Missed connection with the online dating IPO? Opportunity is knocking on another chance at a meet-cute.
Insert "adjuvanted" before "COVID-19 vaccine" in first and fifth paragraphs.
Deputy Prime Minister Heng Swee Keat has “left behind big shoes to fill” at the Ministry of Finance (MOF), said Education Minister Lawrence Wong on Friday (23 April).
(Bloomberg) -- As lawmakers wrangle over President Joe Biden’s latest trillion-dollar stimulus package, currency investors are already picking the winners of the infrastructure spending boom that the plan is likely to unleash.They’re focusing on countries that are major sources of the copper needed to bolster the electrical grid, the iron ore for steel rebar, and nickel for battery-powered vehicles. For those who don’t typically invest directly in metals, foreign exchange is a prime way to express these views. The expectation is that certain commodity-linked currencies will get an extra jolt on top of the support from the broader reflation trade that’s dominated markets for months.With the president’s $2.25 trillion framework in mind, Tom Nakamura of AGF Management says he’s adding Canadian dollar exposure, while Jack McIntyre at Brandywine Global Investment Management is gaining confidence in his firm’s holdings of currencies such as Canada’s and Chile’s. Peter Azzinaro at Manulife Investment Management, meanwhile, who already likes the loonie and the Australian dollar, says he’s also starting to look at the Chilean peso.Biden’s proposal still faces steep challenges, and Republicans have countered with a much smaller offer. But early assessments are already forming in currencies, where investors are looking past the potential drag on growth from tax hikes in the plan. Instead, they’re focusing on its potential to bolster economies across much of the commodity-producing world, with Europe and Asia also eyeing infrastructure improvements.“Investors are not only banking on the global recovery trade, but they are also looking at a longer pipeline of infrastructure spending,” said Amarjit Sahota, a currency strategist and executive director of foreign-exchange services provider Klarity FX. “They’re getting more stubborn in holding those positions and aren’t letting go.”Of course, sussing out to what degree expectations for fresh infrastructure spending are driving markets is a challenge. Exchange rates depend on a dizzying, globe-spanning array of inputs -- including general risk sentiment, growth and interest-rate differentials, and these days, the relative success of vaccination campaigns.Futures EvidenceBut futures positions reflect the conviction behind the start of what’s known as a “supercycle” of demand for certain commodities, which could stretch over the next decade.Speculators that use leverage have unwound short futures positions on the Aussie since last year and have become less bearish on the loonie. Meanwhile, investors turned bullish on the Chilean peso as copper prices rose, data from that nation’s central bank show. Not all commodity currencies are benefiting, though: Futures show leveraged speculators remain bearish on the South African rand.There are other signs metals-linked currencies are getting an extra boost lately. The Canadian and Australian dollars are outperforming many major currencies this year. Meanwhile, the Chilean peso has been one of the best-performing emerging-market currencies versus the greenback of the past year, out of roughly two dozen.Question of TimingAt AGF, which oversees C$40.5 billion ($32 billion), Nakamura says he’s boosted Canadian dollar exposure over the past several months, while remaining overweight the Aussie, on the view that infrastructure spending can only be a tailwind.“One of the tricky things with trying to express opportunities on the infrastructure plan, through currencies, is getting the timing right,” he said. “It can take quite a while to get to procurement, and trying to gauge when you can expect to see the impact on those countries’ economies is quite difficult.”“But one of the appeals of commodities currencies -- whether they’re from the G-10 or large parts of the emerging-market complex -- is that infrastructure creates a level of support for these currencies and countries,” he said.At Brandywine, which manages about $62 billion, McIntyre says he’s grown only more committed to his firm’s holdings of currencies of energy- and metals-producing countries, like Canada and Chile, along with Brazil, Colombia, Indonesia, Norway, New Zealand and Russia, and “is not looking to fade them.”Chile is the world’s biggest producer of copper, which isn’t far from a nine-year high. Australia, another major copper producer, is also a key source of iron ore, the main ingredient in steel. Meanwhile, Canada has both copper and iron ore -- along with nickel.Steel BounceWhen Biden announced his infrastructure plan on March 31, American steel prices jumped almost 6%, with U.S. producers seen as one of the biggest beneficiaries of a deal that passes.Even an infrastructure plan that comes in as low as $600 billion, roughly the amount Republicans offered Thursday, would spur an additional 30% increase in U.S. spending on metals through 2025, according to Chris Plummer, chief executive of metals and mining consulting company Metal Strategies Inc., who cited figures from Dodge Data & Analytics.At Manulife Investment, which managed C$966 billion ($773 billion) as of December, Azzinaro says he has a “favorable” view on the currencies of Canada, Australia, Mexico and New Zealand, and that he’s starting to look into Chile.A senior strategist on global multi-sector fixed income, he says his team has taken positions in those countries’ bonds and is looking to add more, expecting spreads to tighten. His group uses currencies to maximize returns, by either hedging or not hedging against the dollar, and sees all of those countries benefiting from infrastructure spending.“Infrastructure and global reflation are all interconnected, and it’s a global story with a multiyear process that we’ve become a lot more positive on,” Azzinaro said. “And right now, the currency market is connecting all the dots.”(Updates size and scope of Chilean peso in ninth paragraph.)For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2021 Bloomberg L.P.
(Bloomberg) -- Stocks trimmed their weekly decline after strong economic data added to evidence the recovery is gaining momentum. Traders also assessed a batch of mixed corporate results. The dollar fell.A gauge of output at U.S. manufacturers and service providers reached a record high in April, while a measure of new-home sales rebounded sharply in March to the highest since 2006. Financial, raw-material and tech shares led gains in the S&P 500. Snap Inc. rallied as the social-media company’s user growth beat estimates, while footwear maker Skechers USA surged on an upbeat outlook. Intel Corp., the biggest chipmaker, and American Express Co. sank on disappointing results.There has been a positive note in much of the Purchasing Managers Index data published Friday around the globe. Japan’s manufacturing activity expanded for the third month in a row ahead of much of the country entering a state of emergency. The euro area saw its recovery gain ground with services returning to growth in April and manufacturing expanding at a record pace.Other corporate highlights:Kimberly-Clark Corp., the maker of Scott toilet paper, slid on steep sales declines that signaled the potential end of a boon triggered by the pandemic.Honeywell International Inc. sank as the industrial giant’s midpoint of its full-year profit forecast missed Wall Street’s estimates.Schlumberger, the world’s biggest crude contractor, said it expects a gradual recovery of oil demand to boost overseas work through the end of this year.Equities whipsawed this week, with a flare-up in global coronavirus cases and news that the White House plans to propose almost doubling the capital-gain tax rate for the wealthy added to the volatility. With stocks trading near all-time highs, traders also waded through earnings reports and economic figures to get a sense on the rebound in activity amid a vaccination rollout.“A phrase I have heard a lot over the last couple of weeks is that the market is in a ‘wait and see’ mode,” wrote Chris Iggo, chief investment officer of core investments at AXA Investment Managers. “The consensus is clear, and we are waiting for the data to confirm that the global economy is at the beginning of a long expansion.”Comparing U.S. stocks to high-yield bonds makes equities “look less stretched,” according to Jeroen Blokland, a manager of multi-asset funds at Robeco. While the Cboe Volatility Index, or the VIX, set a 14-month low last week, the yield spread for the Bloomberg Barclays U.S. Corporate High-Yield Index reached its narrowest since July 2007 in the previous week. “Equities are relatively attractive versus high yield” on this basis, he wrote in a blog post.These are some of the main moves in markets:StocksThe S&P 500 rose 0.5% at 10:04 a.m. New York time.The Stoxx Europe 600 Index decreased 0.6%.The MSCI All-Country World Index gained 0.1%.CurrenciesThe Bloomberg Dollar Spot Index fell 0.3%.The euro climbed 0.4% to $1.2068.The Japanese yen appreciated 0.3% to 107.62 per dollar.BondsThe yield on 10-year Treasuries rose one basis point to 1.54%.Germany’s 10-year yield decreased two basis points to -0.27%.Britain’s 10-year yield fell one basis point to 0.729%.CommoditiesWest Texas Intermediate crude fell 0.2% to $61.33 a barrel.Gold rose 0.4% to $1,789.30 an ounce.For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2021 Bloomberg L.P.
The online personal lender announced on Twitter that it has refiled its S-4 with the Securities and Exchange Commission.
The "Pro-green Government Policies and Incentives Power the Electric Bus Market" report has been added to ResearchAndMarkets.com's offering.
LEO Pharma presents long-term safety and efficacy data for tralokinumab in adults with moderate-to-severe atopic dermatitis at AAD VMX 2021.
The North America swimming pool treatment chemicals for residential application market was valued at US$ 3,938. 74 million in 2019 and is projected to reach US$ 4,896. 87 million by 2027; it is expected to grow at a CAGR of 2.New York, April 23, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "North America Swimming Pool Treatment Chemicals for Residential Application Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Product Type" - https://www.reportlinker.com/p06065027/?utm_source=GNW 7% from 2020 to 2027. The rapid growth of the market in this region is attributed to the ever-increasing disposable income of the middle-income group population along with the rising residential construction sector. Additionally, the presence of major market players in the region is also contributing to the market growth. However, the increasing use of natural filtration systems in pools is likely to restrain the market growth.Swimming pool treatment chemicals are used in water treatment processes to eliminate microorganisms of all life stages and sizes.They also keep the water clean and balance the pH level of the water.Some chemicals are used to balance pH levels and offer shock treatment.Swimming pool treatment chemicals are typically manufactured in liquid and powder forms, as well as in concentrates and ready-to-use formulations.The swimming pool treatment chemicals market benefits primarily from the rising popularity of swimming among fitness conscious people as a recreational activity.Additionally, the surge in residential construction and the resultant rise in the number of swimming pools is also fueling the demand for these chemicals.Demand for effective disinfectants such as salts of hypochlorite has escalated significantly since these help remove algae and bacteria from swimming pools. Furthermore, increased consciousness about the quality of pool water, coupled with the strict government regulations and guidelines regarding pool safety, is also fostering the use of swimming pool treatment chemicals.The COVID-19 outbreak has had a brutal impact on the chemicals industry, with the lockdown leading to temporary shutdown of manufacturing facilities and pause of operations.In view of the devastating effects of the SARS-CoV-2 pandemic, players are focusing on bolstering their supply chains while accelerating their manufacturing processes to develop a wider range of swimming pool treatment chemicals, in a bid to prevent further revenue losses.Also, with the construction industry picking up speed following the outbreak, the North America swimming pool treatment chemicals for residential application market is expected to grow in the ensuing period.Based on product type, the North America swimming pool treatment chemicals for residential application market is segmented into sanitizers, balancers, shocks, algaecides, and others. The sanitizers segment held the largest share of the market in 2019, whereas the balancers segment is estimated to register the highest CAGR in the market during the forecast period.A few of the primary and secondary sources associated with this report on the North America swimming pool treatment chemicals for residential application market are the Pool Water Treatment Advisory Group, United States Environmental Protection Agency (EPA), and US Department of Health and Human Services, among others.Read the full report: https://www.reportlinker.com/p06065027/?utm_source=GNWAbout ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.__________________________ CONTACT: Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001
New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years Nearly 30 data presentations at AAD and ESPD across clinical and real-world settings, including the impact of Dupixent on disease measures in uncontrolled moderate-to-severe atopic dermatitis Late-breaking Phase 2 data for rilzabrutinib, an investigational therapy for pemphigus vulgaris, a rare, debilitating autoimmune disease, to be presented at AAD PARIS – April 23, 2021 - New analyses from Dupixent® (dupilumab) trials evaluated infection incidence reduction and reinforced the need for no laboratory monitoring in patients six years and older with moderate-to-severe atopic dermatitis. Additional analyses evaluated response rates across a broad population, and the impact of Dupixent on disease extent and severity, quality of life (QoL), and itch. These and other data from real-world settings and clinical trials, including the Dupixent open-label extension (OLE) trials, will be presented at the American Academy of Dermatology (AAD VMX 2021), April 23-25, and at the 20th European Society for Pediatric Dermatology Annual Meeting (ESPD 2021), May 12-14. “The depth and breadth of data being presented at AAD and ESPD support the use of Dupixent in adults, adolescents and children six years and older, addressing multiple critical disease measures such as itch, disease extent and severity, and certain skin infections,” said Naimish Patel, M.D. Head of Global Development in Immunology and Inflammation at Sanofi. “In addition, our expanded efforts in research and development in the immunology space, including rilzabrutinib, underscores our long-term commitment to addressing serious dermatological conditions with unmet patient needs.” Results from a subgroup analysis of the Phase 2 study evaluating rilzabrutinib, an investigational oral Bruton’s tyrosine kinase inhibitor (BTKi), for the treatment of pemphigus vulgaris (PV), include the rates of control of disease activity in patients with moderate-to-severe disease. These data will be presented as a late-breaking abstract oral presentation at AAD VMX 2021. PV is a rare, debilitating autoimmune disease that causes blistering of the skin and mucus membranes. Abstracts to be presented at AAD VMX 2021 Pediatric efficacy and QoL data for Dupixent Abstract 27350: Dupilumab Improves Eczema Area and Severity Index Regional Scores Across All Anatomical Regions in Children Aged 6–11 Years with Severe Atopic Dermatitis (AD), Amy S. PallerAbstract 27375: Dupilumab Provides Early and Sustained Improvement of Sleep Disturbance in Children ≥ 6 Years With Severe Atopic Dermatitis (AD) and Adolescents With Moderate-to-Severe AD, Amy S. PallerAbstract 27389: Rapid and Sustained Improvement in Itch in Children Aged 6–11 Years With Severe Atopic Dermatitis (AD) Treated With Dupilumab: Analysis From the LIBERTY AD PEDS Phase 3 Trial, Amy S. PallerAbstract 27394: Dupilumab Provides Clinically Meaningful Improvement in Atopic Dermatitis (AD) Signs, Symptoms, and Quality of Life in Children With Severe AD: Results From the LIBERTY AD PEDS Phase 3 Clinical Trial, Amy S. PallerAbstract 27406: Dupilumab Improves Signs and Symptoms of Severe Atopic Dermatitis in Children Aged 6–11 Years With and Without Comorbid Asthma, Mark BoguniewiczAbstract 27406: Dupilumab Treatment Improves Health-Related Quality of Life in Children Aged ≥6 to <12 Years With Severe Atopic Dermatitis, Alan Irvine Adult efficacy data for Dupixent Abstract 26839: Dupilumab With Topical Corticosteroids Results in Rapid and Sustained Improvement in Adults with Moderate-to-Severe Atopic Dermatitis Across All Anatomic Regions Over 52 Weeks, Andrew BlauveltAbstract 27571: Dupilumab Provides Clinically Meaningful Responses in Adults With Moderate-To-Severe Atopic Dermatitis (AD): Results From LIBERTY AD CHRONOS Study, Jonathan I. Silverberg Long-term data from Dupixent OLE studies, up to three years in adults and up to one year in adolescents (aged 12-17 years) and children (aged 6-11 years) with moderate-to-severe atopic dermatitis. Abstract 26313: Efficacy and Safety of Dupilumab for up to 1 Year in a Phase 3 Open-Label Extension (OLE) Trial (LIBERTY AD PED-OLE) in Adolescents With Uncontrolled, Moderate-To-Severe Atopic Dermatitis (AD), Andrew BlauveltAbstract 26875: 52-Week Laboratory Safety Findings From an Open-Label Extension (OLE) Study of Dupilumab in Adolescent Patients With Atopic Dermatitis (LIBERTY AD PED-OLE), Michael J. CorkAbstract 26880: Long-Term Efficacy and Safety Data for Dupilumab in a Phase 3, Open-Label Extension Trial (LIBERTY AD PED-OLE) in Patients Aged ≥6 to <12 Years With Uncontrolled, Moderate-to-Severe Atopic Dermatitis (AD), Michael J. CorkAbstract 27419: Laboratory Safety of Long-Term Dupilumab Treatment in Adults With Moderate-to-Severe Atopic Dermatitis: Open-Label Extension (OLE) Study, Andrew BlauveltAbstract 27424: Infections in Adults with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab: Long-Term Data from an Open-Label Extension (OLE) Study, Andrew Blauvelt Real-world data for Dupixent Abstract 27434: Early Trends of Disease Improvement in Adult Patients With Atopic Dermatitis Treated With Dupilumab: Real-World Data From the PROSE Registry, Jerry Bagel Abstracts presenting data on the burden and impact of atopic dermatitis include: Abstract 27430: Worldwide Survey Shows That Atopic Dermatitis Is Associated with a High Disease Burden in Children, Stephan WeidingerAbstract 27473: Worldwide Survey Shows That Atopic Dermatitis in Children is Associated with a Negative Impact on Their Families, Sebastien BarbarotAbstract 28081: Strategies to Improve Quality of Atopic Dermatitis Care in the North America: Results from the Atopic Dermatitis Quality of Care (ADQoC) Initiative, Peter Lio A late-breaking abstract oral presentation for rilzabrutinib: Treatment with Rilzabrutinib Results in Rapid and Significant Decrease in Steroid Use and Improved Quality of Life in Patients with Chronic Relapsing Pemphigus: BELIEVE Phase 2 Study, Dedee F. Murrell Abstracts to be presented at ESPD 2021 Abstracts related to data evaluating efficacy, safety and impact on health-related quality of life of Dupixent include: Efficacy data ESPD21-0326: Dupilumab Provides Clinically Meaningful Improvement in Atopic Dermatitis (AD) Signs, Symptoms, and Quality of Life in Children With Severe AD, Stephan WeidingerESPD21-0330: Dupilumab Improves EASI Regional Scores Across All Anatomical Regions in Children Aged ≥6–<12 Years With Severe Atopic Dermatitis, Michael J. CorkESPD21-0331: Rapid Itch Improvement in Children With Severe Atopic Dermatitis Treated With Dupilumab: A Phase 3 Subset Analysis, Gil YosipovitchESPD21-0332: Dupilumab Significantly Improves Signs and Symptoms of Atopic Dermatitis Assessed by SCORAD in Children Aged ≥6 to <12 Years, Sebastien BarbarotESPD21-0334: Dupilumab Treatment Improves Health-Related Quality of Life in Children Aged ≥6 to <12 Years With Severe Atopic Dermatitis, Alan IrvineESPD21-0340: Dupilumab Improved Itch in Children Aged 6–11 Years With Severe Atopic Dermatitis: Analysis from the LIBERTY AD PEDS Trial, Amy S. PallerESPD21-0341: Dupilumab Treatment Improves Sleep in Children Aged ≥6 to <12 Years With Severe Atopic Dermatitis, Amy S. Paller Long-term data ESPD21-0335: Long-Term Efficacy and Safety of Dupilumab in a Phase 3, Open-Label Extension Trial in Children With Uncontrolled, Moderate-to-Severe Atopic Dermatitis, Michael J. Cork Safety data ESPD21-0200: Increased Incidence of Conjunctivitis With Dupilumab Treatment in Adolescents Appears to be Specific to Atopic Dermatitis, Marjolein De Bruin-WellerESPD21-0308: Laboratory Safety of Dupilumab in Children Aged ≥6–<12 Years With Severe Atopic Dermatitis: Results From a Phase 3 Trial, Andreas Wollenberg Results from a qualitative survey on the impact of atopic dermatitis ESPD21-0322: AD-GAP: A Global, Cross-sectional, Qualitative Survey of Children/Adolescents Aged 6−17 Years With Moderate-to-Severe Atopic Dermatitis, Their Carers, and Physicians, Stephan Weidinger About DupixentDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis. Dupixent is approved in the U.S. to treat patients aged 6 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled. Outside of the U.S., Dupixent is approved for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including those in the EU and Japan. Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP. Across all approved indications globally, more than 260,000 patients have been treated with Dupixent. Dupilumab Development ProgramTo date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven in part by type 2 inflammation or other allergic processes, including pediatric asthma (6 to 11 years of age, Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3) and food allergies (Phase 2). The use of dupilumab in these settings is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. About RilzabrutinibRilzabrutinib is an oral, reversible covalent, Bruton’s tyrosine kinase (BTK) inhibitor being investigated for the treatment of immune mediated diseases. BTK is involved in innate and adaptive immune responses and is a signaling molecule in immune mediated diseases. Rilzabrutinib pre-clinical data demonstrate an ability to help block inflammatory immune cells, eliminate autoantibody destructive signaling, and prevent new autoantibody production without depleting B cells. Rilzabrutinib has the potential to target the underlying disease pathogenesis and has not been shown to alter platelet aggregation. The clinical significance of this data is under investigation. Rilzabrutinib is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. Editor’s Note: Rilzabrutinib has been granted orphan drug designation by the FDA for both pemphigus vulgaris (and from the European Commission for the treatment of pemphigus vulgaris and pemphigus foliaceus) and for its investigational use in immune thrombocytopenia (ITP). In November 2020, we announced that rilzabrutinib was granted FDA Fast Track Designation for ITP. About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life Media Relations ContactsSally Bain Tel.: +1 (781) 264-1091Sally.Bain@sanofi.com Investor Relations - ParisEva Schaefer-JansenArnaud Delepine Investor Relations – North AmericaFelix LauscherFara BerkowitzSuzanne Greco IR main line:Tel.: +33 (0)1 53 77 45 45investor.relations@sanofi.comhttps://www.sanofi.com/en/investors/contact Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press Release
Stock futures pointed to a higher open Friday morning, steadying after selling off sharply on Thursday following a report that President Joe Biden was eyeing a proposal to increase the capital gains tax rate on wealthy individuals.
NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION, DISTRIBUTION OR DISSEMINATION DIRECTLY, OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OTTAWA, April 23, 2021 (GLOBE NEWSWIRE) -- Leonovus Inc. (TSXV:LTV) (the “Company” or “Leonovus”), announces that it has amended certain terms of its public offering, that was previously announced on March 29, 2021 (the “Offering”). Pursuant to the amended terms, the Offering of units of the Company (the “Units”) will be conducted at a price of $0.56 per Unit (the “Offering Price”) for minimum gross proceeds of $2,500,000 and maximum gross proceeds of $4,000,000. Each Unit shall be comprised of one common share of the Company (a “Common Share”) and one Common Share purchase warrant of the Company (a “Warrant”). Each Warrant is exercisable into one Common Share (a “Warrant Share”) at a price of $0.70 for a period of 36 months following completion of the Offering. The Offering is being led by Research Capital Corporation as lead agent and sole bookrunner (the “Lead Agent”), on behalf of a syndicate of agents, including Canaccord Genuity Corp. (collectively with the Lead Agent, the “Agents”). The Company has granted the Agents an option (the “Over-Allotment Option”) to cover over-allotments and for market stabilization purposes, exercisable in whole or in part at the sole discretion of the Agents, at any time up to 30 days from the closing of the Offering, to increase the size of the Offering by up to 15% of the number of Units (and/or the components thereof) sold pursuant to the Offering, on the same terms and conditions of the Offering. The net proceeds raised under the Offering will be used for product development and management, sales and marketing, operating expenses, and general and administrative expenses as well as for working capital requirements and other general corporate purposes. The closing of the Offering is currently expected to be on or about the week of May 3, 2021, or on such date as the Lead Agent and the Company may agree upon, and is subject to certain conditions including, but not limited to the execution of an agency agreement and the receipt of all necessary regulatory approvals including the approval of the TSX Venture Exchange (the “Exchange”). The Company will use commercially reasonable efforts to list the Common Shares, the Warrants and the Warrant Shares on the Exchange, subject to the Company fulfilling all of the listing requirements of the Exchange. The Units are to be sold on a "best efforts" basis through the Agents by way of short form prospectus filed in each of the provinces of Canada (except Québec) and in other jurisdictions outside of Canada and the United States on an exempt basis in accordance with applicable securities laws. The securities described in this press release have not been and will not be registered under the United States Securities Act of 1933, as amended (“U.S. Securities Act”) or any state securities laws. Accordingly, the securities may not be offered or sold in the United States (as such term is defined in Regulation S under the U.S. Securities Act) or to, or for the account or benefit of, a U.S. person (as such term is defined in Regulation S under the U.S. Securities Act) except pursuant to transactions exempt from registration under the U.S. Securities Act and under the securities laws of any applicable state. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of these securities in the United States. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements. About Leonovus Leonovus is a secure data management software company. The Leonovus suite of data management tools offer an organization what it needs for a complete end-to-end data-centric solution. This solution can stand on its own, or it can easily integrate with the organization's zero-trust strategy and architecture. It takes seamless advantage of the organization's existing storage infrastructure and network architecture, working on-premises, in the cloud, or both. It extends the data-centric controls across the entire architecture, including cloud resources. And it supplies these cybersecurity capabilities for the full lifespan of the data and beyond. The flexible and straightforward solution does not require changes in the method of data use. Applications, services, and users all interact with the data the same way they always have. The system ensures the right users get access to the correct data at the right time, but securely. In addition to working with existing systems, the Leonovus solution aids in the organization's digital transformation by enabling ultramodern data concepts necessary for the data-driven world. These capabilities are included in an automated solution requiring little operations effort and no new skills or expertise needed. The main elements of the Leonovus Unified Smart Data Management suite are: Data Discovery - classification and understanding of your existing data sets.Smart Filer - transparent file-based data controls for cost, flexibility, and scalability.Vault - multi-cloud data management for data lifespan.Data View Gateways - controlled repository internal/external data sharing.Smart Secure Data Lake - a multi-sourced context-rich repository for advanced analytics.Consolidata - multi-sourced data collation and aggregation for near real-time insights.XVault – protocol independent, ultra-secure remote data sharing solution; coming soon. Each is available independently or together as a comprehensive solution set. To learn more, please visit www.leonovus.com. For More Information, please contact:George PretliChief Financial Officer+1.613.319.3540gpretli@leonovus.com Caution regarding forward-looking information This press release contains forward-looking statements and information, which may involve risks and uncertainties, including in relation to pricing and terms of the Offering, receipt of regulatory and Exchange approval of the Offering, the issuance of a receipt for the final short form prospectus, the use of proceeds from the Offering, and the closing of the Offering and timing thereof. The results or events predicted in these statements may differ materially from actual results or events. Factors that might cause a difference include, but are not limited to, competitive developments, risks associated with Leonovus' growth, the state of the financial markets, regulatory risks and other factors. There can be no assurance or guarantees that any statements of forward-looking information contained in this release will prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral statements containing forward-looking information are based on the estimates and opinions of management on the dates they are made and expressly qualified in their entirety by this notice. Unless otherwise required by applicable securities laws, Leonovus disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers should not place undue reliance on any statements of forward-looking information that speak only as of the date of this release. Further information on Leonovus' public filings, including its most recent audited consolidated financial statements, are available at www.sedar.com. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
FORM 8.3 IRISH TAKEOVER PANELDISCLOSURE UNDER RULE 8.3 OF THE IRISH TAKEOVER PANEL ACT, 1997, TAKEOVER RULES, 2013DEALINGS BY PERSONS WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE 1. KEY INFORMATION Name of person dealing (Note 1)State Street Global Advisors & AffiliatesCompany dealt inWillis Towers Watson plc.Class of relevant security to which the dealings being disclosed relate (Note 2)US$0.000304635 ordinary sharesDate of dealing22nd April 2021 2. INTERESTS AND SHORT POSITIONS (a) Interests and short positions (following dealing) in the class of relevant security dealt in (Note 3) LongShort Number(%)Number(%)(1) Relevant securities6,384,201 4.95012% (2) Derivatives (other than options)N/A (3) Options and agreements to purchase/sellN/A Total6,384,201 4.95012% (b) Interests and short positions in relevant securities of the company, other than the class dealt in (Note 3) Class of relevant security:LongShort Number(%)Number(%)(1) Relevant securitiesN/A (2) Derivatives (other than options)N/A (3) Options and agreements to purchase/sellN/A TotalN/A 3. DEALINGS (Note 4) (a) Purchases and sales Purchase/saleNumber of relevant securitiesPrice per unit (Note 5)Purchase100234.14Purchase12233.15Purchase50233.15Purchase1,672233.15Purchase290233.15Purchase18233.15Purchase27233.15Purchase332233.15Purchase115233.15Purchase63233.15Sale1,520233.15Sale6,080233.15Sale2,128233.15Sale464233.15Sale3,364233.15Sale45233.15 (b) Derivatives transactions (other than options transactions) Product name, e.g. CFDNature of transaction (Note 6)Number of relevant securities (Note 7)Price per unit (Note 5)N/A (c) Options transactions in respect of existing relevant securities (i) Writing, selling, purchasing or varying Product name, e.g. call optionWriting, selling, purchasing varying etc.Number of securities to which the option relates (Note 7)Exercise priceType, e.g. American, European etc.Expiry dateOption money paid/received per unit (Note 5)N/A (ii) Exercising Product name, e.g. call optionNumber of securitiesExercise price per unit (Note 5)N/A (d) Other dealings (including transactions in respect of new securities) (Note 4) Nature of transaction (Note 8)DetailsPrice per unit (if applicable) (Note 5)N/A 4. OTHER INFORMATION Agreements, arrangements or understandings relating to options or derivatives Full details of any agreement, arrangement or understanding between the person disclosing and any other person relating to the voting rights of any relevant securities under any option referred to on this form or relating to the voting rights or future acquisition or disposal of any relevant securities to which any derivative referred to on this form is referenced. If none, this should be stated.N/A Is a Supplemental Form 8 attached? (Note 9)NO Date of disclosure23rd April 2021 Contact nameLionel ColacoTelephone number 020 33956098If a connected EFM, name of offeree/offeror with which connectedN/AIf a connected EFM, state nature of connection (Note 10)N/A
The company faced challenges last year in expanding the label of its only drug. Will 2021 bring different results?
Turkey's membership negotiations to join the European Union should be formally suspended if Ankara continues on its autocratic track, EU lawmakers said on Friday, saying a decision was urgent as basic freedoms in the country are curtailed. Lawmakers in the European Parliament's Foreign Affairs Committee voted 49 in favour, four against and with 14 abstentions on their report on Turkey's EU candidacy, which now goes to the full plenary next month and, if accepted, becomes the parliament's official position. After years of stalemate on Turkey's bid to join the world's biggest trading bloc, negotiations launched in 2005 have come to a halt, although they are not officially suspended.
(Bloomberg) -- Day two of President Joe Biden’s international climate summit commences on Friday. Biden pledged during the first day of the virtual event to slash U.S. greenhouse gas emissions in half by the end of the decade, part of a plan to bring the U.S. back into the global fight against climate change.Day two will focus on innovation and the economic opportunity in fighting climate change. This is designed to refute skepticism from some blue-collar workers and labor leaders. While renewable energy jobs are growing at a fast clip, labor groups say they pay less than fossil-fuel positions and that companies have opposed unionization.Speakers on Friday include U.S. Secretary of Energy Jennifer M. Granholm, Israeli Prime Minister Benjamin Netanyahu, United Arab Emirates Prime Minister Sheikh Mohammed Bin Rashid Al Maktoum, Bill Gates and Michael Bloomberg.Click here to see schedule of events for two-day summit.Kenya Calls for Investment into Geothermal in Clean Energy Push (9:55 a.m.)Kenya is wooing investors to tap its vast geothermal resources to produce electricity as part of plans to make its grid 100% renewable energy from the current 90%, president Uhuru Kenyatta said at the summit.“Our geothermal potential is great and the amount currently tapped is less than 10% and this presents huge investment opportunities across the technology value chain as well as huge opportunities for employment of young Africans across our country,” Kenyatta said in a virtual address from Nairobi. “The better off countries, working in collaboration with private sectors should support developing countries secure financial resources required to implement climate adaptation programs.”Kenya commits to reduce emissions by 32% by 2030 and targets 100% clean cooking by 2028, ahead of the 2030 UN target. Kenyatta said 80% of households depend on biomass for cooking.UAE Strikes Deal for Global Agriculture Innovation (9:51 a.m.)The United Arab Emirates has reached a deal with the U.S., Israel, Denmark, Brazil and other nations to accelerate global agricultural innovations and research to fight climate change.The five-year initiative, the Agriculture Innovation Mission for Climate, will also help deliver jobs and enhance economic growth, UAE Prime Minister Sheikh Mohammed Bin Rashid Al Maktoum said at the summit.“The UAE is considered to be the first in the Middle East to pioneer Carbon capture and storage technologies, and our oil sector is considered to be the lowest carbon emitter in the world,” the sheikh said. “Climate change is not a temporary concern, it is rather a global challenge.”Gates Says Cost of Green Energy Must Come Down (9:39 a.m.)Microsoft Corp. co-founder Bill Gates said clean power’s biggest problem boils down to cost.“Almost all of our zero-carbon technologies are more expensive than their fossil fuel counterparts” Gates said. “To provide all the benefits of the modern lifestyle to people around the world, we need new, zero-carbon products that are just as affordable -- that have what I call a green premium of zero.”Gates is candid about the scale of the challenge. It will be hard to drive the creation of “breakthrough technologies that allow us to eliminate emissions throughout the physical economy, he said, “but we can do it if we invest in innovation and build the infrastructure for the transition to a clean economy.”Read more: Inside Bill Gates’ Brain as He Tackles Climate Change: InterviewGates said that means tapping the power of markets to fund and deploy these innovations, including “by finding creative ways to finance technologies and by leveling the paying field so they can compete with fossil fuels.” Gates himself launched Breakthrough Energy Ventures in 2017 with the goal of investing in early-stage climate startups. -- by Jennifer A. DlouhyU.S. Seeks to Drive 80% Cut in Cost of Hydrogen (8:58 a.m.)The U.S. will set a goal of reducing the cost of renewable hydrogen by 80% by 2030 making it competitive with natural gas, Energy Secretary Jennifer Granholm said.Energy companies and others are increasingly eyeing hydrogen as a possible carbon-free fuel, and it is seen as a clean solution for fueling cars, trucks and ships as well as heating buildings, though the cost of producing it remains a barrier.The agency also plans to reduce the cost of carbon capture, industrial fuels and energy storage and “slash battery cell prices in half,” Granholm said.“This is our generation’s moonshot,” Granholm said. “Going big on our ambitions means that we’re going to create jobs for millions of people.” -- Ari NatterCities, Businesses ‘Hold the Key’ to Fighting Climate Change (8:25 a.m.)While much of the summit has focused on the world leaders who are participating, Michael Bloomberg, United Nations special envoy on climate ambition and solutions, stressed the role of businesses and cities in curbing emissions.In the past four years, as the federal government under President Donald Trump turned away from policies to curb emissions, corporations and local governments stepped up their efforts in the U.S. That’s shown that policies that cover smaller entities can still have a big impact of reducing greenhouse gases.“Cities and businesses hold the key to defeating climate change,” Bloomberg, the former mayor of New York, said. “They are responsible for the vast majority of emissions.” (Michael Bloomberg, the founder and majority owner of Bloomberg LP, the parent company of Bloomberg News, has committed $500 million to launch Beyond Carbon, a campaign aimed at closing the remaining coal-powered plants in the U.S. by 2030 and slowing the construction of new gas plants.) -- Will WadeKerry Cites ‘Historic’ Economic Opportunities (8:23 a.m.)The first day of President Joe Biden’s climate summit focused on driving more carbon cuts, with warnings about the consequences of inaction. Day two is about proving that action is in everyone’s best economic interest too.“The world’s largest market in history is opening before our own eyes right now,” Special Presidential Envoy for Climate John Kerry said at the start of the summit Friday. “And it’s going to create millions of high-quality, good-paying jobs around the world, especially in countries that seize this agenda.”“Today is going to be about that vision,” and about the “remarkable economic opportunity” that springs from climate action, Kerry said. “We’re going to hear from governments, entrepreneurs, communities and labor leaders about how they see the future.” -- Jennifer A. DlouhyFor more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2021 Bloomberg L.P.
ROSEMONT, Ill., April 23, 2021 (GLOBE NEWSWIRE) -- The AAD VMX 2021, a virtual meeting experience taking place April 23-25, will feature the latest information on skin, hair and nails, presented by world-renowned experts in the field of dermatology. Board-Certified Dermatologist Warns Consumers About the Dangers of Skin Bleaching to Achieve a Lighter Complexion Despite the potential dangers of skin bleaching products, the global market for skin lighteners last year was estimated at $8.6 billion. With the market projected to reach $12.3 billion by 2027, a board-certified dermatologist from the American Academy of Dermatology expresses concern about this growing trend and the unintended health consequences of pursuing lighter skin at any cost. Read more. Board-Certified Dermatologist Shares How Visible Light Impacts the Skin Visible light is all around us. From nature’s sunlight to artificial light sources from ceiling lights, our phones, computer screens and TVs, we may be exposed to more visible light than ever before, but what does that mean for our skin? Read more. New Research Focuses on a Growing Pandemic Problem – "Zoom Dysmorphia" During the pandemic, there was a shift to remote work, and demand for video conferencing increased. A board-certified dermatologist shares findings revealing how increased exposure on camera, combined with the distorting effects of front-facing cameras, is leading patients to think negatively about their appearance and seek cosmetic care — a new phenomenon she calls “Zoom Dysmorphia.” Read more. To view this release in a media-rich format, go to: https://aad.new-media-release.com/2021/aadvmx/ CONTACTS: Nicole Dobkin (847) 240-1746 ndobkin@aad.org Julie Landmesser (847) 240-1714 JLandmesser@aad.org
Detailed results from Phase 2b study of roflumilast foam in scalp and body psoriasis featured in late-breaking oral presentationData demonstrate roflumilast foam was well-tolerated and improved scalp and body psoriasis as early as two weeks after treatment initiationFour additional posters feature data that support roflumilast foam for the treatment of seborrheic dermatitis and roflumilast cream for mild-to- severe chronic plaque psoriasis WESTLAKE VILLAGE, Calif., April 23, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced the presentation of new data demonstrating the safety and efficacy of roflumilast foam for the treatment of scalp and body psoriasis in a late-breaking oral presentation at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) held on April 23-25, 2021. The company is also showcasing data from four additional posters during the meeting, including a presentation on the safety and efficacy of roflumilast foam in the treatment of seborrheic dermatitis and three posters related to roflumilast cream in mild-to-severe chronic plaque psoriasis, including its impact on itch and use for steroid-sensitive areas. Roflumilast cream and foam are investigational once-daily, topical formulations of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor. “Psoriasis and seborrheic dermatitis can significantly impact quality of life and are very challenging to treat, particularly long-term,” said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis. “These new data add to the growing body of evidence supporting the potential of roflumilast, if approved, as an important, new treatment option for people affected by these chronic dermatological conditions.” New findings from the late-breaking presentation demonstrate that roflumilast foam significantly improved both scalp and body psoriasis, with improvement as early as two weeks after treatment initiation. The primary endpoint of Scalp Investigator’s Global Assessment (S-IGA) success (clear/almost clear and ≥2-grade reduction from baseline) at week eight was achieved by 59.1% of patients receiving roflumilast foam versus 11.4% of patients receiving vehicle (P<0.0001), with 34.3% of roflumilast foam-treated and 3.4% of vehicle-treated patients rated clear at week eight. Body IGA success at week eight was achieved by 40.3% and 6.8% of patients receiving roflumilast foam and vehicle, respectively (P<0.0001).Roflumilast foam was well-tolerated in the study. The incidence of treatment-related adverse events (TEAEs), application site adverse events (AEs), and discontinuations due to AEs were low and similar to vehicle. The most common TEAEs were application site pain (1.0% vs. 3.8%), diarrhea (1.5% vs. 0%), COVID-19 (1.5% vs. 1.9%), sinusitis (0.5% vs. 1.9%), psoriasis (0.5% vs. 1.9%), and hypertension (1.5% vs. 1.0%) for roflumilast foam and vehicle, respectively. Discontinuation due to AEs was 2.5% for roflumilast foam and 1.9% for vehicle. In the study, no patients in either group experienced any serious AEs.“Many current treatment options for psoriasis often carry significant limitations, particularly when being used to treat body areas covered with hair, which result in poor outcomes and additional patient burden,” said lead investigator Leon Kircik, M.D., Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, Indiana University Medical Center, and Medical Director, Physicians Skin Care, DermResearch, and Skin Sciences, Louisville, KY. “Roflumilast once-daily foam, a novel formulation specifically designed for use on hair-bearing areas of the body like the scalp, but usable on all areas of the body, demonstrated significant benefit on both scalp and non-scalp areas. These positive results are encouraging for patients and clinicians who are desperate for new treatments that can simplify disease management, be used in all areas of the body, and ultimately improve the patient experience.” Key findings from the other roflumilast foam and cream presentations include: Efficacy and Safety of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis in a Randomized, Double-blind, Vehicle-controlled Phase 2 Study Findings from this Phase 2 study demonstrated roflumilast foam is a safe, well-tolerated, and effective treatment in patients with seborrheic dermatitis. Treatment with roflumilast foam led to significant improvement in IGA Success, as well as erythema and scaling individually, and symptomatic improvement in itch in patients. Improvements in IGA Success were statistically significant at the first post-baseline visit at week two and continued through week eight. Rates of treatment-related AEs, discontinuations due to AEs, and application-site pain were low and similar to vehicle. Correlation of Itch Response to Roflumilast Cream with Disease Severity and Patient-Reported Outcomes in Patients with Chronic Plaque Psoriasis The Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey showed that the top factor contributing to disease severity in psoriasis according to patients was itch, but according to physicians, it was location/size of lesions. Consistent with these findings, the baseline data from this Phase 2b study in patients with chronic plaque psoriasis demonstrated that patient-reported itch was not always consistent with physician-assessed disease severity and that patients with mild disease can still experience considerable itch. In this Phase 2b study, treatment with roflumilast cream resulted in rapid and robust improvement in the severity of itch, itch-related sleep loss, and quality of life in patients with chronic plaque psoriasis. Roflumilast Cream Significantly Improves Chronic Plaque Psoriasis in Patients with Steroid-Sensitive Area Involvement Many patients with psoriasis have plaques on difficult to treat areas such as the face or intertriginous regions. Topical corticosteroids and vitamin D derivatives must be used with caution in these areas because they can cause side effects or tolerability problems, especially with long-term use. In this Phase 2b study, roflumilast cream was well-tolerated and provided significant improvements in investigator and patient‑assessed outcomes in participants with steroid-sensitive area involvement in a post-hoc analysis of the face, neck, or intertriginous areas in patients with chronic plaque psoriasis. The PASI-HD Improved Precision in Measuring Disease Severity in Subjects with Mild-to-Moderate Plaque Psoriasis Treated with Roflumilast Cream, a PDE4 Inhibitor The Psoriasis Area and Severity Index (PASI) is the gold standard measure in psoriasis clinical trials, but lacks sensitivity where the affected area is <10% body surface area. Most patients with chronic plaque psoriasis have mild-to-moderate disease, thus a higher level of discrimination for the assessment of disease severity is needed. PASI-HD is proposed as a modification to PASI to provide higher discrimination of the effects of treatment in areas with <10% involvement. This post-hoc analysis of the Phase 2b study of roflumilast cream in patients with mild-to-moderate plaque psoriasis, demonstrated that PASI-HD is more precise as compared to PASI for scoring disease severity in areas of disease involvement <10%. For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Join the conversation with the hashtag #AADVMX2021. About Scalp and Body PsoriasisPsoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the U.S. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Scalp psoriasis is a manifestation of plaque psoriasis characterized by plaques in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Scalp psoriasis is present in nearly half of Americans with psoriasis. As with psoriatic plaques on other parts of the body, scalp psoriasis is often itchy and sometimes painful. It can also be associated with hair loss. About Seborrheic DermatitisSeborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic, or recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often on the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back. About Topical Roflumilast Cream & FoamRoflumilast Cream and Foam are once-daily, topical formulations of a highly potent and selective PDE4 inhibitor (roflumilast). The foam formulation is to treat inflammatory dermatoses in hair-bearing areas of the body, such as the scalp, although it is usable in all areas of the body. Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors for dermatology. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, atopic dermatitis, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis’ robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company’s lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Forward-Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Investor and Media Contact:Heather Rowe Armstrongharmstrong@arcutis.com805-418-5006 ext. 740
Daily treatment with sofpironium bromide gel was generally well-tolerated over 48 weeks of treatment Efficacy assessments showed a clinically meaningful and sustained improvement in sweat severity through the 48 weeks of treatment Data presented today in a late-breaking oral presentation at AAD VMX 2021 Management to host an investor call today at 12:00 p.m. EDT BOULDER, Colo., April 23, 2021 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced results from its Phase 3 open-label, long-term safety study (“ARGYLE” or “LTSS”), which were also presented today in a late-breaking oral presentation at the American Academy of Dermatology’s (“AAD”) 2021 Virtual Meeting Experience (“VMX”). The ARGYLE study assessed the long-term safety and efficacy of topical, once-daily treatment with sofpironium bromide gel, 5% and 15% for 48 weeks in patients nine years and older with primary axillary hyperhidrosis, or excessive underarm sweating. “We are pleased that the ARGYLE study results further strengthen the safety, tolerability and efficacy data previously observed in our Phase 2b study of sofpironium bromide gel.” said Deepak Chadha, Brickell’s Chief Research & Development Officer. “As was observed with earlier clinical studies, the majority of side effects were mild or moderate in severity and transient in nature. Sofpironium bromide gel, 5% and 15% both led to sustained improvements in sweating severity for the majority of patients through the end of 48 weeks of treatment. These data contribute to our understanding of the long-term use of sofpironium bromide gel as a potential novel treatment for the millions of patients suffering from this chronic and debilitating condition.” “In this LTSS study, sofpironium bromide gel was generally well-tolerated with continued efficacy during 48 weeks in patients with primary axillary hyperhidrosis. In addition, we were pleased to see that the incidence of patients with any treatment-emergent adverse events decreased over time, as did the number of discontinuations,” commented Stacy Smith, MD, a practicing dermatologist and participating investigator in this study. “Taking into consideration that patients did not have the conventional option to acclimate to treatment prior to enrolling in this standalone long-term safety study, the observed safety profile is even more encouraging.” ARGYLE: Phase 3 Open-Label Long-Term Safety Study Results The ARGYLE study evaluated the long-term safety and efficacy of sofpironium bromide gel, 5% and 15% for 48 weeks of treatment in patients nine years or older with primary axillary hyperhidrosis. The study enrolled 300 patients at 30 U.S. sites. Patients were randomized to receive either sofpironium bromide gel, 5% or 15% in a 1:2 ratio. Subjects applied the assigned investigational product once daily at bedtime to both axillae for 48 weeks, followed by a 4-week post-treatment visit. This study was not conducted as a conventional Phase 3 open-label “extension” study where patients from pivotal studies roll over into an open-label extension study. ARGYLE thus provides a more complete clinical data set evaluating treatment-naïve primary axillary hyperhidrosis patients who received sofpironium bromide gel for 48 weeks and evaluated for an additional 4 weeks after the end of treatment. 190 patients completed the full study duration of 52 weeks. The treatment-related treatment-emergent adverse events (TEAEs) for sofpironium bromide gel, 5% (22.5%) and 15% (50.8%) were mostly mild or moderate in severity and transient in nature. The most common and expected treatment-related TEAEs reported were blurred vision (4.9%; 18.8%), dry mouth (8.8%; 16.8%), pruritis (5.9%; 14.7%), pain (3.9%; 14.7%), dermatitis (5.9%; 9.1%), erythema (4.9%; 7.6%), irritation (4.9%; 5.6%), mydriasis (1.0%; 5.1%) and urinary retention (2.9%; 3.6%). The patient discontinuations due to treatment-related TEAEs included blurred vision (2.0%; 7.1%), pruritis (0%; 2.0%), dermatitis (1.0%; 2.0%), dry mouth (0%; 1.5%), pain (0%; 1.5%), erythema (1.0%; 0.5%), irritation (0%; 1.0%), urinary hesitation (1.0%; 0%) and mydriasis (0%; 0.5%). Overall, TEAEs and discontinuations demonstrated decreased incidence over time as patients in the long-term study acclimated to treatment. No treatment-related serious adverse events (SAE) were observed in adult and pediatric patients and no new safety signals emerged. With respect to studied efficacy, the 5% and 15% gel groups exhibited clinically meaningful improvement in axillary hyperhidrosis severity as measured by the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax), a proprietary patient-reported outcome scale. For both 5% and 15% dose groups, responders with a 1-point (86.1%; 85.8%) and 2-point (69.4%; 61.9%) improvement on HDSM-Ax PRO scale showed a gradual and continual improvement in sweat severity through the 48 weeks of treatment. Overall, the safety, tolerability and efficacy results for sofpironium bromide gel, 5% and 15% in ARGYLE were consistent with prior clinical experience and no unexpected safety findings were observed. There were no clinically significant changes in laboratory parameters or vital signs over 48 weeks of treatment. Late-Breaking Oral Presentation at AAD VMX 2021 An on-demand video of the virtual late-breaking oral presentation by Dr. Smith will be available to attendees of the AAD VMX 2021 starting at 10:00 a.m. EDT. The presentation is titled, “A Multicenter, Randomized, Open-label, Phase 3 Long-term Safety Study (LTSS) of Topically Applied Sofpironium Bromide Gel, 5% and 15% in Subjects with Axillary Hyperhidrosis.” Today’s Conference Call and Webcast Information Brickell’s management will host a conference call geared toward industry and the investment community today at 12:00 p.m. EDT where Dr. Stacy Smith will discuss the ARGYLE study results, followed by a Q&A session. The conference call will be accessible to the public, and the dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13718742. A live webcast of the conference call can be accessed through the Investors tab on the Brickell Biotech website at https://www.brickellbio.com. A replay of the webcast also will be available on Brickell’s website in the Investors tab shortly after conclusion of the call and will be available for approximately 90 days. U.S. Pivotal Phase 3 Cardigan I and Cardigan II Studies The Company is currently conducting the U.S. Phase 3 Cardigan I and Cardigan II clinical studies evaluating sofpironium bromide gel, 15% in approximately 350 subjects (per study) aged nine and older with primary axillary hyperhidrosis and expects to announce topline data in the fourth quarter of 2021. If successful, the results from these studies, combined with ARGYLE, are expected to form the basis of a prospective New Drug Application in the U.S. for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis. Additional details of the Cardigan I and II studies can be found on https://clinicaltrials.gov under identifiers NCT03836287 and NCT03948646, respectively. About Sofpironium Bromide Sofpironium bromide is Brickell’s lead investigational product candidate and is a new chemical entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are intended to exert their action locally and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. Sofpironium bromide gel, 15% is currently being evaluated in a U.S. pivotal Phase 3 clinical program for the treatment of primary axillary hyperhidrosis, and sofpironium bromide gel, 5% is approved in Japan for the same indication under the brand name ECCLOCK®. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida. About Hyperhidrosis Hyperhidrosis is a debilitating, life-altering medical condition where a person sweats beyond what is physiologically required for thermoregulation of the body. More than 15 million people, or 4.8% of the population of the United States, and 12.76% of the population in Japan, are believed to suffer from hyperhidrosis1,2. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States. Additional information can be found on the International Hyperhidrosis Society website: https://www.sweathelp.org/. About Brickell Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on the development of innovative and differentiated prescription therapeutics for debilitating skin diseases with a focus on its lead asset sofpironium bromide for the treatment of hyperhidrosis. Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell’s strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative and differentiated pharmaceutical products that Brickell believes can be successful in the marketplace and transform lives by solving currently unmet patient needs. For more information, visit https://www.brickellbio.com. Cautionary Note Regarding Forward-Looking Statements Any statements made in this press release relating to future financial, business and/or research and clinical performance, conditions, plans, prospects, trends, or strategies and other such matters, including without limitation, the anticipated timing, scope, design and/or results of ongoing and future clinical trials, intellectual property rights, including the validity, term and enforceability of such, the expected timing and/or results of regulatory approvals and prospects for commercializing any of Brickell’s product candidates, or research collaborations with its partners, including in Japan, the United States or any other country, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict,” “potential,” “look forward” and similar expressions and their variants, as they relate to Brickell, Kaken or any of Brickell’s partners, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including without limitation, ability to obtain adequate financing to advance product development, ability to maintain and enforce intellectual property rights, potential delays for any reason in product development and clinical trial enrollment, regulatory changes, supply chain disruptions, unanticipated demands on cash resources, any disruption to its business caused by the current COVID-19 pandemic, interruptions, disruption or inability by Kaken to supply and commercialize the product in Japan, or obtain or retain adequate pricing or reimbursement, and other risks associated with developing and obtaining regulatory approval for and commercializing product candidates. Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell’s filings with the United States Securities and Exchange Commission (SEC), which are available at https://www.sec.gov (or at https://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements. 1 Doolittle et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 2016; 308: 743-749.2 Fujimoto et al. Epidemiological study and considerations of focal hyperhidrosis in Japan. J Dermatol 2013; 40: 886-90. Brickell Investor Contact:Dan FerryLifeSci Advisors(617) 430-7576daniel@lifesciadvisors.com
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