U.S. FDA Approves Amgen’s (NASDAQ:AMGN) Imdelltra
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U.S. FDA Approves Amgen’s (NASDAQ:AMGN) Imdelltra

Story Highlights

The U.S. FDA has approved Amgen’s Imdelltra therapy for small cell lung cancer.

The U.S. Food and Drug Administration (FDA) has approved Amgen’s (NASDAQ:AMGN) Imdelltra (tarlatamab-dlle) therapy for extensive-stage small cell lung cancer (ES-SCLC). Small cell lung cancer is the most deadly form of lung cancer.

The FDA’s approval for Imdelltra is for use as a second or later line of treatment for patients whose disease has progressed while on or after chemotherapy. This drug therapy received accelerated approval due to its promising response rate and duration observed in clinical studies.

The U.S. FDA granted accelerated approval to Imdelltra based on a Phase 2 clinical trial that showed a robust objective response rate (ORR) of 40% in SCLC patients who had failed at least two prior treatments. These patients received a 10 mg dose twice a week of Imdelltra.

Is AMGN a Good Stock to Buy?

Analysts remain cautiously optimistic about AMGN stock, with a Moderate Buy consensus rating based on 11 Buys, eight Holds, and one Sell. Over the past year, AMGN has increased by more than 40%, and the average AMGN price target of $322.75 implies an upside potential of 2.55% from current levels.

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