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Amgen Drops; FDA Urges Post-Marketing Study for Drug Candidate

Amgen will test whether a lower dose of its Lumakras cancer-drug candidate works better for patients than the dose it has been studying.
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Amgen  (AMGN) - Get Amgen Inc. Report dropped Wednesday after the biotech giant said the the U.S. Food and Drug Administration proposed that it conduct a post-marketing study for Lumakras, a candidate drug to treat non-small-cell lung cancer. 

The FDA wants to compare the safety and efficacy of the once-daily treatment with Lumakras, generically sotorasib, versus a lower daily dose of the drug. 

Amgen agreed with the FDA's suggestion and now expects results from the study in late 2022. The Thousand Oaks, Calif., company does not expect the move to affect the timelines of the agency's ongoing priority review of the drug. 

Amgen shares at last check were down 7.6% to $235.79. 

Baird analysts rate Amgen underperform. They called the Lumakras update "kind of odd," according to Bloomberg.

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"Shifting combo study timelines and a decision to start exploring a dose that is one-quarter the dose that is the basis of the [new-drug application] submission makes up feel like something is off," analyst Brian Skorney said. 

"We do expect investors to walk away from the call a bit more skeptical about what is going on behind the scenes in Amgen's KRAS program, which could weigh on the stock." 

Amgen says Lumakras, taken by mouth, is a small-molecule KRASG12C inhibitor that treats patients with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer.

J.P. Morgan's Cory Kasimov said "there was a fair amount of confusion on the call" related to Lumakras. 

"While it appears that we will get some data at [the American Society of Clinical Oncology], the key updates are likely skewed to second-half 2021 and 2022," Kasimov said. 

Cowen's Yaron Werber says that the delay "likely signals tolerability issues," while also saying that he expects the drug to win approval, "but all eyes are now on combo data."