Shares in pharmaceutical giant AstraZeneca (AZN) failed to get better today in pre-market trading despite its new self-treatment for lupus – a major killer of young women – being approved in the U.S.
Claim 55% Off TipRanks
- Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions
- Discover top-performing stock ideas and upgrade to a portfolio of market leaders with Smart Investor Picks
Lupus Autoinjector Wins Approval
AstraZeneca said its new once-weekly autoinjector pen called Saphnelo for the treatment of systemic lupus erythematosus (SLE) in adults had been given the green light by the U.S. Food and Drug Administration. It is already approved in the EU and Japan, and is under regulatory review in several other countries around the world.
The FDA approval was based on results from AZN’s Phase III TULIP-SC trial, which revealed that the use of the pen had led to a “statistically significant and clinically meaningful reduction in disease activity.”
Susan Manzi, MD, MPH, chair of the Allegheny Health Network (AHN) Medicine Institute, director of the Lupus Center of Excellence at the AHN Autoimmunity Institute and principal investigator of the TULIP-SC trial, said: “The approval makes this important medicine more convenient and accessible for many more patients. With its proven ability to significantly reduce disease activity and the risk of organ damage, it has been a much-needed innovation in lupus, which is a serious and often debilitating autoimmune condition impacting millions worldwide.”
Leading Killer of Young Women
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, added: “Since its launch, Saphnelo IV infusion has helped tens of thousands of people with systemic lupus erythematosus achieve lower disease activity with fewer steroids and has been shown to help many achieve remission.”
SLE is an autoimmune disease in which the immune system attacks healthy tissue in the body. Over 3.4 million people globally are affected by SLE and is among the leading causes of death in young women in the US. It is more common among Asian, Black or Hispanic populations.
The approval comes just ahead of AZN’s Q1 earnings report on April 29. It is expected to report earnings of $2.57 per share, which will indicate a year-over-year increase of 3.6%. Revenues are expected to be $14.98 billion, up 10.2% from the year-ago quarter.
This is set to further boost the AZN share price, which has climbed 37% over the last 12 months. That’s down to a strong drug pipeline and encouraging trial developments in a range of diseases from cancer to high blood pressure.
Is AZN a Good Stock to Buy Now?
On TipRanks, AZN has a Moderate Buy consensus based on 12 Buy, 2 Hold and 1 Sell ratings. Its highest price target is $276.67. AZN stock’s consensus price target is $222, implying a 16.99% upside.
