CSL Limited - CSLLY STOCK NEWS

CSL Seqirus has been awarded a contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to produce 4.8 million doses of pre-pandemic H5N1 vaccine for the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program. This is the fourth such award for CSL Seqirus, reinforcing its role in pandemic preparedness. The company's Holly Springs, NC facility, built through a public-private partnership with BARDA, can produce up to 150 million doses within six months of a pandemic declaration. The facility is the largest cell-based influenza vaccine producer globally.

CSL and Arcturus Therapeutics announced pivotal data published in Nature Communications demonstrating the efficacy and tolerability of their novel self-amplifying (sa-mRNA) COVID-19 vaccine, ARCT-154. The vaccine, the first of its kind approved in Japan, showed 100% efficacy against severe COVID-19 in healthy adults aged 18-59 and over 90% efficacy in older adults or those with comorbidities. The study, covering phases 1 through 3b, indicated that two 5 μg doses were well-tolerated and provided robust protection against multiple strains, including Omicron BA 4/5. The results underline the potential of the sa-mRNA technology to offer long-lasting immunity and superior protection compared to traditional mRNA vaccines.

CSL and Arcturus Therapeutics announced that Nature Communications published results from an integrated phase 1/2/3a/3b study on ARCT-154, a self-amplifying mRNA COVID-19 vaccine. The study demonstrates that two 5 μg doses of ARCT-154 were well-tolerated and provided significant protection against multiple COVID-19 strains. The vaccine showed 100% efficacy against severe COVID-19 in healthy individuals aged 18-59 and over 90% efficacy in at-risk populations. These results add to previous findings showing superior immunogenicity to Omicron BA 4/5 and longer-lasting immunity compared to conventional mRNA boosters. The vaccine's approval in Japan marks a significant milestone in the fight against COVID-19.

CSL Seqirus, a business of CSL, announced a real-world evidence study showing that a cell-based quadrivalent influenza vaccine was more effective than egg-based vaccines in preventing test-confirmed influenza over three seasons. The study revealed a relative vaccine effectiveness of at least 10% higher for the cell-based vaccine across three flu seasons.

CSL Vifor and Travere Therapeutics receive conditional marketing authorization from the European Commission for FILSPARI (sparsentan) for the treatment of IgA Nephropathy, marking a significant advancement in non-immunosuppressive therapy for this rare kidney disease.

CSL Vifor receives Health Canada authorization for Ferinject to treat iron deficiency anemia and heart failure, expanding treatment options for patients.

CSL Seqirus is prepared to deliver its influenza vaccine portfolio for the 2024/25 U.S. season following FDA recommendations. The company will transition to trivalent formulations, excluding the B/Yamagata strain. CSL Seqirus received FDA approval for its trivalent vaccines and aims to improve vaccine confidence and immunization rates globally.

CSL Limited reports strong financial performance with revenue of $8.05 billion, a 11% increase. Net profit after tax is $1.90 billion, up 20% on a constant currency basis. CSL Behring's portfolio growth, especially in immunoglobulins, drove the positive results. The company reaffirms its guidance for FY24 with anticipated NPATA of $2.9 billion to $3.0 billion at constant currency.

CSL (ASX:CSL; USOTC:CSLLY) announces Phase 3 AEGIS-II trial results for CSL112, which did not meet primary efficacy endpoint of MACE reduction at 90 days. No immediate regulatory filing planned. Ongoing analysis to be presented at ACC Scientific Sessions in April 2024.