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CSL Limited (CSL.AX)

273.30

-5.15

(-1.85%)

At close: April 26 at 4:10 PM GMT+10

Travere Therapeutics and CSL Vifor Announce European Commission Approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

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 3 PROTECT Study SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with p

GlobeNewswire 2 days ago

TVTX

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CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

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). The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

PR Newswire 2 days ago

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TVTX
CSL Limited (ASX:CSL) On An Uptrend: Could Fundamentals Be Driving The Stock?

CSL's (ASX:CSL) stock is up by 1.2% over the past month. We wonder if and what role the company's financials play in...

Simply Wall St. 24 days ago

CSL.AX
-1.85%
10 Best Long Term ASX Stocks To Invest In

In this piece, we will take a look at the ten best long term ASX stocks to invest in. If you want to skip our overview of the Australian stock market, then you can take a look at the 5 Best Long Term ASX Stocks To Invest In. Australia is one of the most prosperous […]

Insider Monkey 27 days ago

SKHHY

CSLLY

QBIEY
Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure

CSL Vifor today announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III* 1 to improve exercise capacity.2 Ferinject has now received marketing authorization

CNW Group last month

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CSL Ltd's Dividend Analysis

CSL Ltd (CSLLY) recently announced a dividend of $0.6 per share, payable on a date yet to be announced, with the ex-dividend date set for 2024-03-11. As investors look forward to this upcoming payment, the spotlight also shines on the company's dividend history, yield, and growth rates. Using the data from GuruFocus, let's look into CSL Ltd's dividend performance and assess its sustainability.

GuruFocus.com last month

CSLLY
CSL Seqirus is Fully Prepared to Implement the FDA's Vaccines and Related Biological Products Advisory Committee Trivalent Influenza Vaccines Strain Selection for the 2024/25 U.S. Season

CSL Seqirus, a global leader in the protection of public health, confirmed it is fully prepared to deliver its influenza vaccine portfolio for the 2024/25 U.S. season, based on the trivalent strains recommended this week by the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC). During the meeting, the committee confirmed the viral strain selection of influenza vaccines for the Northern Hemisphere 2024/25 season, which aligns with the F

PR Newswire last month

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An Intrinsic Calculation For CSL Limited (ASX:CSL) Suggests It's 21% Undervalued

Key Insights Using the 2 Stage Free Cash Flow to Equity, CSL fair value estimate is AU$362 Current share price of...

Simply Wall St. 2 months ago

CSL.AX
-1.85%
Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy

Committee for Medicinal Products for Human Use (CHMP) recommends approval of the conditional marketing authorization (CMA) for sparsentan for the treatment of IgA nephropathy (IgAN) in Europe Positive CHMP opinion is based on pivotal Phase 3 PROTECT Study results European Commission decision is expected in Q2 2024 SAN DIEGO, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (NASDAQ: TVTX) and CSL Vifor today announced that the European Medicines Agency’s (EMA) CHMP has recommended ap

GlobeNewswire 2 months ago

TVTX

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Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.

PR Newswire 2 months ago

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CSL
CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human])

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced top-line results from the Phase 3 AEGIS-II trial evaluating the efficacy and safety of CSL112 (apolipoprotein A-I [human]) compared to placebo in reducing the risk of major adverse cardiovascular events (MACE) in patients following an acute myocardial infarction (AMI). The study did not meet its primary efficacy endpoint of MACE reduction at 90 days. As a result, there are no plans for a near-term regulatory filing. There wer

PR Newswire 2 months ago

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New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

KING OF PRUSSIA, Pa. & SAN DIEGO, February 05, 2024--Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine. ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).

Business Wire 2 months ago

ARCT

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Are Medical Stocks Lagging Cardinal Health (CAH) This Year?

Here is how Cardinal Health (CAH) and CSL Limited Sponsored ADR (CSLLY) have performed compared to their sector so far this year.

Zacks 2 months ago

CAH

CSL.AX
-1.85%
CSL's (ASX:CSL) investors will be pleased with their decent 60% return over the last five years

Generally speaking the aim of active stock picking is to find companies that provide returns that are superior to the...

Simply Wall St. 2 months ago

CSL.AX
-1.85%
Harris Poll Survey Finds People Receiving Treatment for CIDP Are Interested in Exploring More Convenient Treatment Options

CSL Behring, a business unit of global biotechnology leader CSL, today announced survey results showing that the majority of surveyed people living with chronic inflammatory demyelinating polyneuropathy (CIDP) agree they are interested in exploring more convenient treatment options (n=98, 82%) and that administering treatment at home is extremely/very important to them (n=100, 72%). However, less than half of people surveyed said they discuss potential new treatment options or switching treatmen

PR Newswire 3 months ago

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CSL Behring Announces Availability of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe

CSL Behring, a business unit of global biotechnology leader CSL, today announced the availability of a 10g prefilled syringe for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid). The Hizentra prefilled syringes provide people living with Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) the ability to elevate their treatment experience by eliminating the need to draw medication from vials. CSL Behring now has a wide range of prefilled syringe s

PR Newswire 3 months ago

CMXHF

CSLLY
CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the publication in Lancet Infectious Diseases of a Phase 3 study showing that a booster dose of ARCT-154, a novel, self-amplifying messenger RNA (sa-mRNA) vaccine, elicited a numerically higher immune response (meeting the non-inferiority criteria) against the original Wuhan-Hu-1 virus strain, and a superior immune response against Omicron BA.4/5 subvariant of SARS-CoV-2 virus compared

PR Newswire 4 months ago

ARCT

CMXHF

CSLLY
CSL Seqirus Commends the National Advisory Committee on Immunization for Preferential Recommendation of Enhanced Influenza Vaccines for Adults 65 and Older

CSL Seqirus commends the National Advisory Committee on Immunization's (NACI's) recent recommendation for adults 65 years of age and older to preferentially receive an enhanced influenza vaccine, which includes adjuvanted, high-dose and recombinant vaccines. This recommendation is based on data from studies that show that all approved enhanced influenza vaccines are effective in reducing the risk of influenza-related hospitalization and medical encounters.

CNW Group 4 months ago

CMXHF

CSLLY
CSL's Garadacimab, a First-in-Class Factor XIIa Inhibitor, Receives FDA and EMA Filing Acceptance

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The company also announced the European Medicines Agency (EMA) has accepted the submission for CSL's Marketing Authorization Application (MAA) for garadacimab. If approved, garadacimab would become the first treatment for H

PR Newswire 4 months ago

CMXHF

CSLLY
CSL Behring's HEMGENIX® (etranacogene dezaparvovec-drlb) Demonstrates at Three Years Post-Treatment Long-Term Durability, Safety and Greater Bleed Protection Versus Prophylactic Treatment in People Living with Hemophilia B

Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) today announced the three-year results from the pivotal HOPE-B study confirming continued long-term durability and safety of HEMGENIX® (etranacogene dezaparvovec-drlb) following a one-time infusion in people living with hemophilia B. The data showing that a one-time infusion of HEMGENIX offers elevated and sustained factor IX activity levels for years were presented in an oral presentation at the 65th American Society of Hematology (ASH) A

PR Newswire 4 months ago

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QURE

Performance Overview

Return	CSL.AX	S&P/ASX 200 [XJO]
YTD	-4.05%	-0.20%
1-Year	-9.37%	+3.55%
3-Year	+4.25%	+7.53%

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CSL Limited (CSL.AX)

Travere Therapeutics and CSL Vifor Announce European Commission Approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

CSL Limited (ASX:CSL) On An Uptrend: Could Fundamentals Be Driving The Stock?

10 Best Long Term ASX Stocks To Invest In

Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure

CSL Ltd's Dividend Analysis

CSL Seqirus is Fully Prepared to Implement the FDA's Vaccines and Related Biological Products Advisory Committee Trivalent Influenza Vaccines Strain Selection for the 2024/25 U.S. Season

An Intrinsic Calculation For CSL Limited (ASX:CSL) Suggests It's 21% Undervalued

Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human])

New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

Are Medical Stocks Lagging Cardinal Health (CAH) This Year?

CSL's (ASX:CSL) investors will be pleased with their decent 60% return over the last five years

Harris Poll Survey Finds People Receiving Treatment for CIDP Are Interested in Exploring More Convenient Treatment Options

CSL Behring Announces Availability of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe

CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster

CSL Seqirus Commends the National Advisory Committee on Immunization for Preferential Recommendation of Enhanced Influenza Vaccines for Adults 65 and Older

CSL's Garadacimab, a First-in-Class Factor XIIa Inhibitor, Receives FDA and EMA Filing Acceptance

CSL Behring's HEMGENIX® (etranacogene dezaparvovec-drlb) Demonstrates at Three Years Post-Treatment Long-Term Durability, Safety and Greater Bleed Protection Versus Prophylactic Treatment in People Living with Hemophilia B

Performance Overview