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Amgen Wins FDA Approval for Breakthrough Lung Cancer Drug

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The FDA has given Amgen (AMGN) the green light to bring its breakthrough lung cancer drug Lumakras to the market. Amgen is a global biotechnology company that focuses on developing solutions to address unmet medical needs.

Lumakras won accelerated regulatory approval to treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults. The FDA approval was based on the outcome of the CodeBreak 100 clinical trial program.

Of the 2.2 million new lung cancer cases diagnosed each year globally, about 84% are of the NSCLC type.

"KRAS has challenged cancer researchers for more than 40 years with many deeming it as 'undruggable'," said Amgen's head of research and development, David Reese.

Amgen described its work on Lumakras as a race against cancer, noting that its team and clinical investigators managed to bring this new treatment to patients in less than three years. The company has sought regulatory approval for the drug in many other jurisdictions outside the U.S. including Canada, Japan, Australia, the U.K., and the E.U.

Amgen plans to host a conference call on June 1 with the investment community to discuss the FDA approval of Lumakras for NSCLC treatment. The company is continuing to study Lumakras as a potential treatment for other cancers. (See Amgen stock analysis on TipRanks)

Piper Sandler analyst Christopher Raymond noted that Lumakras secured early FDA approval. Raymond reiterated a Buy rating on Amgen stock with a price target of $255, which implies 7.17% upside potential. The analyst will wait for details about the drug's launch plan at the June 1 conference before making any adjustments to his estimates.

“The drug's label looks about as expected, but the price of $17,900 per month is a bit lower than we had anticipated,” said Raymond.

Consensus among analysts on Wall Street is a Moderate Buy based on 8 Buy, 9 Hold, and 2 Sell ratings. The average analyst price target of $244 implies 2.55% upside potential to the current price.

AMGN scores a 9 out of 10 on TipRanks’ Smart Score rating system, indicating the stock is likely to outperform the market.

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