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.

If approved, garadacimab will be the first and only once-monthly treatment inhibiting factor XIIa to prevent attacks in HAE patients – a community CSL has been serving for more than 40 years MARBURG, Germany , Dec. 13, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorization for garadacimab as a once-monthly prophylactic treatment for hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. Garadacimab is a monoclonal antibody that targets activated factor XII (factor XIIa), a plasma protein that plays a key role in attacks of swelling in people with HAE, thereby inhibiting the HAE cascade at the top to prevent HAE attacks.

CSL Receives Positive CHMP Opinion for Garadacimab in Hereditary Angioedema (HAE)

Exelixis

Investors interested in Medical - Biomedical and Genetics stocks are likely familiar with Exelixis (EXEL) and CSL Limited Sponsored ADR (CSLLY). But which of these two stocks presents investors with the better value opportunity right now?

EXEL vs. CSLLY: Which Stock Is the Better Value Option?

Investors with an interest in Medical - Biomedical and Genetics stocks have likely encountered both Exelixis (EXEL) and CSL Limited Sponsored ADR (CSLLY). But which of these two companies is the best option for those looking for undervalued stocks?

EXEL vs. CSLLY: Which Stock Should Value Investors Buy Now?

Investors looking for stocks in the Medical - Biomedical and Genetics sector might want to consider either Exelixis (EXEL) or CSL Limited Sponsored ADR (CSLLY). But which of these two companies is the best option for those looking for undervalued stocks?

EXEL or CSLLY: Which Is the Better Value Stock Right Now?

Results of the first season of a randomized study showed adjuvanted and high-dose influenza vaccines did not differ in effectiveness against PCR-confirmed influenza. This is the first randomized study to evaluate the relative vaccine effectiveness of adjuvanted influenza vaccines compared to high-dose influenza vaccines for prevention of lab-confirmed influenza.

New Data Presented at IDWeek 2024 Show Adjuvanted and High-Dose Influenza Vaccines are Comparable in Protecting Adults 65 Years of Age and Older Against Seasonal Influenza

Travere Therapeutics

Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).

CSL Vifor and Travere Therapeutics Announce Swissmedic approval of FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

Analysis from a dynamic model showed the need to increase influenza vaccination rates in the U.S. to at least 45% to avoid saturation of hospital system resources, particularly in intensive care units (ICUs).1 Results from multiple real-world evidence (RWE) studies over different seasons showed improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing outpatient test-confirmed influenza across different age groups, including as young as 6 months.2,3 A model based on RWE from the 2022-23 flu season study estimated that the use of a cell-based influenza vaccine would have averted a significant burden of influenza-related illnesses compared to an egg-based influenza vaccine.4 SUMMIT, N.J. , Oct. 16, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced new data from five studies reinforcing the importance of seasonal influenza vaccination and exhibiting the benefits of cell-based influenza vaccines among people aged 6 months to 64 years.

CSL Seqirus Presents Data at IDWeek 2024 Highlighting the Urgent Need to Increase Influenza Vaccination Rates and the Benefits of Cell-Based Influenza Vaccines

CSL Seqirus has received a Biomedical Advanced Research and Development Authority (BARDA) award to complete the fill and finish process for additional pre-pandemic vaccines to further support the U.S. government's outbreak and preparedness response.  BARDA has requested adjuvanted H5N1 pre-pandemic vaccines and additional H5N8 antigen as part of its decision to expand its portfolio of pre-pandemic vaccines.

CSL Seqirus, a Global Leader in Pandemic Preparedness, Announces Sixth BARDA Award in Response to Avian Influenza

Results from real-world evidence (RWE) studies to be presented at OPTIONS XII show the effectiveness of cell-based and MF59® adjuvanted influenza vaccines. Results from different studies suggested improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing test-confirmed influenza across different age groups, including children as young as six months.1,2 Results from a real-world study covering the 2023/24 season showed that cell-based vaccine was effective against medically attended, laboratory-confirmed influenza, with vaccine effectiveness (VE) highest in children six months to three years of age at 88%, compared with unvaccinated participants.3 RWE studies can play a key role in assessing influenza vaccine effectiveness each season.

CSL Seqirus Presents Real-World Evidence at OPTIONS XII Conference Highlighting Effectiveness of Influenza Vaccinations

Arcturus Therapeutics

WALTHAM, Mass. & SAN DIEGO--(BUSINESS WIRE)---- $ARCT #ClinicalTrial--Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and self-amplifying messenger RNA (sa-mRNA) pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a head-to-head study demonstrating that self-amplifying (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to the conventional mRNA vaccine Comirnaty® for up to one year against Wuhan-Hu-1, Omicron BA.4-5 and certain other variants, and at one-sixth the dose.

Self-Amplifying mRNA COVID-19 Vaccine Demonstrates Superior Immune Response Compared with mRNA Vaccine at 12 Months Post-Vaccination

Biomedical Advanced Research and Development Authority (BARDA) and CSL Seqirus will expand their reserves of MF59® adjuvant to the equivalent of 40 million doses as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). The multi-year $121.4 million award from BARDA is the fifth avian influenza pandemic preparedness award for CSL Seqirus.

CSL Seqirus, a Global Leader in Pandemic Preparedness, Announces Fifth BARDA Award in Response to Avian Influenza Outbreak

Veltassa ®  offers effective and well-tolerated long-term potassium control in chronic kidney disease and chronic heart failure patients 1-5 Zeria Pharmaceutical Co., Ltd. to market Veltassa® in Japan ST.

Veltassa® (patiromer) approved in Japan for the treatment of adults with hyperkalemia

PHILADELPHIA, Sept. 17, 2024 (GLOBE NEWSWIRE) -- In an era where artificial intelligence (AI) is transforming industries and reshaping our daily lives, it is more important than ever to equip the next generation with the skills and knowledge to harness these powerful tools.

Mark Cuban Foundation and CSL Bring Free AI Bootcamp to Philadelphia Teens

Following the launch of Accumulus Synergy's innovative cloud-based information exchange platform, CSL joins the nonprofit industry association Following the launch of Accumulus Synergy's innovative cloud-based information exchange platform, CSL joins the nonprofit industry association

CSL Joins Accumulus Synergy to Drive Industry Change

Approval underscores CSL and Arcturus Therapeutics' commitment to delivering disruptive technologies to combat COVID-19 and other respiratory viral diseases to protect public health KOSTAIVE®, the world's first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, was approved for adults 18 years of age and older in November 2023 The updated sa-mRNA COVID-19 vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants Meiji Seika Pharma, CSL's exclusive partner in Japan, will begin vaccine distribution in time for the October COVID-19 vaccination campaign  CSL and Arcturus Therapeutics' partnership delivers on the promise to advance innovative vaccine technology for viral respiratory diseases KING OF PRUSSIA, Pa. and SAN DIEGO , Sept.

Japan's Ministry of Health, Labor and Welfare Approves CSL and Arcturus Therapeutics' Updated Self-amplifying mRNA COVID-19 Vaccine for Protection against JN.1 Strain, to be Distributed in Japan by Meiji Seika Pharma

CSLLY's FY 2024 results were good thanks to the outperformance of the Behring segment; the company's net profit in constant currency terms grew +15% YoY to $2.91 billion, which was in line with expectations. But CSL Limited's FY 2025 earnings guidance was a miss, and this is likely attributable to the expected underperformance of the Seqirus and Vifor segments. My rating for CSL Limited stays as a Hold, as the company's strong FY 2024 earnings growth was obscured by its disappointing FY 2025 bottom line guidance.

CSL Limited: Good Results Overshadowed By Below-Expectations Guidance

CSL Limited (OTCQX:CSLLY) Q4 2024 Results Conference Call August 12, 2024 9:00 PM ET Company Participants Joy Linton - CFO Chris Cooper - Head, IR Paul McKenzie - MD, CEO & Executive Director Ken Lim - Chief Strategy Officer Conference Call Participants Lyanne Harrison - Bank of America Saul Hadassin - Barrenjoey Gretel Janu - Evans & Partners Steve Wheen - Jarden Andrew Goodsall - MST Marquee David Low - JPMorgan Craig Wong-Pan - RBC David Stanton - Jefferies Laura Sutcliffe - UBS Mathieu Chevrier - Citi David Bailey - Macquarie Joy Linton Good morning, everyone, and welcome to CSL's Financial Year 2024 Results Presentation. I'm Joy Linton, CSL's Chief Financial Officer.

CSL Limited (CSLLY) Q4 2024 Earnings Call Transcript

Shares of CSL Ltd fell more than 3% on Tuesday after the Australian biotech firm forecast an annual profit that was higher than a year earlier but below market consensus.

Australia's CSL falls on weaker-than-expected annual profit forecast

Genmab - ADR

Investors looking for stocks in the Medical - Biomedical and Genetics sector might want to consider either Genmab A/S Sponsored ADR (GMAB) or CSL Limited Sponsored ADR (CSLLY). But which of these two stocks is more attractive to value investors?

GMAB vs. CSLLY: Which Stock Is the Better Value Option?

CSL Seqirus is the only manufacturer to offer a differentiated influenza vaccine for all eligible people aged six months and older in the United States. Centers for Disease Control and Prevention (CDC) trend findings indicate a significant decline in influenza vaccination rates, which poses a serious risk to public health infrastructure and underscores the importance of receiving an annual influenza vaccination.1,2 According to the CDC, it is recommended that all eligible people aged six months and older receive their annual influenza vaccine, especially people at an increased risk of severe influenza-related complications, such as older adults, pregnant people, and children under five years old.2 ,3 SUMMIT, N.J.

CSL Seqirus Begins Shipping Its Portfolio of Influenza Vaccines for the 2024/25 Flu Season

MARBURG, Germany, July 04, 2024 (GLOBE NEWSWIRE) -- Global biotechnology leader CSL Behring (ASX: CSL) today announced that two hemophilia B patients were treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec) at Hemophilia Treatment Centers in France. This milestone achievement makes HEMGENIX® the first gene therapy administered as a treatment in a real-world setting for hemophilia B in Europe.

CSL Behring Announces First Two Patients Treated with HEMGENIX® (etranacogene dezaparvovec) Gene Therapy for Hemophilia B in Europe

CSL Seqirus to complete the fill and finish process for pre-pandemic vaccine to support the U.S. government's outbreak and preparedness response. Outbreaks of highly pathogenic avian influenza (HPAI) viruses in birds and livestock have been reported in the U.S. Fourth avian influenza pandemic preparedness award to CSL Seqirus under a multi-year agreement with Biomedical Advanced Research and Development Authority (BARDA).

CSL Seqirus, a Proud Champion of Pandemic Preparedness, Announces U.S. Government Award in Response to Avian Influenza

KING OF PRUSSIA, Pa. & SAN DIEGO--(BUSINESS WIRE)---- $ARCT #ClinicalTrial--Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announce Nature Communications has published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT-154, a novel self-amplifying (sa-mRNA) COVID-19 vaccine and the world's first approved sa-mRNA COVID-19 vaccine. The results demonstrate that two 5 μg doses of ARCT-154, sa-mRNA vaccine, were.

Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics' COVID-19 Vaccine

A real-world evidence (RWE) study recently published in Open Forum Infectious Diseases (OFID) examined three consecutive U.S. flu seasons in the United States. The study suggests that cell-based quadrivalent influenza vaccine (QIVc) may have the potential to be more effective than egg-based vaccines (QIVe) in preventing test-confirmed influenza.

Recently Published Real-World Evidence Study Shows Effectiveness of Cell-Based Quadrivalent Influenza Vaccine Over Three Seasons

First non-immunosuppressive therapy for the treatment of IgA Nephropathy (IgAN) approved in Europe Conditional marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial ST. GALLEN, Switzerland and SAN DIEGO, April 24, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).

News for CSL Ltd Stock (CSLLY)