HomeMarket NewsFDA Concerns with Amgen May Impact Mirati Therapeutics, says Jones Research

FDA Concerns with Amgen May Impact Mirati Therapeutics, says Jones Research

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Iryna Drozd

The FDA’s concerns over Amgen’s confirmatory study for its KRAS drug Lumakras may have implications for Mirati Therapeutics (NASDAQ:MRTX), according to Jones Research. As Mirati prepares to release Phase 3 topline results for its own KRAS drug, it will need to address the FDA’s concerns raised in a recently released document ahead of an advisory committee meeting on Lumakras. The document revealed a clear negative sentiment and highlighted potential biases in the Phase 3 study for Lumakras.

Jones Research analysts wrote, “We believe the advisory committee meeting could negatively impact Lumakras’ confirmatory approval, which could be a positive readthrough for MRTX in the short term. However, in the long term, Mirati would have to consider the FDA’s concerns before announcing their Phase topline results, expected in 2024.” The research group also noted that Amgen’s Lumakras has a PDUFA date of December 24, when the FDA is expected to decide on full approval.

Jones Research holds a buy rating on Mirati with a price target of $47.

Earlier briefing materials released for the advisory committee meeting on Lumakras indicated the FDA reviewers’ concerns about the study’s support for full approval.

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