CSL Ltd (ASX: CSL) shares are on the move on Tuesday.
In morning trade, the biotechnology giant's shares are up slightly to $239.65.
Image source: Getty Images
Why are CSL shares rising?
Investors have been bidding the company's shares higher today after it announced the receipt of US Food & Drug Administration (FDA) approval for one of its therapies.
According to the release, the US FDA has approved Andembry for immediate launch in the United States.
Andembry helps prevent attacks of hereditary angioedema (HAE). It is the first and only treatment targeting factor XIIa for prophylactic use to provide sustained protection from attacks of HAE in adult and paediatric patients aged 12 years and older. The release notes that HAE occurs in about 1 in 50,000 people of any ethnic group.
This therapy is also the only treatment to offer once-monthly dosing from the start for all patients and is administered via an autoinjector. The company highlights that it inhibits the top of the HAE cascade by targeting factor XIIa.
CSL's pivotal placebo-controlled Phase 3 Vanguard trial and its open-label extension study showed that Andembry reduced the median number of HAE attacks by more than 99%.
This US FDA approval builds on other recent approvals for the treatment. This includes in Australia, the United Kingdom, the European Union, Japan, Switzerland and United Arab Emirates.
The company will now launch Andembry in the United States immediately, with availability expected through its third-party specialty pharmacy network before the end of June.
Should you invest?
The team at Bell Potter continues to rate CSL shares as a buy. In fact, the broker has the biotech on its coveted Australian Equities Panel. These are its top picks.
Commenting on its view of the stock, the broker said:
CSL presents an attractive buying opportunity as we expect the margin recovery phase for CSL to drive above-market earnings growth over the next few years. CSL trades at a 12-month forward PE of ~22x, representing a discount to its 10- year average of ~31x. Furthermore, the company will continue to deleverage the balance sheet over the next few years. Given the company's proven quality and growth prospects, we believe significant upside remains.
Bell Potter currently has a buy rating and $335.00 price target on its shares. Based on its current share price, this implies potential upside of 40% over the next 12 months.
