Here is STAT’s Biotech Scorecard, our regular ledger of stock-moving biotech events, for the fourth quarter.
After months spent drafting comfortably in Amgen’s KRAS-blocking wake, the time has finally come for Mirati Therapeutics to show its own work. Up until now, Amgen has done all the heavy lifting when it comes to showcasing clinical data on drugs targeting KRAS, the buzzy cancer protein once thought to be “undruggable” because of its spherical structure. Does Mirati have a better KRAS-blocking drug, or not? The first opportunity to compare the rival KRAS drugs comes on Oct. 28, when Mirati is expected to present its first clinical data at a cancer conference.
The Food and Drug Administration advisory panel scheduled to review expanded use of the Amarin heart drug Vascepa is Nov. 14. As a reminder, this is the advisory panel that Amarin thought would be unnecessary for its fish oil-derived product — until the FDA decided otherwise. Circle Nov. 12 on your calendar. That’s when the FDA will post its internal medical review of Vascepa along with the questions and issues it wants the panel’s outside experts to consider two days later. The FDA’s deadline to decide on an expansion of the Vascepa label is Dec. 28.
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