Mirati Therapeutics was already a few quarters behind Amgen in the KRAS race after the May 2021 Lumakras approval. Now, the biotech could be 19 months behind Amgen in getting its non-small cell lung cancer (NSCLC) drug approved.
The FDA said it will make a decision on Mirati's adagrasib Dec. 14, but that's not a hard and fast date, as we know from the Lumakras decision, which came 12 weeks early last year.
It's a blow to Mirati, which expected a green light in the second quarter, CEO David Meek said at the annual J.P. Morgan Healthcare Conference in January. It also appears to be a blow to investors, who brought Mirati's shares below $100 for the first time since June 2020.
Shares dipped about 11% to $95.30 apiece in premarket trading.
The FDA indicated it doesn't intend to hold an advisory committee meeting ahead of its decision, Mirati said. "We are confident the adagrasib NDA is approvable," a company spokesperson said in an emailed statement.
The company brought the drug to the FDA's doorsteps in the last weeks of 2021, just months after Meek joined as CEO in September and quickly cleared out key C-suite positions, including medical leader Joseph Leveque, M.D., and operating chief Daniel Faga.
It wasn't immediately clear whether the FDA's decision date was pushed back to later in the year because Lumakras has already been approved. SVB Leerink analysts think that scenario is "highly unlikely" given adagrasib's accelerated approval tag and the fact the confirmatory study has yet to wrap up.
"Equally plausible, in our view, is the possibility that the agency has a backlog of reviews exiting the pandemic and has decided to take a more conservative approach to review timelines versus missing deadlines," the analysts wrote in a note.
Amgen could be "further entrenched as a first-mover," but in the end, the decision date is only a few months later than anticipated, so the impact is likely to be "marginal," the analysts stated.
Furthermore, the analysts noted, adagrasib can potentially have an advantage over Lumakras in first-line NSCLC in combination with Keytruda, in metastatic colorectal cancer and in pancreatic cancer.
Perhaps that goes to what Meek hinted at during his JPM presentation in saying, "adagrasib is going to be a very big drug for a very long time."