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New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years

New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients withatopic dermatitis as young as 6 years N…

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New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients withatopic 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 childrensix 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, includingrilzabrutinib, 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. Paller
  • Abstract 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. Paller
  • Abstract 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. Paller
  • Abstract 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. Paller
  • Abstract 27406: Dupilumab Improves Signs and Symptoms of Severe Atopic Dermatitis in Children Aged 6–11 Years With and Without Comorbid Asthma, Mark Boguniewicz
  • Abstract 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 Blauvelt
  • Abstract 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 DupixentOLE 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 Blauvelt
  • Abstract 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. Cork
  • Abstract 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. Cork
  • Abstract 27419: Laboratory Safety of Long-Term Dupilumab Treatment in Adults With Moderate-to-Severe Atopic Dermatitis: Open-Label Extension (OLE) Study, Andrew Blauvelt
  • Abstract 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 Weidinger
  • Abstract 27473: Worldwide Survey Shows That Atopic Dermatitis in Children is Associated with a Negative Impact on Their Families, Sebastien Barbarot
  • Abstract 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 Weidinger
  • ESPD21-0330: Dupilumab Improves EASI Regional Scores Across All Anatomical Regions in Children Aged ≥6–<12 Years With Severe Atopic Dermatitis, Michael J. Cork
  • ESPD21-0331: Rapid Itch Improvement in Children With Severe Atopic Dermatitis Treated With Dupilumab: A Phase 3 Subset Analysis, Gil Yosipovitch
  • ESPD21-0332: Dupilumab Significantly Improves Signs and Symptoms of Atopic Dermatitis Assessed by SCORAD in Children Aged ≥6 to <12 Years, Sebastien Barbarot
  • ESPD21-0334: Dupilumab Treatment Improves Health-Related Quality of Life in Children Aged ≥6 to <12 Years With Severe Atopic Dermatitis, Alan Irvine
  • ESPD21-0340: Dupilumab Improved Itch in Children Aged 6–11 Years With Severe Atopic Dermatitis: Analysis from the LIBERTY AD PEDS Trial, Amy S. Paller
  • ESPD21-0341: 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-Weller
  • ESPD21-0308: 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 Dupixent
Dupixent 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 Program
To 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 Rilzabrutinib
Rilzabrutinib 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

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Markets Insider and Business Insider Editorial Teams were not involved in the creation of this post.

“The depth and breadth of data being presented at AAD and ESPD support the use of Dupixent in adults, adolescents and childrensix 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, includingrilzabrutinib, underscores our long-term commitment to addressing serious dermatological conditions with unmet patient needs.”

Source: https://markets.businessinsider.com/news/stocks/new-dupixent-dupilumab-analyses-reinforce-long-term-safety-and-efficacy-profile-in-patients-with-atopic-dermatitis-as-young-as-6-years-1030338905

new-dupixent®-(dupilumab)-analyses-reinforce-long-term-safety-and-efficacy-profile-in-patients-with-atopic-dermatitis-as-young-as-6-years

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Two new Florida cruises have cabins for solo travelers – see inside the ships

The Solo Suite available in 2022. Atlas Ocean Voyages Over the last month, Oceania Cruises and Atlas Ocean Voyages have unveiled ships with si…

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The cruise industry is gradually resuming operations, and at the same time, some cruise lines are tapping into a specific segment of customers: solo travelers.

volunteer employees boarding a cruise ship carrying luggageVolunteer Royal Caribbean employees for the Freedom of the Seas sailing at PortMiami on June 20.

Marta Lavandier/AP Photo

Over the past month, two Florida-based cruise lines – including a newcomer to the industry – have unveiled new ships with cabins designed for lone travelers.

top view of the World NavigatorThe World Navigator.

Atlas Ocean Voyages

But solo cruising isn’t a new trend: Cruise lines like Royal Caribbean, Virgin Voyages, and Norwegian have already successfully rolled out single-person accommodations.

a bed next to a desk, tv, and mirrorThe Solo Insider.

Virgin Voyages

Source: Royal Caribbean, Virgin Voyages, Norwegian Cruise Line

And so far, it’s been a success. For brands like Virgin, these solo rooms “perform really well,” John Diorio, the cruise line’s associate vice president of sales, told Johanna Jainchill for Travel Weekly.

a bathroom with a shower, sink, mirrorThe Solo Insider.

Virgin Voyages

Source: Travel Weekly

Staying in solo suites allows independent travelers to bypass paying single supplements, the fees that come with staying in a room designed for more than one occupant.

a bed besides a balcony with views of the oceanThe Anthem of the Seas’ Studio Ocean View Stateroom with a balcony.

Royal Caribbean International

Some solo travelers see this single supplement as a “major obstacle” and a “penalization” for solitary vacations, Alberto Aliberti, president of Atlas Ocean Voyages, told Insider in an email statement.

a bed besides a balcony with views of the oceanThe Quantum of the Sea’ Superior Studio Ocean View with a balcony.

Royal Caribbean International

Fort Lauderdale, Florida-based Atlas Ocean Voyages just debuted this month, and it’s the first luxury cruise line to join the market in over 20 years, according to the company.

the exterior of the World NavigatorThe World Navigator.

Atlas Ocean Voyages

Source: Insider

To cater to this solo traveler segment, Atlas Ocean Voyages decided to include single-person suites aboard its first and and only vessel.

a rendering of a bed facing a TV with a window in the backThe Solo Suite available in 2022.

Atlas Ocean Voyages

The brand’s World Navigator cruise ship has 98 guest rooms that can accommodate just under 200 travelers.

a bed besides a armchair, lights, and a nightstandThe Veranda Stateroom.

Atlas Ocean Voyages

Beginning March 2022, the World Navigator will also have six 183-square-foot suites designated for solo travelers.

a rendering of a bed facing a TV with a window in the backThe Solo Suite available in 2022.

Atlas Ocean Voyages

These single rooms – which Aliberti says have prompted “very positive responses” – will come with the same perks as the ship’s other suites. This includes binoculars and in-room Nespresso coffee, a stocked mini-refrigerator, and bar and butler services.

a rendering of a bed facing a TV with a window in the backThe Solo Suite available in 2022.

Atlas Ocean Voyages

Similarly, in July, Norwegian Cruise Line Holdings’ Oceania Cruises brand announced plans for its Vista cruise ship, which will officially debut in 2023.

a living room with a couch, coffee table, and deskThe Concierge Level Solo Veranda stateroom.

Oceania Cruises

Source: Oceania Cruises

The Miami-based cruise line’s upcoming ship will have “concierge level solo veranda staterooms” created for lone travelers, a first for the cruise line.

a bed tucked away in the corner of the suite with the living room in the backgroundThe Concierge Level Solo Veranda stateroom.

Oceania Cruises

Like Atlas Ocean Voyages, solo guests sailing with Oceania will have the same luxury amenities as other concierge level passengers, such as free laundry and access to the Concierge Lounge.

a living room with a couch, coffee table, desk, and bed in the backgroundThe Concierge Level Solo Veranda stateroom.

Oceania Cruises

And according to Aliberti, that’s the point. Many of these “underserved” solo travelers want the suite amenities, just not the single supplement payments.

a table with seats and a mirrorThe Solo Insider.

Virgin Voyages

Source: https://markets.businessinsider.com/news/stocks/photos-florida-cruise-ships-cabins-for-solo-travelers-2021-8

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Blackstone’s betting $6 billion on the rental market – here’s why private-equity loves real estate right now

Jonathan Gray, Blackstone president and chief operating officer Heidi Gutman/NBCUniversal via Getty Images Blackstone is all-in on rent resets…

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Jonathan GrayJonathan Gray, Blackstone president and chief operating officer

Heidi Gutman/NBCUniversal via Getty Images

  • Blackstone is all-in on rent resets and long-term property assets to combat potential inflation.
  • Private equity firms have trillions of dollars in cash to put to work on acquisitions.
  • Blackstone’s share price ticked over $100 for the first time this month.
  • See more stories on Insider’s business page.

It’s been quite the month for Blackstone.

The private-equity behemoth is part of a consortium of investors that bought Medline for about $34 billion, its share price ticked over $100 for the first time, and it’s doubling down on residential real estate with a $6 billion Home Partners of America buy.

It’s a bet on scorching demand for housing continuing, and also a defensive move as inflation worries start to seep into investors’ minds. The average price of a home topped $350,000 for the first time inn May, according to the National Association of Realtors, logging the largest-ever increase in prices since the NAR began tracking data.

“Whether it’s apartments, storage facilities for warehouse distribution, or single-family homes, private-equity is getting into this as an inflation hedge,” Nicholas Tsafos, a partner with accounting firm EisnerAmper, told Insider.

Home Partners, which owns more than 17,000 homes in the US, rents out these properties, but tenants have an opportunity to someday buy the home.

In the single-family rental arena, private-equity firms can hike rents, while also holding onto profitable, tangible assets.

“Because interest rates are low, and with the potential for a pick-up in inflation, private-equity also feels the need to be long on hard assets,” Tsafos said. “In real estate, you buy it today and then flip it for a higher price.”

Jon Gray, Blackstone’s president and COO, alluded to it during the firm’s earnings call in April when he said multi-family apartments that come with the ability to reset rents were key for Blackstone.

The firm bought many houses at remarkable discounts after the housing market crashed in 2007. It accumulated a number of single-family homes through a former portfolio company Invitation Homes. Blackstone sold its final block of shares in the company in 2019.

The private-equity shop also favors logistics spaces, such as warehousing, life sciences offices, and media and studio businesses with offices, according to a June 22 research note from UBS.

In October, Blackstone made a handsome investment when it sold life sciences real-estate company BioMed Realty for $14.6 billion, after acquiring it for about $8 billion in January 2016.

And it’s not just Blackstone. Fellow private-equity investor KKR is investing in My Community Homes, a platform that buys and manages single-family rental properties, according to Bloomberg.

KKR will invest in My Community Homes through its real-estate and private-credit vehicles.

A spokesperson for KKR was not immediately available to comment.

The Carlyle Group said in May that it provided up to $300 million to Four Springs Capital Trust, a private REIT that acquires and manages single-tenant properties with long-term net leases.

Four Springs will use the money to build its portfolio, which encompasses 122 properties across 29 states, Carlyle said in a press release.

The move on real estate comes while private investment firms sit on more than $1 trillion in cash. Borrowing costs, too, remain subdued as the Fed keeps interest rates at all-time lows.

Given the sheer amount of dry powder available, coupled with accommodative credit markets, private-equity is keen to conduct a surfeit of acquisitions, and isn’t shy about injecting large sums of equity into prospective investments.

Medline, for example, is expected to raise roughly $17 billion from the debt markets, while the private investors are providing a similar amount in equity.

“Big leveraged buyouts are back in vogue,” said Christopher Zook, chairman and CIO of alternative investment manager CAZ Investments. “Whether it’s KKR or Blackstone, they have large capital to put to work. So they’ve got to do a ton of deals.”

Disclaimer: KKR holds a majority stake in Insider’s parent company, Axel Springer.

It’s been quite the month for Blackstone.

Source: https://markets.businessinsider.com/news/stocks/blackstone-home-partners-america-single-family-rental-real-estate-inflation-2021-6-1030556791

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Trading the Fed, plus insights from a 99th-percentile fund manager

Hello and welcome to Insider Investing. I'm Joe Ciolli, and I'm here to guide you through the current market and investing landscape. Here…

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Hello and welcome to Insider Investing. I’m Joe Ciolli, and I’m here to guide you through the current market and investing landscape. Here’s what’s on the docket:

If you aren’t yet a subscriber to Insider Investing, you can sign up here.

Have thoughts on the newsletter? Just want to talk markets? Feel free to drop me a line at [email protected] or on Twitter @JoeCiolli.

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The Federal Reserve left interest rates steady this past week while setting the stage for two hikes by year-end 2023. Traders, who took a wait-and-see approach before the Fed meeting, quickly sprung into action. Insider spoke with Wall Street and crypto investors to gauge how to position for the hawkish shift.

Read the full story here:

The Fed has left rates steady while signaling 2 potential hikes by the end of 2023. Here is what to do with your stocks, bonds, and digital assets, according to top Wall Street and crypto investors.99th-percentile insights and stock picks Dave Ellison

Hennessy Funds

Financial-sector stocks have outperformed the rest of the market over the last several months. Hennessy Funds’ Dave Ellison – who’s in the 99th percentile compared to peers over the past year – told Insider he expects their strong performance to continue. He shared 5 financial stocks to buy now in order to take advantage of the remaining upside.

Read the full stories here:

Dave Ellison has beaten 99% of his peers over the last year managing the Hennessy Small-Cap Financial Fund. He breaks down why he thinks financial stocks still have room to run – and shares 5 names to bet onSPAC shorts SPACs and hedge funds 2x1

Brian Snyder/Reuters; Michael Loccisano/Getty Images; Samantha Lee/Insider

Short interest in SPACs stood at $3.2 billion in mid-June, up from $2.7 billion. The uptick in SPAC shorts comes as the market works to recover from a weeks-long slowdown, and one ETF manager expects recently “de-SPACed” companies to see short activity surge soon. Exclusive data shows the 20 most-shorted blank-check companies right now.

Read the full stories here:

Bets against SPACs are revving back up as the market attempts a comeback. Here are the 20 most-shorted blank-check companies now.YOU’RE INVITED: A Millennial Guide to Home Ownership

Join us and learn how to navigate the complicated process of buying a home in today’s hot market on Tuesday, June 22 at 12 p.m. ET – during a free, hour-long virtual event presented by Fidelity.

Register here.

Stock pick central

Seeking experts who are willing to name names? Look no further:

Have thoughts on the newsletter? Just want to talk markets? Feel free to drop me a line at [email protected] or on Twitter @JoeCiolli.

Source: https://markets.businessinsider.com/news/stocks/trading-fed-99th-percentile-picks-spac-short-selling-insider-investing-2021-6-1030537490

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