors: Robert Bhisitkul; Viral Kansara; Thomas CiullaConclusions: CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection. Axitinib has intrinsic high potency and pan-VEGF inhibition through receptor blockade. In pharmacokinetic studies, CLS-AX demonstrated prolonged duration. The U.S. Food and Drug Administration has accepted Clearside’s Investigational New Drug Application and a Phase 1/2a clinical trial in wet age-related macular degeneration (wet AMD) is expected to initiate by the end of 2020. Title: Systemic Therapy and Efficacy of CLS-TA: Results from the Phase 3 PEACHTREE Clinical Trial Authors: Quan Nguyen; Thomas Ciulla Conclusions: These post hoc results corroborate the pre-specified study analyses in the PEACHTREE trial. The visual acuity and macular edema improvements associated with suprachoroidally injected CLS-TA versus the control in treating macular edema associated with noninfectious uveitis, was noted regardless of administration of systemic therapy at baseline. About Clearside’s Suprachoroidal Space (SCS®) Injection Platform Clearside’s patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside’s proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. Clearside’s unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy. About CLS-AX (axitinib injectable suspension) CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD. About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye and being investigated for the treatment of macular edema associated with non-infectious uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (“Bausch Health”) (NYSE/TSX: BHC), has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and exclusive options for the right to commercialize and develop XIPERE in Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health’s affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea. About Clearside Biomedical Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. Clearside’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX and XIPERE, including the timing of initiation of and data from the Phase 1/2a clinical trial for CLS-AX in wet AMD, as well as the timing of data from preclinical studies in Clearside’s integrin inhibitor program. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 13, 2020, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor and Media Contacts:Jenny Kobin Remy Bernarda ir@clearsidebio.com(678) 430-8206 Source: Clearside Biomedical, Inc. logo color s and clearside.jpg Clearside Biomedical, Inc. IN THIS STORY
- 31. jan. 2022 · Endret31. jan. 2022 · Endrethttps://www.nasdaq.com/articles/a-stock-to-consider-as-biotech-solutions-proliferate-2020-11-12 A Stock to Consider as Biotech Solutions Proliferate CONTRIBUTOR Martin Tillier PUBLISHED NOV 12, 2020 11:04AM EST Biotech - Shutterstock photo CREDIT: SHUTTERSTOCK PHOTO FEATURED IN SMART INVESTING Learn More One of the things that has struck me as the pharma industry has come up with a response to Covid-19 is just how mainstream the once niche area of biotech has become, and how dependent we have become on what are known as “large molecule” therapies. Basically, the first place we now look for solutions to medical problems is within our own bodies, rather than chemistry, for answers. The fact that biotech solutions to a novel virus were sought -- and hopefully found -- shouldn’t come as much of a surprise, given the medical fields that biotech already serves. My wife, for example, works for a (privately owned) pharma company in the dermatology field. That is an area traditionally served primarily by creams and the like, but they too are launching a monoclonal antibody next year. It seems that there is a shift away from treating symptoms with chemical compounds and towards attacking diseases within the body. That is true in another area of medicine that may not immediately occur to some people: ophthalmology. We tend to think of drops and surgeries to treat eye diseases, but here too, there is a movement towards biotech solutions. One company that specializes in those therapies is Clearside Biomedical (CLSD). When I first came across Clearside, I was reluctant to write about it or buy the stock myself, for a few reasons (Full disclosure: I intend to buy this stock within the next day or two). First and foremost, the chart is not exactly inspiring: There are a few reasons for that. Other firms have already launched therapies in the space, giving them first to market advantage. As with all small biotech firms, cash flow at this point in the process has been a worry. Trials are being conducted and preparations made for a product launch, and all of that costs money at a time when sales are basically zero. Companies like Clearside often receive advance payments from licensing partners when they hit development milestones, but it is often uncertain whether they will enable the company to last through the later stages of development without selling the family jewels to stay afloat. The first of those issues don’t worry me in this case. First to market can be a plus, but it can also be a negative. The first product to market uncovers potential problems and patient resistance to new treatments, and has to work to overcome this, often making subsequent entrants easier and cheaper to launch. In addition, CLSD’s lead candidate right now, CLS-AX, targets wet AMD (Age-related Macular Degeneration), a market that has plenty of room for multiple therapies, because AMD affects over 11 million people in America right now. That patient population is predicted to double by 2050 as the U.S. population continues to skew older. Cash burn is a more worrying problem, but recent news here allays some of the fears about that for CLSD. Their Q3 results released on Thursday showed a lower loss than expected, and most analysts now believe that the company has enough cash and projected cash flow to last until around Q3 2021. That should give time for a product launch, assuming good trial results, and the better than expected numbers this quarter are a good sign that the company’s management has a handle on the potential problem. Obviously, a stock like CLSD is not for everybody. It is a high risk/high reward play, but if you are able to bear that degree of risk, it looks like a decent way to play the march towards the ubiquity of biotech in general. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
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- 31. jan. 2022 · Endret31. jan. 2022 · EndretCLSD INSIDE OWNERSHIP at $1.69 ⚡️🍀🤑 since yesterday it’s 6% up... lets hope it stay up. Took small portion playing with 1000 stocks to stay safe side Investors who take an interest in Clearside Biomedical, Inc. (NASDAQ:CLSD) should definitely note that insider Bradford Whitmore recently paid US$1.69 per share to buy US$105k worth of the stock. Although the purchase only increased their holding by 2.1%, it is still a solid purchase in our view. https://www.google.co.uk/amp/s/simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-clsd/clearside-biomedical/news/bradford-whitmore-of-clearside-biomedical-inc-nasdaqclsd-jus/amp Bradford Whitmore of Clearside Biomedical, Inc. (NASDAQ:CLSD) Just Spent US$105k On Shares BySimply Wall StPublished2020-11-19T04:53:37.310Z NasdaqGM:CLSD Investors who take an interest in Clearside Biomedical, Inc. (NASDAQ:CLSD) should definitely note that insider Bradford Whitmore recently paid US$1.69 per share to buy US$105k worth of the stock. Although the purchase only increased their holding by 2.1%, it is still a solid purchase in our view. View our latest analysis for Clearside Biomedical The Last 12 Months Of Insider Transactions At Clearside Biomedical Notably, that recent purchase by insider Bradford Whitmore was not the only time they bought Clearside Biomedical shares this year. They previously made an even bigger purchase of US$572k worth of shares at a price of US$1.65 per share. That means that an insider was happy to buy shares at around the current price of US$1.70. While their view may have changed since the purchase was made, this does at least suggest they have had confidence in the company's future. If someone buys shares at well below current prices, it's a good sign on balance, but keep in mind they may no longer see value. The good news for Clearside Biomedical share holders is that insiders were buying at near the current price. In the last twelve months Clearside Biomedical insiders were buying shares, but not selling. The chart below shows insider transactions (by companies and individuals) over the last year. If you click on the chart, you can see all the individual transactions, including the share price, individual, and the date! insider-trading-volume NasdaqGM:CLSD Insider Trading Volume November 19th 2020 Clearside Biomedical is not the only stock that insiders are buying. For those who like to find winning investments this free list of growing companies with recent insider purchasing, could be just the ticket. Insider Ownership Another way to test the alignment between the leaders of a company and other shareholders is to look at how many shares they own. We usually like to see fairly high levels of insider ownership. From our data, it seems that Clearside Biomedical insiders own 7.9% of the company, worth about US$6.5m. Whilst better than nothing, we're not overly impressed by these holdings. So What Does This Data Suggest About Clearside Biomedical Insiders? It is good to see the recent insider purchase. And the longer term insider transactions also give us confidence. But we don't feel the same about the fact the company is making losses. We would certainly prefer see higher levels of insider ownership but analysis of the insider transactions suggests that Clearside Biomedical insiders are expecting a bright future. So these insider transactions can help us build a thesis about the stock, but it's also worthwhile knowing the risks facing this company. Our analysis shows 4 warning signs for Clearside Biomedical (1 is concerning!) and we strongly recommend you look at them before investing. If you would prefer to check out another company -- one with potentially superior financials -- then do not miss this free list of interesting companies, that have HIGH return on equity and low debt. For the purposes of this article, insiders are those individuals who report their transactions to the relevant regulatory body. We currently account for open market transactions and private dispositions, but not derivative transactions. Promoted If you decide to trade Clearside Biomedical, use the lowest-cost* platform that is rated #1 Overall by Barron’s, Interactive Brokers. Trade stocks, options, futures, forex, bonds and funds on 135 markets, all from a single integrated account. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. *Interactive Brokers Rated Lowest Cost Broker by StockBrokers.com Annual Online Review 2020
- 31. jan. 2022 · Endret31. jan. 2022 · Endrethttps://www.nasdaq.com/press-release/clearside-biomedical-announces-data-presentations-at-the-american-academy Clearside Biomedical Announces Data Presentations at the American Academy Ophthalmology (AAO) 2020 Annual Meeting and Publication on the Suprachoroidal Injection Procedure in Translational Vision Science and Technology PUBLISHED NOV 16, 2020 7:05AM EST ALPHARETTA, Ga., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that two presentations of Clearside preclinical and clinical data were given at the virtual American Academy Ophthalmology (AAO) 2020 Annual Meeting. Clearside also announced a clinical characterization of the suprachoroidal injection procedure across three retinal disorders was published in the Association for Research in Vision and Ophthalmology (ARVO) peer-reviewed, Medline-indexed journal, Translational Vision Science and Technology, which can be accessed here. The data described in this paper demonstrate that suprachoroidal injection was well accepted by physician-investigators, and that the device and procedure may accommodate a wide range of anatomic and demographic variables. These data suggest that suprachoroidal injection could be readily adopted in clinical practice for targeted, compartmentalized delivery of ocular therapies. “Reflecting on the past year, I am grateful to our team and the numerous physicians and researchers who have delivered 33 presentations on our assets and suprachoroidal space (SCS®) injection platform during 2020,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. “In addition to our conference presentations, we have placed four publications in peer reviewed journals to further educate the medical community on our clinical progress. This coverage and attention on our programs have established Clearside as the leader in suprachoroidal delivery. We look forward to continuing to advance our suprachoroidal delivery programs with data expected in 2021 from our CLS-AX (axitinib injectable suspension) Phase 1/2a clinical trial, and our integrin inhibitor preclinical studies.” Dr. Ciulla continued, “In addition to our internal progress, we are pleased with the advancements of our clinical development partners. This weekend at the AAO conference, suprachoroidal delivery was featured by our gene therapy partner, REGENXBIO, as well as in a late breaking presentation from Aura Biosciences in choroidal melanoma. Both of these companies are using our SCS Microinjector® to deliver their assets into the suprachoroidal space.” Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)Authors: Robert Bhisitkul; Viral Kansara; Thomas CiullaConclusions: CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection. Axitinib has intrinsic high potency and pan-VEGF inhibition through receptor blockade. In pharmacokinetic studies, CLS-AX demonstrated prolonged duration. The U.S. Food and Drug Administration has accepted Clearside’s Investigational New Drug Application and a Phase 1/2a clinical trial in wet age-related macular degeneration (wet AMD) is expected to initiate by the end of 2020. Title: Systemic Therapy and Efficacy of CLS-TA: Results from the Phase 3 PEACHTREE Clinical Trial Authors: Quan Nguyen; Thomas Ciulla Conclusions: These post hoc results corroborate the pre-specified study analyses in the PEACHTREE trial. The visual acuity and macular edema improvements associated with suprachoroidally injected CLS-TA versus the control in treating macular edema associated with noninfectious uveitis, was noted regardless of administration of systemic therapy at baseline. About Clearside’s Suprachoroidal Space (SCS®) Injection Platform Clearside’s patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside’s proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. Clearside’s unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy. About CLS-AX (axitinib injectable suspension) CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD. About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye and being investigated for the treatment of macular edema associated with non-infectious uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (“Bausch Health”) (NYSE/TSX: BHC), has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and exclusive options for the right to commercialize and develop XIPERE in Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health’s affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea. About Clearside Biomedical Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. Clearside’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX and XIPERE, including the timing of initiation of and data from the Phase 1/2a clinical trial for CLS-AX in wet AMD, as well as the timing of data from preclinical studies in Clearside’s integrin inhibitor program. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 13, 2020, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor and Media Contacts:Jenny Kobin Remy Bernarda ir@clearsidebio.com(678) 430-8206 Source: Clearside Biomedical, Inc. logo color s and clearside.jpg Clearside Biomedical, Inc. IN THIS STORY
- 31. jan. 2022 · Endret31. jan. 2022 · Endrethttps://www.nasdaq.com/articles/a-stock-to-consider-as-biotech-solutions-proliferate-2020-11-12 A Stock to Consider as Biotech Solutions Proliferate CONTRIBUTOR Martin Tillier PUBLISHED NOV 12, 2020 11:04AM EST Biotech - Shutterstock photo CREDIT: SHUTTERSTOCK PHOTO FEATURED IN SMART INVESTING Learn More One of the things that has struck me as the pharma industry has come up with a response to Covid-19 is just how mainstream the once niche area of biotech has become, and how dependent we have become on what are known as “large molecule” therapies. Basically, the first place we now look for solutions to medical problems is within our own bodies, rather than chemistry, for answers. The fact that biotech solutions to a novel virus were sought -- and hopefully found -- shouldn’t come as much of a surprise, given the medical fields that biotech already serves. My wife, for example, works for a (privately owned) pharma company in the dermatology field. That is an area traditionally served primarily by creams and the like, but they too are launching a monoclonal antibody next year. It seems that there is a shift away from treating symptoms with chemical compounds and towards attacking diseases within the body. That is true in another area of medicine that may not immediately occur to some people: ophthalmology. We tend to think of drops and surgeries to treat eye diseases, but here too, there is a movement towards biotech solutions. One company that specializes in those therapies is Clearside Biomedical (CLSD). When I first came across Clearside, I was reluctant to write about it or buy the stock myself, for a few reasons (Full disclosure: I intend to buy this stock within the next day or two). First and foremost, the chart is not exactly inspiring: There are a few reasons for that. Other firms have already launched therapies in the space, giving them first to market advantage. As with all small biotech firms, cash flow at this point in the process has been a worry. Trials are being conducted and preparations made for a product launch, and all of that costs money at a time when sales are basically zero. Companies like Clearside often receive advance payments from licensing partners when they hit development milestones, but it is often uncertain whether they will enable the company to last through the later stages of development without selling the family jewels to stay afloat. The first of those issues don’t worry me in this case. First to market can be a plus, but it can also be a negative. The first product to market uncovers potential problems and patient resistance to new treatments, and has to work to overcome this, often making subsequent entrants easier and cheaper to launch. In addition, CLSD’s lead candidate right now, CLS-AX, targets wet AMD (Age-related Macular Degeneration), a market that has plenty of room for multiple therapies, because AMD affects over 11 million people in America right now. That patient population is predicted to double by 2050 as the U.S. population continues to skew older. Cash burn is a more worrying problem, but recent news here allays some of the fears about that for CLSD. Their Q3 results released on Thursday showed a lower loss than expected, and most analysts now believe that the company has enough cash and projected cash flow to last until around Q3 2021. That should give time for a product launch, assuming good trial results, and the better than expected numbers this quarter are a good sign that the company’s management has a handle on the potential problem. Obviously, a stock like CLSD is not for everybody. It is a high risk/high reward play, but if you are able to bear that degree of risk, it looks like a decent way to play the march towards the ubiquity of biotech in general. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
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200
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Høy
0,47VWAP
Lav
0,431OmsetningAntall
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VWAP
Høy
0,47Lav
0,431OmsetningAntall
0,1 356 816
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