The CSL Limited (ASX: CSL) share price is trading lower on Tuesday afternoon.
At the time of writing, the biotherapeutics giant's shares are down slightly to $298.06.
What's going on with the CSL share price?
The CSL share price is trading slightly lower today amid broad market weakness.
This weakness appears to have offset the release of a positive announcement relating to CSL's product portfolio.
According to the release, the European Commission has granted conditional marketing authorisation for HEMGENIX (etranacogene dezaparvovec).
This is for the first gene therapy option for the treatment of severe and moderately severe Hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors by a single infusion.
This follows approval by the US Food and Drug Administration for HEMGENIX for the same indications in November.
But wait there's more…
Another positive that CSL has announced relates to the garadacimab or CSL312 therapy, which is currently undergoing phase 3 clinical trials.
Garadacimab is CSL's investigational monoclonal antibody that is being developed as a long-term prophylactic treatment for patients with hereditary angioedema (HAE).
The good news is that results from the trial, the first to investigate targeting activated Factor XII (FXIIa) to prevent HAE attacks, showed that once-monthly subcutaneous injections significantly reduced the attack rate compared to placebo.
Based on these results, CSL will proceed with regulatory submissions to global health authorities later this calendar year for full approval of garadacimab.
This could be a very big positive for CSL's future. Goldman Sachs has recently suggested that garadacimab could end up being a "pipeline in a product" thanks to multiple end use possibilities. It commented:
CSL312 is a humanised anti-factor XIIa monoclonal antibody in development for multiple indications including as a subcutaneous therapy for HAE, with the potential for administration every 4 weeks (vs. every 2-3 days for Haegarda). Given its early position in the coagulation cascade, there is also potential application in various other disorders (including fibrosis, cardiovascular and inflammatory indications).
