$AMAM:
red to green today:
company is not going to pass up the opportunity to get this to fast track approval given the critical need of this drug.
FDA is flexible with critical need cancer drugs that have such a strong profile:
With investors reacting the way they did, it’s safe to say they were impressed with the results; considering how big the breast cancer market is, the drug’s potential has caused a bit of a stir.
Cowen analyst Phil Nadeau also likes what he’s seeing here, noting: "ARX-788 continues to have a good safety profile with no AEs leading to discontinuation or drug-related SAEs. Our consultants have called ARX788's activity in HER2 pretreated patients 'robust' and think that its activity in Enhertu and Kadcyla failures in particular is likely to ensure ARX788 a place in the treatment paradigm."
It should be noted, the results are preliminary and that it is still a mid-stage trial and further Phase 3 testing will be required, although given the strong results, the company might decide to try and fast-track this drug to approval.
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