At the time of writing, the biotherapeutics company’s shares are fetching $294.15.
CSL share price flat following R&D update
During FY 2021, CSL invested more than US$1 billion in its R&D activities across six therapeutic areas, four scientific platforms, and two businesses.
Management notes that there were a number of highlights during the period. These include:
The Seqirus business advancing its first-of-its-kind adjuvanted, cell-based seasonal influenza vaccine (aQIVc) and increasing its work on its self-amplifying mRNA (sa-mRNA) development program. In fact, earlier this month, the Biomedical Advanced Research and Development Authority (BARDA) awarded Seqirus a multi-year contract to provide clinical development services to evaluate the safety, immunogenicity, and dose-sparing capability of two H2Nx influenza vaccine candidates. One is using a combination of Seqirus’ FDA-licensed cell-based and adjuvanted technologies, and the other is using its next generation sa-mRNA platform.
CSL has started a new collaboration with the Walter and Eliza Hall Institute for Medical Research (WEHI). This is one of the most prominent medical research and medicine development organisations in Australia. The two parties will work together to create a Centre for Biologic Therapies.
Another item highlighted by management is the impending Phase III study of 4-Factor Prothrombin Complex Concentrate to improve survival rates in traumatic injury and acute major bleeding. In addition, the company notes that the VANGUARD Phase III clinical trial for Garadacimab, a treatment in hereditary angioedema (HAE), has enrolled its last patient two months ahead of schedule. Recruitment from the AEGIS-II Phase III study of CSL112 (ApoA-1) for treatment of acute coronary syndrome is also progressing despite COVID-19 impact on clinical trial sites and patients.
Finally, on the licence front, CSL revealed that preparations are underway for EtranaDez, a gene therapy for haemophilia B, to submit a Biologics Licence Application for the US and Marketing Authorisation Application for the EU.
CSL’s Executive Vice President, Head of R&D, and Chief Medical Officer, Dr. Bill Mezzanotte, commented: “We continue to evolve as a leading plasma-based biotechnology company with purposeful diversity in therapeutic areas, scientific platforms and strategic alliances.”
“We are continuing to invest in our core plasma business while also enhancing our other scientific platforms to better deliver on our promise to discover, develop and provide innovations that save and improve lives around the world,” he added.