CSL Ltd

CSL Ltd. is a biopharmaceutical company, which engages in the manufacture, marketing, and distribution of biopharmaceutical and allied products. It operates through the following segments: CSL Behring, CSL Seqirus, and CSL Vifor. The CSL Behring segment provides plasma products, gene therapies, and recombinants. The CSL Seqirus segment includes predominantly influenza related products and provides pandemic services to governments. The CSL Vidor segment focuses on the distribution of products in the therapeutic areas of iron deficiency and nephrology. The company was founded on November 2, 1961 and is headquartered in Melbourne, Australia.

CSL Limited's FY 2024 profit guidance outlined in a recent announcement last week came in below expectations, and this led to a meaningful correction in its share price. The company's earnings guidance for the new fiscal year was negatively affected by unfavorable foreign exchange assumptions, while its other metrics relating to demand and expenses are pretty healthy. I view the recent correction in CSL Limited's shares as a buying opportunity, as I think that its actual FY 2024 performance should be better than what its guidance suggests.

CSL Limited: Fiscal 2024 Outlook In The Spotlight

uniQure

HEMGENIX®, the first and only FDA approved gene therapy for hemophilia B, has been proven to elevate and sustain factor IX levels for years, significantly reduce the rate of annual bleeds versus standard of care, and reduce or eliminate the need for prophylactic treatment in 94% of patients (51 out of 54) after a one-time infusion KING OF PRUSSIA, Pa. , June 20, 2023 /PRNewswire/ -- Global biotechnology leader CSL Behring today announced that the first patient has received U.S. Food and Drug Administration (FDA) approved HEMGENIX® (etranacogene dezaparvovec-drlb) for hemophilia B in the United States.

CSL Behring Announces the First Patient Has Received FDA-Approved HEMGENIX® (etranacogene dezaparvovec-drlb) for Hemophilia B

Injectafer® (ferric carboxymaltose) is now the first and only intravenous (i.v.) iron replacement therapy in the U.S. indicated for improvement in exercise capacity in adult patients with symptomatic heart failure who have iron deficiency ST.

Injectafer® approved in the U.S. for the treatment of iron deficiency in patients with heart failure

Cara Therapeutics

Recommendation will enable eligible patients in England, Wales and Northern Ireland to access the first licensed treatment for moderate-to-severe chronic kidney disease (CKD)-associated pruritus in adult patients on haemodialysis ST. GALLEN, Switzerland and STAMFORD, Conn.

Kapruvia® (difelikefalin) recommended by England's NICE for the treatment of adults with moderate-to-severe CKD-associated pruritus

CSL Limited is one of the largest global biotechnology companies globally that specializes in the research, development, and manufacturing of plasma-based therapies, vaccines, and other pharmaceutical products. The combination of long-term revenue reacceleration, margin expansion, capacity expansion, and great execution led to shareholder value creation. The resilient nature of the company's products protects it from macro downturns.

CSL Limited: Well Placed To Execute Growth Plans And Generate Shareholder Value

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Tavneos® newly introduced in the 2022 European Alliance of Associations for Rheumatology (EULAR) recommendations for the management of ANCA-associated vasculitis (AAV) Recommendations recognize Tavneos®' ability to induce and sustain remission, lower glucocorticoids-induced toxic effects and potentially improve renal function in patients with GPA/MPA ST. GALLEN, Switzerland , March 28, 2023 /PRNewswire/ -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) is pleased to announce that Tavneos® has been included in the revised EULAR AAV management recommendations, as one of several important updates in the 2022 version.

Tavneos® (avacopan) included in updated EULAR recommendations for the management of AAV

The site will support CSL's growing R&D portfolio, accelerating the development of next-generation mRNA technology for vaccines WALTHAM, Mass. , March 27, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL; USOTC:CSLLY) today celebrated the official opening of the company's new state-of-the-art research and development (R&D) center in Waltham, Massachusetts.

CSL Opens New, State-of-the-Art Vaccine Research and Development Facility in Waltham, Massachusetts

Significant reduction in number of attacks support the potential of once-monthly garadacimab as a prophylactic therapy for patients with hereditary angioedema KING OF PRUSSIA, Pa. , March 1, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL;USOTC:CSLLY), announced that The Lancet  has published results from the Phase 3 VANGUARD study evaluating garadacimab (CSL312) as a once-monthly, prophylactic treatment for attacks due to hereditary angioedema (HAE).

The Lancet Publishes Pivotal Phase 3 Data on CSL's First-in-Class Garadacimab for HAE

Majority of patients were attack free during the entire six-month treatment period (61.5%) Study results presented for first time at 2023 AAAAI Annual Meeting; global regulatory submissions anticipated later in the calendar year Garadacimab underscores CSL's promise to develop innovative medicines for people living with rare diseases like HAE, a community CSL has been serving for 40 years KING OF PRUSSIA, Pa. , Feb. 26, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today presented results from the pivotal placebo-controlled Phase 3 VANGUARD clinical trial of garadacimab (CSL312).

CSL's Phase 3 Study Shows First-In-Class Garadacimab Provides Patients with Significant HAE Attack Prevention with Monthly Dosing

Data follow the historic approval of the first gene therapy for hemophilia B, which reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion 18-month data support the efficacy and safety of HEMGENIX® and the ongoing benefit of this treatment HEMGENIX® is approved for adults with hemophilia B in the United States, European Union and European Economic Area KING OF PRUSSIA, Penn. , Feb. 23, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) today announced the publication in the New England Journal of Medicine (NEJM) (Vol.

CSL's HOPE-B Data Published in the New England Journal of Medicine, Demonstrating Efficacy and Durability of HEMGENIX® (etranacogene dezaparvovec-drlb)

CSL recognized in Forbes and Statista's Best Large-sized Employer category for the fourth time since 2018. KING OF PRUSSIA, Pa.

Biotech Leader CSL Again Named Among America's Best Employers by Forbes

CSL Limited's 1H FY 2023 net profit came in +10% above analysts' expectations, as a result of both solid revenue growth and significant margin improvement. I also have a positive opinion about the planned introduction of the new hemophilia B gene therapy product in the US, and the company's new CEO appointment.

CSL Limited Remains A Buy As Earnings Beat Expectations

CSL Limited (OTCPK:CSLLY) Q2 2023 Earnings Conference Call February 13, 2023 7:00 PM ET Company Participants Mark Dehring - Head, Investor Relations Paul Perreault - Chief Executive Officer Joy Linton - Chief Financial Officer Paul McKenzie - Chief Operating Officer Conference Call Participants David Stanton - Jefferies Andrew Goodsall - MST Marquee David Low - JPMorgan Lyanne Harrison - Bank of America Chris Cooper - Goldman Sachs Steve Wheen - Jarden Sean Laaman - Morgan Stanley Saul Hadassin - Barrenjoey Gretel Janu - Credit Suisse Craig Wong-Pan - RBC David Bailey - Macquarie Mark Dehring Ladies and gentlemen, good morning and welcome to CSLs First Half Results call for Fiscal 2023. It's Mark Dehring speaking and joining me online is Paul Perreault, CSL's, Chief Executive Officer; Paul McKenzie, CSL's, incoming Chief Executive Officer and Joy Linton, CSL's, Chief Financial Officer.

CSL Limited (CSLLY) Q2 2023 Earnings Call Transcript

CSL Limited Sponsored ADR (CSLLY) could be a great choice for investors looking to make a profit from fundamentally strong stocks that are currently on the move. It is one of the several stocks that made it through our "Recent Price Strength" screen.

What Makes CSL Limited Sponsored ADR (CSLLY) a Good Fit for 'Trend Investing'

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Medical and energy companies, including oil stocks, lead the list of the 100 best stocks in 2022. The post 100 Best Stocks Of 2022: Oil Stocks And Medicals Shine appeared first on Investor's Business Daily.

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ST. GALLEN, Switzerland--( BUSINESS WIRE )--Regulatory News:

Cancellation of remaining publicly held registered shares of Vifor Pharma AG

Dr Paul McKenzie appointed Chief Executive Officer and Managing Director of CSL from 6 March 2023 MELBOURNE, Australia , Dec. 12, 2022 /PRNewswire/ -- The Board of Directors of CSL Limited (ASX:CSL; USOTC:CSLLY) today announces that it has appointed Dr Paul McKenzie as Chief Executive Officer (CEO) and Managing Director of CSL from 6 March 2023.  Dr McKenzie will succeed Mr Paul Perreault, who has advised the Board of his intention to retire after serving 10 years in the role, and more than 25 years with the company.

CSL Announces Next CEO & Managing Director

Arcturus Therapeutics

CSL to access late-stage next-generation mRNA platform technology, enabling development of vaccines for COVID-19, influenza, multi-pathogen pandemic preparedness and other respiratory pathogens KING OF PRUSSIA, Pa. , Dec. 12, 2022 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announced that its subsidiary, CSL Seqirus, finalized its global collaboration and license agreement with Arcturus Therapeutics Holdings Inc ("Arcturus Therapeutics"; NASDAQ: ARCT).

CSL Announces Closing of Global Collaboration and Licensing Agreement with Arcturus Therapeutics

ST. GALLEN, Switzerland & BEIJING--( BUSINESS WIRE )--Regulatory News:

Ferinject® approved in Chinafor the treatment of iron deficiency in adult patients

Iron Deficiency Day 2022: CSL Vifor calls to take iron seriously

-  This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion -  With the approval of HEMGENIX, CSL now offers an even more comprehensive portfolio of treatments for people living with hemophilia B, ushering in a new era of treatment options KING OF PRUSSIA, Pa. , Nov. 22, 2022 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) today announced that the U.S. Food and Drug Administration (FDA) approved HEMGENIX® (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with hemophilia B.

U.S. Food and Drug Administration approves CSL's HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B

CSL Limited's recent R&D investor briefing suggests that the company has been able to build a strong R&D pipeline without overspending. Separately, CSL Limited expects the top line of its recently acquired pharmaceuticals company to generate a reasonably good revenue CAGR above +10% for the midterm.

CSL Limited: R&D Efforts And M&A Deal In The Limelight

Pipeline advancements and investment in innovation and disruptive technologies to help fuel sustainable, profitable growth for CSL's three businesses, CSL Behring, CSL Seqirus and CSL Vifor, in the decades ahead MELBOURNE, Australia and KING OF PRUSSIA, Pa. , Nov. 2, 2022 /PRNewswire/ -- At its annual R&D investor briefing today, global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) demonstrated how its growing, innovative pipeline is well-positioned to meet the current and future needs of patients and public health.

News for CSL Ltd Stock (CSLLY)