Amgen Bags FDA Approval for Tezspire to Treat Severe Asthma

Biopharmaceutical company Amgen Inc. (NASDAQ:AMGN) recently revealed that it has received Food and Drug Administration’s (FDA) approval for Tezspire, a biologic for severe asthma to treat adult and pediatric patients aged 12 years and older.

Following the news, shares of the company appreciated marginally to close at $224.32 in Friday’s extended trading session.

Strategic Impact

Following a Priority Review by the FDA and based on results from the PATHFINDER clinical trial program, Tezspire’s results from the NAVIGATOR Phase 3 trial led to its approval.

Notably, Tezspire is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase 2 and 3 clinical trials.

Management Commentary

The Executive Vice-President of Research and Development at Amgen, David M. Reese, M.D., said, “Today’s approval by the FDA marks the first time patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels. Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options.”

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Price Target

Recently, Wells Fargo analyst Mohit Bansal initiated coverage on the stock with a Hold rating and a price target of $210, which implies downside potential of 5.6% from current levels.

Consensus among analysts is a Hold based on 4 Buys, 10 Holds and 1 Sell. The average Amgen price target of $229.31 implies upside potential of 3.1% from current levels. Shares have declined about 2.1% over the past year.

Bloggers Sentiment

TipRanks data shows that financial blogger opinions are 96% Bullish on AMGN, compared to the sector average of 70%.